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14 Articles in Volume 18, Issue #7
A 2018 Update: The Federal Pain Research Strategy
A Commentary on Medical Cannabis
Are Abuse-Deterrent Opioids Appropriate for Your Pain Patient?
Behind the AHRQ Report
Challenges Facing Abuse-Deterrent Formulations
Demystifying Opioid Abuse-Deterrent Technologies
Editorial: Our Clinical Pain Neighborhood
Independent Pain Practice: A Case Example
Inside Performing Arts Medicine
Letters to the Editor: ACT Therapy; Compounded Topicals
Nerve Growth Factor and Targeting Chronic Pain
Pain Control for Athletes: What Works?
Quality Training: One Center’s Experience with Pain Assessment
The Importance of Developing Professional Relationships in Pain Practice

Behind the AHRQ Report

Understanding the limitations of “non-pharmacological, non-invasive” therapies for chronic pain.
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A commentary

In the current restrictive regulatory climate that governs opioid analgesic therapy for chronic pain, there is much discussion of “alternative” therapies and “integrative medicine.” Unfortunately for proponents of such measures, the state of medical evidence in trials literature is very weak, reflecting weaknesses of trial design, execution, and size. This is perhaps unintentionally illustrated by a major systematic review released in June 2018 by the Agency for Healthcare Research and Quality (AHRQ), an agency of the US Health and Human Services Department.1

Scope of the AHRQ Review

In its review, AHRQ sought to “assess which noninvasive nonpharmacological treatments for common chronic pain conditions improve function and pain for at least one month after treatment.”1 The selected therapies focused on areas common to traditional “alternative therapies,” but did not include medical marijuana, electrostimulation devices, or corticosteroid injections. The review incorporated randomized controlled trials literature across the following categories of chronic pain, including interventions demonstrated to “[improve] function and/or pain for at least one month:”1

  • Chronic Low Back Pain: exercise, psychological therapies (primarily cognitive behavioral therapy, or CBT), spinal manipulation, low-level laser therapy, massage, mindfulness-based stress reduction, yoga, acupuncture, and multidisciplinary rehabilitation, or MDR)

  • Chronic Neck Pain: exercise, low-level laser therapy, the Alexander Technique, acupuncture

  • Chronic Tension Headache: spinal manipulation

  • Fibromyalgia: exercise, CBT, myofascial release massage, tai chi, qigong, acupuncture, and MDR

  • Osteoarthritis: exercise, ultrasound for the knee; exercise, manual manipulation and therapy for the hip.

Cross-roadsPrescribers are at a crossroads when it comes opioid therapy.

The researchers identified 4,996 candidate trial reports in medical literature, which they narrowed down to 1,193 reports for full-text review, and then further characterized 218 publications that met rigorous quality criteria. Many of the trials excluded from the final AHRQ report failed to follow patients for longer than one month after trials were completed. Interestingly, a shortage of long-term randomized trials was one of the factors said to imply a lack of long-term effectiveness in opioid analgesics by the writers of the CDC Guideline on Prescribing Opioids for Chronic Pain.2,3 A crucial difference between controlled trials of alternative treatments and trials of opioids is that there is nothing that intrinsically precludes long-term trials of the former, whereas extended controlled trials of opioids are infeasible due of high drop-out rates in patients randomized to placebo.

What the Review Really Focused On

As noted in the issued AHRQ report, “most effects were small. Long-term evidence was sparse.”1 In this context, “small” does not quite do justice to the details of the many tables in this 1,000-page report. For many therapy trials, the magnitude of changes in reported pain levels was less than one point on a scale of 0 to 10. The systematic review also characterized strength of medical evidence as “weak” in more than 150 reports of short-term, intermediate, or long-term outcomes.

“The majority of trials compared nonpharmacological interventions with usual care, waitlist, no treatment, attention control, or placebo/sham (93%); few trials employed pharmacological treatments (5%) or exercise (17%).”

However, buried deeply in the report, readers also learn that “it is assumed that most patients with chronic pain likely continued medications and other therapies or practices during the trials. These factors may have resulted in substantial mixing of effects of the intervention and co-interventions. These factors possibly attenuated observed effects.”

Four crucial points should, therefore, be borne in mind when considering the AHRQ analysis, as described below.

Pain Magnitude

Most of the reviewed trials enrolled patients with “moderate” pain intensity (> 5 on a 10-point numerical scale). However, the commonly used interval or analog pain scales, unlike the more complex McGill Pain Questionnaire, have demonstrated almost no correlation with a more objective measure of pain intensity.4 Thus, the validity of the endpoint measure is cause for serious concern. Further, how certain is it that a patient who rates their pain as 5 out of 10 would provide the same rating after having experienced 10/10 pain? These considerations call into doubt the comparability of the patients in trials of opioid therapy versus patients in trials of alternative therapies. The true test of the effectiveness of an alternative therapy would be its ability to achieve sustained reduction in opioid dosage. None of the indexed trials attempted this comparison.

Meaningfulness of Pain Improvement

Treatment-associated improvements in objective outcomes speak for themselves. For instance, treatment with new oral anticoagulants reduces stroke risk by 70% in patients with atrial fibrillation. However, the same cannot be said of subjective outcome measures. What does it mean to say that an alternative treatment reduced scores on a numerical outcome scale by 0.5 – 0.79 standard deviations (a moderate effect size)? A more meaningful outcome measure would be whether or not pain was adequately controlled. Alternatively, meaningfulness could be measured in pragmatic terms as a quantitative reduction in a clinically objectifiable outcome such as opioid dosage, enabled by alternative therapy.

Hawthorne Effect

The Hawthorne effect, simply stated, is that human beings do better when close attention is paid to them and they feel valued. Thus, it is quite possible that some or all of the beneficial effects documented in trials of alternative therapies accrued substantially or entirely to the Hawthorne effect. Hawthorne effect was not mentioned in the AHRQ document and no efforts were made to control for it.

Trial Progression

Last updated on: October 3, 2018
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