ABSTRACT
BACKGROUND: Breast reconstruction with implants can be complicated by symptomatic capsular contracture, especially after radiotherapy. A phase I, nonrandomized clinical trial demonstrated improvement in capsular contracture and avoidance of revision surgery with low-level laser therapy. This phase II, double-blind, randomized controlled trial assessed the efficacy of low-level laser for treating capsular contracture in women with breast reconstruction following mastectomy for breast cancer. METHODS: Participants had completed their definitive implant-based reconstruction a minimum of 6 months previously and were randomized to weekly treatments over 6 weeks with either an active or inactive low-level laser handpiece (Riancorp LTU-904). Pain, tightness, arm movement, and appearance were assessed by patient questionnaires. Breast symmetry, shape, naturalness, softness, and grade of contracture were assessed by clinician reports. Participants were assessed at 1 and 6 months after completion of the treatments. RESULTS: A total of 42 patients (intervention arm, n = 20; placebo, n = 22) were assessed in the trial. Thirty-two had postmastectomy radiotherapy. There was no significant difference in the change in any patient-reported outcomes or clinician-reported outcomes of breast symmetry, shape, or naturalness for the two groups. There was a significantly greater improvement in clinician-reported breast softness (p < 0.05) and degree of contracture (p < 0.05) in the placebo group at both 1- and 6-month follow-up. CONCLUSION: Low-level laser is not an effective therapy for breast implant capsular contracture in reconstruction patients. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, I.
