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NCT03336099: VALS
Assessment of the Effect of Spa Treatment on the Functional Severity of Arthrosis
NA trial testing Spa Treatment in Osteoarthritis, Knee in 120 participants. Completed in 13 June 2017.
13 June 2017
Quick facts
| Lead sponsor | Le Syndicat Intercommunal pour le Thermalisme et l'Environnement |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 120 |
| Start date | 29 March 2016 |
| Primary completion | 13 June 2017 |
| Estimated completion | 13 June 2017 |
| Sites | 1 location across France |
Drugs / interventions tested
- Spa Treatment
Conditions studied
- Osteoarthritis, Knee — all drugs for Osteoarthritis, Knee →
- Pain — all drugs for Pain →
Sponsor
Le Syndicat Intercommunal pour le Thermalisme et l'Environnement
Who can join
18 and older, any sex, with Osteoarthritis, Knee or Pain. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Assessment of the effect of spa treatment on the functional severity of arthrosis. Official title: Evolution of clinical state of patients with rheumatic disease on lower limbs or rachis, 6 months after spa treatment. Primary outcome measure: * Measuring the effect of spa treatment on functional severity of arthrosis * Proportion of patients with a WOMAC score augmented by 9 or more, 6 months after enrollment (minimal clinically important difference) Secondary outcome measures * Quantitative evaluation of pain * Comparison of mean Visual Analogue Scale (VAS) pain scale between enrollment and 6 months after * Quantitative evaluation of WOMAC * Comparison of mean WOMAC between enrollment and 6 months after * Impact of spa treatment on the patient's metabolism * Height and Weight (BMI calculation) * Blood pressure * Heart rate * Quality of life * 36-Item Short Form (SF36) at enrollment, 3 months and 6 months * EuroQol 5 Dimensions (EQ5D) questionnaire at enrollment, 3 months and 6 months * Opinion of doctor and patient * Semi-quantitative scale collected at enrollment, 3 months and 6 months * Treatment follow-up * Self-evaluation of pain * Self-evaluation of pain with VAS pain scale every 6 week
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03336099
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Spa Treatment
Trials testing the same drug.
- NCT03538470 — Assessment of the Effect of Spa Treatment on Rheumatological Conditions · NA · unknown
Other recruiting trials for Osteoarthritis, Knee
Currently open trials in the same condition.
- NCT07509307 — AMAZE 6: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Knee · Phase 3 · recruiting
- NCT06488144 — Rehabilitation for Arthritis of The Knee: mainTaining Improvement for Veterans · Phase 3 · recruiting
- NCT07386561 — Virtual Reality Therapy and Non-Sleep Deep Rest Relaxation After Joint Arthroplasty · NA · active not recruiting
- NCT07514598 — Effect of J-Shaped Incision After Total Knee Arthroplasty (J-TKA) · NA · active not recruiting
- NCT07058623 — Nurse-Led Telehealth vs In-Person Follow-Up After Total Knee Replacement · NA · recruiting
Other Le Syndicat Intercommunal pour le Thermalisme et l'Environnement trials
Trials by the same sponsor.
- NCT05449743 — Assessment of the Effect of Spa Therapy on the Quality of Life of Patients with Chronic Venous Insufficiency (NEYRAC) · NA · completed
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 NCT03336099 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Le Syndicat Intercommunal pour le Thermalisme et l'Environnement
- Last refreshed: 8 November 2017
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/NCT03336099.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing