Clinical Research – About Us or the Patient?

Clinical research is one component of the three-legged stool we call evidence-based practice. My experience in fellowship training was to pour over the evidence and learn how to become a critical consumer of evidence. It was a great experience and opened up my eyes to the need to read research beyond the abstract.  Not all evidence is created equal of course.

Efficacy research studies

We strive to produce controlled studies full of internal validity that can demonstrate the efficacy of an intervention which often is compared to a underwhelming control group. Sometimes I feel it could be reduced to the following: I am going to compare the intervention I spent 10,000 hours training in, paid money to learn, and have a huge belief in (lack of equipoise) versus this “warm pile of garbage” intervention in the form of detuned ultrasound or something similar. To me, often all we learn from these studies is that doing something is better than doing nothing.  I have already discussed the caution I think we need to take with short-term changes.

Effectiveness research studies

Clinicians then rightfully complain that a researcher’s tightly controlled research setting looks nothing like the clinical world they live and practice in. We then look to create studies with high amounts of external validity that are more consistent with the clinical world we live in. Equipoise strikes again here as clinicians’ beliefs often influences the outcomes we find .  It makes sense that when we discuss a narrative of treatment with a patient we are trained and comfortable in we elicit greater expectations and treatment effect likely from descending modulation.

Pain is complex!!!

Pain is complex. There are many potential inputs the nervous system must process and decide on when in scrutinizes and decides on its appropriate response.  Melzack’s neuromatrix model, while not perfect, is one of the better models of pain we have.  If we think about how health care works within the model we can see that categorical thinking where we all see pain through our narrow view limits our understanding of the whole.  Research as a result has been limited by these narrow views.

Is research able to control for the following complexity?

  • A patient’s base of genetics from mom and dad,
  • How their genetics have been modified to meet the survival needs of their unique life experience (epigenetics)
  • How they were raised and conditioned to behave, cope, and respond to pain
  • The social and environmental context they have lived in currently and in the past (including family and work)
  • The resulting baseline stress system states their life experiences and survival needs have created (endocrine, immune, autonomic)
  • The degree their peripheral nervous system, spinal cord, and brain are modulating input
  • Attitudes
  • Beliefs
  • Compensation issues
  • Confusing diagnosis issues or lack thereof
  • Baseline emotional state
  • Knowledge

I am sure I could add more but the point is asking the question of when have you seen a significant number of the above considered as part of the inclusion or exclusion criteria of a quantitative study?

We can continue to pump out research that attempts to break a patient down to some quantifiable variable and disregard much of the above.  On the other hand, maybe we can push to understand the unique experience of pain each patient brings to us. Kory Zimney discusses this eloquently in his post on the lived experience of pain.  Qualitative studies may not be in vogue but they seem to be greatly lacking in our profession.   It seems we are set on the continuous pursuit of validation of technical skill in while in disregard of the suffering human being’s experience that led them to seek our help.   We research the human pain experience where the human body is treated as a machine where a controlled input will produce a consistent quantifiable output.  Unfortunately any “controlled input” needs to navigate a neuro-immune-endocrine system that has been shaped and electrochemically wired based on the above factors.  Sure we throw in a fear avoidance belief questionnaire or other yellow flag variable in there to see it’s mediating effect, but we often never just ask the patient what they thought about the whole experience.

Do we truly think a more complex technique or variable is the answer to treating and understanding this complexity?

I often hear clinicians discuss how the subjective examination is the most important component of the patient encounter yet this is not reflected in our research.  Reducing a patient’s pain to some quantifiable variable is a far too reductionist view on an extremely complex process.  Qualitative research gives use the opportunity to hear themes that permeate the environment, culture, and society a patient lives in that drives the pain behavior they display in front of you each day in the clinic.  Combining qualitative and quantitative methods could allow us to hear the patient’s yellow flags speak to us and seek to develop an understanding of their effects on the quantitative variables under study.  I suspect studies like these will validate what I feel are the most powerful tools in our toolbox – empathetic listening ears and educating mouths.

If it we proclaim that clinical practice should be all about the patient then why should we treat research differently?  I will leave you with a quote from Gordon Waddell that I have shared in the past but speaks nicely to this issue:

“…It is no longer enough to know about anatomy and pathology. The biopsychosocial approach opens a whole new perspective on how people behave and cope with illness. It reveals the limitations of our treatment and of our professional skills. It exposes us to the difficulties and stress of dealing with emotions. We must accept that patients are not neat packages of mechanics or pathology, but suffering human beings. Professional life may be much simpler if we stick to physical treatment of mechanical problems, but health care demands that we treat human beings.”

We can do better understanding the suffering human being in front of us.  Let’s push our research to help us.

Mark Kargela

Mark has been practicing physical therapy since 2003. He spent the his career pursuing expertise in manual therapy treatments. When he recognized that manual therapy had limited success in chronic pain he began intense study of pain neuroscience and advanced training. He practices in Glendale, Arizona where he is a Clinical Assistant Professor and runs Midwestern University's Physical Therapy Institute. He also teaches nationally for Modern Pain Care and lectures across the country on spine care and persistent pain.