Impact of a Specific Training Program on the Neuromodulation of Pain in Fibromyalgia Subjects
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      Fibromyalgia affects 1.4 now 2.2% of the general population whose symptom is the presence of
      widespread pain in all four quadrants of the body. Currently, there is no causal treatment of
      fibromyalgia syndrome.

      The aim of this study is the evaluation of a specific training program on controls of pain in
      fibromyalgia patients by balancing the stress axis.

      The primary endpoint is the improvement in the Visual Analogue Scale VAS difference) measured
      during the test of the thermode (difference between the average VAS measured between the 10th
      and 40th second of P1 and the average VAS measured between the 10th and 40th of the second
      P3) between D0 (3rd consultation) and M24 (5th consultation - end of study visit), which will
      be compared in the two groups..Salivary cortisol is also tested.
    

Detailed description: 
      A specific training program under the guidance of a physiotherapist, a professor of Adapted
      Physical Activity (APA) and individualized whose objective is to strengthen the
      parasympathetic tone and modulate the reactivity of the sympathetic system and the report of
      the Hypothalamic-Pituitary-Adrenal (HPA) axis.This training program consists of three
      sessions of 45 minutes of physical activity per week for 2 years. The exercise intensity is
      initially very low and will be gradually increased according to your abilities and your
      tolerance to stress. A 6-Minute Walk Test (6MWT) will be carried out by the physiotherapist
      and by Professor APA, every 6 months to monitor the progression. For tracking the training
      program, a phone call is scheduled every week during the first 3 months, then a phone call
      every 15 days during the following months until the end of the study.Evaluation of
      neuromodulation of pain will be measured thanks to thermodeTest , experimental method
      implementing a tonic thermal pain using a "Peltier type Thermode" 3 cm2 model TSA II and
      immersion in a bath of cold water.

      Participants will be randomly assigned to 2 groups, "Training" group or "Control" group.

      The control group is a training program supervised by physical therapists and teachers in
      Adapted Physical Activity, identical to the active program in its follow-up, but the
      intensity of the sessions is lower.

      Study schedule :

        -  1st visit : screening visit at D-30

        -  2nd visit : inclusion at D-7

        -  3rd visit at D0

        -  4st visit between M6 and M9

        -  5th visit at M24

      The patients included in the study will receive in addition to the training program, taking
      into bio-psycho-social multidisciplinary.
    

Intervention name(s): thermode (TSA-II model); Adapted Physical Activity; Physical activity
Intervention type(s): Device; Other; Other
Intervention description(s): thermal stimulation with test thermode
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: VAS; thermode test; training program; 6MWT