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

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ClinicalTrials.gov Identifier: NCT02486965
Recruitment Status : Recruiting
First Posted : July 1, 2015
Last Update Posted : January 18, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest

Tracking Information
First Submitted Date  ICMJE February 26, 2015
First Posted Date  ICMJE July 1, 2015
Last Update Posted Date January 18, 2019
Study Start Date  ICMJE October 2015
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 30, 2015)
Pain as assessed by Visual analog scale [ Time Frame: baseline to 24 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02486965 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 30, 2015)
  • salivary cortisol [ Time Frame: baseline to 24 months ]
    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 ]
    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 ]
  • Hospital Anxiety Depression Scale (HADS) [ Time Frame: baseline to 24 months ]
  • Pressure Pain Threshold (PSS) [ Time Frame: baseline to 24 months ]
  • International Physical Activity Questionnaire (IPAQ) [ Time Frame: baseline to 24 months ]
  • Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: baseline to 24 months ]
  • Saint-Antoine Pain Questionnaire (SAPQ) [ Time Frame: baseline to 24 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of a Specific Training Program on the Neuromodulation of Pain in Fibromyalgia Subjects
Official Title  ICMJE Impact of a Specific Training Program on the Neuromodulation of Pain in Fibromyalgia Subjects
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Condition  ICMJE Fibromyalgia
Intervention  ICMJE
  • Device: thermode (TSA-II model)
    thermal stimulation with test thermode
  • Other: Adapted Physical Activity
  • Other: Physical activity
Study Arms  ICMJE
  • 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

    Interventions:
    • Device: thermode (TSA-II model)
    • 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
    Intervention: Other: Adapted Physical Activity
Publications * 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, Bodéré 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 30, 2015)
110
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2019
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Celine BODERE, Doctor 0298347308 ext +33 cel.bodere@wanadoo.fr
Contact: Anais BONNABESSSE, Doctor 0610934368 ext +33 anais.bonnabesse@gmail.com
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02486965
Other Study ID Numbers  ICMJE DOUFISPORT (RB 14.076)
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Brest
Study Sponsor  ICMJE University Hospital, Brest
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gildas L'HEVEDER, Doctor CHRU Brest
PRS Account University Hospital, Brest
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP