Auriculotherapy Treatment in Fibromyalgia (Fib-Auric)

• ClinicalTrials.gov Identifier: NCT02764788
• Recruitment Status: Completed
• First Posted: May 6, 2016
• Last Update Posted: August 31, 2022
• Sponsor: Hopital Foch
• Information provided by (Responsible Party): Hopital Foch

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Fibromyalgia	Other: Specific auriculotherapy; Other: non-specific auriculotherapy; Other: seed auriculotherapy	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Actual Study Start Date: April 27, 2016
• Actual Primary Completion Date: March 9, 2022
• Actual Study Completion Date: March 9, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Effect of otherapy on the health of patients with fibromyalgia syndrome [ Time Frame: 3 months ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

France

Hopital Foch

Suresnes, France, 92150

Sponsors and Collaborators

Hopital Foch

Investigators

• Principal Investigator: Mireille Michel-Cherqui, MD; Hopital Foch

More Information

• Responsible Party: Hopital Foch
• ClinicalTrials.gov Identifier: NCT02764788
• Other Study ID Numbers: 2015/27; 2015-A01842-47 ( Other Identifier: ANSM )
• First Posted: May 6, 2016
• Last Update Posted: August 31, 2022
• Last Verified: August 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Hopital Foch:

Auriculotherapy

Additional relevant MeSH terms:

Fibromyalgia; Myofascial Pain Syndromes; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases