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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.
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 :
The patients included in the study will receive in addition to the training program, taking into bio-psycho-social multidisciplinary.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| training group | Experimental | The training program consists of three sessions of 45 minutes of physical activity per week for 2 years. During the first 6-9 months, two individual workouts, supervised by a physiotherapist and a session in Living. Depending on the capacity and exercise tolerance of the patient, patients realize the second phase of training until 2 years of the study: three exercise sessions from 45 to 60 minutes per week of which group session led by a professor of Adapted Physical Activity (APA) and 2 autonomous sessions. Thermal stimulation with test thermode Thermic stimulations (tonic heat pain stimulation and cold-pressor test) are used to test excitatory and inhibitory pain mechanisms |
|
| control group | Placebo Comparator | 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 than that of the training group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| thermode (TSA-II model) | Device | thermal stimulation with test thermode |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pain as assessed by Visual analog scale | baseline to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| salivary cortisol | three times : 3th visit at Day 0, 4th visit between month 6 and 9, 5th visit at month 24 | baseline to 24 months |
| heart rate variability | three times : 2th visit at Day -7, 4th visit between month 6 and 9, 5th visit at month 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gildas L'HEVEDER, Doctor | CHRU BREST | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHRU Brest | Brest | 29200 | France | |||
| CHU Rennes |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30782715 | Derived | Le Fur Bonnabesse A, Cabon M, L'Heveder G, Kermarrec A, Quinio B, Woda A, Marchand S, Dubois A, Giroux-Metges MA, Rannou F, Misery L, Bodere C. Impact of a specific training programme on the neuromodulation of pain in female patient with fibromyalgia (DouFiSport): a 24-month, controlled, randomised, double-blind protocol. BMJ Open. 2019 Jan 25;9(1):e023742. doi: 10.1136/bmjopen-2018-023742. |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Adapted Physical Activity |
| Other |
|
| Physical activity | Other |
|
| baseline to 24 months |
| Fibromyalgia Impact Questionnaire (FIQ) | baseline to 24 months |
| Hospital Anxiety Depression Scale (HADS) | baseline to 24 months |
| Pressure Pain Threshold (PSS) | baseline to 24 months |
| International Physical Activity Questionnaire (IPAQ) | baseline to 24 months |
| Pittsburgh Sleep Quality Index (PSQI) | baseline to 24 months |
| Saint-Antoine Pain Questionnaire (SAPQ) | baseline to 24 months |
| Rennes |
| 35033 |
| France |
| D009422 |
| Nervous System Diseases |