THERMARTHROSE: Gonarthrosis and Water Cure

Pain Clinical Trial

Official title:

Evaluation of the Effects of a Water Cure on Gonarthrosis: Randomized Clinical Study Including Water Cure Versus Continuation of the Usual Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00348777
• Other study ID #: DCIC 06 06
• Status: Completed
• Phase: Phase 3
• First received: July 4, 2006
• Last updated: June 21, 2011
• Start date: June 2006
• Est. completion date: January 2008

Study information

• Verified date: June 2011
• Source: Association Francaise pour la Recherche Thermale
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The main objective of this study is to evaluate the therapeutic effect of a thermal treatment on gonarthrosis, with an increase of the number of patients presenting a clinically significant improvement.

Description:

Gonarthrosis is a frequent pathology and the prevalence increase with age (prevalence: 6,1% in an adult population more than 30 years old and 40% after 75 years). It has a large impact on the quotidian life of the patients and it cause important costs for social protection. Relative to the treatment, numerous recommendations have been proposed (EULAR, ACR specifically). But no one of them recommends thermal treatment even if it is largely used in Europe and especially in France for the treatment of this pathology. Several prospective controlled randomized studies have evaluated the effect of the thermal treatments in rheumatology and some of them are relative, in part, to Gonarthrosis. So, we conduct a phase III randomized, controlled, single blind study evaluating the therapeutic effect at 6 month of a thermal cure on gonarthrosis.

In a situation of physical treatment, it's impossible to use a placebo as control: blind can't be respected. Whatever the methodology employed, non blind of the patient create a bias. So, we hope that the Zelen method for randomization will reduce the bias due to the dissatisfaction of the patients in the control group.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 462
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• ACR criteria: knee pain and one of the tree following conditions: Age > 50 years, Morning stiffness< 30 minutes and articular crackling.

• osteophytes visible on knee radiography.

• knee radiography less than 3 years old: face, schuss, axial of kneecap cliché.

• Actual gonarthrosis intensity on Visual Analogic Scale > or = 30mm.

Exclusion Criteria:

• arthrosis limited to the femoro-patellar compartments.

• severe depressive syndrome, psychosis.

• Thermal cure less than 6 month before.

• Contra-indication or predictable inability to tolerate thermal cure.

• Profession lied to hydrotherapy.

• previous knee treatments:

• massage, physiotherapy and acupuncture since less than 1 month;

• infiltration since less than 3 months;

• NSAI since less than 5 days;

• analgesic since less than 12 hours;

• modification in the medicinal anti-arthrosis treatment since less than 3 months.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis, Knee
• Pain

Intervention

Drug:
• thermal cure
thermal cure of 18 days including movement in swimming pool, mud-bath, shower, massage and thermal steam
• 3 days access to watering place at 6 months
access to watering place for movement in swimming pool, sauna and hammam.

Locations

Country	Name	City	State
France	Cabinet médical	Balaruc-les-Bains
France	Cabinet Médical	Chambery
France	Hôpital thermal	DAX

Sponsors (1)

Lead Sponsor	Collaborator
Association Francaise pour la Recherche Thermale

Country where clinical trial is conducted

France, 

References & Publications (5)

Jordan KM, Arden NK, Doherty M, Bannwarth B, Bijlsma JW, Dieppe P, Gunther K, Hauselmann H, Herrero-Beaumont G, Kaklamanis P, Lohmander S, Leeb B, Lequesne M, Mazieres B, Martin-Mola E, Pavelka K, Pendleton A, Punzi L, Serni U, Swoboda B, Verbruggen G, Zimmerman-Gorska I, Dougados M; Standing Committee for International Clinical Studies Including Therapeutic Trials ESCISIT. EULAR Recommendations 2003: an evidence based approach to the management of knee osteoarthritis: Report of a Task Force of the Standing Committee for International Clinical Studies Including Therapeutic Trials (ESCISIT). Ann Rheum Dis. 2003 Dec;62(12):1145-55. Review. — View Citation

Ravaud P, Giraudeau B, Logeart I, Larguier JS, Rolland D, Treves R, Euller-Ziegler L, Bannwarth B, Dougados M. Management of osteoarthritis (OA) with an unsupervised home based exercise programme and/or patient administered assessment tools. A cluster randomised controlled trial with a 2x2 factorial design. Ann Rheum Dis. 2004 Jun;63(6):703-8. — 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 changes in patient reported outcomes in knee and hip osteoarthritis: the minimal clinically important improvement. Ann Rheum Dis. 2005 Jan;64(1):29-33. Epub 2004 Jun 18. — 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

Zelen M. Randomized consent designs for clinical trials: an update. Stat Med. 1990 Jun;9(6):645-56. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the more small change clinically relevant of the WOMAC indice and/or of pain.		at 6 months	No
Secondary	WOMAC indice and pain (EVA)		at inclusion and 1, 3, 6 and 9 months	No
Secondary	The clinically acceptable symptom for the patient		at 6 months	No
Secondary	Clinical evaluation		at inclusion and 1, 3 and 6 months	Yes
Secondary	Opinion of the patient and the physician		at 1, 3 and 6 months	No
Secondary	Quality of life: questionnaire SF-36		inclusion and 1, 3, 6 and 9 months	No
Secondary	Treatments: medicinal consumption, physical treatments, hospitalization, consumption of cares getting back by the Medicaid of Savoie (CPAM, only for the study centre of Aix-les-Bains)		inclusion and 1,3,6 months	Yes