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

Not Applicable

Recruiting

• Conditions: Breast Cancer; Musculoskeletal Pain
• Interventions: Device: Auriculotherapy for analgesic use; Device: Placebo auriculotherapy

• Registration Number: NCT03096041
• Lead Sponsor: Centre Francois Baclesse

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-20
• Study First Submitted QC: 2017-03-24
• Study First Posted: 2017-03-30
• Study Start: 2017-07-05
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-04
• Last Update Posted: 2024-07-05
• Primary Completion: 2025-07
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 216

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental arm	Auriculotherapy for analgesic use	Auriculotherapy for analgesic use
Controle arm	Placebo auriculotherapy	Placebo auriculotherapy

Primary Outcome Measures

Name	Time	Method
Decrease in the overall pain score	3 months after auriculotherapy initiation	The proportion of patients with a 2-point or greater decrease in the overall pain

Trial Locations

Locations (7)

IGR; 🇫🇷 Villejuif, France

Hôpital Cognac-Jay - Forcilles; 🇫🇷 Férolles-Attilly, France

Centre Oscar Lambret; 🇫🇷 Lille, France

Groupe Hospitalier Paris St Joseph; 🇫🇷 Paris, France

Centre François Baclesse; 🇫🇷 Caen, France

Hôpital Privé Paul d'Egine; 🇫🇷 Champigny sur Marne, France

CHU Grenoble; 🇫🇷 Grenoble, France