Electroacupuncture vs. Auricular Acupressure vs. Waitlist Control for Breast Cancer Endocrine Therapy-Related Joint Pain

Официальное название

Electroacupuncture Versus Auricular Acupressure Versus WaitliSt Control for Endocrine Therapy-related Joint Pain in Patients With Breast Cancer (EASE): A Pragmatic Multicenter Randomised Controlled Trial

Обзор

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.

Вмешательства

• Процедура Electroacupuncture Group
  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
• Процедура Auricular Acupressure Group
  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 perceive

Первичные конечные точки

• The Worst Pain score of the Brief Pain Inventory-Short Form [Срок оценки: Baseline, 4 weeks, 8 weeks, 12weeks, 16 weeks]

Вторичные конечные точки (6)

• The pain severity score of the Brief Pain Inventory-Short Form [Срок оценки: Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks]
• The pain interference score of the Brief Pain Inventory-Short Form [Срок оценки: Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks]
• The Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES) scale [Срок оценки: Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks]
• The Patient-Reported Outcomes Measurement Information System Global Health scale (PROMIS Global Health) [Срок оценки: Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks]
• The EuroQol 5-Dimension 5-Level (EQ-5D-5L) [Срок оценки: Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks]
• Credibility/Expectancy Questionnaire（CEQ） [Срок оценки: Baseline, 4 weeks, 8 weeks]

Критерии участия

Критерии включения

• 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;
• Self-reported worst joint pain score of ≥3 on a 0-10 Visual Analogue Scale (VAS) during the past week;
• Life expectancy ≥1 year;
• Voluntarily sign the informed consent.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 4 центра

• Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital — Тяньцзинь
• Tianjin Medical University Cancer Institute & Hospital — Тяньцзинь
• Affiliated Hospital of Qinghai University — Xining
• Qinghai Provincial Hospital of Traditional Chinese Medicine — Xining

Идентификаторы

NCT: NCT07490938 · LCLX2026001 · GZY-KJS-2025-061

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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