OBJECTIVE: To test the efficacy of low-level laser therapy on lateral ankle sprains as an addition to a standardized treatment regimen, a trial was conducted in which high-dose laser (5 J/cm2), low-dose laser (0.5 J/cm2), and placebo laser therapy (0 J/cm2) at skin level were compared. DESIGN: Randomized, double-blind, controlled clinical trial with a follow-up of 1 year. Patients, therapists, assessors, and analysts were blinded to the assigned treatment. SETTING: An ambulatory care setting. PATIENTS: After informed consent and verification of exclusion criteria, 217 patients with acute lateral ankle sprains were randomized to three groups from September 1, 1993, through December 31, 1995. INTERVENTIONS: Twelve treatments of 904 nm laser therapy in 4 weeks as an adjunct to a standardized treatment regimen of 4 weeks of brace therapy combined with standardized home exercises and advice. The laser therapy device used was a 904 nm Ga-As laser, with 25-watt peak power and 5,000 or 500 Hz frequency, a pulse duration of 200 nsec, and an irradiated area of 1 cm2. PRIMARY OUTCOME MEASURES: Pain and function as reported by the patient. RESULTS: Intention-to-treat analysis of the short-term results showed no statistically significant difference on the primary outcome measure, pain (p = 0.41), although the placebo group showed slightly less pain. Function was significantly better in the placebo group at 10 days (p = 0.01) and 14 days (p = 0.03) after randomization. The placebo group also performed significantly better on days of sick leave (p = 0.02) and at some points for hindrance in activities in daily life and pressure pain, as well as subjective recovery (p = 0.05). Intention-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 = 0.04) than in the other two groups (high laser, n = 13; placebo, n = 13). Subgroup analysis to correct for possible confounders did not alter these findings. CONCLUSIONS: Neither high- nor low-dose laser therapy is effective in the treatment of lateral ankle sprains.

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