Auriculotherapy Treatment in Fibromyalgia (Fib-Auric)

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.

Study Overview

• Status: Completed
• Conditions: Fibromyalgia
• Intervention / Treatment: Other: Specific auriculotherapy; Other: non-specific auriculotherapy; Other: seed auriculotherapy

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Suresnes, France, 92150
    • Hôpital Foch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Specific auriculotherapy; Auriculotherapy on specific points with needles	Other: Specific auriculotherapy; Specific auriculotherapy with needles
Sham Comparator: Non-specific auriculotherapy; Auriculotherapy on non-specific auriculotherapy points with needles	Other: non-specific auriculotherapy; non-specific auriculotherapy with needles
Placebo Comparator: Seed auriculotherapy; Auriculotherapy on non-specific auriculotherapy points with seeds	Other: seed auriculotherapy; non-specific auriculotherapy with seeds

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Effect of otherapy on the health of patients with fibromyalgia syndrome	3 months

Collaborators and Investigators

• Sponsor: Hopital Foch

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2016
• Primary Completion (Actual): March 9, 2022
• Study Completion (Actual): March 9, 2022

Study Registration Dates

• First Submitted: May 4, 2016
• First Submitted That Met QC Criteria: May 5, 2016
• First Posted (Estimate): May 6, 2016

Study Record Updates

• Last Update Posted (Actual): August 31, 2022
• Last Update Submitted That Met QC Criteria: August 30, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Auriculotherapy
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: 2015/27; 2015-A01842-47 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No