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.

Copyright 2003 by the American Congress of Rehabilitation Medicine and the American Academy of Physical Medicine and Rehabilitation