Clinical trial NCT03336099: Assessment of the Effect of Spa Treatment on the Functional Severity of Arthrosis
Official title: Evolution of Clinical State of Patients With Rheumatic Disease on Lower Limbs or Rachis, 6 Months After Spa Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Pain
Lead sponsor: Le Syndicat Intercommunal pour le Thermalisme et l'Environnement
Sponsor class: OTHER
Collaborators: name: Floralis
First posted: 2017-11-08
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Assessment of the effect of spa treatment on the functional severity of arthrosis.

Official title: Evolution of clinical state of patients with rheumatic disease on lower limbs or rachis, 6 months after spa treatment.

Primary outcome measure:

* Measuring the effect of spa treatment on functional severity of arthrosis

  * Proportion of patients with a WOMAC score augmented by 9 or more, 6 months after enrollment (minimal clinically important difference)

Secondary outcome measures

* Quantitative evaluation of pain

  * Comparison of mean Visual Analogue Scale (VAS) pain scale between enrollment and 6 months after
* Quantitative evaluation of WOMAC

  * Comparison of mean WOMAC between enrollment and 6 months after
* Impact of spa treatment on the patient's metabolism

  * Height and Weight (BMI calculation)
  * Blood pressure
  * Heart rate
* Quality of life

  * 36-Item Short Form (SF36) at enrollment, 3 months and 6 months
  * EuroQol 5 Dimensions (EQ5D) questionnaire at enrollment, 3 months and 6 months
* Opinion of doctor and patient

  * Semi-quantitative scale collected at enrollment, 3 months and 6 months
* Treatment follow-up
* Self-evaluation of pain

  * Self-evaluation of pain with VAS pain scale every 6 week

Detailed description: Arthrosis and rheumatic diseases on the whole consist in a huge and frequent public health problem, with consequences notably including the well-known pain phenomena.

Spa treatments are part of the mainstream therapeutic arsenal of non-medical treatments proposed to this kind of patients.

A recent French study estimated the direct cost of arthrosis in France to 1.6 billion euros in 2002. Half of it was attributable to hospital expenses (800 million euros). Arthrosis required 13 million consultations and drug expenses amounting to 570 million euros. These expenses were increased by 156% compared to 1993 due to the raise of the number of treated patients (+54%) and the cost for each patient (+2.5% per year). This study concerned patients with arthrosis on the lower limbs, with an significant portion of these expenses attributable to the disease.

Different thermal clinical trials of good quality have led to the recognition of spa in the treatment of chronic low back pain.

Several controlled and randomized prospective trials already evaluated the effect of spa treatment for the other main indications claimed by crenotherapy in rheumatology : chronic low back pain, coxarthrosis, hand arthrosis, fibromyalgia, rheumatoid polyarthritis, psoriatic arthritis, chronic cervicalgia.

The THERMARTHROSE study by Forestier has demonstrated the efficacy of spa treatment as a rheumatologic indication for gonarthrosis on WOMAC and VAS pain scale. Following the model of this study, the sponsor chose to use the WOMAC as the primary endpoint for the VALS study.

It has been developed by Bellamy in 1988, and it is a functional index aimed on the locomotor system.

Nowadays, the WOMAC is more used than the Lequesne index because it has better internal consistency reliability. However, complementary validation efforts were necessary to calculate the minimal clinically important difference whereas the pertinence of the Lequesne index is immediately perceptible, being purely qualitative.

With studies in thermal environment, spa treatment is a composite entity including the effect of water itself, but also kinesiotherapy, rest, education... The spa of Vals-les-Bains wishes to obtain a new therapeutic orientation: the rheumatologic orientation. According to the recommendations of the Academy of Medicine, a prolonged observation of a cohort with repeated measures is required for any spa wishing to acquire the accreditation for a new orientation.

Toward this goal, the sponsor wish to undertake a prospective study with repeated measures in order to analyze the evolution at 6 month of the clinical state of patients with a rheumatologic disease on the lower limbs or the rachis and taken over for spa treatment at Vals-les-Bains. Since rheumatologic treatments at Vals-les-Bains are not covered by the health insurance, they will not be billed to the patients

Eligibility criteria: Inclusion Criteria:

* Patient with arthrosis or other rheumatic disease, located on the lower limbs or the rachis
* Rheumatic indication for spa treatment
* Diminution of mobility
* Affiliation to the French social security system or equivalent
* Available for a 6-months follow-up and an 18-days spa treatment

Exclusion Criteria:

* Pregnancy, parturient or breast feeding
* Psychiatric illness or social situation that would preclude study compliance
* Contraindication to spa treatment
* Predictable intolerance to thermal treatment

Primary outcomes:
measure: Measuring the effect of spa treatment on functional severity of arthrosis
timeFrame: 6 months
Secondary outcomes:
measure: Quantitative evaluation of pain
timeFrame: at baseline, 3 and 6 months
measure: Quantitative evaluation of WOMAC
timeFrame: at baseline, 3 and 6 months
measure: Patient's BMI
timeFrame: at baseline, 3 and 6 months
measure: Quality of life
timeFrame: at baseline, 3 and 6 months
measure: Quality of life
timeFrame: at baseline, 3 and 6 months
measure: Opinion of doctor and patient
timeFrame: at baseline, 3 and 6 months
measure: Number of treatments prescribed
timeFrame: at baseline, 3 and 6 months
measure: Changes in treatments prescribed
timeFrame: at baseline, 3 and 6 months
measure: Treatments duration
timeFrame: at baseline, 3 and 6 months
measure: Self-evaluation of pain
timeFrame: at baseline, 1.5, 3, 4.5 and 6 months
measure: patient examination
timeFrame: at baseline, 3 and 6 months
Other outcomes:
Locations:
city: Vals Les Bains
country: France
facility: Thermes de Vals Les Bains
state: Ardèche
Study officials:
affiliation: Ardèche Méridionale Hospital
name: Ludovic BACONNIER
role: PRINCIPAL_INVESTIGATOR
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