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NCT02486965: DOUFISPORT

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

Completed NA Last updated 22 April 2022
What this trial tests

NA trial testing thermode (TSA-II model) in Fibromyalgia in 60 participants. Completed in 21 October 2021.

Timeline
7 October 2015
Primary endpoint
21 February 2019
21 October 2021

Quick facts

Lead sponsorUniversity Hospital, Brest
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposesupportive care
Enrollment60
Start date7 October 2015
Primary completion21 February 2019
Estimated completion21 October 2021
Sites2 locations across France

Drugs / interventions tested

Conditions studied

Sponsor

University Hospital, Brest

Who can join

Adults 18 to 60, female only, with Fibromyalgia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. 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.
    Le Fur Bonnabesse A, Cabon M, L'Heveder G, Kermarrec A, et al · · 2019 · cited 6× · PMID 30782715 · DOI 10.1136/bmjopen-2018-023742

Verify or expand the search:

Other recruiting trials for Fibromyalgia

Currently open trials in the same condition.

Other University Hospital, Brest trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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