Fibromyalgia Clinical Trial
— DOUFISPORTOfficial title:
Impact of a Specific Training Program on the Neuromodulation of Pain in Fibromyalgia Subjects
Verified date | April 2022 |
Source | University Hospital, Brest |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | October 21, 2021 |
Est. primary completion date | February 21, 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: - Diagnosis of fibromyalgia is clearly established by the criteria of the American College of Rheumatology (ACR). - Body Mass Index (BMI) between 18.5 and 24.9 kg / m² (normal weight at HAS). - Spontaneous pain intensity greater than 3/10 on a VAS. Pain triggered by palpation must be equal to or greater than 4/10 of the EVA. - Patients with a medical certificate to the sport. Exclusion Criteria: - Systemic disease, whether or not, generating pain musculoskeletal - Heart disease, respiratory, endocrine, metabolic or neurological. - Patients and patient pregnant lactating or planning to become pregnant within 2 years. - Patients who have changed in the last 2 months any pharmacological treatment. - Patients taking drugs that affect the heart rate variability - Patients who have conditions that could affect the cortisol levels - Patients with a psychiatric diagnosis of schizophrenia, delusional disorder and other personality disorders - Patients taking substances affecting cortisol secretion |
Country | Name | City | State |
---|---|---|---|
France | CHRU Brest | Brest | |
France | CHU Rennes | Rennes |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Brest |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain as assessed by Visual analog scale | baseline to 24 months | ||
Secondary | 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 | |
Secondary | heart rate variability | three times : 2th visit at Day -7, 4th visit between month 6 and 9, 5th visit at month 24 | baseline to 24 months | |
Secondary | Fibromyalgia Impact Questionnaire (FIQ) | baseline to 24 months | ||
Secondary | Hospital Anxiety Depression Scale (HADS) | baseline to 24 months | ||
Secondary | Pressure Pain Threshold (PSS) | baseline to 24 months | ||
Secondary | International Physical Activity Questionnaire (IPAQ) | baseline to 24 months | ||
Secondary | Pittsburgh Sleep Quality Index (PSQI) | baseline to 24 months | ||
Secondary | Saint-Antoine Pain Questionnaire (SAPQ) | baseline to 24 months |
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