Electroacupuncture Versus Auricular Acupressure Versus WaitliSt Control for Endocrine Therapy-Related Joint Pain in Patients With Breast Cancer (EASE): Study Protocol for a Pragmatic Multicenter Randomised Controlled Trial.

Abstract

BackgroundThe incidence of breast cancer has been steadily increasing in recent years. Endocrine therapy, as a first-line treatment, is typically required for 5 to 10 years. However, joint pain is one of the most common adverse effects, affecting 50%-70% of patients and significantly compromising treatment adherence and quality of life. Current management strategies have limited efficacy. Electroacupuncture has been shown to alleviate joint pain intensity and improve related symptoms, but the need for frequent hospital visits imposes a logistical burden on patients and their families, which may reduce adherence and limit accessibility. Auricular acupressure offers a simple and safe alternative that provide sustained stimulation, and facilitates hospital-guided, home-based self-management between clinic visits. This trial aims to evaluate the effectiveness and safety of electroacupuncture and auricular acupressure versus waitlist control for endocrine therapy-related joint pain in patients with breast cancer.Methods and analysisThis multicentre, pragmatic, three-arm randomised controlled trial will enrol 200 eligible participants with breast cancer experiencing endocrine therapy-related joint pain. Participants will be randomised in a 2:2:1 ratio to receive electroacupuncture, auricular acupressure, or waitlist control. The primary outcome is the change from baseline to week 8 in the Brief Pain Inventory-Short Form (BPI-SF) worst pain score. Secondary outcomes include the BPI-SF pain severity and pain interference scores, the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health scale, the Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES), the EuroQol-5 Dimension 5-Level (EQ-5D-5L), the Quantitative Analgesic Questionnaire (QAQ), and the Credibility/Expectancy Questionnaire (CEQ). Intervention adherence, endocrine therapy usage, and adverse events will also be recorded. Analyses will follow the modified intention-to-treat principle. The trial will compare each active intervention with the waitlist control and assess whether auricular acupressure is non-inferior to electroacupuncture.Ethics and DisseminationThis study protocol has been approved by the ethics committees of the participating institutions. The trial results will be disseminated through peer-reviewed publications and conference presentations.