Evaluation of Functional Improvement After Spa Therapy in Fontcaude Center

Not Applicable

Withdrawn

• Conditions: Knee Osteoarthritis
• Interventions: Other: Spa Treatment

• Registration Number: NCT03289078
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

Evaluation of functional improvement after spa therapy in Fontcaude center, for knee osteoarthritis Background. Knee osteoarthritis is the first indication of spa therapy in rheumatology. This therapeutic represents a non pharmacological treatment and is recommended by OARSI.

In order to obtain agreement for spa therapy, the center Fontcaude, needs to show clinical improvement for patients, as demonstrated in the Thermarthrose study. This center is near Montpellier and could improve patients localised in this area.

Detailed Description

Methods: randomised prospective clinical trial of patients with knee osteoarthritis.

The spa therapy group received 18 days of therapy over 3 weeks. Patients in the control group received 18 days of therapy over 3 weeks after the 6-month follow-up visit.

Follow-up was at 3 and 6 months, by a visit to the examination.

The hypothesis of our study is to demonstrate clinical improvement at six months. The main endpoint is the number of patients achieving minimal clinically important improvement (MCII) at 6 months, defi ned as ≥19.9 mm on the visual analogue pain scale and/or ≥9.1 points in a normalised Western Ontario and McMaster Universities osteoarthritis index function score.

Study Timeline

• Study First Submitted: 2017-09-18
• Study First Submitted QC: 2017-09-18
• Study First Posted: 2017-09-20
• Study Start: 2017-10
• Primary Completion: 2020-04
• Study Completion: 2020-10
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-11
• Last Update Posted: 2021-05-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Thermal care	Spa Treatment	Spa Treatment realised daily 6 days a week during 18 days

Primary Outcome Measures

Name	Time	Method
Achievement of minimal clinically important improvement (MCII) at 6 months	30 months	The main endpoint is the number of patients achieving minimal clinically important improvement (MCII) at 6 months, defined as ≥19.9 mm on the visual analogue pain scale and/or ≥9.1 points in a normalised Western Ontario and McMaster Universities osteoart

Secondary Outcome Measures

Name	Time	Method
Achievement of minimal clinically important improvement (MCII) at 3 months	30 months	The second outcome measure is the number of patients achieving minimal clinically important improvement (MCII) at 3 months, defi ned as ≥19.9 mm on the visual analogue pain scale and/or ≥9.1 points in a normalised Western Ontario and McMaster Universities osteoarthritis index function score, and also the safety.