Phase 3 Study Randomized Evaluating the Efficacy of Auriculotherapy in Patients With Musculoskeletal Pain by Aromatase Inhibitors

Auriculotherapy is a complementary medicine, with few side effects, without contraindication, inexpensive and not very restrictive.Its efficacy has been found in several tests especially for the treatment of intraoperative pain. It remains more controversial in other indications. Evaluation of the value of auriculotherapy is often difficult because of the methodological limitations of the trials conducted. In the daily practice, the auriculotherapy is proposed to improve the articular pains of patients treated by AA. This Phase III study aims at validate this approach.

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Key information

Conditions

Musculoskeletal Pain Breast Cancer Breast Diseases Breast Neoplasms Muscular Diseases Musculoskeletal Diseases Neoplasms Neoplasms by Site Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centre François Baclesse, Caen, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Patient over 18 years of age
Patients with anti-aromatases in adjuvant treatment of breast cancer
Menopausal women
Treatment with aromatase inhibitors (anti-aromatase, AA) initiated for more than 3 months. In the case of a change in anti-aromatase, the last treatment must be started for more than 3 months.
Musculoskeletal pain appearing or increased under AA:
Overall pain score of QCD ≥3 (on a scale of 0 to 10)
Pain on at least 2 sites
Pain for at least 3 months
History of radiotherapy and / or adjuvant chemotherapy authorized
Patients may have received tamoxifen
Patient affiliated to a social security system
Patient mastering the French language and able to complete the evaluation questionnaires
Free and Informed Consent

Exclusion criteria

Patients who have already undergone treatment in auriculotherapy for the same indication
Patient benefiting at the same time from a PNCAVT (acupuncture or homeopathy) for musculoskeletal pain
Wearing hearing aids hindering the placement of semi-permanent needles (ASP)
Wearing of a valve prosthesis
Patient under guardianship or unable to give informed consent
Patient unable to undergo medical follow-up for geographical, social or psychopathological reasons

Treatment and study plan

Auriculotherapy for analgesic use

Device

The ASP will be applied to specific pain points

Placebo auriculotherapy

Device

The ASP will be applied to placebo points (not specific to pain)

Primary outcomes

Decrease in the overall pain score

Time frame: 3 months after auriculotherapy initiation

The proportion of patients with a 2-point or greater decrease in the overall pain

Sponsors and collaborators

Lead sponsor

Centre Francois Baclesse

Other

Registry information

Official study title

Phase 3 Study Randomized Against Placebo, Evaluating the Efficacy of Auriculotherapy in Patients With Musculoskeletal Pain by Aromatase Inhibitors in Adjuvant Treatment of Breast Cancer (TRIPLE-A)

Acronym: TRIPLE-A

Important dates

Study start: 2017
Primary completion: 2025
Study completion: 2025
First posted: Mar 30, 2017
Registry last updated: Sep 12, 2025

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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