ABSTRACT
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+/-.10 vs 1.05+/-.11, P <.001), less muscle stiffness (43.1+/-1.21 vs 47.6+/-1.21, P=.008), and increased flexibility (18.6+/-.44 cm vs 16.5+/-.45 cm, P=.001) compared with placebo. Disability was also reduced in the heatwrap group (5.3 vs 7.4, P=.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.
Subject(s)
Hot Temperature/therapeutic use , Low Back Pain/therapy , Physical Therapy Modalities/methods , Acute Disease , Adolescent , Adult , Disability Evaluation , Female , Hot Temperature/adverse effects , Humans , Low Back Pain/diagnosis , Low Back Pain/physiopathology , Male , Middle Aged , Muscle, Skeletal/physiopathology , Pain Measurement , Physical Therapy Modalities/adverse effects , Prospective Studies , Range of Motion, Articular , Single-Blind Method , Treatment OutcomeABSTRACT
STUDY DESIGN: A prospective, randomized, single (investigator) blind, comparative efficacy trial was conducted. OBJECTIVE: To compare the efficacy of continuous low-level heat wrap therapy (40 C, 8 hours/day) with that of ibuprofen (1200 mg/day) and acetaminophen (4000 mg/day) in subjects with acute nonspecific low back pain. SUMMARY OF BACKGROUND DATA: The efficacy of topical heat methods, as compared with oral analgesic treatment of low back pain, has not been established. METHODS: Subjects (n = 371) were randomly assigned to heat wrap (n = 113), acetaminophen (n = 113), or ibuprofen (n = 106) for efficacy evaluation, or to oral placebo (n = 20) or unheated back wrap (n = 19) for blinding. Outcome measures included pain relief, muscle stiffness, lateral trunk flexibility, and disability. Efficacy was measured over two treatment days and two follow-up days. RESULTS: Day 1 pain relief for the heat wrap (mean, 2) was higher than for ibuprofen (mean, 1.51; P = 0.0007) or acetaminophen (mean, 1.32; P = 0.0001). Extended mean pain relief (Days 3 to 4) for the heat wrap (mean, 2.61) also was higher than for ibuprofen (mean, 1.68; P = 0.0001) or acetaminophen (mean, 1.95; P = 0.0009). Lateral trunk flexibility was improved with the heat wrap (mean change, 4.28 cm) during treatment (P
