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

Primary Purpose

Knee Osteoarthritis

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Spa Treatment
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Knee Osteoarthritis

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Thermal care

    Standard Care

    Arm Description

    Spa Treatment realised daily 6 days a week during 18 days

    Usual care

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    September 18, 2017
    Last Updated
    May 11, 2021
    Sponsor
    University Hospital, Montpellier
    Collaborators
    FONTCAUDE's Vichy SPA center, Juvignac
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03289078
    Brief Title
    Evaluation of Functional Improvement After Spa Therapy in Fontcaude Center
    Acronym
    FONTCAUDE
    Official Title
    Evaluation of Functional Improvement After Spa Therapy in Fontcaude Center, for Knee Osteoarthritis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    No financing
    Study Start Date
    October 2017 (Anticipated)
    Primary Completion Date
    April 2020 (Anticipated)
    Study Completion Date
    October 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Montpellier
    Collaborators
    FONTCAUDE's Vichy SPA center, Juvignac

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Knee Osteoarthritis

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Thermal care
    Arm Type
    Experimental
    Arm Description
    Spa Treatment realised daily 6 days a week during 18 days
    Arm Title
    Standard Care
    Arm Type
    No Intervention
    Arm Description
    Usual care
    Intervention Type
    Other
    Intervention Name(s)
    Spa Treatment
    Intervention Description
    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)
    Primary Outcome Measure Information:
    Title
    Achievement of minimal clinically important improvement (MCII) at 6 months
    Description
    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
    Time Frame
    30 months
    Secondary Outcome Measure Information:
    Title
    Achievement of minimal clinically important improvement (MCII) at 3 months
    Description
    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.
    Time Frame
    30 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Isabel TAVARES, PH
    Organizational Affiliation
    CHU de Montpellier
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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