Nonpharmacologic Therapies for Acute and Chronic Low Back Pain: A Review of the Evidence for an American Pain Society/American College of Physicians Clinical Practice Guideline

By R. Chou, L. Huffman. Annals of Internal Medicine, 2007

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Many nonpharmacologic therapies are available for treatment of low back pain. In 1 study of primary care clinicians, 65% reported recommending massage therapy; 55% recommended therapeutic ultrasonography; and 22% recommended, prescribed, or performed spinal manipulation (1). In another study, 38% of patients with spine disorders were referred to a physical therapist for exercise therapy, physical therapies, or other interventions (2). Other noninvasive interventions are also available, including psychological therapies, back schools, yoga, and interdisciplinary therapy. Clinicians managing low back pain vary substantially in the noninvasive therapies they recommend (3). Although earlier reviews found little evidence demonstrating efficacy of most noninvasive therapies for low back pain (46), many more randomized trials are now available. This article summarizes current evidence on noninvasive therapies for low back pain in adults. It is part of a larger evidence review commissioned by the American Pain Society and the American College of Physicians to guide recommendations for management of low back pain (7). Pharmacologic therapies are reviewed in a separate article in this issue (8). Methods Data Sources and Searches An expert panel convened by the American Pain Society and American College of Physicians determined which nonpharmacologic therapies would be included in this review. Appendix Table 1 shows the 17 therapies chosen by the panel and how we defined and grouped them. Several therapies that have not been studied in the United States or are not widely available (such as acupressure, neuroreflexotherapy, spa therapy, and percutaneous electrical nerve stimulation) are reviewed in the complete evidence review (7). Therapies solely involving advice or back education are also reviewed separately, as are surgical and interventional pain procedures. Appendix Table 1. Included Interventions We searched MEDLINE (1966 through November 2006) and the Cochrane Database of Systematic Reviews (2006, Issue 4) for relevant systematic reviews, combining terms for low back pain with a search strategy for identifying systematic reviews. When higher-quality systematic reviews were not available for a particular intervention, we conducted additional searches for primary studies (combining terms for low back pain with the therapy of interest) on MEDLINE, the Cochrane Central Register of Controlled Trials, and PEDro. Full details of the search strategies are available in the complete evidence report (7). Electronic searches were supplemented by reference lists and additional citations suggested by experts. We did not include trials published only as conference abstracts. Evidence Selection We included all randomized, controlled trials meeting all of the following criteria: 1) reported in English, or in a non-English language but included in an English-language systematic review; 2) evaluated nonpregnant adults (>18 years of age) with low back pain (alone or with leg pain) of any duration; 3) evaluated a target therapy; and 4) reported at least 1 of the following outcomes: back-specific function, generic health status, pain, work disability, or patient satisfaction (9, 10). We excluded trials of low back pain associated with acute major trauma, cancer, infection, the cauda equina syndrome, fibromyalgia, and osteoporosis or vertebral compression fracture. Because of the large number of studies on therapies for low back pain, our primary source for trials was systematic reviews. When multiple systematic reviews were available for a target therapy, we excluded outdated systematic reviews, which we defined as systematic reviews with a published update or those published before 2000. When a higher-quality systematic review was not available for a particular therapy, we included all relevant randomized, controlled trials. We also supplemented systematic reviews with data from recent, large (>250 patients) trials. Data Extraction and Quality Assessment For each included systematic review, we abstracted information on search methods; inclusion criteria; methods for rating study quality; characteristics of included studies; methods for synthesizing data; and results, including the number and quality of trials for each comparison and outcome in patients with acute (<4 weeks' duration) low back pain, chronic/subacute (>4 weeks' duration) low back pain, and back pain with sciatica. If specific data on duration of trials were not provided, we relied on the categorization (acute or chronic/subacute) assigned by the systematic review. For each trial not included in a systematic review, we abstracted information on study design, participant characteristics, interventions, and results. We considered mean improvements of 5 to 10 points on a 100-point visual analogue pain scale (or equivalent) to be small or slight; 10 to 20 points, moderate; and more than 20 points, large or substantial. For back-specific functional status, we classified mean improvements of 2 to 5 points on the RolandMorris Disability Questionnaire (RDQ; scale, 0 to 24) and 10 to 20 points on the Oswestry Disability Index (ODI; scale, 0 to 100) as moderate (11). We considered standardized mean differences of 0.2 to 0.5 to be small or slight; 0.5 to 0.8, moderate; and greater than 0.8, large (12). Some evidence suggests that our classification of mean improvements and standardized mean differences for pain and functional status are roughly concordant in patients with low back pain (1318). Because few trials reported the proportion of patients meeting specific thresholds (such as >30% reduction in pain score) for target outcomes, it was usually not possible to report numbers needed to treat for benefit. When those were reported, we considered a relative risk of 1.25 to 2.00 for the proportion of patients reporting greater than 30% pain relief to indicate a moderate benefit. Two reviewers independently rated the quality of each included trial. Discrepancies were resolved through joint review and a consensus process. We assessed internal validity (quality) of systematic reviews by using the Oxman criteria (Appendix Table 2) (19, 20). According to this system, systematic reviews receiving a score of 4 or less (on a scale of 1 to 7) have potential major flaws and are more likely to produce positive conclusions about effectiveness of interventions (20, 21). We classified such systematic reviews as lower quality; those receiving scores of 5 or more were graded as higher quality. Appendix Table 2. Quality Rating System for Systematic Reviews We did not abstract results of individual trials if they were included in a higher-quality systematic review. Instead, we relied on results and quality ratings for the trials as reported by the systematic reviews. We considered trials receiving more than half of the maximum possible quality score to be higher quality for any quality rating system used (22, 23). We assessed internal validity of randomized clinical trials not included in a higher-quality systematic review by using the criteria of the Cochrane Back Review Group (Appendix Table 3) (24). When blinding was not feasible, we removed blinding of providers (for studies of acupuncture, spinal manipulation, and massage) or blinding of patients and providers (for studies of back schools, exercise, psychological interventions, interdisciplinary rehabilitation, and functional restoration) as a quality criterion; thus, the maximum score was 10 or 9, respectively. We considered trials receiving more than half of the total possible score to be higher quality and those receiving less than or equal to half to be lower quality (22, 23). Appendix Table 3. Quality Rating System for Randomized, Controlled Trials Data Synthesis We assessed overall strength of evidence for a body of evidence by using methods adapted from the U.S. Preventive Services Task Force (25). To assign an overall strength of evidence (good, fair, or poor), we considered the number, quality and size of studies; consistency of results among studies; and directness of evidence. Minimum criteria for fair and good quality ratings are shown in Appendix Table 4. Appendix Table 4. Methods for Grading the Overall Strength of Evidence for an Intervention Consistent results from many higher-quality studies across a broad range of populations support a high degree of certainty that the results of the studies are true (the entire body of evidence would be considered good quality). For a fair-quality body of evidence, results could be due to true effects or to biases operating across some or all of the studies. For a poor-quality body of evidence, any conclusion is uncertain. To evaluate consistency, we classified conclusions of trials and systematic reviews as positive (the therapy is beneficial), negative (the therapy is harmful or not beneficial), or uncertain (the estimates are imprecise, the evidence unclear, or the results inconsistent) (20). We defined inconsistency as greater than 25% of trials reaching discordant conclusions (positive vs. negative), 2 or more higher-quality systematic reviews reaching discordant conclusions, or unexplained heterogeneity (for pooled data). Role of the Funding Source The funding source had no role in the design, conduct, or reporting of this review or in the decision to publish the manuscript. Results Size of Literature Reviewed We reviewed 1292 abstracts identified by searches for systematic reviews of low back pain. Of these, 96 seemed potentially relevant and were retrieved. A total of 40 systematic reviews (2670) met inclusion criteria (see Appendix Table 5 for quality ratings and Appendix Table 6 for characteristics and results of the systematic reviews that evaluated efficacy). We excluded 59 systematic reviews (71129), most frequently because they met our criteria for outdated reviews or did not report results for patients with low back pain (Appendix Table 7). Five recent, large (>200 patients) tr

Subfields: Complementary and alternative medicine, Pharmacology, Physiology

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