Fib-Auric: Auriculotherapy Treatment in Fibromyalgia

Sponsor

Hopital Foch (Other)

Overall Status

Recruiting

CT.gov ID

NCT02764788

Collaborator

(none)

100

Enrollment

Location

Arms

77.1

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

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	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Actual Study Start Date :

Apr 27, 2016

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Oct 1, 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

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

Effect of otherapy on the health of patients with fibromyalgia syndrome [3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

	Site	City	State	Country	Postal Code
1	Hopital Foch	Suresnes		France	92150

Sponsors and Collaborators

Hopital Foch

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hopital Foch

ClinicalTrials.gov Identifier:

NCT02764788

Other Study ID Numbers:

2015/27
2015-A01842-47

First Posted:

May 6, 2016

Last Update Posted:

Aug 30, 2021

Last Verified:

Aug 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Hopital Foch

Auriculotherapy

Additional relevant MeSH terms:

Fibromyalgia

Myofascial Pain Syndromes

Study Results

No Results Posted as of Aug 30, 2021