Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| GZY-KJS-2025-061 | Other Grant/Funding Number | National Administration of Traditional Chinese Medicine Scientific and Technological Project |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electroacupuncture Group | Experimental | The electroacupuncture protocol follows a standardized framework consisting of a core acupoint formula combined with individualized local points. The core formula includes GV26 (Shuigou), LI4 (Hegu), PC6 (Neiguan), ST36 (Zusanli), GB34 (Yanglingquan), LR3 (Taichong), and SP6 (Sanyinjiao). For the individualized component, 1 to 4 additional acupoints are selected based on the two most severely affected joint areas. Acupuncture frequency: Acupuncture is performed twice a week, 30 minutes each time, for 8 weeks, totaling 16 sessions. |
|
| Auricular Acupressure Group | Experimental | Auricular point sticking prescription: Basic auricular points combined with the corresponding auricular points of the affected joints. Auricular point frequency: Twice a week, the sticker is removed after 2 days and reapplied the next day, for 8 weeks, totaling 16 sessions. |
|
| Waitlist Control Group | No Intervention | After random grouping, only the basic treatment plan is adopted, and no acupoint stimulation therapy is received within 16 weeks. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electroacupuncture Group | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline, 4 weeks, 8 weeks, 12weeks, 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks |
| The pain interference score of the Brief Pain Inventory-Short Form |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Li Li | Contact | 86+18222626653 | lilitcm@foxmail.com | |
| Jing Xue | Contact | xuejing506@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Li Li | First Teaching Hospital of Tianjin University of Traditional Chinese Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital | Tianjin | China |
IPD will not be shared to protect participant privacy and comply with institutional data governance policies.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Auricular Acupressure Group | Procedure | 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. |
|
The mean of 7 items (general activity, mood, walking, work, relations, sleep, enjoyment). Min: 0, Max: 10. Higher scores mean a worse outcome. |
| 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. | 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). | 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. | 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. | Baseline, 4 weeks, 8 weeks |
| Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks |
| Safety and acupuncture-related adverse events | At the end of 8 weeks of treatment |
| 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). | At the end of 8 weeks of treatment |
| 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). | Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks |
| Tianjin Medical University Cancer Institute & Hospital | Tianjin | China |
|
| Affiliated Hospital of Qinghai University | Xining | China |
|
| Qinghai Provincial Hospital of Traditional Chinese Medicine | Xining | China |
|