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

NCT07490938 | Not Yet Recruiting

• 2 other identifiers: LCLX2026001GZY-KJS-2025-061
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Breast Cancer Survivors; Endocrine Therapy-Induced Joint Pain

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• The pain severity score of the Brief Pain Inventory-Short Form

  Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks

• The pain interference score of the Brief Pain Inventory-Short Form

  Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks

• The Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES) scale

  Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks

• The Patient-Reported Outcomes Measurement Information System Global Health scale (PROMIS Global Health)

  Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks

• The EuroQol 5-Dimension 5-Level (EQ-5D-5L)

  Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks

Other Outcomes (4)

• The Quantity Analgesic Questionnaire (QAQ)

  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

  At the end of 8 weeks of treatment

Study Arms (3)

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.

Procedure: Electroacupuncture Group

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.

Procedure: Auricular Acupressure Group

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.

Interventions

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.

Electroacupuncture Group

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.

Auricular Acupressure Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Teaching Hospital of Tianjin University of Traditional Chinese Medicine: lead

Study Sites (4)

Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital

Tianjin, China

Location

Tianjin Medical University Cancer Institute & Hospital

Tianjin, China

Location

Affiliated Hospital of Qinghai University

Xining, China

Location

Qinghai Provincial Hospital of Traditional Chinese Medicine

Xining, China

Location

Study Officials

• Li Li

  First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

  STUDY CHAIR

Central Study Contacts

Li Li

CONTACT

86+18222626653; lilitcm@foxmail.com

Jing Xue

CONTACT

xuejing506@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Breast Cancer Endocrine Therapy-Related Joint Pain Research

Study Record Dates

• First Submitted: March 12, 2026
• First Posted: March 24, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)