Transcutaneous electrical acupoint stimulation for intercostobrachial nerve syndrome after breast cancer surgery: a randomized controlled trial protocol.

INTRODUCTION: Intercostobrachial nerve (ICBN) syndrome is a common peripheral sensory nerve injury following axillary surgery for breast cancer. It is characterized by persistent numbness and burning pain extending from the affected axilla to the medial aspect of the upper arm, as well as restricted shoulder joint mobility, which severely impacts postoperative recovery and quality of life. Current interventions primarily focus on symptomatic analgesia and functional exercises, lacking standardized external treatment protocols to promote nerve repair. Transcutaneous electrical acupoint stimulation (TEAS) combines the advantages of acupuncture and transcutaneous electrical stimulation. It is non-invasive and has high patient acceptance. Preliminary studies suggest it can promote axonal regeneration and myelin formation, yet scientific evidence-based evidence for ICBN syndrome is lacking. This study aims to systematically evaluate the therapeutic effects and safety of TEAS on ICBN syndrome through a prospective, randomized, sham-controlled trial, providing evidence-based medical evidence for clinical practice.

METHODS AND ANALYSIS: This prospective, randomized, sham-controlled clinical trial will be conducted at the Yunnan Provincial Hospital of Traditional Chinese Medicine. We plan to recruit 200 patients with ICBN syndrome after breast cancer surgery. Participants will be randomly assigned in a 1:1 ratio to either the TEAS group or the Sham TEAS group, with 100 cases in each group. Both groups will start receiving treatment on the first postoperative day, administered once every other day. Ten sessions will constitute one course, for a total of three courses. The primary outcome measure is CMS. Secondary outcome measures include MMT, EMG, VAS, SWMT, FACT-B, SF-36, and TCM-SD. Adverse events will be recorded throughout the study.

CLINICAL TRIAL REGISTRATION: https://itmctr.ccebtcm.org.cn/mgt/project/view/2041939715654978881, identifier, ITMCTR2024000864.