Self-administered versus lymphedema therapist-administered complex decongestive therapy protocol in breast cancer-related lymphedema: a non-inferiority randomized controlled trial with three-month follow-up.

PURPOSE

The aim of this study was to demonstrate that a self-administered complex decongestive therapy (CDT) protocol is not inferior to certified lymphedema therapist (CLT)-administered CDT in the management of lymphedema and health-related outcomes in patients with breast cancer-related lymphedema (BCRL).

METHODS

Fifty patients with BCRL were randomly assigned to two experimental groups: (1) a CLT-administered CDT group (n = 25) or a self-administered CDT group (n = 25). CDT was a multimodal approach in two experimental conditions consisting of patient education, manual lymph drainage, multi-layer bandaging, therapeutic exercises and skin/nail care. Lymphedema severity was assessed using circumference measurement, and BCRL-related symptoms were assessed using a numerical rating scale. The following measurement methods were used to assess health-related outcomes: universal goniometer for range of motion (ROMs), hand grip dynamometer for peripheral muscle strength, disabilities of the arm, shoulder and hand (DASH) questionnaire for disability level, International Physical Activity Questionnaire-Short Form (IPAQ-SF) for physical activity level, the checklist for individual strength (CIS) for fatigue and upper limb lymphedema quality of life questionnaire (ULL-27) for quality of life.

RESULTS

Following CDT, there was a significant decrease in lymphedema severity and lymphedema-related symptoms in both groups (p < 0.001). There was no significant difference between the groups regarding the mean difference in health-related outcomes following CDT (post-treatment-baseline) (p < 0.05). Lymphedema severity and symptoms remained stable during the 3-month follow-up periods in the CLT-administered CDT group (p > 0.05). There was a decrease in the severity of lymphedema, stiffness, heaviness and fatigue in the self-administered CDT group at 3-month follow-up (p < 0.05), while pain and tingling remained unchanged (p > 0.05).

CONCLUSION

The present findings demonstrated self-administered CDT protocol is not inferior to CLT-administered CDT in the management of lymphedema and reduction of lymphedema-related disabilities.