Fibromyalgia Clinical Trial
Official title:
QOL Efficacy of Adapted Physical Activity for Patients With Fibromyalgia : Single-center, Prospective, Randomized With Biological and Cerebral Evaluation
Verified date | August 2020 |
Source | Assistance Publique Hopitaux De Marseille |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Fibromyalgia affects at least 4% of the population. This chronic painful pathology is a
source of social exclusion with a major impact on professional activity;
To our knowledge, no study has demonstrated with sufficient evidence the effectiveness of the
practice of well-defined adapted physical activity (APA) via a reproducible program of
physical activity that has been the mechanisms of action that underlie this efficacy by
biology and functional brain imaging (PET CT) in this context.
In addition, the publications mention recruitment difficulties, a high drop-out rate and a
difficult maintenance of the benefits of physical activity in the long term, or even a return
to the initial level after a few months.
The programs evaluated do not seem to take into account the peculiarities of patients, their
coping coping strategies, associated with chronic pain and disability . In order to reinforce
the durability of the benefits of our intervention, we make modulating factors of "coping"
styles of therapeutic targets in their own right, as well as muscular strength, aerobic
capacity or flexibility. Thus, cognitive-behavioral therapy (CBT) procedures validated in the
treatment of chronic pain are adapted and transposed to our APA program in order to propose
specific strategies.
"Fibromy'activ" aims to act upstream and downstream of the formation of health inequalities
found in the population suffering from fibromyalgia and favored by the natural evolution of
the disease: These workshops tend to favorably influence the course of life and to define a
reproducible interdisciplinary protocol.
It is a question of making accessible and reproducible the practice of adapted physical
activity (APA), non-medicinal therapeutic recommended by the HAS since 2010 , by the EULAR in
2016, but not refunded, poorly protocolized therefore not reproducible and little
implementation. It is part of the spirit of the amended Health Act with the coming into force
of the application decree since March 2017 "Physical Prescription".
Status | Completed |
Enrollment | 80 |
Est. completion date | August 10, 2020 |
Est. primary completion date | June 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: Female or male subject, 18 years of age or older, not pregnant, not breastfeeding, not deprived of liberty; - Subject with fibromyalgia meeting the criteria of the American College of Rheumatology (ACR) - Subject managed by the Center for Assessment and Pain Management of CHU Timone or addressed to it in consultation / day hospital; - Subject free from any general illness or serious psychiatric disorders, and any infectious, inflammatory, tumoral, vascular, degenerative or traumatic pathology of the central nervous system, determined during the interrogation; - Subject not having a history of alcoholism or drug addiction, - Subject with no contraindication to PET scintigraphy (pregnancy and lactation), - Subject with no indication of physical activity; - Subject whose general state and comprehension of French makes it possible to complete a questionnaire; - Topic with average pain> 4/10 at EN - Subject affiliated with Social Security - Subject who has read, understood and signed informed consent after informing and accepting protocol rules Exclusion Criteria: • Major subject under legal protection or unable to express their consent: L1121-8 of the CSP - Subject presenting a contraindication to the practice of physical activity, to scintigraphic scanning by PET, - Subject deprived of liberty following a judicial or administrative decision - Subject with psychiatric illness or Personality Disorder making group work difficult - Subject refusing to participate in the study or not signing the consent |
Country | Name | City | State |
---|---|---|---|
France | Assistance Publique Des Hopitaux de Marseille | Marseille | Paca |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique Hopitaux De Marseille |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The Fibromyalgia Impact Questionnaire | FIQ Questionnaire was developed in 1991 as a specific measuring instrument for assessing the health status of patients with fibromyalgia. The validation of this adaptation and the evaluation of its psychometric properties were carried out by Perrot in 2002. self-administered, exploring ten dimensions of the impact of pathology on quality of life. Scale from 0 to 10, a high figure corresponding to a greater disadvantage or handicap. The analysis of the evolution of the FIQ over time, spontaneously or under treatment, is therefore dimension by dimension, in order to maintain a clinical informative value, as well as by an aggregate score ( corresponding to the algebraic sum of the dimensions evaluated, compared to 100 units). A weighting of the aggregate score is expected when the patient can not assess impact on professional activity. |
1 hour |
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