OBJECTIVE: To evaluate the efficacy of 8 hours of continuous low-level heatwrap therapy for the treatment of acute nonspecific low back pain (LBP). DESIGN: Prospective, randomized, parallel, single-blind (investigator), placebo-controlled, multicenter clinical trial. SETTING: Five community-based research facilities. PARTICIPANTS: Two-hundred nineteen subjects, aged 18 to 55 years, with acute nonspecific LBP. INTERVENTION: Subjects were stratified by baseline pain intensity and gender and randomized to one of the following groups: evaluation of efficacy (heatwrap, n = 95; oral placebo, n = 96) and blinding (oral ibuprofen, n = 12; unheated back, wrap n = 16). All treatments were administered for 3 consecutive days with 2 days of follow-up. MAIN OUTCOME MEASURES: Primary: day 1 mean pain relief (0- to 5-point verbal response scale). Secondary: muscle stiffness (101-point numeric rating scale), lateral trunk flexibility (fingertip-floor distance), and Roland-Morris Disability Questionnaire over 3 days of treatment and 2 days of follow-up. RESULTS: Heatwrap therapy was shown to provide significant therapeutic benefits when compared with placebo during both the treatment and follow-up period. On day 1, the heatwrap group had greater pain relief (1.76 +/- 0.10 versus 1.05 +/- 0.11, p < 0.001), less muscle stiffness (43.1 +/- 1.21 versus 47.6 +/- 1.21, p = 0.008), and increased flexibility (18.6 +/- 0.44 cm versus 16.5 +/- 0.45 cm, p = 0.001) compared with placebo. Disability was also reduced in the heatwrap group (5.3 versus 7.4, p = 0.0002). Adverse events were mild and infrequent. CONCLUSION: Continuous low-level heatwrap therapy was shown to be effective for the treatment of acute, nonspecific LBP.

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