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

NCT02486965 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-04-22

No results posted yet for this study

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

Interventions

DEVICE

thermode (TSA-II model)

thermal stimulation with test thermode

OTHER

Adapted Physical Activity

OTHER

Physical activity

Sponsors & Collaborators

  • University Hospital, Brest

    lead OTHER

Principal Investigators

  • Gildas L'HEVEDER, Doctor · CHRU Brest

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-07
Primary Completion
2019-02-21
Completion
2021-10-21

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02486965 on ClinicalTrials.gov