Evaluation of Functional Improvement After Spa Therapy in Fontcaude Center
NCT ID: NCT03289078
Last Updated: 2021-05-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2017-10-31
2020-10-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Thermal care
Spa Treatment realised daily 6 days a week during 18 days
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)
Standard Care
Usual care
No interventions assigned to this group
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
* Patient presenting a EVA ≥3 with a corresponding radiology at least of 1year
* Patient affiliated with a social security system
Exclusion Criteria
* 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.
40 Years
75 Years
ALL
No
Sponsors
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FONTCAUDE's Vichy SPA center, Juvignac
UNKNOWN
University Hospital, Montpellier
OTHER
Responsible Party
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Principal Investigators
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Isabel TAVARES, PH
Role: PRINCIPAL_INVESTIGATOR
CHU de Montpellier
Other Identifiers
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9846
Identifier Type: -
Identifier Source: org_study_id
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