- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03336099
Assessment of the Effect of Spa Treatment on the Functional Severity of Arthrosis (VALS)
Evolution of Clinical State of Patients With Rheumatic Disease on Lower Limbs or Rachis, 6 Months After Spa Treatment
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
Study Overview
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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ardèche
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Vals Les Bains, Ardèche, France, 07600
- Thermes de Vals Les Bains
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Spa Treatment
Bicarbonate and sulfurated water cares in Vals-les-Bains thermal cure center, massage, cataplasm.
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measuring the effect of spa treatment on functional severity of arthrosis
Time Frame: 6 months
|
Proportion of patients with a WOMAC score augmented by 9 or more, at 6 months compared to baseline (minimal clinically important difference)
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quantitative evaluation of pain
Time Frame: at baseline, 3 and 6 months
|
Comparison of mean VAS pain scale between baseline, 3 and 6 months
|
at baseline, 3 and 6 months
|
Quantitative evaluation of WOMAC
Time Frame: at baseline, 3 and 6 months
|
Comparison of mean WOMAC between baseline, 3 months and 6 months
|
at baseline, 3 and 6 months
|
Patient's BMI
Time Frame: at baseline, 3 and 6 months
|
weight and height will be combined to report BMI in kg/m2
|
at baseline, 3 and 6 months
|
Quality of life
Time Frame: at baseline, 3 and 6 months
|
SF36 questionnaire at baseline, 3 and 6 months
|
at baseline, 3 and 6 months
|
Quality of life
Time Frame: at baseline, 3 and 6 months
|
EQ5D questionnaire at baseline, 3 and 6 months
|
at baseline, 3 and 6 months
|
Opinion of doctor and patient
Time Frame: at baseline, 3 and 6 months
|
Semi-quantitative scale collected at baseline, 3 and 6 months
|
at baseline, 3 and 6 months
|
Number of treatments prescribed
Time Frame: at baseline, 3 and 6 months
|
Type of treatments prescribed at baseline, 3 and 6 months will be collected
|
at baseline, 3 and 6 months
|
Changes in treatments prescribed
Time Frame: at baseline, 3 and 6 months
|
changes in treatments prescribed at baseline, 3 and 6 months will be collected
|
at baseline, 3 and 6 months
|
Treatments duration
Time Frame: at baseline, 3 and 6 months
|
Duration of treatments prescribed at baseline, 3 and 6 months will be collected
|
at baseline, 3 and 6 months
|
Self-evaluation of pain
Time Frame: at baseline, 1.5, 3, 4.5 and 6 months
|
Self-evaluation of pain with VAS pain scale at baseline, 1.5, 3, 4.5 and 6 months
|
at baseline, 1.5, 3, 4.5 and 6 months
|
patient examination
Time Frame: at baseline, 3 and 6 months
|
heart rate
|
at baseline, 3 and 6 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Ludovic BACONNIER, Ardèche Méridionale Hospital
Publications and helpful links
General Publications
- Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.
- Elkayam O, Ophir J, Brener S, Paran D, Wigler I, Efron D, Even-Paz Z, Politi Y, Yaron M. Immediate and delayed effects of treatment at the Dead Sea in patients with psoriatic arthritis. Rheumatol Int. 2000;19(3):77-82. doi: 10.1007/s002960050107.
- Forestier R, Desfour H, Tessier JM, Francon A, Foote AM, Genty C, Rolland C, Roques CF, Bosson JL. Spa therapy in the treatment of knee osteoarthritis: a large randomised multicentre trial. Ann Rheum Dis. 2010 Apr;69(4):660-5. doi: 10.1136/ard.2009.113209. Epub 2009 Sep 3.
- Huskisson EC. Measurement of pain. Lancet. 1974 Nov 9;2(7889):1127-31. doi: 10.1016/s0140-6736(74)90884-8. No abstract available.
- Tubach F, Ravaud P, Baron G, Falissard B, Logeart I, Bellamy N, Bombardier C, Felson D, Hochberg M, van der Heijde D, Dougados M. Evaluation of clinically relevant states in patient reported outcomes in knee and hip osteoarthritis: the patient acceptable symptom state. Ann Rheum Dis. 2005 Jan;64(1):34-7. doi: 10.1136/ard.2004.023028. Epub 2004 May 6.
- Franke A, Reiner L, Pratzel HG, Franke T, Resch KL. Long-term efficacy of radon spa therapy in rheumatoid arthritis--a randomized, sham-controlled study and follow-up. Rheumatology (Oxford). 2000 Aug;39(8):894-902. doi: 10.1093/rheumatology/39.8.894.
- Buskila D, Abu-Shakra M, Neumann L, Odes L, Shneider E, Flusser D, Sukenik S. Balneotherapy for fibromyalgia at the Dead Sea. Rheumatol Int. 2001 Apr;20(3):105-8. doi: 10.1007/s002960000085.
- Constant F, Collin JF, Guillemin F, Boulange M. Effectiveness of spa therapy in chronic low back pain: a randomized clinical trial. J Rheumatol. 1995 Jul;22(7):1315-20.
- Konrad K, Tatrai T, Hunka A, Vereckei E, Korondi I. Controlled trial of balneotherapy in treatment of low back pain. Ann Rheum Dis. 1992 Jun;51(6):820-2. doi: 10.1136/ard.51.6.820.
- Leplege A, Ecosse E, Verdier A, Perneger TV. The French SF-36 Health Survey: translation, cultural adaptation and preliminary psychometric evaluation. J Clin Epidemiol. 1998 Nov;51(11):1013-23. doi: 10.1016/s0895-4356(98)00093-6.
- Neumann L, Sukenik S, Bolotin A, Abu-Shakra M, Amir M, Flusser D, Buskila D. The effect of balneotherapy at the Dead Sea on the quality of life of patients with fibromyalgia syndrome. Clin Rheumatol. 2001;20(1):15-9. doi: 10.1007/s100670170097.
- van Tubergen A, Landewe R, van der Heijde D, Hidding A, Wolter N, Asscher M, Falkenbach A, Genth E, The HG, van der Linden S. Combined spa-exercise therapy is effective in patients with ankylosing spondylitis: a randomized controlled trial. Arthritis Rheum. 2001 Oct;45(5):430-8. doi: 10.1002/1529-0131(200110)45:53.0.co;2-f.
- Van Tubergen A, Boonen A, Landewe R, Rutten-Van Molken M, Van Der Heijde D, Hidding A, Van Der Linden S. Cost effectiveness of combined spa-exercise therapy in ankylosing spondylitis: a randomized controlled trial. Arthritis Rheum. 2002 Oct 15;47(5):459-67. doi: 10.1002/art.10658.
- Verhagen AP, de Vet HC, de Bie RA, Kessels AG, Boers M, Knipschild PG. Balneotherapy for rheumatoid arthritis and osteoarthritis. Cochrane Database Syst Rev. 2000;(2):CD000518. doi: 10.1002/14651858.CD000518.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Protocol 2.0
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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