Trial record 37 of 126 for:    fibromyalgia | Open Studies | Interventional Studies

Impact of a Specific Training Program on the Neuromodulation of Pain in Fibromyalgia Subjects (DOUFISPORT)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2015 by University Hospital, Brest
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest
ClinicalTrials.gov Identifier:
NCT02486965
First received: February 26, 2015
Last updated: June 30, 2015
Last verified: June 2015
  Purpose

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.


Condition Intervention
Fibromyalgia
Device: thermode (TSA-II model)
Other: Adapted Physical Activity
Other: Physical activity

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: Impact of a Specific Training Program on the Neuromodulation of Pain in Fibromyalgia Subjects

Resource links provided by NLM:


Further study details as provided by University Hospital, Brest:

Primary Outcome Measures:
  • Pain as assessed by Visual analog scale [ Time Frame: baseline to 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • salivary cortisol [ Time Frame: baseline to 24 months ] [ Designated as safety issue: No ]
    three times : 3th visit at Day 0, 4th visit between month 6 and 9, 5th visit at month 24

  • heart rate variability [ Time Frame: baseline to 24 months ] [ Designated as safety issue: No ]
    three times : 2th visit at Day -7, 4th visit between month 6 and 9, 5th visit at month 24

  • Fibromyalgia Impact Questionnaire (FIQ) [ Time Frame: baseline to 24 months ] [ Designated as safety issue: No ]
  • Hospital Anxiety Depression Scale (HADS) [ Time Frame: baseline to 24 months ] [ Designated as safety issue: No ]
  • Pressure Pain Threshold (PSS) [ Time Frame: baseline to 24 months ] [ Designated as safety issue: No ]
  • International Physical Activity Questionnaire (IPAQ) [ Time Frame: baseline to 24 months ] [ Designated as safety issue: No ]
  • Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: baseline to 24 months ] [ Designated as safety issue: No ]
  • Saint-Antoine Pain Questionnaire (SAPQ) [ Time Frame: baseline to 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 110
Study Start Date: August 2015
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: training group

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

Device: thermode (TSA-II model)
thermal stimulation with test thermode
Other: Adapted Physical Activity Other: Physical activity
Placebo Comparator: control group
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
Other: Adapted Physical Activity

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02486965

Contacts
Contact: Celine BODERE, Doctor 0298347308 ext +33 cel.bodere@wanadoo.fr
Contact: Anais BONNABESSSE, Doctor 0610934368 ext +33 anais.bonnabesse@gmail.com

Locations
France
CHRU Brest Not yet recruiting
Brest, France, 29200
Contact: Gildas L'HEVEDER, Doctor    0298347308 ext +33    gildas.lheveder@chu-brest.fr   
Contact: Céline BODERE, Doctor    0298016489 ext +33    celine.bodere@univ-brest.fr   
CHU Rennes Not yet recruiting
Rennes, France, 35033
Contact: François CARRE, Professor    0299284133    francois.carre@univ-rennes1.fr   
Sponsors and Collaborators
University Hospital, Brest
Investigators
Principal Investigator: Gildas L'HEVEDER, Doctor CHRU Brest
  More Information

No publications provided

Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT02486965     History of Changes
Other Study ID Numbers: DOUFISPORT (RB 14.076)
Study First Received: February 26, 2015
Last Updated: June 30, 2015
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by University Hospital, Brest:
VAS
thermode test
training program
6MWT

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neuromuscular Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on August 27, 2015