Assessment of the Effect of Spa Treatment on the Functional Severity of Arthrosis

NCT03336099 | Completed

• 1 other identifier: Protocol 2.0
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

Osteoarthritis, Knee; Pain

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (11)

• Quantitative evaluation of pain

  at baseline, 3 and 6 months

• Quantitative evaluation of WOMAC

  at baseline, 3 and 6 months

• Patient's BMI

  at baseline, 3 and 6 months

• Quality of life

  at baseline, 3 and 6 months

• Quality of life

  at baseline, 3 and 6 months

Study Arms (1)

Spa Treatment

EXPERIMENTAL

Bicarbonate and sulfurated water cares in Vals-les-Bains thermal cure center, massage, cataplasm.

Other: Spa Treatment

Interventions

Spa Treatment OTHER

* Bath with immersion shower * Overall shower, penetrating shower * Multiple local application cataplasm * Single local application cataplasm * Inhalation or collective steam bath * Individual physiotherapy technique

Spa Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Le Syndicat Intercommunal pour le Thermalisme et l'Environnement: lead
• Floralis: collaborator

Study Sites (1)

Thermes de Vals Les Bains

Vals-les-Bains, Ardèche, 07600, France

Location

Related Publications (14)

• 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.

  PMID: 11354556 BACKGROUND

• 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.

  PMID: 7562765 BACKGROUND

• 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.

  PMID: 10776684 BACKGROUND

• 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.

  PMID: 10952746 BACKGROUND

• Huskisson EC. Measurement of pain. Lancet. 1974 Nov 9;2(7889):1127-31. doi: 10.1016/s0140-6736(74)90884-8. No abstract available.

  PMID: 4139420 BACKGROUND

• 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.

  PMID: 1535495 BACKGROUND

• 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.

  PMID: 9817119 BACKGROUND

• 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.

  PMID: 11254234 BACKGROUND

• 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.

  PMID: 15130902 BACKGROUND

• 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.

  PMID: 11642642 BACKGROUND

• 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.

  PMID: 12382292 BACKGROUND

• 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.

  PMID: 10796385 BACKGROUND

• 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.

  PMID: 1593914 BACKGROUND

• 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.

  PMID: 19734131 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee; Pain

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ludovic BACONNIER

  Ardèche Méridionale Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2017
• First Posted: November 8, 2017
• Study Start: March 29, 2016
• Primary Completion: June 13, 2017
• Study Completion: June 13, 2017
• Last Updated: November 8, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)