LOW-LEVEL LASER THERAPY IN ANKLE SPRAINS - A RANDOMIZED CLINICAL-TRIAL

Objective: To test the efficacy of low-level laser therapy on lateral ankle sprains as an addition to a standardized treatment regimen, a tr ial was conducted in which high-dose laser (5J/cm(2)), low-dose laser (0.5J/cm(2)), and placebo laser therapy (0J/cm(2)) at skin level were compared. Design: Randomized, double-blind, controlled clinical trial with a follow-up of 1 year. Patients, therapists, assessors, and analy sts were blinded to the assigned treatment. Setting: An ambulatory car e setting. Patients: After informed consent and verification of exclus ion criteria, 217 patients with acute lateral ankle sprains were rando mized to three groups from September 1, 1993, through December 31,1995 . Interventions: Twelve treatments of 904nm laser therapy in 4 weeks a s an adjunct to a standardized treatment regimen of 4 weeks of brace t herapy combined with standardized home exercises and advice. The laser therapy device used was a 904nm Ga-As laser, with 25-watt peak power and 5,000 or 500Hz frequency, a pulse duration of 200nsec, and an irra diated area of 1cm(2). Primary Outcome Measures: Pain and function as reported by the patient. Results: Intention-to-treat analysis of the s hort-term results showed no statistically significant difference on th e primary outcome measure, pain (p =.41), although the placebo group s howed slightly less pain. Function was significantly better in the pla cebo group at 10 days (p =.01) and 14 days (p =.03) after randomizatio n. The placebo group also performed significantly better on days of si ck leave (p =.02) and at some points for hindrance in activities in da ily life and pressure pain, as well as subjective recovery (p =.05). I ntention-to-treat analysis showed that total days of absenteeism from work and sports were remarkably lower in the placebo group than in the laser groups, ranging from 3.7 to 5.3 and 6 to 8 days, respectively. The total number of relapses at 1 year in the low-dose laser group (n = 22) was significantly higher (p =.04) than in the other two groups ( high laser, n = 13; placebo, n = 13). Subgroup analysis to correct for possible confounder; did not alter these findings. Conclusions: Neith er high- nor low-dose laser therapy is effective in the treatment of l ateral ankle sprains. (C) 1998 by the American Congress of Rehabilitat ion Medicine and the American Academy of Physical Medicine and Rehabil itation.