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

Pain Clinical Trial

— VALS  

Official title:

Evolution of Clinical State of Patients With Rheumatic Disease on Lower Limbs or Rachis, 6 Months After Spa Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03336099
• Other study ID #: Protocol 2.0
• Status: Completed
• Phase: N/A
• First received: April 24, 2017
• Last updated: November 7, 2017
• Start date: March 29, 2016
• Est. completion date: June 13, 2017

Study information

• Verified date: November 2017
• Source: Le Syndicat Intercommunal pour le Thermalisme et l'Environnement
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 13, 2017
• Est. primary completion date: June 13, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee
• Pain

Intervention

Other:
• 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

Locations

Country	Name	City	State
France	Thermes de Vals Les Bains	Vals Les Bains	Ardèche

Sponsors (2)

Lead Sponsor	Collaborator
Le Syndicat Intercommunal pour le Thermalisme et l'Environnement	Floralis

Country where clinical trial is conducted

France, 

References & 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. — View Citation

Constant F, Collin JF, Guillemin F, Boulangé M. Effectiveness of spa therapy in chronic low back pain: a randomized clinical trial. J Rheumatol. 1995 Jul;22(7):1315-20. — View Citation

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. — View Citation

Forestier R, Desfour H, Tessier JM, Françon 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. — View Citation

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. — View Citation

Huskisson EC. Measurement of pain. Lancet. 1974 Nov 9;2(7889):1127-31. — View Citation

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. — View Citation

Leplège 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. — View Citation

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. — View Citation

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. Epub 2004 May 6. — View Citation

Van Tubergen A, Boonen A, Landewé R, Rutten-Van Mölken 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. — View Citation

van Tubergen A, Landewé R, van der Heijde D, Hidding A, Wolter N, Asscher M, Falkenbach A, Genth E, Thè 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. — View Citation

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. Review. Update in: Cochrane Database Syst Rev. 2003;(4):CD000518. — View Citation

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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Quantitative evaluation of pain	Comparison of mean VAS pain scale between baseline, 3 and 6 months	at baseline, 3 and 6 months
Secondary	Quantitative evaluation of WOMAC	Comparison of mean WOMAC between baseline, 3 months and 6 months	at baseline, 3 and 6 months
Secondary	Patient's BMI	weight and height will be combined to report BMI in kg/m2	at baseline, 3 and 6 months
Secondary	Quality of life	SF36 questionnaire at baseline, 3 and 6 months	at baseline, 3 and 6 months
Secondary	Quality of life	EQ5D questionnaire at baseline, 3 and 6 months	at baseline, 3 and 6 months
Secondary	Opinion of doctor and patient	Semi-quantitative scale collected at baseline, 3 and 6 months	at baseline, 3 and 6 months
Secondary	Number of treatments prescribed	Type of treatments prescribed at baseline, 3 and 6 months will be collected	at baseline, 3 and 6 months
Secondary	Changes in treatments prescribed	changes in treatments prescribed at baseline, 3 and 6 months will be collected	at baseline, 3 and 6 months
Secondary	Treatments duration	Duration of treatments prescribed at baseline, 3 and 6 months will be collected	at baseline, 3 and 6 months
Secondary	Self-evaluation of pain	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
Secondary	patient examination	heart rate	at baseline, 3 and 6 months