OBJECTIVE: To test the feasibility of a randomized controlled trial to assess the clinical effectiveness of low-level laser therapy (LLLT) when used in addition to eccentric exercise in the management of Achilles tendinopathy. BACKGROUND DATA: LLLT has emerged as a possible treatment modality for tendon injuries. Over the past 20 years only three human studies have investigated LLLT for Achilles tendinopathy. MATERIALS AND METHODS:Twenty patients were randomized into an active laser or placebo group; all patients, therapists, and investigators were blinded to allocation. All patients were given a 12-week eccentric exercise program and irradiated three times per week for 4 wk with either an active or placebo laser at standardized points over the affected tendons. Irradiation parameters in the active treatment group were: 810 nm, 100 mW, applied to six points on the tendon for 30 s, for a total dose of 3 J per point and 18 J per session. Outcome measures were the VISA-A questionnaire, pain, and isokinetic strength. Patients were measured before treatment and at 4 and 12 wk. Analysis of covariance was used to analyze data, using the effects of baseline measurements as a covariate. RESULTS: Within groups, there were significant improvements (p < 0.05) at 4 and 12 wk for all outcome measures, except eccentric strength for the placebo group at 4 wk (p = 0.11). Based on the results of the current study, recruitment of 20 subjects per group would be required to perform an adequately powered study based on minimally important clinical differences in VISA-A scale. CONCLUSION: This study has demonstrated the feasibility of undertaking a randomized controlled trial of LLLT for Achilles tendinopathy. Conclusions regarding effectiveness cannot be made due to the low statistical power of this pilot study.
RCT Entities:
OBJECTIVE: To test the feasibility of a randomized controlled trial to assess the clinical effectiveness of low-level laser therapy (LLLT) when used in addition to eccentric exercise in the management of Achilles tendinopathy. BACKGROUND DATA: LLLT has emerged as a possible treatment modality for tendon injuries. Over the past 20 years only three human studies have investigated LLLT for Achilles tendinopathy. MATERIALS AND METHODS: Twenty patients were randomized into an active laser or placebo group; all patients, therapists, and investigators were blinded to allocation. All patients were given a 12-week eccentric exercise program and irradiated three times per week for 4 wk with either an active or placebo laser at standardized points over the affected tendons. Irradiation parameters in the active treatment group were: 810 nm, 100 mW, applied to six points on the tendon for 30 s, for a total dose of 3 J per point and 18 J per session. Outcome measures were the VISA-A questionnaire, pain, and isokinetic strength. Patients were measured before treatment and at 4 and 12 wk. Analysis of covariance was used to analyze data, using the effects of baseline measurements as a covariate. RESULTS: Within groups, there were significant improvements (p < 0.05) at 4 and 12 wk for all outcome measures, except eccentric strength for the placebo group at 4 wk (p = 0.11). Based on the results of the current study, recruitment of 20 subjects per group would be required to perform an adequately powered study based on minimally important clinical differences in VISA-A scale. CONCLUSION: This study has demonstrated the feasibility of undertaking a randomized controlled trial of LLLT for Achilles tendinopathy. Conclusions regarding effectiveness cannot be made due to the low statistical power of this pilot study.