By Ellen Feldman, MD
Altru Health System, Grand Forks, ND
Dr. Feldman reports no financial relationships relevant to this field of study.
SUMMARY POINTS
- This article examines updated evidence on potential harms and benefits of nonpharmacologic interventions for acute or chronic radicular or non-radicular low back pain.
- The authors described the effect of treatment separately on pain and on functioning, considering the quality of evidence and magnitude of effect.
- There was a small to moderate effect from multiple nonpharmacologic interventions for chronic low back pain; most interventions are found to be effective for pain relief and less effective for functional improvement or return to work.
- For acute low back pain, most episodes resolved without interventions; acupuncture has evidence for efficacy in addressing both pain and function.
SYNOPSIS: Developed for use in the new American College of Physicians guidelines, the authors reviewed evidence regarding non-pharmacologic interventions in treatment of low back pain.
SOURCE: Chou R, Deyo R, Friedly J, et al. Nonpharmacologic therapies for low back pain: A systematic review for an American College of Physicians Clinical Practice Guideline. Ann Intern Med 2017;166:493-505.
Nonpharmacologic integrative treatments are the “backbone” of the recently released 2017 American College of Physicians (ACP) Clinical Practice Guideline for the treatment of acute, subacute, and chronic low back pain.1 This publication, noting equivalent performance of pharmaceuticals and nonpharmaceuticals in the treatment of low back pain, recommends integrative measures as first-line treatment. This shift away from conventional therapeutics attracted attention in the popular press as well as across the medical community.2,3 In part, the evidence supporting these recommendations originated in the work of Chou et al.
The goal of the study by Chou et al was to review recent evidence of the use of nonpharmacologic treatments for acute and chronic low back pain to assist the update of the 2007 ACP guideline. Acute low back pain was defined as pain lasting less than four weeks, subacute was defined as pain lasting four to 12 weeks, and chronic low back pain was pain lasting more than 12 weeks. Investigations included in the reviews covered both radicular and non-radicular low back pain, but excluded pain from causes such as cancer, fracture, high-velocity trauma, and progressive neurologic deficits.
The study sourced from a wide array of randomized clinical trials (RCTs) published in English between 2008 and 2016, including trials of exercise, spinal manipulation, acupuncture, massage, mind-body interventions, psychological therapies, and multidisciplinary rehabilitation. Most trials involved comparisons to “usual care,” waitlist, or placebo; high-quality head-to-head comparisons were included when identified.
Outcomes were quantified separately regarding the effect on pain and function. Strength of evidence was evaluated and ranked for each of these categories by two independent investigators. Each investigator used standardized criteria to weigh the strength or quality of evidence (A Measurement Tool to Assess Systemic Reviews or U.S. Preventive Services Task Force criteria for RCTs).4,5
The magnitude of effect on pain and on function was classified as small, moderate, or large using a standardized point system. This same point system is used in the ACP review and attempts standard measurement of pain and functioning with separate tools — a Visual Analog Scale (VAS) or numerical index for pain and specific questionnaires for function. In measuring the effect of an intervention on pain, for example, a movement of 5-10 points on a VAS is considered small, a 10-20 point shift is moderate, and a change greater than 20 points would be considered to have a large or substantial effect. In the entire ACP Clinical Practice Guidelines (including nonpharmaceuticals and pharmaceuticals), no one agent performed well enough to fit into this last category, indicating no agent demonstrated a large or substantial effect on pain or functioning.
A total of 114 publications across all modalities were included in the analysis. Each publication varied in the number of RCTs, ranging from two trials (involving almost 500 participants) for tai chi to 122 trials for exercise. See Table 1 for selected results from the trials.
Table 1: Selected Results |
|
Exercise vs. Usual Care |
|
|
Pain relief in chronic (> 6 months) low back pain |
|
|
Magnitude of effect |
Small |
|
Strength of evidence |
Moderate |
|
Functional improvement in chronic (> 6 months) low back pain |
|
|
Magnitude of effect |
Small |
|
Strength of evidence |
Moderate |
|
Pain relief in acute (< 6 months) low back pain |
|
|
Magnitude of effect |
No effect |
|
Strength of evidence |
Low |
|
Functional improvement in acute (< 6 months) low back pain |
|
|
Magnitude of effect |
No effect |
|
Strength of evidence |
Low |
Tai chi vs. Control |
|
|
Pain relief in chronic (> 6 months) low back pain |
|
|
Magnitude of effect |
Moderate |
|
Strength of evidence |
Low |
|
Functional improvement in chronic (> 6 months) low back pain |
|
|
Magnitude of effect |
Small |
|
Strength of evidence |
Low |
Yoga vs. Education or Usual Care |
|
|
Pain relief in chronic (> 6 months) low back pain |
|
|
Magnitude of effect |
Small to moderate |
|
Strength of evidence |
Low |
|
Functional improvement in chronic (> 6 months) low back pain |
|
|
Magnitude of effect |
Small to moderate |
|
Strength of evidence |
Low |
Mindfulness-based Stress Reduction vs. Usual Care |
|
|
Pain relief in chronic (> 6 months) low back pain |
|
|
Magnitude of effect |
Small |
|
Strength of evidence |
Moderate |
|
Functional improvement in chronic (> 6 months) low back pain |
|
|
Magnitude of effect |
Small |
|
Strength of evidence |
Moderate |
Acupuncture vs. No Acupuncture or Sham |
|
|
Pain relief in chronic (> 6 months) low back pain |
|
|
Magnitude of effect |
Moderate |
|
Strength of evidence |
Moderate |
|
Functional improvement in chronic (> 6 months) low back pain |
|
|
Magnitude of effect |
Moderate |
|
Strength of evidence |
Moderate |
|
Pain relief in acute (< 6 months) low back pain |
|
|
Magnitude of effect |
Small |
|
Strength of evidence |
Low |
|
Functional improvement in acute (< 6 months) low back pain |
|
|
Magnitude of effect |
No effect |
|
Strength of evidence |
Low |
Spinal Manipulation vs. Inert or Sham |
|
|
Pain relief in chronic (> 6 months) low back pain |
|
|
Magnitude of effect |
No effect to small |
|
Strength of evidence |
Low |
|
Functional improvement in chronic (> 6 months) low back pain |
|
|
Magnitude of effect |
Unable to determine |
|
Strength of evidence |
Unable to determine |
|
Pain relief in acute (< 6 months) low back pain |
|
|
Magnitude of effect |
No effect |
|
Strength of evidence |
Low |
|
Functional improvement in acute (< 6 months) low back pain |
|
|
Magnitude of effect |
No effect |
|
Strength of evidence |
Low |
Adverse effects. Very few studies reported harm. Typically, reports of adverse effects were minor and included temporary intensification of pain or a localized irritation.
Radicular pain. There were few trials and only very limited evidence regarding the effectiveness of the interventions when pain radiated into the lower extremity or was accompanied by neuropathies. Notably, the ACP Clinical Practice Guidelines cover only non-radiating pain. This is clearly an area where further work and studies are needed before recommendations can be stated.
COMMENTARY
Low back pain holds the unfortunate distinction of being one of the most common reasons for primary healthcare visits in the United States. In addition, low back pain can be a significant economic burden associated not only with high healthcare costs but also with decreased work productivity. Acute episodes (lasting < 4 weeks) typically resolve on their own with or without treatment, yet up to 30% of patients experience lingering pain or discomfort up to one year after an episode.4
Chou et al studied a plethora of nonpharmaceutical interventions for low back pain with a goal of contributing to the evidence base of the ACP Clinical Practice Guidelines. At a first glance, the significance of the findings is less than impressive; the strength of evidence ranges from low to moderate and the magnitude of effect tops out at moderate.
However, putting these results into perspective is essential to interpreting this study and the results. For example, the ACP Clinical Guidelines note similar effect from a variety of pharmaceutical agents, with only low to moderate quality evidence supporting the use of NSAIDs and opioids and only small to moderate magnitude of effect for these.1 In fact, no single intervention had evidence of effect powerful enough to be ranked as a “strong” level of effect.
Overall, these findings help shed new light on the significance of Chou et al’s work and assist in understanding the ACP recommendations to select nonpharmacologic treatment as a first attempt to manage low back pain. This publication follows on the heels of the CDC’s 2016 guidelines that recommend avoiding use of opioid medications for most acute pain and, recognizing the rising rate of opioid prescriptions written by primary care providers and the potential for addiction and danger in overdose from these agents, only in very specific and limited instances of chronic pain.5
The potential for harm from both opioid and nonopioid pharmaceuticals tends to sway treatment (all else being equal) away from these agents. There is much less known about the potential for harm from nonpharmaceuticals. Adverse effects from these interventions generally are limited in scope, for example, to site of impact, such as in acupuncture, or specific muscle strain in exercise. Although there is less intuitive concern about negative side effects from the specified nonpharmaceutical interventions, controlled studies looking at potential for harm are necessary before these can be recommended confidently for treatment.
Clinical applications of the findings for nonpharmaceutical interventions also could become more compelling with additional quality, large-scale studies comparing the interventions head-to-head and specifically with innovative techniques that allow blinded control groups to eliminate bias.
One of the difficulties of adapting findings from the low back pain studies into clinical use is the lack of universal availability of quality providers (i.e., not every community has an acupuncturist or tai chi instructor) and of affordability of the interventions, which typically are not reimbursed by insurance providers. As more high-quality studies are published, there is hope that this situation will begin to shift in response to increased evidence of efficacy and consequent demand.
Even in today’s climate, the integrative provider, trained to look from a holistic perspective, is uniquely positioned to treat patients with low back pain. Expertise and knowledge regarding nonpharmaceutical interventions and local practitioners lends the integrative provider a prime role in creating individualized recommendations to fit into a particular community or lifestyle. Understanding and feeling competent in knowing when and how to blend nonpharmaceuticals with pharmaceutical agents strengthens this position. With more rigorous studies driving development of a body of information regarding side effects, mechanism of action, and relative risks of multiple therapies, the future of integrative practice in medicine looks increasingly relevant.
ACP Clinical Practice Guidelines on Pain
The three recommendations for treatment from the ACP Clinical Practice Guidelines1 are as follows:
Recommendation 1:
Given that most patients with acute or subacute low back pain improve over time regardless of treatment, clinicians and patients should select nonpharmacologic treatment with superficial heat (moderate-quality evidence), massage, acupuncture, or spinal manipulation (low-quality evidence). If pharmacologic treatment is desired, clinicians and patients should select nonsteroidal anti-inflammatory drugs or skeletal muscle relaxants (moderate-quality evidence). (Grade: strong recommendation)
Recommendation 2:
For patients with chronic low back pain, clinicians and patients should initially select nonpharmacologic treatment with exercise, multidisciplinary rehabilitation, acupuncture, mindfulness-based stress reduction (moderate-quality evidence), tai chi, yoga, motor control exercise, progressive relaxation, electromyography biofeedback, low-level laser therapy, operant therapy, cognitive behavioral therapy, or spinal manipulation (low-quality evidence). (Grade: strong recommendation)
Recommendation 3:
In patients with chronic low back pain who have had an inadequate response to nonpharmacologic therapy, clinicians and patients should consider pharmacologic treatment with nonsteroidal anti-inflammatory drugs as first-line therapy, or tramadol or duloxetine as second-line therapy. Clinicians should only consider opioids as an option in patients who have failed the aforementioned treatments and only if the potential benefits outweigh the risks for individual patients and after a discussion of known risks and realistic benefits with patients. (Grade: weak recommendation, moderate-quality evidence)
REFERENCES
- Qaseem A, Wilt T, McLean RM, et al. Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med 2017;166:514-530. Doi: 10.7326/M16-2367.
- Kolata G. Lower Back Ache? Be Active and Wait It Out, New Guidelines Say. The New York Times. Available at: https://www.nytimes.com/2017/02/13/health/lower-back-pain-surgery-guidelines.html. Accessed March 31, 2017.
- Hackethal V. New ACP Guidelines for Nonradicular Low Back Pain. Medscape. Available at: http://www.medscape.com/viewarticle/875737. Accessed March 31, 2017.
- Shea BJ, Bouter LM, Peterson J, et al. External Validation of a Measurement Tool to Assess Systematic Reviews (AMSTAR). PLOS One http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0001350. Accessed March 31, 2017.
- U.S. Preventive Services Task Force. Available at: https://www.uspreventiveservicestaskforce.org/Page/Name/about-the-uspstf. Accessed March 31, 2017.
- Freburger JK, Holmes GM, Agans RP, et al. The rising prevalence of chronic low back pain. Arch Intern Med 2009;169:251-258.
- Centers for Disease Control and Prevention. CDC Guideline for Prescribing Opioids for Chronic Pain — United States, 2016. Available at: https://www.cdc.gov/mmwr/volumes/65/rr/rr6501e1.htm. Accessed March 31, 2017.
Developed for use in the new American College of Physicians guidelines, the authors reviewed evidence regarding non-pharmacologic interventions in treatment of low back pain.
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