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AHRQ Report
Few Surprises but Confirmation of a Dearth of Evidence for Most Therapies Used for Treating Low Back Pain

ARTICLE IN BRIEF

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THERE IS LIMITED EVIDENCE to support most non-pharmacological and alternative approaches to treating low back pain, according to the new analysis.

An analysis released by the Agency for Healthcare Research and Quality found that there is a dearth of evidence for most therapies used for low back pain today. But the report found that time and careful management will resolve most low-back pain issues in a relatively short period of time.

A large review of randomized clinical trials of noninvasive therapies for treating low back pain found a lack of high-quality data for most treatments being used today and little new research that might affect current treatment guidelines.

The 808-page analysis released by the Agency for Healthcare Research and Quality (AHRQ) of the Department of Health and Human Services in February reported that for acute back pain, time and careful early management will resolve most issues in a relatively short period of time. It reported that psychological therapies and multidisciplinary rehabilitation are both effective for chronic persistent pain, a finding that is consistent with earlier reviews and current treatment recommendations.

Research supporting some current pharmacological options — such as opioids, nonsteroidal anti-inflammatory drugs (NSAIDs), and muscle relaxants — shows small, short-term benefits for pain and function, and there is limited evidence to support most nonpharmacological and alternative approaches, according to study investigator Richard Deyo, MD, MPH, the Kaiser-Permanente endowed professor of evidence-based medicine at Oregon Health and Science University (OHSU) in Portland.

The Pacific Northwest Evidence-based Practice Center (EPC) at OHSU prepared the report, and OHSU researchers, including EPC Director Roger Chou, MD, a professor of medicine, medical informatics, and clinical epidemiology, conducted the research.

“I think the most important thing is the paucity of strong evidence,” Dr. Deyo told Neurology Today in a telephone interview. “Most therapies out there can offer only modest benefits, and many are not supported by strong evidence at all.”

The findings were generally consistent with those of earlier systematic reviews, in part because the report built on a prior review and utilized previously published high-quality systematic reviews.

The analysis found that after a short period of intervention with pain medications, where necessary, active physical therapies like exercise and superficial heat remain the best option for most patients, Dr. Deyo said.

The report noted that new evidence has also shown that ibuprofen is not very effective, nor is acetaminophen or corticosteroids, while NSAIDs may help a number of patients in the early acute stages.

The study divided low back pain into three categories: acute (less than four weeks duration), subacute (four to 12 weeks), and chronic (12 weeks or more). The review included non-radicular low back pain, radicular pain from disc herniation, and symptomatic spinal stenosis.

The report noted that very few quality studies have specifically addressed patients with radiculopathy, so there was too little evidence for the investigators to make any recommendations.

Dr. Deyo said the report did not evaluate the risk of opioid dependence or addiction among patients who were given such drugs.

“The problem is that most randomized studies on this have been too small and too short to assess risk of addiction and dependence,” he explained.

However, a 2015 analysis by the OHSU investigators, including Drs. Chou and Deyo, published in 2015 by the Annals of Internal Medicine, concluded that there was a lack of evidence to determine the effectiveness of long-term opioid therapy for improving chronic pain and function, while evidence did support a dose-dependent risk for serious harm, include addiction, dependence, and overdose. (See “More Findings from the AHQR on Low-Back Pain Therapies.”)

RISK-BENEFIT STRATIFICATION

“Overall, there isn't much in the way of any major new findings regarding individual therapies in the report — nothing that's much different than what we have known for some time,” said Gary M. Franklin, MD, FAAN, a research professor in the department of environmental and occupational health sciences at the University of Washington in Seattle, who was not involved with the analysis.

“However, the report's take-away messages are very important. Perhaps the most important thing to emphasize is that preventing the transition from acute and subacute pain to chronic pain, and potentially long term disability, is critical. For example, an injured worker with low back pain that has kept him or her out of work for two weeks should be considered like someone who has had a heart attack, something to deal with on a more urgent basis.”

The report suggests that physicians should use a brief instrument that screens these patients for important psychosocial barriers to recovery, he noted.

One such tool is the “STarT Back” instrument, developed at Keele University in Staffordshire, UK, which is used to stratify patients to ensure they receive the best treatment packages based on their individual prognosis or their risk of a poor clinical outcome. (For more about the stratified-care approach, visit www.keele.ac.uk/sbst/.)

A recent study of the program, cited in the AHRQ report, found that stratified assessment and treatment is more effective than usual care without it, especially when higher-risk patients receive more intensive cognitive-behavioral therapy.

“This suggests that psychologically-based therapies and multidisciplinary rehabilitation may be the most effective approach in higher-risk patients,” said Dr. Franklin.

Dr. Franklin added: “Multimodal care, say combining active physical therapy, such as graded exercise, with cognitive-behavioral therapy, may have the largest impact on attaining clinically meaningful improvement in pain and function.”

“On the other hand,” he said, “the report also emphasizes that use of passive modalities, common in physical therapy practice, is not very effective. It is important that neurologists who prescribe ongoing physical therapy for patients with more chronic low back pain should emphasize in their prescription that active modalities be the predominant mode of treatment, and that meaningful improvement in pain and function using brief validated instruments should be documented to justify continuing or stopping such therapy. “

The STarT Back study also suggests that such an approach could significantly decrease disability from back pain and reduce lost workdays, said Dr. Franklin, an expert in workers' compensation. He said that a major problem, especially with regard to workers' compensation, is that improper diagnosis and/or inappropriate treatment delays people returning to work as soon as possible, typically by between two and six weeks.

“Performing such screening early can help determine the best steps to take for each patient,” he told Neurology Today. “What we do not want to happen — and it is happening — is that very modest musculoskeletal injuries can evolve into long-term disability. One of the ways this can happen is with inappropriate receipt of opioids for non-specific musculoskeletal disorders early on following an injury.”

He also said that in terms of treatment of acute low back pain, the report emphasizes the use of NSAIDs and application of heat, one of the few passive modalities shown to be effective. “You also want to avoid MRI scanning in routine low back pain in the absence of red flags, such as fever or neurologic findings,” he added.

Although the AHRQ report did not include the types of observational studies that have demonstrated greatly increased potential risk for addiction and dependence in chronic pain patients, the benefits of opioid medications in the new report was less than 10 percent, and only for short-term treatment.

“Compared with the risk of dependence and addiction, research has shown that up to 30 percent of patients can become addicted or dependent on opioids. From a risk-benefit standpoint, a 10 percent benefit to a 30 percent risk is not that good,” Dr. Franklin noted.

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DR. RICHARD DEYO: “I think the most important thing is the paucity of strong evidence. Most therapies out there can offer only modest benefits, and many are not supported by strong evidence at all.”

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DR. GARY M. FRANKLIN: “Perhaps the most important thing to emphasize is that preventing the transition from acute and subacute pain to chronic pain, and potentially long term disability, is critical. For example, an injured worker with low back pain that has kept him or her out of work for two weeks should be considered like someone who has had a heart attack, something to deal with on a more urgent basis.”

MORE FINDINGS FROM THE AHRQ ON LOW-BACK PAIN THERAPIES

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  • Tricyclic antidepressants are not effective versus placebo for pain relief.
  • Some evidence supports the use of complementary and alternative medicine therapies, such as acupuncture, spinal manipulation, and massage.
  • Therapies that appear to be effective for pain or function include exercise, yoga, and tai chi; various psychological therapies; multidisciplinary rehabilitation; acupuncture; and low-level laser therapy.
  • Although acupuncture was no more effective than sham acupuncture in some trials, other reviews found that the overall evidence (including pooled analyses) suggests a beneficial effect on pain.
  • New evidence that acetaminophen is ineffective for acute low back pain calls into question its appropriateness as a recommended therapy, although other factors, such as low cost, favorable side-effect profile, and effectiveness for other acute pain conditions, could also impact decisions regarding its use.
  • Duloxetine, a serotonin-norepinephrine reuptake inhibitor, has specifically been approved for low back pain, and it appears to be more effective with a better safety profile than tricyclic antidepressants.
  • Patients with low back pain account for a high proportion of the opioid prescriptions. Decisions on opioids must weigh short-term and modest benefits against potential harms. Risk assessment, careful patient selection, and close monitoring and follow-up are recommended.
  • Systemic corticosteroids continue to be used for radicular back pain despite trials showing that they are ineffective.
  • The review supports clinical practice guidelines that found insufficient evidence to recommend most physical therapies, even though they are still commonly used in clinical practice. There was insufficient evidence to determine which patients are most likely to benefit from specific non-pharmacological therapies that were found to be effective.
  • The review also supports practice guidelines that found insufficient evidence to recommend most physical modalities other than superficial heat. However, these therapies are still commonly used in clinical practice.
  • There is some evidence that greater patient expectations of benefit from a particular treatment are associated with greater benefits, suggesting that patient preference should be considered in selecting therapies.

LINK UP FOR MORE INFORMATION:

•. Noninvasive treatment for low back pain: Effective health care program. Comparative Effectiveness Review Number 169 http://effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?productid=2192&pageaction=displayproduct, Agency for Healthcare Research and Quality, DHHS. AHRQ Publication No. 16-EHC004-EF, February 2016.
    •. Hill JC, Whitehurst DG, Lewis M, et al. Comparison of stratified primary care management for low back pain with current best practice (STarT Back): a randomized controlled trial http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(11)60937-9/references. Lancet 2011; 378:1560–1571.
    •. Chou R, Turner JA, Devine EB, Deyo RA, et al. The effectiveness and risks of long-term opioid therapy for chronic pain: A systematic review for a National Institutes of Health Pathways to Prevention Workshop http://annals.org/article.aspx?articleid=2089370. Ann Intern Med 2015;162: 276–286.