The purpose of this pragmatic, multicenter, randomized controlled trial is to evaluate the clinical effectiveness and safety of electroacupuncture and auricular acupressure for improving joint pain related to endocrine therapy in breast cancer patients. A total of 200 participants will be recruited and randomly assigned to one of three groups: the Electroacupuncture Group (n=80), the Auricular Acupressure Group (n=80), or the Waitlist Control Group (n=40), using a central stratified block randomization method. The primary objective is to compare changes in Worst Pain Item score among the three groups from baseline to the end of the treatment period, as measured by the Brief Pain Inventory-Short Form (BPI-SF). Secondary objectives include assessing pain interference, overall health status through the PROMIS scale, and quality of life specifically related to endocrine therapy using the FACT-ES. Additionally, the study will evaluate analgesic medication use (QAQ), patient expectations (Acupuncture Expectancy Scale), treatment adherence, and the occurrence of adverse events. By comparing these interventions, this study aims to generate high-quality evidence for the management of treatment-related arthralgia in breast cancer survivors.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
200
Electroacupuncture is performed using the basic prescription combined with the prescription for the affected joints. Basic prescription: Shuigou (GV26), Hegu (LI4), Neiguan (PC6), Zusanli (ST36), Yanglingquan (GB34), Taichong (LR3), Sanyinjiao (SP6). On this basis, 1 to 4 additional acupoints are selected based on the two most severely affected joint areas. Needle selection: The acupuncture needles (40 or 75 mm x 0.25 mm gauge, and 40 mm x 0.18 mm gauge, Huatuo, Suzhou, China) will be used. An electroacupuncture stimulator (SDZ-V, Huatuo, Suzhou, China) will be used, delivering alternating frequencies of 2 Hz/10 Hz with no more than four electrode pairs simultaneously.
The auricular acupressure protocol is formed by combining the basic auricular point prescription and the auricular point prescription corresponding to the affected joints. The basic points include Shenmen, Sympathetic, Endocrine, and Subcortex, while the additional points are selected by the acupuncturist based on the 1-2 joint regions with the most pain as reported by the patient. Once identified, Vaccaria seed (Zhongyan Taihe, Beijing, China) is taped onto the points until the patient perceives a distinct sensation of soreness or tenderness. Participants will be instructed to apply pressure to each ear three times per day, pressing each side for approximately 3 minutes per session. The auricular patches will be removed 2 to 4 days after during a follow-up visit at the clinic.
Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
Tianjin, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, China
Affiliated Hospital of Qinghai University
Xining, China
Qinghai Provincial Hospital of Traditional Chinese Medicine
Xining, China
The Worst Pain score of the Brief Pain Inventory-Short Form
A single-item numeric rating scale. Min: 0, Max: 10. Higher scores mean a worse outcome (more severe pain).
Time frame: Baseline, 4 weeks, 8 weeks, 12weeks, 16 weeks
The pain severity score of the Brief Pain Inventory-Short Form
The mean of 4 items (worst, least, average, and pain "now"). Min: 0, Max: 10. Higher scores mean a worse outcome.
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks
The pain interference score of the Brief Pain Inventory-Short Form
The mean of 7 items (general activity, mood, walking, work, relations, sleep, enjoyment). Min: 0, Max: 10. Higher scores mean a worse outcome.
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks
The Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES) scale
A scale assessing quality of life in patients receiving endocrine therapy. Min: 0, Max: 76 (for the ES subscale). Higher scores mean a worse outcome.
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks
The Patient-Reported Outcomes Measurement Information System Global Health scale (PROMIS Global Health)
10 items assessing physical, mental, and social health. Results are typically converted to T-scores. Min: 0, Max: 100(standardized). Higher scores mean a better outcome (better health).
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks
The EuroQol 5-Dimension 5-Level (EQ-5D-5L)
It comprises two primary components: the EQ-5D-5L Index Score and the EQ Visual Analogue Scale (EQ VAS). For the Index Score, values typically range from less than 0 to 1, where higher scores indicate better health-related quality of life. The EQ VAS provides a self-rated assessment of overall health on a scale from 0 to 100, where higher scores represent better self-rated health.
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks
Credibility/Expectancy Questionnaire（CEQ）
It utilizes two different scoring formats-a 1-9 Likert scale and a 0%-100% percentage scale. The composite score for a single factor typically ranges from a minimum of 3 to a maximum of 27. Higher scores indicate a better outcome, representing a higher psychological expectation for symptom improvement.
Time frame: Baseline, 4 weeks, 8 weeks
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