4 Take Home Points from Ascend 2017

WebPT’s 4th annual Ascend Conference took place in Washington, D.C. the weekend of September 29th. Rehab therapists from around the world attended business discussions on increasing revenue, outcomes, payment reform, Medicare audits, healthcare, and much more. There was SO much to learn over two full days. If you didn’t get a chance to attend, you can still benefit from the great material presented! Check out my main take away points below!

Be where your feet are

Whether you’re at home, work, lunch, or meeting someone for the first time, give him or her your utmost attention. We live in a world where distractions are everywhere. It’s not uncommon today to see two people dining together while staring at their phones instead of engaging in each other. This breaks my heart.

Alan Stein Jr.

Alan Stein Jr. hit this point home during the keynote address day 1 at WebPT’s Ascend Event. He emphasized giving everyone in your life your full attention while focusing on the things and people that make you the happiest throughout your day. It’s so easy to lose sight of what we cherish most in life. I challenge you to put your phone down, worry less, listen more, and be where your feet are.

 

Outcomes, outcomes, outcomes

Healthcare, as we know it today, is changing. We’re moving from a fee-for-service system to a value-based care system. So what does that mean? Currently, clinics get paid based off of the services they provide. $100 for an eval, $10 for a modality, whatever it may be. By 2019 this could be something of the past for Medicare payment. The Merit-Based Payment System or MIPS will provide payment based on quality and performance in the clinic. How can that be measured? OUTCOMES. MIPS will account for plus or minus 9% of your Medicare payments. Losing 9% for low performance on outcomes is a BIG deal. Check out my interview on the matter with CEO of WebPT, Nancy Ham. How can you lessen the stress of the payment reform? Prepare.

Prepare for Payment Reform

Discussing Payment Reform

Start now by using data-driven outcomes. Measure not only outcomes but also patient satisfaction. One of the biggest questions during the discussion on outcomes was, “What about non-compliance?” It’s not always easy to have a patient complete their plan of care and that can lead to loss of success with outcomes. Practice owners Mike Mundry and Mike Manzo gave great advice on how to increase participation in patient-reported outcome measures. When determining patient satisfaction, consider emailing the report straight from the clinician. Patients are more likely to open and respond when they know it came straight from their provider. Why not give a paper report in the clinic? This can skew results. If a clinician hands you a satisfaction survey and stands over you smiling would you be honest with your report? I’d feel pretty pressured. Accuracy is key.

What about those patients who never show up for a formal discharge? This is tricky. Try contacting the patient through multiple routes. Give a phone call and ask them to come in for one more visit and a new HEP, email the outcome directly, consider mailing the outcome to patients who might not use the computer as often. Start practicing these measures now and determine your faults and successes before the payment reform begins. Refine your skills, try different outcome measures, find what works best for you now so you don’t have to panic later when change comes.

CPT Codes are important

As you know, new CPT codes came out this year. CMS projected that initial evaluation complexity codes would add up to 25% low complexity, 50% moderate complexity, and 25% high complexity. WebPT researched their data from the first 6 months of the year to see if those projections are in alignment with what we’re seeing in the clinic. Guess what? They’re not. After collecting over 500,000 initial evaluation CPT codes reported, WebPT determined the rehab industry is actually submitting around 45% low complexity, 45% moderate complexity, and only 10% high complexity. What does this mean? As of right now, these complexities don’t reimburse differently, BUT one day they could.

Rick Gawenda, PT emphasized the importance of choosing the correct CPT code for your evaluation. Professionals need to report accurately because in the future each code could come with a dollar amount. Let’s say you’re choosing the low complexity CPT code for every evaluation because, right now, it doesn’t affect how much you’re getting paid. Then, CMS comes out and decides to pay a certain percentage more for high complexity and less for low complexity. If you start increasing your evaluation codes to higher complexities compared to what was first projected, you could be looking at a Medicare audit. Learn the identifiers for each complexity, choose accurately, avoid the audit.

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Check out the Talus Media Talks interview with Nancy Ham, CEO of WebPT:

Whiplash: JOSPT Special Issues Highlight the Challenges Facing Clinicians, Patients

The Journal of Orthopedic and Sports Physical Therapy (JOSPT) recently released a special issue on the topic of whiplash-associated disorders (WAD). This July 2017 publication followed up on the October 2016 issue, both with guest editors Dr. James Elliot, an associate professor at Northwestern University, and Dr. Dave Walton, an associate professor at the University of Ontario. This rare opportunity to have outside editors underscores the challenge that not only clinicians are facing when treating WAD, but the imperative need that patients with WAD struggle with on a daily basis. From an overarching perspective, the special issues highlight that WAD is not simply an orthopedic condition, yet one that encapsulates the physical, social, and cognitive aspects of the patient at hand, which works to complicate the treatment approach further.

Whiplash-associated disorders are common neck injuries, most often seen in motor vehicle accidents. In Europe and North America, WAD is seen in 300 per 100,000 individuals in an emergency room setting.1 The annual cost of personal injury claims in the United States alone is estimated to be around $230 billion.1 In addition, consistent international data suggests that approximately 50% of those who sustain a whiplash injury will actually not recover and continue to report ongoing pain and associated disability one year after the injury.1 This low rate of improvement underscores the idea that whiplash has other psychosocial components. A 2014 article in the Journal of Physiotherapy discuss that of those who have sustained a whiplash injury, many concurrently are affected by mental health concerns, as well. 25% of those with WAD have post-traumatic stress disorder, 31% have a “major depressive episode,” and 20% have generalized anxiety disorder.1 This combined psychiatric involvement leads to poorer outcomes, secondary to the elevated levels of disability, chronic pain, and physical activity that these patients have.

Talus Media’s Eric Robertson had the opportunity to interview Elliot and Walton recently to discuss the special issues, as well as the current landscape of WAD in a physical therapy setting. The conversation discussed many components of WAD, including the approach that clinicians take when treating patients. Elliot stated that:

“Considering whiplash as a homogenous type condition and treating it as a homogenous condition is really at the crux of really why we haven’t seen fantastic results of management strategies.”

The two also argued that therapists should not be looking at whiplash from a biomechanical or tissue-focused perspective, “It might be more valuable to take an approach that moves away from the tissue at fault, because so far that has proven to be a fool’s game, and move more toward the question of ‘what is the likelihood the patient is going to get better.'” Elliot and Walton did, however, state that they do believe there may be the involvement of some specific tissues in the body. “We do have some fairly compelling evidence that it looks like in some discrete number of people with chronic problems that their white matter in their cord may have been damaged or certainly involved in some of these changes in muscle structure and function.”

The two JOSPT special issues are available online from both October 2016 and July 2017. In addition, the full interview with Dr. Elliot and Dr. Walton is available on Talus Media Talks. What is your experience in treating WAD? Do you feel as if there is something missing in the treatment of these patients? Let us know what you think on our Facebook page.

 

References:

  1. Sterling M. Physiotherapy management of whiplash-associated disorders (WAD). J Physiother. 2014; 60(1):5-12.

Photo by Vladlane Vadek

Where #GetPT1st Doesn’t Work: The Bottom Line

Paths to Recovery
Used with permission from The Wall Street Journal, WSJ.com. Copyright 2007 Dow Jones & Company, Inc. All rights reserved.

This year marks this image’s 10th birthday. It has been shared, tweeted, and promoted (without proper citation) with reckless abandonment by the physical therapy profession as how things should be. #GetPT1st. It works. We make health care cheaper!

The image is not a bad one. In fact, on the surface it looks quite positive! However, there’s more to it. What we have done is innately human; we have taken the bit of the picture that validates our argument and magnified it to justify our own means, ignoring the overriding argument. This doesn’t mean we’re horrible people, it just means there’s a bigger story. And that story, unfortunately, is the key to why this model has failed to change healthcare as we know it. The image, often credited to the well-known Virginia Mason Study, was actually compiled by the Wall Street Journal and published in a 2007 article: A Novel Plan Helps Hospital Wean Itself Off Pricey Tests.

For those unfamiliar with the Virginia Mason Study, it goes something like this (the full text is available here):

The Virginia Mason Medical Center in Seattle was losing money in 1998. To reduce waste and inefficiency within the system, they started streamlining, using the “lean” methodology of the Toyota Production System. Two years after they implemented the “Virginia Mason Production System,” several Seattle-based employers and their health plans (i.e. major payers such as Aetna) came to Virginia Mason with a complaint: The payer was paying more for care at Virginia Mason than any other health system in the Seattle area.

Thus began what is now referred to as the “marketplace collaborative.” And this is what we all want to hear. Virginia Mason executives sat down with payers & employers to identify their priority areas, as well as develop clinical value streams that enhanced value while cutting out inefficiencies and increasing value to the patient. These value streams helped to standardize care, considering the most efficient way to accomplish a goal, as well as the best evidence-based practice. The low back pain value stream is what the image in question depicts.

The end result? Decreased use of imaging, better patient satisfaction rates, more rapid return to function, and decreased costs. Employers were happy, because they saved money. Patients were happy, because who doesn’t love getting better faster?

So obviously, this is fantastic. Our patients are getting better, evidence-based care, with less unnecessary imaging and quicker return to function.

But it hasn’t been implemented nationally. The answer to the inevitable “Why not?” lies in the WSJ article:

Because Virginia Mason Medical Center lost money.

In fact, not only did the not-for-profit lose money, it was in the red. The much-lauded image (which maybe garners 1-2 lines of actual text in the story) is embedded in an ode to the health care system in the United States. Health care is not incentivized based on patient satisfaction. It’s based on fee-for-service. That means that more service means more money, whether that service is needed or not. And the kicker? Less expensive services, such as therapy, do not garner high reimbursement rates. So, where Virginia Mason used to make $100 on every case that passed through their spine clinic, they were now seeing losses of $200 on every case.

“With each MRI that Aetna and the employers avoided at around $850, Virginia Mason lost about $450 in profit.”

–Fuhrmans, 2007

There are several major points the article makes:

  1. Employers and payers brought about change in the system.

Virginia Mason’s incentive to change their system actually came from their payers saying “You cost too much.” In business, money talks. Health care is a business.

  1. Payers care about cost. Providers care about patient satisfaction.

The article details the initial sit down with Virginia Mason executives, Aetna, and major employers, including Starbucks. In short, chaos erupted when Virginia Mason stated that patients were their most important customers, because guess who’s writing the bulk of the check? Providers, including physicians, were not concerned about cost; they were concerned about quality patient care.

  1. It’s a gamble: payers must be willing to pay more for less costly treatments.

To make this system work, Virginia Mason went to Annette King, Starbucks’ benefits director, and told her the model, while it saved Starbucks & Aetna money, was not sustainable for the medical center. She, in turn, went to Aetna to negotiate higher reimbursement rates on therapy. Virginia Mason broke even. When the article was written in 2007, Aetna was the only payer that had agreed to do this.

The key in this picture isn’t patients. Patients, actually, weren’t involved in negotiating any part of the Virginia Mason study. They benefitted. But it was the employers and payers who made the system sustainable.

So, does #GetPT1st work like we show in this image? No, it’s not that simple (though I wish it was). Direct access is a beautiful thing, and there is merit in marketing our profession to the masses, because we can cultivate a base of support. Improving health literacy so that patients are making educated decisions about their care and advocate for improved access is incredibly valuable. Increasing our visibility and letting people know we exist is a piece of the puzzle. But the Virginia Mason study, or rather its failure to proliferate, teaches us that what it comes down to is the bottom line. Unfortunately, in the current health care system, getting PT 1st is not sustainable. Creating sustainability for this dream system requires a coordinated effort that cuts inefficiency through provider education and streamlining of best practices while simultaneously convincing payers to reimburse less expensive treatments at a higher rate. Clap if you believe in fairies.

The true heroes of the PT world are the policy and payment specialists, because we must get paid. Not just to pay rent, but to make our services a viable option for health care systems to utilize.

Continue to support consumer facing movements such as #GetPT1st and #ChoosePT, because it is a piece of the bigger picture, and hey, it’s easy. But you must understand that if you are not simultaneously engaged in advocacy and payment reform, you have missed the entire point.

References

Blackmore, C. C., Mecklenburg, R. S., & Kaplan, G. S. (2011). At Virginia Mason, collaboration among providers, employers, and health plans to transform care cut costs and improved quality. Health Affairs30(9), 1680-1687.

Fuhrmans, V. (2007, January 12). A Novel Plan Helps Hospital Wean Itself Off Pricey Tests. Wall Street Journal. Retrieved from http://www.wsj.com/articles/SB116857143155174786

Dr. Manual Therapy, Or How I Came to Stop Worrying and Love the Placebo

With a central theme based on cinema, and a message potentially confused as a doomsday device for manual therapy, Dr. Joel Bialosky’s (along with Drs. Bishop and Penza) latest commentary in JOSPT, “Placebo Mechanisms of Manual Therapy, A Sheep in Wolf’s Clothing?” certainly deserves a Dr. Strangelove derivative title. But, is it really doomsday for manual therapy?

The fascinating thing about this must-read paper is the re-framing of placebo as a negative, non-specific sequitur of bad outcomes, to one of a specific, powerful, and necessary aspect of many interventions. To me, this is perhaps the key to how there can be so many different schools of manual therapy, and passionate adherence to each, and despite vastly different application, the apparent effectiveness of each. It’s as if we are all using different codes to access the same central computer, only to perform the same essential task.

The authors of this commentary leave us with a warning:

“Manual therapists, having invested large amounts of time perfecting their craft, may be troubled by the prospect of placebo as a primary mechanism.” Bialosky, Bishop, and Penza

I too, would like to issue a warning:

“The anti-manual crowd of therapists should also be careful to not mis-interpret the data around placebos by mistakenly believing this science is justification to not perform manual therapy.” Robertson

In a perfect world, the two groups would equally understand that specific active mechanisms of analgesia through physical therapy remain elusive despite the overall effectiveness of said treatment. Indeed, if we could work to understand the critical factors needed that result in a positive outcome for patients, perhaps we would be more effective at applying them, and less judgmental of people using a different coding set to access the “computer.”

Yet I wonder, what would happen to those practitioners stripped of their passion to defend their specific approach? Maybe that is the real doomsday device!

 

What are the Issues with Therapeutic or Trigger Point Dry Needling? 9 Considerations to Ponder

Dry needling continues to garner increasing popularity within physical therapy. And, the focus is not just clinical, a pubmed search for “physical therapy” and “dry needling” illustrates an 8 fold increase of manuscripts from 2010 to 2015 (66) compared to 2000 to 2005 (8).1,2

The number of continuing education courses, certifications, and companies offering dry needling continues to rapidly expand. Further, there appears to be no shortage of anecdotal reports of the remarkable “power” of this intervention and clinical experiences suggesting it’s “the next big thing.” But, I have some questions, and justified concerns regarding the outpatient orthopaedic physical therapist’s most invasive intervention. Larry Benz has commented “trigger point dry needling is not #physicaltherapy.”3

Yes, while there is a paucity of evidence, TDN probably works in some instances-likely more to “meaning effect” and placebo than anything else (which of course is fine but in states with informed consent forms it probably works as a  nocebo).  My concern is the nocebo effect of TDN on our profession.

The irrational exuberance around TDN within the #physicaltherapy profession is ironic if not downright damaging.  We fight and defend for direct access, expanded scopes of practice, evidence as the core basis of our interventions, and being recognized in the healthcare chain as force multipliers within the musculoskeletal world yet state legislators in many states are hearing PT’s fight for the right to stick needles into patients. TDN is hardly a transformative intervention and regardless it does not define #physicaltherapy.

Like Larry, I am concerned and request that we as a profession take a moment to appraise this intervention, in terms of applicable clinical evidence and appropriate critical reasoning, before enthusiastically implementing dry needling, let alone recommending it to patients in professional publications.4 Further, the issues and assessments are not limited to dry needling specifically, as the approach can be applied to other interventions and concepts such as cupping.

Clinicians utilizing dry needling will exclaim “dry needling is not acupuncture!”, but the paradox is proponents continue to use acupuncture“evidence” (of both traditional Chinese medicine and biomedical flavors) to supposedly support their practice. Obviously, dry needling is not actually acupuncture. I’m not sure it even bears repeating that rarely is dry needling the sole intervention provided by a physical therapist. But, given the invasive nature and significant learning cost, in terms of both time and money, the addition of dry needling to a treatment plan as either an additive intervention or in replacement of other interventions, seems suspect without research supporting significant improvement in outcomes.5 And, this improvement should be specific to needling itself, not the byproduct of other non-specific mechanisms. Or, alternatively, needling must illustrate some measurable, or even highly plausible, physiologic effect known to improve a patient’s condition, main complaint, or medical diagnosis.

What issues with dry needling should be considered?

1) Acupuncture Literature Applies
2) Dry Needling Research is Underwhelming and Misrepresented
3) Poor Terminology Surrounding Needling, Trigger Points, and Myofascial Pain
4) Lessons from the Evolution of Manual Therapy: Manipulation
5) Treatment Targets and Proposed Mechanisms
6) Insights from the Study of Pain
7) Risk vs. Benefit and Invasiveness
8) Cost and Time
9) Bias in Research Interpretation and Conflicts of Interest

The Acupuncture Literature Applies

I contend that the acupuncture literature can provide us with some insights on the specific effects of inserting a needle into human flesh, be they physiologic, psychologic, perceptual, or otherwise.6 Of course, this is dependent on the assumption that any specific meaningful effects exist beyond transient, clinically irrelevant short term improvements in symptoms and subjective reports likely mediated by meaning response, expectation, context, non-specific effects, and placebo.7

In short, it is unambiguously clear from high quality investigations, systematic reviews, and meta analyses that acupuncture is nothing more than a “theatrical placebo.8 The research illustrates:

  • Poorly designed smaller studies with high risk for bias showing promising results
  • Larger, well controlled studies show no meaningful clinical benefit
  • Needling location doesn’t matter
  • Needle depth doesn’t matter
  • Skin penetration doesn’t matter18
  • The needle doesn’t even matter, toothpicks work just as well

Interestingly, similar to potential mechanisms in manual therapy what does appear to modulate, or predict, small observed outcomes in select patients is expectation, patient beliefs, and individual practitioner factors among others.7,9-14 Specifically,

The individual practitioner and the patient’s belief had a significant effect on outcome. The 2 placebos were equally as effective and credible as acupuncture. Needle and non-needle placebos are equivalent. An unknown characteristic of the treating practitioner predicts outcome, as does the patient’s belief (independently). Beliefs about treatment veracity shape how patients self-report outcome, complicating and confounding study interpretation.

Whether studied as a means to move qi along meridians or under a more western and biomedical informed lens, acupuncture has consistently failed to show that is an effective treatment.15 Such results should not only give us pause regarding the recommendation of acupuncture to patients for the treatment of various painful problems, but should also raise serious questions regarding the enthusiastic implementation of dry needling into physical therapist practice, clinical research agendas, and post professional education.

If needle insertion, needle location, needle depth, or even using a toothpick do not seem to affect outcomes in acupuncture, I’m perplexed by those who propose dry needling is somehow, in some way profoundly physiologically different.16-18 And furthermore, how anyone can subsequently claim dry needling location, depth of penetration, and other specific factors relating to application technique can robustly impart some important physiologic effect or meaningfully impact on clinical outcomes. Physical therapists should likely temper claims of mechanistic specificity, or effect, and be cautious in citing acupuncture literature to support the practice of dry needling.

Dry Needling Research is Underwhelming and Misrepresented

Many will claim the research around dry needling is growing, and promising results suggest broad applicability. Oddly, some will state that dry needling is not acupuncture and in the next breath cite flawed, or misinterpreted, acupuncture literature as a seemingly evidence base plea for the usefulness of dry needling. While the volume of manuscripts relating to dry needling continues to rise, the actual trial data is underwhelming at best, if not outright negative. Yet, articles in professional magazines, clinical perspectives, and (flawed) systematic reviews positively frame the intervention as effective.19-21 These assertions may mislead casual readers to conclude the data supporting dry needling is quite strong. This is not the case. Harvie, O’Connell, and Moseley at Body in Mind conclude:22

We contend that a far more parsimonious interpretation…is that dry needling is not convincingly superior to sham/control conditions and possibly worse than comparative interventions. At best, the effectiveness of dry needling remains uncertain but, perhaps more likely, dry needling may be ineffective. To base a clinical recommendation for dry needling on such fragile evidence seems rash and risks exposing patients to an unnecessary invasive procedure.

A more recent systematic review effectiveness of trigger point dry needling for multiple body regions concluded “The majority of high-quality studies included in this review show measured benefit from trigger point dry needling for MTrPs in multiple body areas, suggesting broad applicability of trigger point dry needling treatment for multiple muscle groups.”23 Unfortunately, that is not what the trials included indicated as only:

  • 47% showed a statistically significant decrease in pain when compared to sham or alternative treatments
  • 26% displayed a statistically significant decrease in disability
  • 42% did not include a sham or control intervention group
  • 32% investigated only the immediate effects (ranging from immediately post-intervention to 72 hours) of TDN which is a research design with remarkable limitations24
  • 3 assessed the quality of the blinding in the sham group
  • 1 was retracted at request of the journal editor

Specifically, one randomized trial effectiveness of trigger point dry needling for plantar heel pain found a number needed to harm (NNH) of 3 and a number needed to treat (NNT) of 4. So, for every 3 patients treated with needling 1 is likely to develop an adverse event while for every 4 patients treated only 1 is likely achieve a beneficial outcome. Or, in other words, patients in the treatment arm were more likely to experience an adverse event than a beneficial outcome. One of the most commonly reported adverse events, in addition to bruising, was an exacerbation of symptoms, which I will argue is only acceptable if intermediate and long term outcomes of dry needling are somehow superior. An invasive intervention that results in more adverse events, lacks long term benefit, or fails to measurably change an underlying physiologic derangement should likely not be employed. Subsequently, available interventions that are effective, less invasive, and less likely to result in symptom exacerbation such as graded exercise/activity/exposure, cardiopulmonary exercise, pain education/therapeutic neuroscience education, and non-invasive manual therapy should be preferentially implemented.

These are significant and specific concerns that require careful consideration.

Poor Terminology: Trigger Points, Myofascial Pain, and Needles

Unfortunately, dry needling is riddled with poor terminology and vague language. Admittedly, such an issue is not unique to dry needling, and thus this entire post is applicable to many interventions and trends within physical therapy: cupping, scraping the skin with instruments (instrumented assisted soft tissue mobilization), and trendy tools in the proverbial tool box.25,26 But, never the less language is a significant issue as researchers attempt to investigate and understand the intervention in greater depth and clinicians continue to broadly implement it into practice. It’s not just semantics, precision in language is an absolute necessity.28

What are the actual differences between trigger point dry needling, dry needling, therapeutic dry needling, intramuscular manual therapy, functional dry needling, systemic dry needling, integrative dry needling, or any other form of physical therapists poking patients with needles?

Regardless of the clinical trial data (which is actually weak), those utilizing a myofascial trigger point approach to dry needling need to acknowledge the current issues with regards to a lack of consistent criteria defining a trigger point, the questionable clinical importance (if any) of the proposed trigger point construct, and the poor reliability in trigger point identification. There are many foundational issues at the core of the trigger point theory including an absolute lack of established validity. John Quintner upon evaluating trigger points:29,30

The existence of such bands had never been demonstrated and it was therefore highly speculative and erroneous to attribute nerve entrapment to such a mechanism. Other weaknesses in their theory included the somewhat metaphysical concepts of “latent trigger points,” “secondary trigger points,” “satellite trigger points” and even “metastasising trigger points”. To further confuse matters, it was later shown that “experts” in MPS diagnosis could not agree as to the location of or even the presence of individual MTrPs in a given patient. The mind-boggling list of possible causative and perpetuating factors for MTrPs was completely devoid of scientific evidence and therefore lacked credibility…Finally, those who became “dry needlers” appeared to be unaware that when justifying their assault on MTrPs they were following the “like cures like” tenet of homeopathy. In their parlance, physical therapists (including physicians) were obliged to create a lesion in muscle tissue in order to cure (“desensitise”) a lesion (for which there was no pathological evidence)…

…subsequent literature was also notable for its failure to acknowledge that the underlying hypothesis was flawed – no one has ever succeeded in demonstrating nociceptive input from putative myofascial trigger points. All subsequent “research” simply assumed the truth of what started out – and remains – as conjecture.

Also, worth mentioning are the significant issues such as tautological reasoning inherent in not just trigger point theories and hypotheses, but also myofascial pain syndromes and fibromyalgia.30-33 I do agree with the term “Therapeutic Dry Needling.” I contend this language and nomenclature separates the technique from theoretical and mechanistic principles, thereby allowing continued growth and open discussion as the science evolves. In addition, the current terms, and many of the accompanying theories, are not fully encompassing of the state of the literature in regards to trigger points, myofascial pain, pain treatment, and possible treatment mechanisms. Lastly, some further perpetuate specific targets and theories of intervention that are quite frankly unreliable, and worse, invalid. Not to mention, understanding will inevitably change over time. Specifically, precise operational definitions are required for scientific inquiry. Vague language leads to vague reasoning and muddies research results. Geoffrey Maitland is credited with the insight “to speak or write in wrong terms means to think in wrong terms.”

In aggregate there is sufficient reason to not only doubt, but discard, the foundational premises  of trigger points, myofasical pain, and potential “needleable lesions” as clinically meaningful entities and necessary treatment targets.34-35

The Evolution of Manual Therapy: Manipulation

History, some may say, is our greatest teacher. A rearward glance into the evolution of manual therapy practice and mechanisms, specifically manipulation, appears eerily applicable to the current discussion. Specific derangements such as sacral nutations, ESRL, FSRL, sacral flares, leg length discrepancies, static posture position, and subtle biomechanical “faults” supposedly necessitated specifically matched techniques for proper symptom resolution. The minute differences between techniques such as angle, spinal level, specific joint mechanics, and other application factors such as speed were presented as highly important to garnering the proper effect. The tissues were hypothesized to be the primary dysfunction and treatment target. Concepts such as the “manipulatable lesion” were developed.

The paradigm of assessment and treatment attempted to mirror diagnostics in other segments of medicine, a laudable effort to be sure. Clusters of information, in the case of manual therapy the patient’s symptoms, palpable dysfunctions, and malalignments, were supposed to be aggregated into a specific diagnosis. Specific diagnoses warranted specific treatment at a specific dosage or speed or spinal level. Unfortunately, the fatal flaw with this diagnostic approach in manual and physical therapy is the overall lack of essential diagnoses, commonplace in medicine, and the high prevalence of nominal diagnoses.36 Outpatient orthopaedics is primarily characterized by pain complaints, often times absent of significant trauma, tissue injury, or diagnosable physiologic derangements. In a failed attempt to solve such a conundrum, nominal diagnosis or clinical syndromes such as patellafemoral pain syndrome or “pain on the front of the knee mostly when squatting or bending the knee with the foot on the ground” and shoulder impingement syndrome or “pain on the front of the shoulder mostly when raising the arm overhead that sometimes feels like a pinch” were created with the goal of improving the specificity of treatment and our ability to match interventions to patient presentation.

Proposed mechanisms included changing tissue length, loosening joint capsule, breaking adhesions, unsticking stuck joints, and improving tissue related joint mobility. Minute, subtle, questionably detectable, but in actuality irrelevant, biomechanical faults were pitched as the cause of patient symptoms. But, years of research now state otherwise.37

Matching a specific manual therapy technique to a specific, theoretical, but quite frankly imaginary, fault proved not only to be futile, but unnecessary.38 The amount of force provided through the hands lacks the speed, acceleration, and load to meaningful change tissue length and other material properties. Manual therapy techniques were shown to result in movement at many levels of the spine. And, the specific technique utilized didn’t seem to matter much. Overall, technique type, long lever vs. short lever, speed, and exact level of the spine didn’t seem to matter much either. Predictors of response to treatment did not include classical palpation and hands on motion testing. Fear avoidance beliefs and length of symptoms did however. The neurophysiologic mechanisms of manual therapy appeared similar to placebo mechanisms.9 Patient expectation of success was important as was therapeutic alliance.11,39,40 Clinician expectation was correlated with outcome. Framing of the intervention’s potential effects seemed to affect degree of analgesia.41

Manual therapy can now be conceptualized as a neurological input and patient interaction whose overall effect, in both direction and magnitude, appear to be related to host of a complicated interacting factors, most of which have little to do with the specific technique.10

Yet, those teaching and researching dry needling appear to be clearing an old trail. Peripheral derangements, specific techniques, and minute, likely minimally important dysfunctions as a root cause of a patient’s symptoms. Assumptions, in my opinion incorrect ones, are leading us down a long road, which if manual therapy and manipulation research is any indication, will require an even longer journey to reverse.

Treatment Targets & Proposed Mechanisms

In addition to vague language, the currently proposed treatment targets and purported mechanisms of dry needling fail to integrate understanding from the acupuncture literature and compose an incomplete consideration of potential mechanistic factors.

Trigger points, latent trigger points, twitch response, trigger point referral patterns, facilitated segments, neuro-trigger points, micro-tissue trauma, chronic local inflammation healed by needle induced inflammation, and the list goes on. The fact that a dense array of sensory receptors of various types, including nociceptors, exist in nearly every layer of tissue including the cutis and subcutis, suggests it is not only possible, but quite likely that stimulation of these receptors is sufficient to produce the proposed therapeutic benefits. This is anatomically and neurologically true regardless of needle depth. The clinical studies of acupuncture support such a claim as neither needle location nor depth nor skin penetration nor the needle itself appear to specifically contribute to outcomes. The skin contains dense array of free nerve endings, and other receptors. Those who present possible dry needling constructs should acknowledge the current, multi-factorial mechanisms of manual therapy and the various factors contributing to overall treatment responses.

  • Can we ascertain specifically which structures are needled?
  • Is it not likely we are needling a host of structures?
  • Can we ascertain the receptors that are stimulated during needling?
  • Is it not likely we are needling various receptors?
  • Can we actually target specific tissues or receptors?
  • Is targeting specific tissue necessary, or even sufficient, for symptom resolution or a positive clinical outcome?
  • Does specificity in anyway affect outcome?

There are many inherent issues with assuming, let alone presenting, specificity of a treatment target and subsequently proposed mechanism based on test/re-test assessments and clinical observations of benefit. Such an explanatory model assumes the underlying theoretical construct is accurate but also that:

1) The test is specific to that tissue, structure, or defined dysfunction (validity)
2) A positive, or negative, test (or test cluster) is accurately identifying the tissue, structure, or defined dysfunction (reliability, sensitivity and specificity)
3) The subsequent treatment intervention is specific to the identified dysfunctional structure and thus
4) The mechanism of effect specifically relies on treatment target, application, and location
5) Resolution of the symptom and clinical outcome is dependent on the preceding

A test/re-test approach, while clinically appropriate for assessing response to treatment, is inappropriate reasoning as a mechanistic explanatory model. So, we must further explore:

  • What is the premise of this intervention?
  • Is it more efficacious, effective, or efficient than other interventions?
  • Are the models of assessment and treatment plausible? Valid? Reliable?
  • Are there other explanations that may explain the observed effects, and thereby question the necessity of needling?
  • Is this intervention as specific to certain tissues or explanatory models as it is presented?
  • Is needling necessary, or even sufficient, for symptom resolution? Or, a positive outcome?

All approaches to and explanations of dry needling need to incorporate current, multi-factorial mechanisms of manual therapy and various factors contributing to overall treatment responses in pain. Such research would suggest that targets and mechanisms of many of our interventions for pain are not nearly as specific as previously assumed and currently presented. With this this in mind, one should be cautious in making claims of specificity. How can all the other potentially stimulated neuro-vascular structures, contextual factors, patient-practitioner interactions, and various other treatment effects be ruled out, or at least addressed as not only potential contributors to outcomes, but confounders to study results?

Pain Science and Complexity

Pain is now understood as a multifactorial, individualized, lived sensory and emotional experience much more profound than mere peripheral nociceptive signaling. The neurophysiologic, psychologic, environmental, contextual, as well as social factors present in the concept of pain are exceedingly complex. And, that is not inclusive of the profound philosophical and linguistic challenges of defining, studying, understanding, educating, and ultimately interacting with someone in pain. Attempting to accurately reconceptualize pain illustrates:42

 …the biology of pain is never really straightforward, even when it appears to be. It is proposed that understanding what is currently known about the biology of pain requires a reconceptualisation of what pain actually is, and how it serves our livelihood. There are four key points:

(i) that pain does not provide a measure of the state of the tissues;
(ii) that pain is modulated by many factors from across somatic, psychological and social domains;
(iii) that the relationship between pain and the state of the tissues becomes less predictable as pain persists; and
(iv) that pain can be conceptualised as a conscious correlate of the implicit perception that tissue is in danger.

These issues raise conceptual and clinical implications

And thus, it is worth mentioning not only a few of the myriad of factors that contribute to symptom severity, symptom report, and seeking medical treatment, but also the the swarm of interacting constructs that contribute to effect.43

Treatment Mechanisms in Pain
>Non-specific effects
>Placebo
>Nocebo
>Patient Expectation
>Provider Expectation
>Context
>Previous Experience
>Believability of the Intervention
>Psychologic State
>Framing and Language Surrounding the Intervention
>Regression to the Mean
>Naturally History
>and others

Obviously, such factors are not unique to dry needling. They are present in all treatments, especially those for pain. But, given the current understanding of pain stemming from a multitude of varied scientific disciplines, how can we assume, let alone propose, that sticking a human in pain with a fine needle contains sufficient and significant effect to be a primary contributor to relief and positive outcomes in both the short and long term? And, more importantly, why should we? It appears we’ve learned little from decades of research into the nature of pain, the mechanisms of treatment, passive vs. active approaches to care, acupuncture, “wet needling,” and manual therapy. Physical therapists, will rightly so I might add, critique the overuse of “wet needling” (and other interventions) by physicians, yet barely raise but a whimper of protest at the proliferation of dry needling. It may be time to refine our internal, smaller picture to facilitate crossing the chasm.44,45

Risk vs. Benefit and Invasiveness

The invasiveness of dry needling within the scope of physical therapist practice presents a unique and complicated challenge when attempting to assess risk vs. benefit in isolation, risk vs. benefit in comparison to other medical procedures, as well as risk vs. benefit in comparison to other physical therapist delivered interventions. It seems we over simplify, and potentially misunderstand risk versus benefit analysis as it applies specifically to physical therapy interventions. Sure, comparing dry needling adverse event types and rates to other medical interventions is tempting. It is an interesting health services inquiry. And, such an approach does hold some value for comparing intervention risks, benefits, and efficacy within the spectrum of the many possible health care interventions. Arguably, and quite plausibly, dry needling within the confines of a physical therapy treatment plan is safer than early imaging, prolonged NSAID use, delayed physical therapy referral, opiates, and of course spinal surgery. But, it seems to me this particular argument, even if compelling, even if true, is a weak and incomplete justification for needling. Although, please note even acupuncture may not be as safe as assumed.46-48

Comparisons regarding the risk, invasiveness, efficacy, and effectiveness of specific physical therapist delivered interventions are necessary.49 These comparisons are required in general, but also specifically within various conditions, complaints, diagnoses, and patient populations. Given the invasiveness, regardless of risk profile, to justify widespread utilization dry needling must illustrate robust effectiveness (or even significantly more efficacy) in relation to other physical therapist delivered interventions. And, any potential effectiveness must be assessed in the context of possible negative effects such as an exacerbation of symptoms and other more significant adverse events.

On the grounds of efficacy, effectiveness, risk, invasiveness, and potential benefit when compared to our other interventions for pain, I can’t understand an argument that currently justifies dry needling. Physical therapists must not merely claim superiority, or justify interventions, on the tenuous foundation that we are less invasive and less risky than other medical interventions. It’s not quite that simple. Physical therapists must provide the same internal scrutiny to comparing our own interventions in addition to comparing physical therapy interventions to physician practice patterns.44 Further, when taking into account the training cost and time it does not make sense to advocate for this intervention.

Training Cost & Time

An often undiscussed problem with dry needling is both the cost and time required to learn the technique. Currently, all states that allow physical therapists to practice dry needling require further training or even certification. So now, unfortunately, physical therapists are burdened not only with assessing the potential applicability, safety, risk and benefit of the intervention, but also the cost (time and money) required to even be granted permission to practice dry needling. Such a situation is quite acceptable for an intervention with robust effectiveness and broad applicability. But, for a single, questionably effective, invasive intervention this seems unnecessary if not wrong. For clinicians, what knowledge could be gained or other skills developed? For professional organizations, what other legislative challenges could be addressed? Who stands to benefit from such a scenario? Well, most obviously those who sell dry needling courses.

Bias in Research Interpretation and Conflicts of Interest

Similar to manual therapy, an alarming number of studies investigate immediate effects only which regardless of results is likely “much ado about nothing.”24 Many of the manuscripts pertaining to dry needling also contain overstated conclusions or even a misrepresentation of results.

In this regard, it is worth noting that many of those publishing positive systematic reviews, providing anecdotes and patient stories of success, and presenting on the potential favorable impact of dry needling teach or directly financially benefit from the teaching of dry needling.19, 20 For example, Kenny Venere and I observed that the authors of a highly positive viewpoint on acupuncture for knee osteoarthritis that was published in PT in Motion not only teach dry needling continuing education courses, but also offer a certification in dry needling.15,50 Oddly, this section and the subsequent statements were edited out of the final printed version of our letter. In any case, one of the authors is the “President of the Spinal Manipulation Institute and Dry Needling Institute of the American Academy of Manipulative Therapy” which offers a postgraduate diploma (which I’ve been openly critical regarding the name).51 The diploma is described as such:

an evidence-based post-graduate training program in the use of high-velocity low-amplitude thrust manipulation and dry needling for the diagnosis and treatment of neuromusculoskeletal conditions of the spine and extremities.

Now, other individuals and companies in the dry needling post-professional education business are all also at risk of being significantly influenced by financial incentives. For example, a program director for another dry needling continuing education company, continues to publish manuscripts defending the construct of myofascial trigger points which are, unsurprisingly, the foundation of their approach to dry needling.51 I’m sure many will contend I’ve unfairly singled out these individuals. But, I am by no means insinuating those financially vested in the dry needling continuing education business are insincere or intentionally misrepresenting trial data.

I do however wish to highlight the potential for interpretation bias of research evidence when significant (or even potential) conflicts of interest and financial incentives are present. Chad Cook, PT, PhD referring to manual therapy research poignantly states don’t always believe what you read:53

…there have been a number of manual therapy studies that were designed by clinicians who have a personal interest in the success of one intervention over another. These clinicians have either a vested interest in the applications that are part of the interventional model because they provide instruction of these techniques in continuing education courses in which they profit from (although it may seem minimal, it is not); or because the tools are part of a philosophical approach or a decision tool that was designed from their efforts or efforts from those they were affiliated with. In nearly all cases, the bias is not intentional and certainly not malicious…

I am concerned that new clinicians, passionate followers of selected manual therapy approaches, and in some occasions, seasoned clinicians, will be mislead because they lack expansive/formal research training with respect to study methodology. Certainly, once information is advocated within the clinical population, it takes years to diffuse its use, even after acknowledgement of its erroneous findings.

Dr. Cook’s concerns, which I urge you to consider, relate intimately to the surge in dry needling literature and clinical application. In physical therapy research the impact of potential conflict of interest and resulting bias of researchers also highly involved in continuing education companies is in a word: unknown. But, it is quite obvious that there is a potential conflict of interest and subconscious bias present for individuals who directly financially benefit from teaching a specific technique, or approach. And, this issue transcends dry needling. Regardless of intent, there is an incentive for positive conclusions surrounding that particular technique or school of thought. What and where are the incentives? I understand, and openly support, those who identify and ask difficult questions surrounding the possible unidentified conflicts of interest which have historically been neither discussed nor disclosed. It absolutely requires consideration. More disclosure within academia and the research literature regarding business relationships and continuing education ties is warranted.

In designing, or interpreting research conscientious checks and balances, for example blinding and proper study methods, must be executed. My sense is that it would be profoundly difficult to conclude an intervention is minimally effective, or even unnecessary, after designing, teaching, and selling courses founded upon the apparent diagnostic power and treatment effectiveness of a single intervention or specific treatment paradigm.

Summary & Conclusion

Unfortunately, I sense that dry needling is the new manipulation, which to be clear is not a compliment nor an endorsement. The intervention is not going away, and precious research dollars, cognitive space, and professional resources will undoubtedly be devoted in attempts to “prove it works” (or even “how does it work?”) which is in direct contrast to the true scientific method which is founded upon falsifiability, or “prove yourself wrong” (or even “does it even work?).

But, in getting to the point, the terminology is poor, the constructs questionable, and the current research underwhelming. Acupuncture literature suggests effects are small and non-specific to needling, and the current dry needling data demonstrates the same pitfalls in both design and interpretation. Note this is our most invasive intervention for pain, and it is technically quite passive. Additionally, many of the theoretical constructs and clinical explanations are myopic, vague, and appear invalid. Assessing risk vs. benefit of the intervention in isolation, and in comparison to other physical therapist delivered interventions, is an important, under discussed complexity of implementing needling into practice. Significant potential conflicts of interest and bias are present in the literature. As if that wasn’t enough, the time and cost to learn this intervention are astounding.

Yet, positive clinician experiences, professional publications, and overly optimistic reviews continue to escalate. Jason Silvernail, DPT, DSc, FAAOMPT asserts:

We should all – every one of us – be nothing but disturbed by our colleagues’ use of emotional anecdotes. I look forward to the day when mentioning an anecdote automatically makes our students shake their heads and turn away…Highly recommend people look into MJ Simmonds’ work on intolerance of uncertainty in our profession and how that anchors practitioners beliefs into concrete and wrong explanatory models loaded with nocebo and external loci of control.

Given the discussed issues, and likely others, the current unbridled enthusiasm and growing popularity of dry needling seems unwarranted, if not a mistake. I urge physical therapists, educators, clinicians, researchers, students, and professional leaders to re-consider.

History, it appears, has taught us little in this regard.

References & Resources

1. Pub Med Search. "Physical Therapy AND "Dry Needling" 2010-2015. Performed August 3, 2015

2. Pub Med Search. "Physical Therapy" AND "Dry Needling" 2000-2005. Performed August 3, 2015

3. Benz L. Trigger Point Dry Needling is Not #PhysicalTherapy. Evidence in Motion Blog. March 2014

 4. JOSPT perspectives for patients. Painful and Tender Muscles: Dry Needling Can Reduce Myofascial Pain Related to Trigger Points. J Orthop Sports Phys Ther. 2013;43(9):635

 5. Ridgeway K. Measuring Outcomes, Outcome Measures, and Treatment Effects. Physical Therapy Think Tank. December 13, 2014

 6. O'Connell N, Moseley GL. Acupuncture research – the path least scientific? The Conversation. October 30, 2012

 7. White P, Bishop FL, Prescott P, Scott C, Little P, Lewith G. Practice, practitioner, or placebo? A multifactorial, mixed-methods randomized controlled trial of acupuncture. Pain. 2012 Feb;153(2):455-62

 8. Novella S. Acupuncture Doesn't Work. Science Based Medicine. June 19, 2013

 8. Colquhoun D, Novella SP. Acupuncture is theatrical placeboAnesth Analg. 2013 Jun;116(6):1360-3

 9. Bialosky JE, Bishop MD, George SZ, Robinson ME. Placebo response to manual therapy: something out of nothing? J Man Manip Ther. 2011 Feb;19(1):11-9

 10. Bialosky JE, Bishop MD, Price DD, Robinson ME, George SZ. The mechanisms of manual therapy in the treatment of musculoskeletal pain: a comprehensive modelMan Ther. 2009 Oct;14(5):531-8

 11. Bialosky JE, Bishop MD, Cleland JA. Individual expectation: an overlooked, but pertinent, factor in the treatment of individuals experiencing musculoskeletal painPhys Ther. 2010 Sep;90(9):1345-55

 12. Linde K, Witt CM, Streng A, et al. The impact of patient expectations on outcomes in four randomized controlled trials of acupuncture in patients with chronic painPain. 2007 Apr;128(3):264-71

 13. Kong J1, Kaptchuk TJ, Polich G, et al. An fMRI study on the interaction and dissociation between expectation of pain relief and acupuncture treatmentNeuroimage. 2009 Sep;47(3):1066-76

 14. Bishop FL, Lewith GT. A Review of Psychosocial Predictors of Treatment Outcomes: What Factors Might Determine the Clinical Success of Acupuncture for Pain? J Acupunct Meridian Stud. 2008 Sep;1(1):1-12

 15. Venere K, Ridgeway KJ. Acupuncture Effect Not Clinically Meaningful. PT in Motion. 2015 Aug;7(7):6-7

 16. Chae Y, Lee IS, Jung WM et al. Psychophysical and neurophysiological responses to acupuncture stimulation to incorporated rubber handNeurosci Lett. 2015 Mar 30;591:48-52

 17. Bulley A, Thacker M, Moseley L. Against all reason- effects of acupuncture and TENS delivered to an artificial handPhysiotherapy . 97 Supplement S1

 18. Cherkin DC, Sherman KJ, Avins AL et al. A randomized trial comparing acupuncture, simulated acupuncture, and usual care for chronic low back painArch Intern Med. 2009 May 11;169(9):858-66

 19. Ries E. Dry Needling: Getting to the Point. PT in Motion. 2015;5

 20. Dunning J, Butts R, Mourad F et al. Dry needling: a literature review with implications for clinical practice guidelinesPhys Ther Rev. 2014 Aug; 19(4): 252–265

 21. Kietrys DM, Palombaro KM, Azzaretto E et al. Effectiveness of dry needling for upper-quarter myofascial pain: a systematic review and meta-analysisJ Orthop Sports Phys Ther. 2013 Sep;43(9):620-34

 22. Harvie DS, O'Connell N, Moseley L. Dry needling for myofascial pain. Does the evidence make the grade? Body in Mind. July 4, 2014

 23. Boyles R, Fowler R, Ramsey D, Burrows E. Effectiveness of trigger point dry needling for multiple body regions: a systematic review. J Man Manip Ther. 2015. DOI: http://dx.doi.org/10.1179/2042618615Y.0000000014

 24. Cook C. Immediate effects from manual therapy: much ado about nothing? J Man Manip Ther. 2011 Feb; 19(1): 3–4

 25. Cotchett MP, Munteanu SE, Landorf KB. Effectiveness of trigger point dry needling for plantar heel pain: a randomized controlled trialPhys Ther. 2014 Aug;94(8):1083-94

 26. Brence J. The Tools We Use. Forward Thinking PT. July 29, 2013
 27. Silvernail J. Why I don't like the 'toolbox' concept. SomaSimple. Discussion Lists. February 8, 2015

 28. Ridgeway KJ. Precision in Language. Physical Therapy Think Tank. May 7, 2014

 29. PubMed Search for Author "Quintner JL[Author]."

 30. Quintner J. The trigger point strikes … out!. Body in Mind. January 20, 2015

 31. Quintner JL, Cohen ML. Fibromyalgia falls foul of a fallacy. Lancet. 1999 Mar 27;353(9158):1092-4

 32. Cohen M, Quintner J. The horse is dead: let myofascial pain syndrome rest in peace. Pain Med. 2008 May-Jun;9(4):464-5

 33. Cohen ML, Quintner JL. Fibromyalgia syndrome, a problem of tautology. Lancet. 1993 Oct 9;342(8876):906-9

 34. Quintner JL, Bove GM, Cohen ML. Response to Dommerholt and Gerwin: Did we miss the point? J Bodywork & Move Ther. July 2015;19(3):394–95

 35. Quintner JL, Bove GM, Cohen ML. A critical evaluation of the trigger point phenomenonRheumatology (Oxford). 2015 Mar;54(3):392-9

 36. Dorko B. Incantation. The Clinicians Manual.

 37. Rupiper M. Over at LinkedIn: Reply to The Drama of Manipulation; is it necessary? SomaSimple. Discussion List. April 7, 2013

 38. Ridgeway KJ, Silvernail J. SI Joint Mechanics in Manual Therapy: Relevance, Please? Physical Therapy Think Tank. March 18, 2012

 39. Ferreira PH, Ferreira ML, Maher CG et al. The therapeutic alliance between clinicians and patients predicts outcome in chronic low back painPhys Ther. 2013 Apr;93(4):470-8

 40. Fuentes J, Armijo-Olivo S, Funabashi M et al. Enhanced therapeutic alliance modulates pain intensity and muscle pain sensitivity in patients with chronic low back pain: an experimental controlled studyPhys Ther. 2014 Apr;94(4):477-89

 41. Bialosky JE, Bishop MD, Robinson ME, Barabas JA, George SZ. The influence of expectation on spinal manipulation induced hypoalgesia: an experimental study in normal subjectsBMC Musculoskelet Disord. 2008 Feb 11;9-19

 42. Moseley GL. Reconceptualising Pain According to Modern Pain Science. Physical Therapy Reviews. 2007; 12: 169–178. Accessed via Body in Mind

 43. Taylor AG, Goehler LE, Galper DI et al. Top-Down and Bottom-Up Mechanisms in Mind-Body Medicine: Development of an Integrative Framework for Psychophysiological Research. Explore (NY). 2010 Jan; 6(1): 29

 44. Venere K. The Bigger Picture. Physiological. May 30, 2015

 45. Silvernail J. Crossing the Chasm - Meso to Ecto. SomaSimple. Discussion List. January 19, 2009

 46. Hall H. Acupuncturist’s Unconvincing Attempt at Damage Control. Science Based Medicine. June 21, 2011

 47. Ernst E. New evidence on the risks of acupuncture. Edzard Ernst. October 13, 2014

 48. Ernst E, Lee MS, Choi TY. Acupuncture: does it alleviate pain and are there serious risks? A review of reviews. Pain. 2011 Apr;152(4):755-64

 49. Venere K. Let’s Talk About Efficacy and Effectiveness. Physiological. September 9, 2014

 50. Dunning J, Butts R, Perreault T. The Evidence of Acupuncture. Viewpoints. PT in Motion. April 20105(4)

 51. Ridgeway KJ. Osteopractor™ Not now, not ever. Physical Therapy Think Tank. May 17, 2012

 52. Fernández-de-las-Peñas C, Dommerholt J. Myofascial trigger points: peripheral or central phenomenon? Curr Rheumatol Rep. 2014 Jan;16(1):395

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 54. Silvernail J. Enough is Enough. SomaSimple. Discussion List. December 11, 2010

What Scientific Ideas are Ready for Retirement?

Every year Edge poses a question and subsequently curates responses from a variety of intellectuals. The result is a fascinating compilation of short essays on a range of ideas orbiting around a central theme. Previous questions include “what scientific concept would improve everybody’s toolkit?” and “what is your favorite deep, elegant, or beautiful explanation?

And in 2014, “what scientific idea is ready for retirement?

Science advances by discovering new things and developing new ideas. Few truly new ideas are developed without abandoning old ones first. As theoretical physicist Max Planck (1858-1947) noted, “A new scientific truth does not triumph by convincing its opponents and making them see the light, but rather because its opponents eventually die, and a new generation grows up that is familiar with it.” In other words, science advances by a series of funerals. Why wait that long?

WHAT SCIENTIFIC IDEA IS READY FOR RETIREMENT?

Ideas change, and the times we live in change. Perhaps the biggest change today is the rate of change. What established scientific idea is ready to be moved aside so that science can advance?

Knowing is Half the Battle

by Laurie R. Santos and Tamar Gendler

The lesson of much contemporary research in judgment and decision-making is that knowledge— at least in the form of our consciously accessible representation of a situation—is rarely the central factor controlling our behavior. The real power of online behavioral control comes not from knowledge, but from things like situation selection, habit formation, and emotion regulation. This is a lesson that therapy has taken to heart, but one that “pure science” continues to neglect.

So, in knowing that knowing is not nearly sufficient, what are we to do? Metacognition, reflective experience, and recognition of incentives are components of improving our decision making performance. Studying cognitive bias, behavior change, and philosophical argument also aid critically thinking. Beyond our own personal, and professional, growth these concepts are salient within clinical practice, patient care, research, and education.

Heights And Lengths And Areas Of Rectangles

by Robert Sapolsky

The problem with “a” gene-environment interaction is that there is no gene that does something. It only has a particular effect in a particular environment, and to say that a gene has a consistent effect in every environment is really only to say that it has a consistent effect in all the environments in which it has been studied to date. This has become ever more clear in studies of the genetics of behavior, as there has been increasing appreciation of environmental regulation of epigenetics, transcription factors, splicing factors, and so on. And this is most dramatically pertinent to humans, given the extraordinary range of environments—both natural and culturally constructed—in which we live.

Sapolsky’s essay illustrates complexity and interaction. While simplicity is important, caution is warranted to avoid over generalization. And, of course, do not discount the effect of dependency. Everything depends; on incentives, environment, previous experience, the current situation, and more. Some factors, and influences, likely have not even been identified. This is especially true in the realm of humans and behavior. An interesting book The Dependent Gene: The Fallacy of Nature vs. Nurture is an in depth exploration and refutation of inaccurate understandings of genetics.

Big Data

by Gary Marcus

But science still revolves, most fundamentally, around a search of the laws that describe our universe. And the one thing that Big Data isn’t particularly good at is, well, identifying laws. Big Data is brilliant at detecting correlation; the more robust your data set, the better chance you have of identifying correlations, even complex ones involving multiple variables. But correlation never was causation, and never will be. All the big data in the world by itself won’t tell you whether smoking causes lung cancer. To really understand the relation between smoking and cancer, you need to run experiments, and develop mechanistic understandings of things like carcinogens, oncogenes, and DNA replication. Merely tabulating a massive database of every smoker and nonsmoker in every city in the world, with every detail about when they smoked, where they smoked, how long they lived, and how they died would not, no matter how many terabytes it occupied, be enough to induce all the complex underlying biological machinery.

Physical therapy likely under utilizes big data and available data sets. None the less, big data inherently contains all the methodological issues of any study or data set: sampling bias, reliability, validity, blinding, confounding factors, operational definitions, and control. Remember, garbage in = garbage out. Big data must be put into context, and properly analyzed. What question is being posed? What questions can the data actually answer? And, what are the limitations? Quantity in data is never a direct substitute for quality. As Marcus asserts, “we should stop pretending big data is magic.” Data, after all, is just data, and is nothing without analysis. Analysis, if conducted improperly or with bad assumptions, breads false interpretation.

Mental Illness is Nothing But Brain Illness

by Joel Gold and Ian Gold

That a theory of mental illness should make reference to the world outside the brain is no more surprising than that the theory of cancer has to make reference to cigarette smoke. And yet what is commonplace in cancer research is radical in psychiatry. The time has come to expand the biological model of psychiatric disorder to include the context in which the brain functions. In understanding, preventing and treating mental illness, we will rightly continue to look into the neurons and DNA of the afflicted and unafflicted. To ignore the world around them would be not only bad medicine but bad science.

The direct parallels to physical therapy are striking. Psychological, contextual, and social factors are now recognized as foundational contributions to symptoms, function, intervention mechanisms, and treatment response. How will education, clinical practice, and research evolve to accommodate such insights?

Only “Scientists” Can Do Science

by Kate Mills

However, limiting the potential contributions of informally trained individuals to the roles of data-collector or data-processor discounts the abilities of citizen scientists to inform study design, as well as data analysis and interpretation. Soliciting the opinions of individuals who are participants in scientific studies (e.g., children, patients) can help traditional scientists design ecologically valid and engaging studies. Equally, these populations might have their own scientific questions, or provide new and diverse perspectives to the interpretation of results.

There is a growing need for individuals to occupy the historically ill defined black box between research science/academia and clinical practice. Further, healthcare yearns for clinicians approaching patient care, clinical data collection, and clinical care from a scientific lens. Scientific and clinical research is challenging, time consuming, and expensive. Well trained, highly skilled researchers and scientists a requirement, I won’t argue otherwise. But, interpreting and translating such knowledge into clinical practice is an often under appreciated skill set. And, formal academic or clinical roles devoted to this necessary bridge are sparse. Conversely, formal means of translating clinical practice, clinical data, or even clinical observations into research (or to academia in general) are lacking. Well designed quality improvement projects are a means of fusing clinicians and scientists, clinical care and research. Yet, many clinicians lack the time and expertise to design projects, ensure proper data collection, analyze, and write manuscripts. Despite this clinicians (and academics) must: ask questions, collect data, and collaborate. We all have a role to play in knowledge creation and translation.

Big Effects Have Big Explanations

by Fiery Cushman

There is, of course, an alternative and very plausible source of big effects: Many small explanations interacting. As it happens, this alternative is worse than the wrong tree—it’s a near-hopeless tree. The wrong tree would simply yield a disappointingly small explanation. But the hopeless tree has so many explanations tangled in knotted branches that extraordinary effort is required to obtain any fruit at all…

…the world has large problems that demand ambitious scientific solutions. Yet science can advance only at the rate of its best explanations. Often, the most elegant ones are clothed around effects of modest proportions.

Physical therapy, as a profession, appears to fall victim to the search for big explanations. The factor, the intervention, the mechanism, the tool, the explanation. But, pause and appreciate the complexity of the therapeutic process. It’s complicated, it’s dynamic, and it takes time. Therapy interventions, inherently, must be the result of a multitude of smaller factors interacting, for better and for worse, to produce effect.

Immediately, I’m reminded of the effective philosophical tool of Occam’s Razor. Now, many misquote Occam’s assertion as the simplest explanation should always be favored. But, there is an often missed subtlety to the Razor originally sharpened by William of Occam. The premise is that the hypothesis with the fewest assumptions should gain favor, not necessarily the simplest. Often, the more complicated the hypothesis the more leaps of logic, and thus, the greater the number of assumptions. But, remarkably simple explanations may rely on astounding, and even grossly inaccurate, assumptions. Or worse, may be initially founded upon a false premise upon which all subsequent assumptions are, to some extent, wrong.

The Pursuit of Parsimony

by Jonathan Haidt

Occam’s razor is a great tool when used as originally designed. Unfortunately, many scientists have turned this simple tool into a fetish object. They pursue simple explanations of complex phenomena as though parsimony were an end in itself, rather than a tool to be used in the pursuit of truth.

Don’t make unwarranted, unfounded assumptions. But, be wary also of oversimplification. Simple is nice, but accuracy is better. It’s complicated after all.

The Power of Statistics

by Emanuel Derman

But nowadays the world, and especially the world of the social sciences, is increasingly in love with statistics and data science as a source of knowledge and truth itself. Some people have even claimed that computer-aided statistical analysis of patterns will replace our traditional methods of discovering the truth, not only in the social sciences and medicine, but in the natural sciences too.

I believe we must be careful not to get too enamored of statistics and data science and thereby abandon the classical methods of discovering the great truths about nature (and man is nature too).

Statistics, despite being a field of study, are merely a tool. And, thus are prone to be misused, abused, and misunderstood.

Statistical Significance

by Charles Seife

It was designed to help researchers distinguish a real effect from a statistical fluke, but it has become a quantitative justification for dressing nonsense up in the mantle of respectability. And it’s the single biggest reason that most of the scientific and medical literature isn’t worth the paper it’s written on.

When used correctly, the concept of statistical significance is a measure to rule out the vagaries of chance, nothing more, nothing less…

Nevertheless, even though statisticians warn against the practice, it’s all too common for a one-size-fits-all finding of statistical significance to be taken as a shortcut to determine if an observation is credible—whether a finding is “publishable.” As a consequence, the peer-reviewed literature is littered with statistically significant findings that are irreproducible and implausible, absurd observations with effect sizes orders of magnitude beyond what is even marginally believable.

Beyond the misuse of significance mentioned, the concept of clinical significance is also important. Statistical significant alone can not support clinical significance, or clinically meaningful effect. And, paradoxically, apparent clinically meaningful effects are not sufficient for statistical significance. Partially, this is why research attempts to construct minimally clinical important change (MCIC) or difference (MCID) for certain measures. Although, even this concept is likely elastic. But, at the foundation of the entire issue, is the misunderstanding and misapplication of statistical significance.

Beware of arrogance! Retire nothing!

by Ian McEwan

Every last serious and systematic speculation about the world deserves to be preserved. We need to remember how we got to where we are, and we’d like the future not to retire us. Science should look to literature and maintain a vibrant living history as a monument to ingenuity and persistence.

I’d contend that more than a few ideas within physical therapy are ready, in fact likely over due, for retirement from discussion and clinical care. What are they? And, how do we guide them into the history books and out of our text books? Can we pay our respects to these ideas by identifying the potential mistakes within them? What lessons could be learned without perpetuating artificial relevance and unwarranted influence?

Beyond Weakness & Function: Integrating the Bio-Psycho-Social to Physical Therapy in Critical Illness #ICUrehab #AcutePT

The short and long term sequelae of critical care span body systems and the international classification of function and disability (ICF) framework domains. Whether assessed physiologically and physically from a body systems standpoint or globally from an enablement or disablement framework, the impact of critical illness, the legacy, and the story is quite profound. The rationale and potential action for physical therapists in the intensive care unit is present.

Utilizing the ICF framework, I ponder where to best fit the importance of psychological constructs? Psychology, within the ICF, could be classified as a body function. Yet, psychological understanding is usually applied at the level of the whole person spanning thoughts, emotions, behavior, and perceptions. Potentially a personal factor? But, my sense is such factors are not merely peripheral in rehabilitation. How about social issues? Social factors are inherently a part of the environment, but are also deeply personal.

What’s beyond weakness and beyond function?

Conceptualizing the environment of critical care and a critical illness course requires, at the very least, considering the perspectives of patients, families, and caregivers.  I think it’s helpful to reflect back on your first experience in a hospital, your first time stepping into an intensive care unit. Whether as a student or young professional or even for personal reasons, was this a welcoming environment? I’m not so sure many of us, or the patients we treat would describe it as such. Sure, we, as clinicians, may be comfortable now. That comfort results in part from exposure and understanding. Exposure to the environment, logistics, and processes. Understanding of the lines, treatments, and procedures.

Patients and their families may report quite different experiences and understanding (or lack thereof). The ICU environment provides inputs. Ponder the 5 senses and the inputs (or lack of inputs) likely to occur. The environment of the ICU is not exactly routine and definitely not calming. It is quite foreign and unsettling…

What is touching the patient? Lines on the skin, an uncomfortable bed, not the softest sheets, maybe a tube in the throat, invasive lines in veins and arteries, cold monitoring wires. Are they moving? What is that? Perhaps even restraints or mitts. A catheter, maybe even a tube in the rectum. Visual input is varied and vision even obstructed. Bed rails to the right and left. Or is it a cell? Crawling ceiling patterns and equipment all around. Is it day or night? What’s that shape? Did that thing move? Artificial light and dark fluctuate seemingly at random. Perhaps the TV flickers. Beeps and buzzes abound. Are those voices outside? “Mrs. Smith, open your eyes and look at me.” Who the hell is that? Maybe a familiar voice. Poking, prodding. “I’m just going to draw some blood here.” A blood pressure cuff inflates, maybe a bit too tight. There’s no drinking, definitely no eating. A dried mouth. “Mrs. Smith what month is it?” “Beep, beep…beep beep.” “Ding….ding….ding.” Oh, the dryness. Just want some water, water, moisture. Pressure, a slide up. Is the skin tearing? An achey backside, pain in the buttocks. Hot, cold. Light, dark. Quiet, chaos. Confusion. Agitation. Pain.

How could one not be delirious? The environment, from a neurologic lens, is quite profound. Inputs via a range of various modalities encoded by different receptors resulting in action potentials travel along neural pathways and arrive at the brain as potential sensations. Subsequently, these neural inputs are assessed and result in possible perceptions and affects. Conversely, there may be a relative lack of input or sensation (mitts, restraints, social interaction, medication effects). Movement, or lack of movement, is also an input. As humans, a certain amount of movement and position change is normal (although, admittedly individually dependent and varied). Cardiopulmonary, neurologic, vestibular, psychologic, and neuro-musculo-skeletal systems, all systems really, are accustomed to it. These systems respond and adapt to movement at a macro and micro scale. Fortunately, much is known regarding the multi-system, micro, macro, global, and specific effects of decreased activity and input.

Sensory Deprivation and Perceptual Isolation?

…extended or forced sensory deprivation can result in extreme anxiety, hallucinations, bizarre thoughts, and depression. A related phenomenon is perceptual deprivation, also called the ganzfeld effect. In this case a constant uniform stimulus is used instead of attempting to remove the stimuli, this leads to effects which has similarities to sensory deprivation. –Wikipedia

Unfortunately, the environment and process of medically treating critical illness and stabilizing organ systems likely predisposes patients to physical, functional, neurocognitive, and psychological impairments.

Cognition and Psychology

Short term psychological and neurocognitve problems during critical illness may include stress, decreased memory, decreased attention, fluctuating wakefulness, confusion, delirium, anxiety, agitation, delusional memories, and depressed mood. Socially, there is an obvious breakdown of normal roles and support. Social interaction is decreased and varied. Roles and responsibilities become blurred at the individual and social level. Overall control is lost, and for some likely decreases in locus of control and self efficacy. Family roles may shift, or completely reverse.

“I was never told by anyone what to expect.” –ICU Survivor

What happens after ICU and hospital discharge? Anxiety. Depressive Symptoms. Depression. Post Traumatic Stress. Post Traumatic Stress Disorder. Decreased quality of life. Care giver burden and stress. Complicated grief. Inability to return to work. Who? Medical ICU patients, those with acute respiratory distress syndrome (ARDS), severe sepsis, sepsis, surgical ICU patients, and those requiring mechanical ventilation.  Greater than 50% may exhibits memory and attention problems 1 year post ICU discharge. Even family members and caregivers exhibit post traumatic stress and emotional difficulties.

Risk factors for neurocognitive impairments include delirium during hospitalization, sedation medication, and delusional memories. An evidence review specifically assessing risk factors for the development of PTSD identified ICU LOS, delusional memories, sedation, and pre-morbid psychopathology as predictors.

Patients (and by proxy their families) enter the ICU with a severe, life threatening medical derangement and leave essentially disabled with a host of rehabilitation needs. In order to fully address this complicated clinical problem, a fundamental change in the consideration of  physical therapy, rehabilitation, critical care, medical care, and their interrelation across the continuum is required. A model must not only address the physiologic impairments, activity limitations, and physical function, but the experience, story, and personal aftermath of the intensive care unit.

Bio-Psycho-Social

People do not ‘have’ diseases, which are really descriptive mechanisms created by contemporary medicine.

People have stories, and the stories are narratives of their lives, their relationships, and the way they experience an illness. –Arthur Kleinman, MD

An individual’s physiology is pathologic, or diseased. An individual, the person, has an experience. The necessity, and power, of expanding the bio-medical model to include psychological and social domains stems from the recognition that complex individuals, people, are the ones that must suffer and cope with their diagnoses. Further, observations and research illustrate the important influence of such domains in both illness and health. Research across diagnoses and disciplines, as well as the philosophical considerations of treating an individual, support the premise of a model that considers more than abnormal anatomy and physiology.

But, the BIO matters. The physiology matters. And, we need to know it really well. Biology, physiology, diagnoses, medical treatment, medications, treatment mechanisms, pathophysiology, body systems. The bio-psycho-social model does not discount nor disregard the biomedical. It’s not biomedical vs. psycho-social. It’s the integration of psycho-social into the biomedical.

BPS_ICF
Merging the Bio-Psycho-Social and ICF. Click image for article.

Even the ICF model is focused primarily on a disease or health condition and how that biology interacts with function. Environmental and personal factors are peripherally connected in the model. There is no robust way to account for psychological and social constructs and contributions.

The bio-psycho-social model attempts to address patients individually, psychologically, and within the influence of their social lattice while integrating the available biomedical knowledge and population based research.

BPS Model Via The Patient Patient. Click image to view website.
BPS Model Via The Patient Patient. Click image to view website.

As layers are added to the conceptual model general research relating to each domain is applied. Included is applicable literature of how these individual constructs interact and potentially affect one another. But, this knowledge must be applied to the individual patient within the specifics of the current situation and the present moment of each domain. For example, general knowledge of biology, psychology, social, environmental, and cultural factors is fused with applicable clinical research ranging from epidemiology to prognostic studies to clinical interventions which is in turn applied to the individual within the specific contexts (personal, social, environmental) relevant to the patient. It’s complicated, but conceptual buckets build cognitive representations to guide thinking, assessment, and decision making.

BPS_Onion_ModelBPS_Onion

 

I’m no psychologist! And, nor should we strive to be. But, physical therapists should aim to develop knowledge and skills in the multitude of systems, domains, and potential constructs that affect movement, function, and disability. Principles of psychology are thus paramount. As therapists, expertise in the domain of rehabilitation and therapeutic processes including behavior change, basic counseling skills, and motivation are needed.

Psychologically informed practice…

recognizes the necessity of understanding and applying psychological constructs into our practice. It also recognizes that function, symptoms, and disability are inherently personal and psychological.

Most physical therapists probably acknowledge the importance of psychosocial factors, and many would assert that they recognize them as part of their clinical practice. However, as Bishop and Foster have documented, simple identification or knowledge of such factors does not lead to a change in focus or style of patient management. Yet, there is persuasive evidence for the influence of a patient’s beliefs, emotional responses, and pain behavior on response to pain, treatment participation, and outcome. – Chris Main & Steven George

Research now illustrates that treatment interventions affect psychological domains, and conversely, that psychologically targeted interventions can affect function, symptoms, and disability. For example:

What about critical illness? Recently, improving patient care through the prism of psychology: application of Maslow’s hierarchy to sedation, delirium, and early mobility in the intensive care unit has been discussed.

A holistic approach to the critically ill and Maslow’s Hierarchy. Click image for article.

How does therapy fit into this hierarchy? How can we? Can physical therapists interface with the entirety of this spectrum? All interventions exhibit affects across body systems and patient domains. This includes psychology and this hierarchy. Even though our “target” may be at the physiologic, activity, or functional level, interventions result in unintended consequences (positive and/or negative) with regard to belonging, esteem and self actualization. Recognizing these constructs can assist in assessing their impact on function, participation, and coping. Meaningful interventions or care processes constructed based on these models, and the resulting understanding, may prove worthwhile and effective. Summarizing research from a multitude of practice areas and diagnoses suggests:

1. Effects of specific interventions cross body systems and patient domains
2. Exercise and activity interventions may result in positive unintended affects
3. All interventions are “non-specific” as effects cross many systems & domains
4. Exercise affects cognition & psychology
5. Psychology affects function & participation

Can physical therapists target interventions to psychological and social domains and issues? Can psychologically informed physical therapist driven interventions affect psychological and social domains and issues? It’s time to find out.

Assessing and Integrating the Evidence

Are we teaching it backwards? Without understanding premise or argument validity in relation to research, an individual article analyses may be useless. A study may be flawed on premise alone even with strong methodology and statistically significant results. A valid argument is false. And, inappropriate conclusions will be drawn. Likely, this will lead to misguided justifications and explanations. Such errors can affect clinical practice, education, and future research.

Plenty of systems and check lists exists for systematically evaluating the quality of an individual study including it’s design and methodology. The PEDro scale  (PEDro Website), The Consort Statement25 Item ChecklistChecklist for Qualitative AnalysisPRISMA for Systematic Reviews and Meta-analyses, and other Critical Appraisal Checklists all guide and contribute to appropriate analysis. But, a critical review should not only critique the rigor of the inquiry and accuracy of the conclusions, but also, and maybe more importantly, assess the study’s plausibility in context of the whole of current scientific understanding.

What does this tell us? What can it tell us given the design? What doesn’t it tell us? Too often scientific research, clinical and otherwise, is interpreted too broadly and thus inaccurately. It’s one of the major flaws of popular “pop” science journalism: over reaching conclusions. The sensational headlines touting miracle cures and “bad” foods that cause cancer. But, even a narrow lens of assessment focused only the specific study may lead to improper understanding. Outside of a purely methodological critique, an article analysis can not, must not, be done in isolation.  The current state of the literature on the topic specifically, in conjunction with basic science generally, must be taken into account.

Is this plausible?

Plausibility must not only take into account previous clinical research and outcomes studies (efficacy and effectiveness), but also basic science and current mechanistic research. Such an approach prevents reinforcing an unlikely or inaccurate explanatory model despite positive outcomes. Unfortunately, physical therapy is likely plagued by positive outcome studies misinterpreted, and thus explicitly or implicitly, supporting a theoretical construct that is (may be) invalid. One example, more specifically, is the variance in explanatory models of manual therapy effect.

What are my beliefs? Biases? Preferred treatment constructs and approaches?

An overlooked area of assessment is ourselves. The person doing the analyzing. It’s imperative that the critical lens of analysis be pointed back upon its user. Rarely will an orthopedic manual physical therapist postulate that manual therapy does not work.  The very best may ponder if the mechanisms are completely outside the current understanding. A physical therapist practicing in an ICU rarely questions the effectiveness of movement and mobility. But, clinicians and researchers should strive to rigorously falsify via the scientific method in order to focus accuracy and understanding over time. Physical therapists are inherently, and understandably, focused on the specifics of treatment that appear most important. What exercise? What technique? What works? Yet, the scientific rigor, and uncomfortable thought, of attempting to prove physical therapy does not work will lead to more specific knowledge on why it does work and the potential attainable outcomes. Seems contradictory, but falsifiability is the basic tenant of hypothesis testing in science. So, ask yourself: what would it take to change my mind? It’s time for some serious critical thinking.

Points to Ponder

  • Hypothesis & Null Hypothesis
  • Plausibility of Hypothesis based on previous research and overall knowledge
  • Methods Critique (utilize checklists)
  • Efficacy vs. Effectiveness Design
  • What is the comparison or control group?
  • Are these groups similar in abstract variables such as frequency, duration, and one on one time?
  • Believability of the comparison or placebo by patient?
  • What the results can tell us given study design
  • What the results can NOT tell us given the study design
  • Plausibility of results from author’s interpretation
  • Plausibility of theoretical model presented or utilized
  • Plausibility of the discussion & conclusion  in relation to understanding on the topic specifically
  • Plausibility based on basic science, physics, mechanics, including tissue mechanics, physiology, psychology
  • How else could the results be explained? Placebo? Regression to the mean? Different mechanisms?
  • Did the authors make the appropriate conclusion?
  • What’s YOUR conclusion and understanding?
  • Overall summary and critique
  • How and why to integrate?

What is the take away?

“That’s valid,” you say, but what do you mean by that? A single statement can be valid by itself if it is a previously proven “truth”, but what about an argument? You remember arguments, right? Premise, premise, therefore conclusion? Funny thing about valid arguments, they have nothing to do directly with truth. Arguments can be valid and false at the same time, just as they can be invalid and true at the same time. What?

Since deductive arguments are the basis of all research, you need to understand this concept. I have quoted before on a podcast, “A flawed study is still a flawed study regardless of p-value or level of evidence. – Erik Meira, When a valid argument can be false

The complications continue. Concepts such as placebo, non-specific effects, nocebo, incentives, behavioral psychology, decision making, logical fallacies, cognitive biases, and epidemiology all play vital roles in not only which treatments we (should) utilize, but how they (may) work. In addition to clinical and scientific research, the understanding of the how’s and why’s of decisions in clinical practice rest upon these concepts (by jennifer). Given where trials of physical therapy interventions are published it’s imperative to read outside the physical therapy specific literature. Research in psychology and behavior assists in a deeper understanding of the importance of the entire treatment encounter in addition to how clinicians make decisions within a treatment encounter.

It is reflective and complex decision-making that integrates all sources of evidence that we should be having serious conversations about, and its that thoughtfulness [PDF] that is required of a doctoring profession – not the myopic and obtuse yes or no to the question: “Are you evidence based?” – Jason Silvernail, DPT, DSc

So, stop volleying RCTs back and forth in an evidence ping pong match, and begin integrating knowledge. The information from seemingly unrelated fields contain insights that can result in true evolution in our understanding of clinical practice. Surprisingly, even many of the randomized control trials of physical therapy interventions are not published in physical therapy specific journals. Ponder how  the “evidence base” should be selected.

We rarely believe we are ignorant, but could we be wrong?

Should we all do the same thing? Perceivable vs. Conceptual Practice Variation

Conceptual variation is more damaging, and a bigger issue, than perceivable, apparent practice variation. Because of the multi-faceted nature of the mechanisms of effect in physical therapy treatments, especially for pain, striving for observable decreases in “practice variation” may not actually solve many of the issues within the profession. The real problem is conceptual differences. The stark contrast between explanatory models, and stories told, results in significant variance in explanation and education received by patients. Patients are still routinely told they have “bad” posture, an SI joint that is “out” and weakness causing their painful problems. Such unhelpful and debunked ideas are the unnecessary imaging of our profession.

Words matter. The stories we tell patients, and those we tell ourselves. It appears that in medicine generally, and orthopedics specifically, the language utilized by clinicians affect not only patient’s understanding, but perceptions including pain, disability, function, and quality of life. Beliefs are powerful. So, why do we keep beating around the bush? There is a remarkable range in treatment paradigms, potential mechanisms, and explanations on why things (appear to) “work.”

Now, to be fair, striving for a decrease in practice variation within physical therapy is a worthwhile endeavor. However, I am not convinced current conceptualizations are the appropriate approach. Assessing variation in medical treatments and practice is likely easier than in physical therapy practice. Why? It’s more concrete. Medical treatment relies heavily on the appropriate diagnosis of essential, or substantial diagnoses. Treatment follows, and is mostly dependent on proper diagnosis. Thus, analysis of timely proper diagnosis, matching of treatment and diagnosis, and actual treatment content is more concrete to study. For physical therapy, a different construct is required. The complexities of the clinical encounter and individual nature of the therapeutic process in conjunction with the many potential and identified mechanisms of treatment effect complicate the study of variance. Striving for utilization of the exact same interventions is likely to be a surface level success. It appears like progress. Therapists are dealing with many nominal diagnoses and messy concepts such as unexplained symptoms, function, and behavior change. (note: medical diagnosis is still very complex and full of challenges)

Specificity should be sought after, but not assumed. As more is understood about the effects of interventions it is becoming apparent that techniques, exercises, and interventions themselves are not as specific as originally assumed. If observably clinicians appear to have no practice variation, but utilize different conceptual frameworks and tell the patient in front of them different stories, gross variation is actually still present. Utilization of similar constructs may result in similar “outcomes,” but with significantly different “interventions.” So, what are the common factors?

Regardless of setting, physical therapists should strive for the most accurate deep models of practice, validated and efficient processes in conjunction with an individualized, assessment based, response dependent approach. The best clinical research evidence should be incorporated. This will lead to less practice variation, you just might not be able to see it. Observational variation in interventions may not actually represent difference in concepts. Conversely, two clinicians may perform exactly the same “interventions” with marked disagreements in conceptual framework, reasoning, patient interaction, and patient education. Maybe the method is not the trick? Maybe the process is as important as the product? It’s high time for the accountable practitioner. That means metacognition, critical thinking, and science based practice. Simple…now only if it were easy.

Measuring Outcomes, Outcome Measures, and Treatment Effects

Measuring outcomes, treatment efficacy, and treatment effectiveness are separate yet interacting constructs. And, it’s more than semantics. Clinically, measuring outcomes masquerades as simple while interpreting these outcomes appropriately can be quite complex. Outcomes bias, or results oriented analysis, presents a significant challenge to the practicing clinician. Outcome measures measure outcomes, not effects of intervention:

Perhaps it is unfortunate that the physiotherapy profession has responded to the perception that physiotherapists must justify what they do by routinely measuring clinical outcomes. The implication is that measures of outcome can provide justification for intervention. Arguably that is not the case. Outcome measures measure outcomes. They do not measure the effects of intervention. Outcomes of interventions and effects of interventions are very different things. Clinical outcomes are influenced by many factors other than intervention, including the natural course of the condition, statistical regression, placebo effects, and so on. (Tuttle (2005) makes this point clearly in his article, in this issue, on the predictive value of clinical outcome measures.)

The implication is that a good outcome does not necessarily indicate that intervention was effective; the good outcome may have occurred even without intervention. And a poor outcome does not necessarily indicate that intervention was ineffective; the outcome may have been worse still without intervention. This is why proponents of evidence-based physiotherapy, including ourselves (Herbert et al 2005), argue it is necessary to look to randomised trials to determine, with any degree of certainty, the effects of intervention. It is illogical, on the one hand, to look to randomized controlled trials for evidence of effects of interventions while, on the other hand, seeking justification for the effectiveness of clinical practice with uncontrolled measurement of clinical outcomes.

Principles of Outcomes Measurement

1. Objective and Measurable
2. Decrease Bias and Improve Accuracy
3. Reliable and Reproducible
4. Valid: Are we measuring what we think?
5. Sensitive to Change: Does the measure detect changes in construct?
6. Patient Report vs. Patient Performance

In addition, measurement of outcomes requires understanding the various constructs and categories that are measurable. This includes, but is not limited to:

Patient Report


Patient Performance

  • Functional Test (5 x Sit to Stand, 6 Minute Walk Test)
  • Functional Task/Activity (squat, stairs)
  • Exercise or Activity Testing


International Classification of Function & Disability Framework

  • Impairments of Body Structure and/or Function
  • Activity Limitations
  • Participation Limitations


Body Systems Level

  • Cognitive
  • Neuromuscular
  • Musculoskeletal
  • Cardiopulmonary
  • Integumentary
  • Psycho-social


Health Services

  • Duration of Care
  • Frequency of Care
  • Number of Visits
  • Future Care Needs
  • Cost
  • Cost Savings
  • Morbidity



These are only a few select constructs and measurements. Another, arguably more complex area of assessment is the narrative and experiential outcome as described by the patient. The patient’s illness narrative, interpretations, and journey through potential suffering.

Differences and disconnect between progression of physical function via patient performance and patient report has been characterized in total hip arthroplasty. “The influence of pain on self-reported physical functioning serves as an explanation for the poor relationship between self-reported and performance-based physical functioning. When using a self-report measure such as the WOMAC, one should realize that it does not seem to assess the separate constructs—physical functioning and pain—that are claimed to be measured.” Both patient report and performance are important. Each can guide further intervention or provide insight into current deficits.

For example, a patient with improvement in performance, but no change in report, may be struggling with recognizing or understanding improvements in certain domains (symptoms, performance, function). Or, perhaps education has not addressed a patient’s main concern or perception. Mistaking outcome measures and measuring clinical outcomes for actual effect of treatment may result in improper (or even pseudo-random) intervention selection and/or patient care approaches. I postulate that this mistake is the prime reason physical therapy as a profession is quick to integrate new, “innovative” treatment “tools” with lack of true prior plausibility. Or, the continued utilization of of interventions in the face of evidence suggesting lack of treatment effect. Mistaking observed and measured clinical outcomes for treatment effectiveness likely results from the post hoc ergo propter hoc logical fallacy.

When we mistake outcomes for effectiveness, we risk assuming causation and subsequently treatment mechanism. Care must be to taken to avoid leaps in logic regarding effectiveness and mechanism of action. A review of the evolution of understanding of manual therapy mechanisms illustrates how continued observation of positive clinical outcomes likely reinforced inaccurate interpretations based upon hypothetical anatomy and biomechanics devoid of true physiology and actual tissue mechanics. We now know much more.

Although, to be fair, construction of care processes, intervention approaches, and treatment paradigms absent of (potential) theoretical mechanistic action is quite challenging. Further, human brains seek explanation for observed clinical events, even within research. So, when treatment X is routinely associated with observed patient report or outcome Y brains will automatically initiate assigning reason Z as the “why.”

Measure everything!

No. Quite the contrary. Clinicians should aim to properly select measures that are relevant to the patient: main complaint, goals, condition, and/or diagnosis (if one exists). In addition, the measures chosen should be sufficiently responsive to change, encompass multiple constructs, and cross domains. While important, relying solely on patient report is an incomplete, flawed approach to measuring outcomes and assessing treatment in the clinical setting.

Two differing scenarios may occur when utilizing outcomes observed or measured in clinic as the primary reasoning for decision making regarding interventions/treatment:

A. Effective interventions may be abandoned when outcome(s) are not improving on the assumption of lack of effect.
B. Ineffective interventions or approaches may be continued when outcomes are improving on the assumption of effect.

In scenario A, the patient may in fact worsen without the treatment. Perhaps progress is predicted to be slower without effective treatment, or natural history suggests a worse trajectory. An effective intervention or process may be ceased prematurely. In scenario B, perhaps improvement is measured. Placebo, non-specific effects, incentives, and/or bias in measuring and patient reporting contribute to the observation of a positive outcome in the clinical environment. “It works!” Or, appears to. But, a multitude of other factors affect the presence of a measured outcome (positive or negative).

The multi-factorial nature of treatment mechanisms, complicate the ability to clinically observe effectiveness. The myriad of reasons why individuals may report and/or exhibit improvements in symptoms, function, and other constructs make “outcomes” a dynamic and complicated subject. Perhaps the condition has a favorable natural history or regression to the mean is present. And, perhaps the patient would have progressed more quickly with a more effective treatment approach. It’s complicated. Don’t take all the credit, and don’t take all the blame. So, what should we do?

Measure nothing, clinical outcomes are meaningless!

No. Quite the contrary. In addition, to selecting appropriate outcomes measurements, clinicians must integrate and understand appropriate current clinical, mechanistic, and basic science research. As science based practitioners, physical therapists are charged to select effective, plausible, safe, and efficient approaches to care that are focused on the individual patient. This is not an argument for the utilization of only specific outcome measurements and interventions with strong randomized control trial level evidence. Plausibility matters. The individual person matters. It’s complicated. And, it’s easy to fool ourselves. Richard Feynman suggests:

The first principle is that you must not fool yourself — and you are the easiest person to fool.

So, measure clinical outcomes. They are important. But, ensure measurements cross constructs and domains. Don’t solely rely on patient reports. And, don’t claim effectiveness based on observation. We must acknowledge the complexity. No one is saying clinical outcomes measurement is not important, or is not illustrative of important concepts. Clinical data and outcomes are vital to self-reflection, integration of evidence, health services, and overall care processes. But, the plural of anecdote is not data, and outcome measures can not illustrate effectiveness. That’s not an argument to not measure outcomes. It’s an argument to improve measurement, and more importantly, understanding.

Resources

1. Evidence Based Physiotherapy: A Crisis In Movement
2. Causation and Evidence Based Practice: An Ontalogical Review
3. Casual Knowledge in Evidence Based Practice
4. Mechanisms: What are they evidence for in evidence based medicine?
5. Placebo use in pain management: The role of medical context, treatment efficacy, and deception in determining placebo acceptability
6. Placebo Response to Manual Therapy: Something out of nothing?
7. The Mechanisms of Manual Therapy
8. The influence of expectation on spinal manipulation induced hypoalgesia
9. Evidence for a direct relationship between cognitive and physical change during an education intervention in people with chronic low back pain
10. The contributing factors of change in therapeutic process
11. RehabMeasures.org