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Completed

NCT Number: NCT02486965

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CHRU Brest, Brest, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

thermode (TSA-II model)

Device

thermal stimulation with test thermode

adapted physical activity

Other

Physical activity

Other

Primary outcomes

  1. Pain as assessed by Visual analog scale

    Time frame: baseline to 24 months

Secondary outcomes

  1. 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

  2. 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

  3. Fibromyalgia Impact Questionnaire (FIQ)

    Time frame: baseline to 24 months

  4. Hospital Anxiety Depression Scale (HADS)

    Time frame: baseline to 24 months

  5. Pressure Pain Threshold (PSS)

    Time frame: baseline to 24 months

  6. International Physical Activity Questionnaire (IPAQ)

    Time frame: baseline to 24 months

  7. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: baseline to 24 months

  8. Saint-Antoine Pain Questionnaire (SAPQ)

    Time frame: baseline to 24 months

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Acronym: DOUFISPORT

Important dates

Study start
2015
Primary completion
2019
Study completion
2021
First posted
Jul 1, 2015
Registry last updated
Apr 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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