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

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
thermode (TSA-II model)
Adapted Physical Activity
Physical activity
Sponsored by
University Hospital, Brest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Fibromyalgia focused on measuring VAS, thermode test, training program, 6MWT

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • CHRU Brest
  • CHU Rennes

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

training group

control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Pain as assessed by Visual analog scale

Secondary Outcome Measures

salivary cortisol
three times : 3th visit at Day 0, 4th visit between month 6 and 9, 5th visit at month 24
heart rate variability
three times : 2th visit at Day -7, 4th visit between month 6 and 9, 5th visit at month 24
Fibromyalgia Impact Questionnaire (FIQ)
Hospital Anxiety Depression Scale (HADS)
Pressure Pain Threshold (PSS)
International Physical Activity Questionnaire (IPAQ)
Pittsburgh Sleep Quality Index (PSQI)
Saint-Antoine Pain Questionnaire (SAPQ)

Full Information

First Posted
February 26, 2015
Last Updated
April 21, 2022
Sponsor
University Hospital, Brest
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1. Study Identification

Unique Protocol Identification Number
NCT02486965
Brief Title
Impact of a Specific Training Program on the Neuromodulation of Pain in Fibromyalgia Subjects
Acronym
DOUFISPORT
Official Title
Impact of a Specific Training Program on the Neuromodulation of Pain in Fibromyalgia Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
October 7, 2015 (Actual)
Primary Completion Date
February 21, 2019 (Actual)
Study Completion Date
October 21, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
VAS, thermode test, training program, 6MWT

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
training group
Arm Type
Experimental
Arm Description
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
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
thermode (TSA-II model)
Intervention Description
thermal stimulation with test thermode
Intervention Type
Other
Intervention Name(s)
Adapted Physical Activity
Intervention Type
Other
Intervention Name(s)
Physical activity
Primary Outcome Measure Information:
Title
Pain as assessed by Visual analog scale
Time Frame
baseline to 24 months
Secondary Outcome Measure Information:
Title
salivary cortisol
Description
three times : 3th visit at Day 0, 4th visit between month 6 and 9, 5th visit at month 24
Time Frame
baseline to 24 months
Title
heart rate variability
Description
three times : 2th visit at Day -7, 4th visit between month 6 and 9, 5th visit at month 24
Time Frame
baseline to 24 months
Title
Fibromyalgia Impact Questionnaire (FIQ)
Time Frame
baseline to 24 months
Title
Hospital Anxiety Depression Scale (HADS)
Time Frame
baseline to 24 months
Title
Pressure Pain Threshold (PSS)
Time Frame
baseline to 24 months
Title
International Physical Activity Questionnaire (IPAQ)
Time Frame
baseline to 24 months
Title
Pittsburgh Sleep Quality Index (PSQI)
Time Frame
baseline to 24 months
Title
Saint-Antoine Pain Questionnaire (SAPQ)
Time Frame
baseline to 24 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gildas L'HEVEDER, Doctor
Organizational Affiliation
CHRU Brest
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHRU Brest
City
Brest
ZIP/Postal Code
29200
Country
France
Facility Name
CHU Rennes
City
Rennes
ZIP/Postal Code
35033
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
30782715
Citation
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.
Results Reference
derived

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

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