Assessment of the Effect of Spa Treatment on the Functional Severity of Arthrosis
NCT ID: NCT03336099
Last Updated: 2017-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
120 participants
INTERVENTIONAL
2016-03-29
2017-06-13
Brief Summary
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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
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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
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Spa Treatment
Bicarbonate and sulfurated water cares in Vals-les-Bains thermal cure center, massage, cataplasm.
Spa Treatment
* Bath with immersion shower
* Overall shower, penetrating shower
* Multiple local application cataplasm
* Single local application cataplasm
* Inhalation or collective steam bath
* Individual physiotherapy technique
Interventions
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Spa Treatment
* Bath with immersion shower
* Overall shower, penetrating shower
* Multiple local application cataplasm
* Single local application cataplasm
* Inhalation or collective steam bath
* Individual physiotherapy technique
Eligibility Criteria
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Inclusion Criteria
* 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
* Psychiatric illness or social situation that would preclude study compliance
* Contraindication to spa treatment
* Predictable intolerance to thermal treatment
18 Years
ALL
No
Sponsors
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Floralis
INDUSTRY
Le Syndicat Intercommunal pour le Thermalisme et l'Environnement
OTHER
Responsible Party
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Principal Investigators
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Ludovic BACONNIER
Role: PRINCIPAL_INVESTIGATOR
Ardèche Méridionale Hospital
Locations
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Thermes de Vals Les Bains
Vals-les-Bains, Ardèche, France
Countries
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References
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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.
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.
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.
Huskisson EC. Measurement of pain. Lancet. 1974 Nov 9;2(7889):1127-31. doi: 10.1016/s0140-6736(74)90884-8. No abstract available.
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.
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.
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.
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.
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.
Other Identifiers
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Protocol 2.0
Identifier Type: -
Identifier Source: org_study_id