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NCT02486965: DOUFISPORT
Impact of a Specific Training Program on the Neuromodulation of Pain in Fibromyalgia Subjects
NA trial testing thermode (TSA-II model) in Fibromyalgia in 60 participants. Completed in 21 October 2021.
21 February 2019
Quick facts
| Lead sponsor | University Hospital, Brest |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | supportive care |
| Enrollment | 60 |
| Start date | 7 October 2015 |
| Primary completion | 21 February 2019 |
| Estimated completion | 21 October 2021 |
| Sites | 2 locations across France |
Drugs / interventions tested
- thermode (TSA-II model)
- Adapted Physical Activity
- Physical activity
Conditions studied
- Fibromyalgia — all drugs for Fibromyalgia →
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):
-
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:
- PubMed search for NCT02486965
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other University Hospital, Brest trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02486965 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospital, Brest
- Last refreshed: 22 April 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02486965.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing