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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

197 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-05

Study Completion Date

2025-07-07

Brief Summary

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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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Detailed Description

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Conditions

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Musculoskeletal Pain Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Single blind

Study Groups

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Experimental arm

Auriculotherapy for analgesic use

Group Type EXPERIMENTAL

Auriculotherapy for analgesic use

Intervention Type DEVICE

The ASP will be applied to specific pain points

Controle arm

Placebo auriculotherapy

Group Type PLACEBO_COMPARATOR

Placebo auriculotherapy

Intervention Type DEVICE

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

Interventions

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Auriculotherapy for analgesic use

The ASP will be applied to specific pain points

Intervention Type DEVICE

Placebo auriculotherapy

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No