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NCT Number: NCT07490938

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

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.

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Key information

Conditions

Breast Cancer Survivors Endocrine Therapy-Induced Joint Pain

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital, Tianjin, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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).

  5. 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.

  6. 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.

Other outcomes

  1. 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.

  2. Safety and acupuncture-related adverse events

    Time frame: At the end of 8 weeks of treatment

  3. 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).

  4. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Jing Xue

CONTACT

[email protected]

Li Li

CONTACT

[email protected]

86+18222626653

Sponsors and collaborators

Lead sponsor

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

Other

Registry information

Official study title

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

Acronym: EASE

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 24, 2026
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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