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.
Histologically or cytologically confirmed breast cancer, stage I-IV, according to the AJCC Cancer Staging Manual (8th edition);
Aged 18-75 years;
Experiencing joint pain attributed to endocrine therapy, including localized or generalized joint pain, with symptoms persisting for at least 1 week;
Completion of all planned surgeries, chemotherapy, and radiotherapy, with a scheduled continuation of endocrine therapy for at least 1 additional year;
Bone metastases involving the same site as the affected joint attributed to endocrine therapy;
History of fracture or surgery involving the affected joints within the past 6 months;
Implanted electronic medical devices;
Not suitable for acupuncture, including but not limited to bleeding tendencies (e.g. coagulation disorders or purpura) or local skin lesions at the intended acupoint sites.
Parallel
Electroacupuncture Group
Procedure/SurgeryElectroacupuncture 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.
Auricular Acupressure Group
Procedure/SurgeryThe 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.
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).
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.
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.
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.
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).
The Quantity Analgesic Questionnaire (QAQ)
The Quantity Analgesic Questionnaire (QAQ) is a clinical assessment tool designed to quantify the total amount of analgesic medication consumed by a patient over a specific period. By accounting for both the potency and the frequency of various medications, the questionnaire provides a standardized numerical value representing the patient's medication burden. The scale typically yields a score where the minimum value is 0, with no fixed maximum value as the total depends on the specific dosages and variety of medications reported. Higher scores mean a worse outcome, as they indicate a higher quantity of analgesic intake and a greater pharmacological burden.
Safety and acupuncture-related adverse events
Treatment Adherence Assessed by the Number of Completed Treatment Sessions
Treatment adherence is assessed by calculating the total number of scheduled intervention sessions the participant completed. Min: 0, Max: 16. Higher scores indicate a better outcome (greater treatment adherence).
Adherence Rate to Endocrine Therapy Based on Patient Diaries
Treatment adherence is assessed using a daily patient diary, where participants record their intake of oral endocrine therapy medications. The adherence rate is calculated as the percentage of days the participant successfully took the medication as prescribed out of the total number of days in the assessment period. Min: 0%, Max: 100%. Higher scores indicate a better outcome (higher treatment adherence).
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