FDA Requiring Patient-Reported Outcomes — Part 3

To read Part 1 and Part 2 of FDA Requiring Patient-Reported Outcomes, please click the links provided.

• https://www.medicalmassage-edu.com/blog/fda-requiring-patient-reported-outcomes-part-1.htm
• https://www.medicalmassage-edu.com/blog/fda-requiring-patient-reported-outcomes-part-2.htm

From the Author

Today’s writing I would like to begin with something that would be laughable—if it weren’t so sad.

A little over 10 years ago, when the “evidence-based massage practice” movement began, something strange happened. Suddenly, every author publishing in professional massage journals started attaching long lists of references. Many of these same authors, who had been publishing for years without citing sources, suddenly filled their articles with references—and this alone was interpreted as evidence-based writing.

Out of curiosity, I began checking those references. What I discovered was disappointing. Very often, the references had absolutely no connection to the actual subject of the article. And even when the references were related to a pathology being discussed, they had no relation whatsoever to massage practice. Zero. Most were copied directly from orthopedic surgeons’ publications, simply inserted to make the article look “scientific.”

Was it laughable? Yes. Was it disgraceful? Absolutely. But above all, it was very sad. At that time, the profession was only about five years into developing its own clinical generation of massage therapists. Many of these therapists were misled, distracted, and discouraged. They couldn’t achieve real clinical results, couldn’t build sustainable practices, became exhausted, and eventually left the profession altogether. That is the truly sad part.

In this third part, I would like to expand on why I am discussing this subject. The answer is simple: it happened before, it is happening today, and if we remain uninformed and unprepared, it will continue to happen many more times. Dishonest people will take advantage of us precisely because we are not informed.

Any constructive criticism or presentation must lead to a practical outcome. Everything I have presented in Parts 1 and 2 is open to debate. In particular, my discussion about evidence-based practice can and should be verified, including the reasons the FDA requires patient-reported outcomes.

For us, the practical outcome is clear: we must not be swayed by slogans. Instead, we should verify—by following the “money factor”—what these new slogans actually mean. How will they affect massage practice? Most importantly, how will they affect our patients? Will they truly help us provide better care?

I decided to write this overview because the so-called “evidence-based miracle” is still active today. For example, there is an individual heavily promoting concussion treatment courses. He claims his teaching is “evidence-based,” that he has conducted research on concussions, and that he trains only physical therapists and assistants—while still allowing massage therapists to attend as a favor.

I personally asked him several times: “You call yourself a concussion doctor. Are you a PhD, DPT, DC, or MD? Where were your research papers published? What evidence are you referring to? Please provide examples.” I never received an answer. Instead, my posts were deleted, while he continued attracting thousands of followers.

This is both disturbing and dangerous. As I wrote in my article on concussions, inadequate treatment of head trauma can lead to tragedy: encephalopathy, including but not limited to dementia, and movement disorders. What this “concussion doctor” is teaching is disguised under the banner of evidence-based medicine. Massage therapists must be able to ask informed and intelligent basic questions.

It began decades ago. In the 1970s, in Canada, peer review became popular in healthcare. Over time, it grew into a kind of “wild west,” where even unqualified individuals began posing as peers. For example, in a massage forum, a therapist recommended that patients drink a few extra glasses of water after treatment. She was harshly attacked by self-proclaimed “evidence-based specialists” demanding proof, since no peer review had been published on the matter.

I intervened and pointed out that recommending hydration is reasonable. In fact, I suggest drinking water both before and after treatment. Massage, to some extent, accelerates lymphatic drainage, and water is the main medium for eliminating metabolic byproducts. For this, I too was attacked—asked to provide “peer review proof” that water transports metabolic waste or that dehydration reduces the benefits of massage. It was absurd.

The “evidence-based” mania became so extreme that one Australian physical therapist, in his peer review, claimed all existing neuroscience data was outdated—including neurophysiology itself! He argued that pain receptors don’t exist, and that even if stabbed by a knife, pain was only generated by fear in the brain, without any peripheral input. Thousands of therapists believed him, paid thousands of dollars, and even declared themselves “neuroscientific revolutionaries.”

This is insanity—but it is real. Please check it for yourself, and correct me if you think I am exaggerating.

History offers many parallels. In 1996, physicist Alan Sokal submitted a deliberately nonsensical paper to the professional top-notch journal . His goal was to expose the journal’s lack of scientific integrity. They published it, proving his point about politically correct pseudoscience.

But not all hoaxes are meant to expose flaws. Many are simply schemes to make money. For example, in the 1970s, Manuel Elizalde, the Philippine Prime Minister, falsely claimed to have discovered a Stone Age tribe, the Tasaday. He restricted access to the area and collected millions in “protection funds,” only for journalists later to discover that the tribe was modernized and coerced into pretending.

Why do people fall for such hoaxes—even today?

More on Evidence-Based Practice

Consider the article published in the New York Times (June 2, 2010), based on an interview with Prof. Michael Tschakovsky of Queen’s University in Ontario. His study, published in Medicine & Science in Sports & Exercise (Wiltshire et al., 2010), concluded:

• Sports massage severely impairs blood flow during the massage stroke.
• This impairment decreases muscle blood flow early in recovery after strenuous exercise.
• Sports massage does not improve lactic acid removal.

The New York Times summarized:

“The results…are a blow, at least to those of us who justify our massages as medicinal.”

If true, this would indeed be a blow to the entire field of massage. But in reality, the study was poorly designed. Neither Prof. Tschakovsky nor the journal’s editorial board had proper knowledge of medical or sports massage. Despite this, the so-called leaders of evidence-based massage embraced the paper as valid—simply because it appeared in a prestigious journal.

Why? Because they were uninformed and/or didn’t love practicing massage.

Let us not make the same mistake. Massage science is a specific clinical science, rooted in general biomedical knowledge but requiring its own standards of research and application.

I will continue expanding on patient-reported outcomes in future parts and explain in detail how I have achieved sustainable results in complex clinical cases.

Please feel free to share agreements, disagreements, and constructive criticism.

Until next time.
Best wishes,
Boris