CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 120 enrolled
Drug / intervention
Spa Treatmentother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03336099
NCT03336099N/ACompleted

Evolution of Clinical State of Patients With Rheumatic Disease on Lower Limbs or Rachis, 6 Months After Spa Treatment

Le Syndicat Intercommunal pour le Thermalisme et l'Environnement·interventional·Posted Nov 8, 2017·Updated Nov 8, 2017

In Brief

A clinical study evaluating Spa Treatment for Osteoarthritis, Knee and Pain. Completed, enrolled 120 participants across 1 site.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance
CollaboratorsFloralis

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedNov 8, 2017
Enrollment StartMar 29, 2016
Primary CompletionJun 13, 2017
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 8.7 years ago

Interventions

Spa Treatmentother

* Bath with immersion shower * Overall shower, penetrating shower * Multiple local application cataplasm * Single local application cataplasm * Inhalation or collective steam bath * Individual physiotherapy technique