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

NCT02486965 | Completed

• 1 other identifier: DOUFISPORT (RB 14.076)
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Fibromyalgia

Keywords

VAS; thermode test; training program; 6MWT

Outcome Measures

Primary Outcomes (1)

• Pain as assessed by Visual analog scale

  baseline to 24 months

Secondary Outcomes (8)

• salivary cortisol

  baseline to 24 months

• heart rate variability

  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

Study Arms (2)

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

Device: thermode (TSA-II model); Other: Adapted Physical Activity; Other: Physical activity

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

Other: Adapted Physical Activity

Interventions

thermode (TSA-II model) DEVICE

thermal stimulation with test thermode

training group

Adapted Physical Activity OTHER

control group; training group

Physical activity OTHER

training group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (2)

CHRU Brest

Brest, 29200, France

Location

CHU Rennes

Rennes, 35033, France

Location

Related Publications (1)

• 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.

  PMID: 30782715 DERIVED

MeSH Terms

Conditions

Fibromyalgia

Interventions

Exercise

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Gildas L'HEVEDER, Doctor

  CHRU Brest

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2015
• First Posted: July 1, 2015
• Study Start: October 7, 2015
• Primary Completion: February 21, 2019
• Study Completion: October 21, 2021
• Last Updated: April 22, 2022

Record last verified: 2022-04

Locations

FR (2)