Evaluation of Functional Improvement After Spa Therapy in Fontcaude Center

NCT03289078 | Withdrawn

• 1 other identifier: 9846
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Achievement of minimal clinically important improvement (MCII) at 3 months

  30 months

Study Arms (2)

Thermal care

EXPERIMENTAL

Spa Treatment realised daily 6 days a week during 18 days

Other: Spa Treatment

Standard Care

NO INTERVENTION

Usual care

Interventions

Spa Treatment OTHER

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)

Thermal care

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• FONTCAUDE's Vichy SPA center, Juvignac: collaborator

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Isabel TAVARES, PH

  CHU de Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2017
• First Posted: September 20, 2017
• Study Start: October 1, 2017
• Primary Completion: April 1, 2020
• Study Completion: October 1, 2020
• Last Updated: May 12, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share