Auriculotherapy Treatment in Fibromyalgia

NCT ID: NCT02764788

Last Updated: 2022-08-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-27
• Study Completion Date: 2022-03-09

Brief Summary

Fibromyalgia (FM) is the most common cause of diffuse pain in the bones and joints, and one of the most frequent causes of referral to the pain management unit. It affects mainly women; they are referred by a rheumatologist, an internal medicine physician or by their family physician.

FM produces various degrees of disability and pain, and has an important impact on quality of life. Sleep disorders, fatigue and cognitive dysfunctions are almost always part of the clinical presentation. The wide range of symptoms and signs, the unknown etiology, the lack of efficacy of pharmacological treatments make management of FM a very difficult task. In France the consensus includes limitation of pharmacological treatment, encouraging physical rehabilitation and referring the patients to a specialized pain clinic where multidisciplinary management will be undertaken. In our hospital the investigators favor non pharmacological therapies and propose to the FM patients to learn relaxation and self-hypnosis, physical rehabilitation and use of trans cutaneous electrical neurostimulation.

Auriculotherapy (AT) is a complementary therapy, based on the idea that the ear is a microsystem which reflects the entire body, represented on the auricle, the outer portion of the ear. Mapping of the auricle has been described, according to the fact that pathology of different organs can induce specific changes in the auricle, for example color change or sensitivity. Treating specific areas, which somehow would be "connected" to the affected organ could also improve the functioning of the body or relieve pain. AT uses placement of needles at points tailored to the patient's pathology. Whatever the mechanisms involved, the effectiveness of ATis currently supported by randomized controlled trials. It is validated by WHO since 1987, mapped in an international nomenclature initially proposed by Nogier.

The investigators regularly use AT in FM patients in our pain management unit to alleviate symptoms as pain, sleep disorders, anxiety. The investigators established a clinical trial in this population to assess impact of FM (assessed with Fibromyalgia Impact Questionnaire) following 3 months of AT management (Primary Outcome). Sleep disorder, fatigue, anxiety and depression, cognitive and physical dysfunction are also evaluated as secondary outcomes. The remnant effect of AT is also evaluated, 3 month after the end of the treatment by the same tests.

Conditions

Fibromyalgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Specific auriculotherapy

Auriculotherapy on specific points with needles

Group Type: EXPERIMENTAL

Specific auriculotherapy

Intervention Type: OTHER

Specific auriculotherapy with needles

Non-specific auriculotherapy

Auriculotherapy on non-specific auriculotherapy points with needles

Group Type: SHAM_COMPARATOR

non-specific auriculotherapy

Intervention Type: OTHER

non-specific auriculotherapy with needles

Seed auriculotherapy

Auriculotherapy on non-specific auriculotherapy points with seeds

Group Type: PLACEBO_COMPARATOR

seed auriculotherapy

Intervention Type: OTHER

non-specific auriculotherapy with seeds

Interventions

Specific auriculotherapy

Specific auriculotherapy with needles

Intervention Type: OTHER

non-specific auriculotherapy

non-specific auriculotherapy with needles

Intervention Type: OTHER

seed auriculotherapy

non-specific auriculotherapy with seeds

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• fibromyalgia (criteria from ACR)

Exclusion Criteria

• history or existing of inflammatory rheumatims, lupus, systemic diseases that may explain the pain syndrom
• history or existing of severe psychiatric desorder
• history or existing of hemophilia
• with anticoagulant treatment
• local counterindication to auriculotherapy
• valvular prosthesis
• auriculotherapy during the last 12 months
• new psychotherpeutic treatment which interfer with auriculotherapy
• pregnancy
• breath feeding
• RMI for the next 5 months

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hopital Foch

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mireille Michel-Cherqui, MD

Role: PRINCIPAL_INVESTIGATOR

Hopital Foch

Locations

Hopital Foch

Suresnes, , France

Countries

France

Other Identifiers

2015-A01842-47

Identifier Type: OTHER

Identifier Source: secondary_id

2015/27

Identifier Type: -

Identifier Source: org_study_id