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

March 31, 2026 updated by: Li Li, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

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

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Tianjin, China
        • Tianjin Medical University Cancer Institute & Hospital
        • Contact:
      • Tianjin, China
        • Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
        • Contact:
      • Xining, China
        • Affiliated Hospital of Qinghai University
        • Contact:
      • Xining, China
        • Qinghai Provincial Hospital of Traditional Chinese Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Electroacupuncture Group

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

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.
Experimental: Auricular Acupressure Group

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
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.
No Intervention: Waitlist Control Group
After random grouping, only the basic treatment plan is adopted, and no acupoint stimulation therapy is received within 16 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Worst Pain score of the Brief Pain Inventory-Short Form
Time Frame: Baseline, 4 weeks, 8 weeks, 12weeks, 16 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
The pain severity score of the Brief Pain Inventory-Short Form
Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks
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
Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks
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
Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks
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)
Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks
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)
Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks
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）
Time Frame: Baseline, 4 weeks, 8 weeks
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Quantity Analgesic Questionnaire (QAQ)
Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks
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.
Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks
Safety and acupuncture-related adverse events
Time Frame: At the end of 8 weeks of treatment
At the end of 8 weeks of treatment
Treatment Adherence Assessed by the Number of Completed Treatment Sessions
Time Frame: At the end of 8 weeks of treatment
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
Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

Investigators

  • Study Chair: Li Li, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

March 12, 2026

First Submitted That Met QC Criteria

March 18, 2026

First Posted (Actual)

March 24, 2026

Study Record Updates

Last Update Posted (Actual)

April 6, 2026

Last Update Submitted That Met QC Criteria

March 31, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • LCLX2026001
  • GZY-KJS-2025-061 (Other Grant/Funding Number: National Administration of Traditional Chinese Medicine Scientific and Technological Project)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will not be shared to protect participant privacy and comply with institutional data governance policies.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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