A Multicentre Randomised Controlled Trial Protocol Investigating the Effectiveness of Kinesio Taping in Persistent Breast and Truncal Oedema

Introduction: Persistent breast and truncal oedema is a burdensome complication following breast cancer treatment. Current therapies are often expensive, time-intensive or lack evidence, underscoring the need for innovative and cost-effective solutions. Kinesio taping has gained attention as a potential supportive intervention, yet high-quality evidence regarding its effectiveness is lacking. Methods: This multicentre, randomised controlled trial will enrol 128 women with chronic breast and/or truncal oedema following breast cancer treatment. Participants will be randomised (1:1) to receive either decongestive lymphatic therapy alone (control group) or in combination with kinesio taping (intervention group). The intervention phase will last 4 weeks, during which participants will attend two physiotherapy sessions per week. In the intervention group, kinesio tape will be applied twice a week for 3 consecutive days. After completion of this phase, participants will enter a 6-month observational follow-up period. The primary outcome is symptom severity, assessed using the Breast Edema Questionnaire. Secondary outcomes include pain, local tissue water and quality of life, measured by the Visual Analogue Scale, Tissue Dielectric Constant, EORTC QLQ-BR23, and EQ-5D-5L. Assessments will be conducted at baseline, post-intervention, and at 3 and 6 months of follow-up. Conclusion: This will be the first randomised controlled trial to evaluate the effectiveness of kinesio taping as an adjunct to standard care for chronic breast and truncal oedema. If proven effective, kinesio taping could offer a low-cost, accessible and well-tolerated additional treatment option to improve symptom management and quality of life in breast cancer survivors.