The Clinical Efficacy and Safety of Electroacupuncture (EA) in Perioperative Rehabilitation of Rotator Cuff Repair Surgery: A Protocol for a Single-Centre, Randomized Controlled Trial

Abstract

Purpose: Pain is one of the main complications after rotator cuff repair. If acute postoperative pain is not effectively controlled, it may lead to chronic persistent pain after surgery. Electroacupuncture (EA) is an effective tool for pain control. However, EA specifically for alleviating postoperative pain after rotator cuff repair has not been studied in randomized controlled trials (RCTs). This pilot study aims to design a RCT to assess the efficacy and safety of EA as an adjunctive therapy during the perioperative period of rotator cuff repair. Patients and Methods: This single-center, subject-and-assessor-blinded, randomized, sham-controlled trial will enroll 112 participants diagnosed with rotator cuff tears and who are scheduled to undergo unilateral arthroscopic rotator cuff repair (ARCR). Participants will be allocated at a 1:1 ratio to receive either EA or sham electroacupuncture (SEA) (using blunt-tip needles and no electrical current). Treatments will be will be administered 2 hours before surgery, 2 hours after surgery and once daily for the following surgery for 2 days (4 treatment sessions in total), and then be followed up for another 1 week. The primary outcome is the changes in visual analogue scale (VAS) scores for resting pain in the affected shoulder. The secondary outcome measures include VAS scores for pain during movement of the affected shoulder, limb swelling scores, dosage of postoperative analgesic drugs, frequency of postoperative nausea and vomiting, heart rate and blood pressure after the operation, sleep quality during the hospital stay. Conclusion: This pilot study will discuss whether EA is a valuable adjunct in postoperative care at relieving pain and improving patients’ quality of life. This RCT will inform the design of a further full-scale trial. Trial Registration: Chinese Clinical Trials Registry, ChiCTR2500103323. Registered on 28 May 2025.