Effect of Radiofrequency Denervation on Pain Intensity Among Patients With Chronic Low Back Pain. The Mint Randomized Clinical Trials

Question  What is the effectiveness of radiofrequency denervation added to a standardized exercise program for patients with chronic low back pain?

Findings  In 3 randomized clinical trials including 681 participants with chronic low back pain originating from the facet joints, sacroiliac joints, or a combination of these or the intervertebral disks, radiofrequency denervation combined with exercise compared with exercise alone resulted in either no significant difference in pain intensity, or a difference smaller than the prespecified minimal clinically important difference after 3 months.

Meaning  The study findings do not support the use of radiofrequency denervation for chronic low back pain originating from these sources.

Reference: JAMA. 2017;318(1):68-81.

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NSAIDs for Chronic Low Back Pain

Clinical Question  Are nonsteroidal anti-inflammatory drugs (NSAIDs) associated with greater pain relief than placebo, other drugs, and nondrug treatments for patients with chronic low back pain?

Bottom Line  Compared with placebo, NSAIDs are associated with a small but significant improvement in pain and disability in patients with chronic low back pain, although this difference became nonsignificant when studies with high risk for bias were excluded. The associated benefits were smaller than the minimal clinically important difference.

Reference: JAMA. 2017;317(22):2327-2328.

Association of Spinal Manipulative Therapy With Clinical Benefit and Harm for Acute Low Back Pain Systematic Review and Meta-analysis

Importance  Acute low back pain is common and spinal manipulative therapy (SMT) is a treatment option. Randomized clinical trials (RCTs) and meta-analyses have reported different conclusions about the effectiveness of SMT.

Objective  To systematically review studies of the effectiveness and harms of SMT for acute (≤6 weeks) low back pain.

Data Sources  Search of MEDLINE, Cochrane Database of Systematic Reviews, EMBASE, and Current Nursing and Allied Health Literature from January 1, 2011, through February 6, 2017, as well as identified systematic reviews and RCTs, for RCTs of adults with low back pain treated in ambulatory settings with SMT compared with sham or alternative treatments, and that measured pain or function outcomes for up to 6 weeks. Observational studies were included to assess harms.

Data Extraction and Synthesis  Data extraction was done in duplicate. Study quality was assessed using the Cochrane Back and Neck (CBN) Risk of Bias tool. This tool has 11 items in the following domains: randomization, concealment, baseline differences, blinding (patient), blinding (care provider [care provider is a specific quality metric used by the CBN Risk of Bias tool]), blinding (outcome), co-interventions, compliance, dropouts, timing, and intention to treat. Prior research has shown the CBN Risk of Bias tool identifies studies at an increased risk of bias using a threshold of 5 or 6 as a summary score. The evidence was assessed using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) criteria.

Main Outcomes and Measures  Pain (measured by either the 100-mm visual analog scale, 11-point numeric rating scale, or other numeric pain scale), function (measured by the 24-point Roland Morris Disability Questionnaire or Oswestry Disability Index [range, 0-100]), or any harms measured within 6 weeks.

Findings  Of 26 eligible RCTs identified, 15 RCTs (1711 patients) provided moderate-quality evidence that SMT has a statistically significant association with improvements in pain (pooled mean improvement in the 100-mm visual analog pain scale, −9.95 [95% CI, −15.6 to −4.3]). Twelve RCTs (1381 patients) produced moderate-quality evidence that SMT has a statistically significant association with improvements in function (pooled mean effect size, −0.39 [95% CI, −0.71 to −0.07]). Heterogeneity was not explained by type of clinician performing SMT, type of manipulation, study quality, or whether SMT was given alone or as part of a package of therapies. No RCT reported any serious adverse event. Minor transient adverse events such as increased pain, muscle stiffness, and headache were reported 50% to 67% of the time in large case series of patients treated with SMT.

Conclusions and Relevance  Among patients with acute low back pain, spinal manipulative therapy was associated with modest improvements in pain and function at up to 6 weeks, with transient minor musculoskeletal harms. However, heterogeneity in study results was large.

Effect of Mindfulness-Based Stress Reduction vs Cognitive Behavioral Therapy or Usual Care on Back Pain and Functional Limitations in Adults With Chronic Low Back Pain

Importance  Mindfulness-based stress reduction (MBSR) has not been rigorously evaluated for young and middle-aged adults with chronic low back pain.

Objective  To evaluate the effectiveness for chronic low back pain of MBSR vs cognitive behavioral therapy (CBT) or usual care.

Design, Setting, and Participants  Randomized, interviewer-blind, clinical trial in an integrated health care system in Washington State of 342 adults aged 20 to 70 years with chronic low back pain enrolled between September 2012 and April 2014 and randomly assigned to receive MBSR (n = 116), CBT (n = 113), or usual care (n = 113).

Interventions  CBT (training to change pain-related thoughts and behaviors) and MBSR (training in mindfulness meditation and yoga) were delivered in 8 weekly 2-hour groups. Usual care included whatever care participants received.

Main Outcomes and Measures  Coprimary outcomes were the percentages of participants with clinically meaningful (≥30%) improvement from baseline in functional limitations (modified Roland Disability Questionnaire [RDQ]; range, 0-23) and in self-reported back pain bothersomeness (scale, 0-10) at 26 weeks. Outcomes were also assessed at 4, 8, and 52 weeks.

Results  There were 342 randomized participants, the mean (SD) [range] age was 49.3 (12.3) [20-70] years, 224 (65.7%) were women, mean duration of back pain was 7.3 years (range, 3 months-50 years), 123 (53.7%) attended 6 or more of the 8 sessions, 294 (86.0%) completed the study at 26 weeks, and 290 (84.8%) completed the study at 52 weeks. In intent-to-treat analyses at 26 weeks, the percentage of participants with clinically meaningful improvement on the RDQ was higher for those who received MBSR (60.5%) and CBT (57.7%) than for usual care (44.1%) (overall P = .04; relative risk [RR] for MBSR vs usual care, 1.37 [95% CI, 1.06-1.77]; RR for MBSR vs CBT, 0.95 [95% CI, 0.77-1.18]; and RR for CBT vs usual care, 1.31 [95% CI, 1.01-1.69]). The percentage of participants with clinically meaningful improvement in pain bothersomeness at 26 weeks was 43.6% in the MBSR group and 44.9% in the CBT group, vs 26.6% in the usual care group (overall P = .01; RR for MBSR vs usual care, 1.64 [95% CI, 1.15-2.34]; RR for MBSR vs CBT, 1.03 [95% CI, 0.78-1.36]; and RR for CBT vs usual care, 1.69 [95% CI, 1.18-2.41]). Findings for MBSR persisted with little change at 52 weeks for both primary outcomes.

Conclusions and Relevance  Among adults with chronic low back pain, treatment with MBSR or CBT, compared with usual care, resulted in greater improvement in back pain and functional limitations at 26 weeks, with no significant differences in outcomes between MBSR and CBT. These findings suggest that MBSR may be an effective treatment option for patients with chronic low back pain.

Trial Registration  clinicaltrials.gov Identifier: NCT01467843

By Daniel C. Cherkin et al, JAMA. 2016;315(12):1240-1249.

Early Physical Therapy vs Usual Care in Patients With Recent-Onset Low Back Pain: A Randomized Clinical Trial

Importance Low back pain (LBP) is common in primary care. Guidelines recommend delaying referrals for physical therapy.

Objective To evaluate whether early physical therapy (manipulation and exercise) is more effective than usual care in improving disability for patients with LBP fitting a decision rule.

Design, Setting, and Participants Randomized clinical trial with 220 participants recruited between March 2011 and November 2013. Participants with no LBP treatment in the past 6 months, aged 18 through 60 years (mean age, 37.4 years [SD,10.3]), an Oswestry Disability Index (ODI) score of 20 or higher, symptom duration less than 16 days, and no symptoms distal to the knee in the past 72 hours were enrolled following a primary care visit. Interventions All participants received education. Early physical therapy (n108) consisted of 4 physical therapy sessions. Usual care (n112) involved no additional interventions during the first 4 weeks.

Main Outcomes and Measures Primary outcome was change in the ODI score (range: 0- 100; higher scores indicate greater disability; minimum clinically important difference, 6 points) at 3 months. Secondary outcomes included changes in the ODI score at 4-week and 1-year follow-up, and change in pain intensity, Pain Catastrophizing Scale (PCS) score, fear-avoidance beliefs, quality of life, patient-reported success, and health care utilization at 4-week, 3-month, and 1-year follow-up.

Results One-year follow-up was completed by 207 participants (94.1%). Using analysis of covariance, early physical therapy showed improvement relative to usual care in disability after 3 months (mean ODI score: early physical therapy group, 41.3 [95% CI, 38.7 to 44.0] at baseline to 6.6 [95% CI, 4.7 to 8.5] at 3 months; usual care group, 40.9 [95% CI, 38.6 to 43.1] at baseline to 9.8 [95% CI, 7.9 to 11.7] at 3 months; between-group difference, −3.2 [95% CI, −5.9 to −0.47], P=.02). A significant difference was found between groups for the ODI score after 4 weeks (between-group difference, −3.5 [95% CI, −6.8 to −0.08], P=.045]), but not at 1-year follow-up (between-group difference, −2.0 [95% CI, −5.0 to 1.0], P=.19). There was no improvement in pain intensity at 4-week, 3-month, or 1-year follow-up (between-group difference, −0.42 [95% CI, −0.90 to 0.02] at 4-week follow-up; −0.38 [95% CI, −0.84 to 0.09] at 3-month follow-up; and −0.17 [95% CI, −0.62 to 0.27] at 1-year follow-up). The PCS scores improved at 4 weeks and 3 months but not at 1-year follow-up (between-group difference, −2.7 [95% CI, −4.6 to −0.85] at 4-week follow-up; – 6 – −2.2 [95% CI, −3.9 to −0.49] at 3-month follow-up; and −0.92 [95% CI, −2.7 to 0.61] at 1- year follow-up). There were no differences in health care utilization at any point.

Conclusions and Relevance Among adults with recent-onset LBP, early physical therapy resulted in statistically significant improvement in disability, but the improvement was modest and did not achieve the minimum clinically important difference compared with usual care.

Early Physical Therapy vs Usual Care in Patients With Recent-Onset Low Back Pain: A Randomized Clinical Trial by Julie M. Fritz, et al. JAMA. 2015;314(14):1459-1467.