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| Continuous low-level heat wrap therapy provides more efficacy than Ibuprofen and acetaminophen for acute low back pain [with consumer summary] |
| Nadler SF, Steiner DJ, Erasala GN, Hengehold DA, Hinkle RT, Beth Goodale M, Abeln SB, Weingand KW |
| Spine 2002 May 15;27(10):1012-1017 |
| clinical trial |
| 5/10 [Eligibility criteria: No; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: No. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
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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 (1,200 mg/day) and acetaminophen (4,000 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 <= 0.009 versus acetaminophen (mean change 2.93 cm), p <= 0.001 versus ibuprofen (mean change 2.51 cm)). The results were similar on day 4. Day 1 reduction in muscle stiffness with the heat wrap (mean 16.3) was greater than with acetaminophen (mean 10.5; p = 0.001). Disability was reduced with the heat wrap (mean 4.9), as compared with ibuprofen (mean 2.7; p = 0.01) and acetaminophen (mean 2.9; p = 0.0007), on day 4. None of the adverse events were serious. The highest rate (10.4%) was reported in the ibuprofen group. CONCLUSION: Continuous low-level heat wrap therapy was superior to both acetaminophen and ibuprofen for treating low back pain.
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