Protocol to Improve Quality of Life, Functionality, and Exercise Capacity in Patients with Axillary Web Syndrome after Breast Cancer: A Randomized Clinical Trial

Objectives : To improve functionality, quality of life, and exercise capacity in women who underwent breast cancer surgery and suffered Axillary Web Syndrome (AWS) as a sequela. Design : Prospective, randomized, single-blind clinical trial. Setting : Single-center study. Participants Forty-six post-breast cancer surgery patients with AWS that restricted functionality, quality of life, and exercise capacity. Interventions : Stretching combined with manual therapy and scar massage to release adhesion and lymphatic cord during 15 physiotherapy sessions of 30 minutes each. Main outcome measures Functionality was evaluated with DASH and Constant Scale, exercise capacity with IPAQ, and quality of life with EORTC QLQ-BR23. Participants were allocated to either intervention or control group using the Excel randomization tool. Blinding of the therapist was not possible due to the study’s nature. Results : Twenty-five patients were assigned to the intervention group and twenty-three to the control group, becoming twenty-four and twenty-two, respectively, for analysis. Significant differences were detected in functionality and quality of life. The intervention effect varied over time with a 95% confidence interval (alpha 0.05) and a statistical power of 90% (beta 0.1). Comparisons between groups showed significant differences in favor of the intervention group at 30, 60, and 90 days of follow-up. Conclusion : Stretching combined with scar massage and manipulative tissue release techniques improved functionality and quality of life in AWS patients. This physiotherapy technique could be considered the treatment of choice for this surgical sequela. Trial Registration: ClinicalTrials.gov Registry (NCT05115799) on June 10 ^th , 2021, and the approval of the Andalucía Ethics Committee (PEIBA code 1909-N1-21, reg. number 171.21).