Clinical trial NCT03289078: Evaluation of Functional Improvement After Spa Therapy in Fontcaude Center
Official title: Evaluation of Functional Improvement After Spa Therapy in Fontcaude Center, for Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: FONTCAUDE's Vichy SPA center, Juvignac
First posted: 2017-09-20
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Achievement of minimal clinically important improvement (MCII) at 6 months
timeFrame: 30 months
Secondary outcomes:
measure: Achievement of minimal clinically important improvement (MCII) at 3 months
timeFrame: 30 months
Other outcomes:
Locations:
Study officials:
affiliation: CHU de Montpellier
name: Isabel TAVARES, PH
role: PRINCIPAL_INVESTIGATOR
References: