JMIR Publications

ABSTRACT

Background:

Post-mastectomy pain syndrome (PMPS) is a prevalent chronic pain condition that occurs after breast cancer surgery, often impairing quality of life in breast cancer survivors. Despite its prevalence, no standardized treatment has been established. Acupuncture has been reported to be an efficacious intervention for the management of chronic pain and may be an effective treatment for PMPS.

Objective:

This study aims to assess the efficacy and safety of acupuncture for PMPS.

Methods:

This is a single-center, single-arm, prospective interventional study. Eligible participants are breast cancer patients who experience chronic postoperative pain in the chest, neck, or shoulder with a Numerical Rating Scale (NRS) score ≥4, are at least six months post–curative treatment, have no evidence of disease recurrence, and are not receiving anticancer treatment at enrollment. Participants receive acupuncture once weekly for 12 sessions, followed by a 4-week observation period. The primary endpoint is the change in the average pain NRS score from baseline to week 16.

Results:

The study commenced in October 2023 and is scheduled to continue through March 31, 2027. The first participant was enrolled on October 24, 2023.

Conclusions:

This study will evaluate the potential role of acupuncture in the management of PMPS. The results will contribute to the evidence base for acupuncture in PMPS and inform the design of future clinical studies. Clinical Trial: This study protocol was registered with the UMIN Clinical Trials Registry on August 14, 2023 (trial registration number: UMIN000051901).