Evaluation of Functional Improvement After Spa Therapy in Fontcaude Center (FONTCAUDE)

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Other: Spa Treatment

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 Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Thermal care; Spa Treatment realised daily 6 days a week during 18 days	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)
No Intervention: Standard Care; Usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Collaborators: FONTCAUDE's Vichy SPA center, Juvignac
• Investigators: Principal Investigator: Isabel TAVARES, PH, CHU de Montpellier

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2017
• Primary Completion (Anticipated): April 1, 2020
• Study Completion (Anticipated): October 1, 2020

Study Registration Dates

• First Submitted: September 18, 2017
• First Submitted That Met QC Criteria: September 18, 2017
• First Posted (Actual): September 20, 2017

Study Record Updates

• Last Update Posted (Actual): May 12, 2021
• Last Update Submitted That Met QC Criteria: May 11, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 9846 (Other Identifier: CTEP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No