Evaluation of Functional Improvement After Spa Therapy in Fontcaude Center

Knee Osteoarthritis Clinical Trial

— FONTCAUDE  

Official title:

Evaluation of Functional Improvement After Spa Therapy in Fontcaude Center, for Knee Osteoarthritis

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03289078
• Other study ID #: 9846
• Status: Withdrawn
• Phase: N/A
• Start date: October 2017
• Est. completion date: October 2020

Study information

• Verified date: May 2021
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2020
• Est. primary completion date: April 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

Inclusion criteria:

• Patient aged 40 to 75 years with radiologic and gonarthrosis radiologic et painful gonarthrosis, unilateral ou bilateral, whatever is the radiographic stage
• Patient presenting a EVA =3 with a corresponding radiology at least of 1year
• Patient affiliated with a social security system

Exclusion criteria:

• Realization of a water cure in the last 6 months
• Infiltration of the knee of less than 3 months
• Impossibility to sign the informed consent or which for reasons geographical, social or psychological could not be regularly followed,
• Person major placed under guardianship or trusteeship,
• Private person of freedom by court or administrative order, nobody being the object of a legal protective measure,
• Patient already included in an interventional clinical protocol,
• Pregnant women
• Contraindication in the water cure:
• Severe change of the general state or debilitating afflictions
• Acute affections and pushed acute(sharp) of the chronic affections
• Grave cardiac insufficiency, unstable arterial high blood pressure
• Severe renal or hepatic insufficiency
• Not healed cutaneous hurts
• Contagious or evolutionary diseases
• Evolutionary Cancers
• Current immunomodulator or immunosupressor Treatment, waves of inflammation.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• Spa Treatment
The spa treatments will be realised daily 6 days a week and during 18 days. The care will be provided is : Swimming pool of mobilization by physical therapist (20 minutes daily, Cataplasms (10 minutes daily), Shower in the jet (10 minutes daily), Shower under affusion (10 minutes daily)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Montpellier	FONTCAUDE's Vichy SPA center, Juvignac

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Achievement of minimal clinically important improvement (MCII) at 6 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	30 months
Secondary	Achievement of minimal clinically important improvement (MCII) at 3 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.	30 months