Fibromyalgia Clinical Trial
Official title:
QOL Efficacy of Adapted Physical Activity for Patients With Fibromyalgia : Single-center, Prospective, Randomized With Biological and Cerebral Evaluation
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".
Fibromy'activ, an adapted physical activity program (APA) for patients with fibromyalgia,
aims to provide lasting symptomatic relief, to favorably influence the life course, to
identify mechanisms of action and to define a reproducible interdisciplinary protocol.
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 . In France, the
prevalence of co-morbidities is increased in pain patients . There is a significant impact on
health care systems. It is very expensive for the society of about € 7,900 / patient / year.
The fibromyalgia population managed at the Center for Assessment and Treatment of Pain CHU
Timone (CETD), is characterized as follows: 50 years of average age, 85% of women with
children in 80% of cases. 60% have a level of education lower than the baccalaureate, less
than 30% have a professional activity. The duration of the pain before the first consultation
is on average 8.1 years. The SPICE score is above average which indicates a higher level of
precariousness. It is associated with dysfunctional pain adjustment strategies, psychological
distress, low acceptance and poor quality of life. The characteristics are close to European
studies
Natural evolution can lead to a total physical, psychological, social deconditioning. A link
has been established between the severity of this pathology, a provider of precariousness and
the poor physical condition, related to physical inactivity. The reverse has been described ,
so the practice of APA brings a significant reduction in symptoms .
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 (level of proof
A), 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".
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