Clinical Trials and other Medical Research for Chronic Spine Pain

The Back Pain Research Field May Soon Change - For The Better

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Does your surgeon have financial ties to your treatment decision?.

Clinical trials and other types of research on back pain may soon change.

Have you experienced this scenario? You make an appointment to see your doctor regarding your neck and/or back pain. She does the standard work up - i.e., she takes a medical history, does a physical exam on you, and possibly refers you for an x-ray, MRI and maybe more. This results in her recommending a treatment that you try, which either doesn't work or is at least partially disappointing in its ability to deliver the relief you are seeking.

She may even refer you to a clinic or spine surgery center - in which she has an invested financial interest.

Or, maybe this alternate scenario is familiar: Before you make a commitment to the treatment your doctor has (possibly very strongly) suggested, you go to another physician for a 2nd opinion - and you get an entirely different diagnosis accompanied by an entirely different recommended treatment plan! You scratch your head wondering which recommendation will better make your pain go away. No one seems willing to answer this important question in an unbiased way.

Related:  Getting Your Back Pain Diagnosed

Although slow in coming, the forces "at the top" have begun to question why such scenarios are increasingly common.  In their "Report of the Task Force on Research Standards for Chronic Low-Back Pain," the National Institute of Health (NIH) Pain Consortium acknowledges the problem, stating that "chronic low-back pain is common and has a major societal impact.

Despite rapidly increasing use of medications, injections, and surgery, functional disability has increased in recent decades."

Related: Back Pain Statistics

The Pain Consortium states that many patients continue to experience pain even after a procedure is complete. They go on to say, "we often cannot identify mechanisms to explain the major negative impact chronic low back pain has on patients' lives."


So what exactly does NIH's Pain Consortium think is the cause of these disconnected and oft-ineffective string of protocols recommended to patients, as well as the poor outcomes that likely arise from them? From the NIH's perspective, the problem seems to lie in terms, classifications, the way data is collected and the way findings are interpreted in medical studies on chronic low back pain.

In this age of "evidence based" medicine, patient and practitioner alike rely on medical studies for making treatment decisions, as well as for decisions about diagnostic testing.

The goal of the NIH Pain Consortium seems to be to get all (or at least as many as they can) chronic low back pain researchers on the same page.  In other words, their aim is for researchers to talk about the same things in the same ways, first when designing the research studies they conduct, and later when interpreting the resultant data.

According to the Report, patient populations (i.e. study participants who are grouped in terms of things like their age, gender, previous history of back pain and more) are not defined in a standard way across all chronic low back pain studies.

The Report asserts that terms and definitions used in medical research are inconsistent, and outcome measures vary widely. Examples of outcome measures include:  How much pain you have after treatment as compared to before, or how much functionality was gained from such treatment. These variations make it difficult to compare and contrast the results of studies, many of which, at their root, actually look at the same treatment or diagnostic method in the the same group of people. Such variations also make replicating (i.e. verifying the results of) findings from older/previously done studies more challenging, they say.

For example, if you think the term "spinal stenosis" is understood and used the same way between patients, doctors, medical scientists, device manufacturers, representatives from the FDA (who approve applications for pain killers and medical devices), physical therapists and holistic practitioners, you may well be mistaken. The NIH says this term is defined differently by researchers in nearly every study.

Related:  Central Canal Stenosis and Neuroformainal Stenosis

The same is true for spine instability, subluxation and radiculopathy, they say.

Other things that are hampered by the lack of consistent terminology across studies on chronic low back pain according to the report include: Pooling data, resolving conflicts when coming to a conclusion about treatment or diagnosis for chronic low back pain, developing consensus among practitioners and experts in related medical disciplines (for example, your pain management specialist, your spine surgeon and your physical therapist), and even getting consensus among practitioners and experts in a single discipline.


The Research Task Force (RTF) that prepared the Report recommends a definition of chronic low back pain that can be used uniformly throughout all relevant medical studies be adopted. This recommendation is defined by 2 factors:

1.) The length of time back pain has been a problem for you (related to a public health statistical measurement called incidence), and,

2.) What proportion of days in the last 6 months involved you having back pain (related to another statistic called period prevalence). They call this 2nd measurement "pain days." Pain days can accumulate within that 6 month period.

For example, the Research Task Force says, if you've had pain on at least half of the days in the last 6 months, you have accumulated at least 3 months worth of pain days.

Related: Incidence

Three months of accumulated low back pain in the past 6 months is the threshold after which pain is defined as chronic, according to the recommendations.

The RTF also recommends classifying chronic low back pain in terms of its impact - in other words, by a combination of the intensity of pain, its interference with your usual activities, and your ability to function physically.

The report gives the RTF's guidelines for what they call a minimal dataset, or the baseline information researchers should be required to collect when doing a study. The Task Force also made recommendations about the way researchers report outcomes (results of treatments) of patients who undergo the treatments studied or being compared in the study.


It is likely clear to researchers, practitioners and even patients, that with few exceptions, guidelines for doing medical studies on chronic low back pain, as well as for making recommendations and reporting patient outcomes have historically been a difficult to decipher - and an even more difficult to apply -  hodge podge of terms and methods.

The Research Task Force says it believes its new recommendations can advance the field of chronic low back pain management, as well as help resolve controversies, and better understand the disease. They state that their recommendations are a living document to which continual improvements that are in line with the research recommendations put forth in the Report will be made.


Deyo R1, Dworkin SF, Amtmann D, Andersson G, Borenstein D, Carragee E, Carrino J, Chou R, Cook K, DeLitto A, Goertz C, Khalsa P, Loeser J, Mackey S, Panagis J, Rainville J, Tosteson T, Turk D, Von Korff M, Weiner DK. Focus Article Report of the NIH Task Force on Research Standards for Chronic Low Back Pain. Clin J Pain. 2014 Aug;30(8):701-12. doi: 10.1097/AJP.0000000000000120.

Deyo RA, Dworkin SF2, Amtmann D2, Andersson G3, Borenstein D4, Carragee E5, Carrino J6, Chou R7, Cook K8, DeLitto A9, Goertz C10, Khalsa P11, Loeser J2, Mackey S5, Panagis J12, Rainville J13, Tosteson T14, Turk D2, Von Korff M15, Weiner DK9. Report of the NIH Task Force on Research Standards for Chronic Low Back Pain. Spine J. 2014 Jun 17. pii: S1529-9430(14)00463-X. doi: 10.1016/j.spinee.2014.05.002. [Epub ahead of print]

Deyo, R, MD, MPH, et. al. Report of the Task Force on Research Standards for Chronic Low-Back Pain. Submitted to the NIH Pain Consortium Executive Committee. Nov 2013

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