THERMARTHROSE: Gonarthrosis and Water Cure - Full Text View

Sponsored by:	Association Francaise pour la Recherche Thermale
Information provided by:	Association Francaise pour la Recherche Thermale
ClinicalTrials.gov Identifier:	NCT00348777

Purpose

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.

Condition	Intervention	Phase
Osteoarthritis, Knee Pain	Drug: thermal cure Drug: 3 days access to watering place at 6 months	Phase III

MedlinePlus related topics: Drinking Water Osteoarthritis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Parallel Assignment, Safety/Efficacy Study
Official Title:	Evaluation of the Effects of a Water Cure on Gonarthrosis: Randomized Clinical Study Including Water Cure Versus Continuation of the Usual Treatment

Further study details as provided by Association Francaise pour la Recherche Thermale:

Primary Outcome Measures:

the more small change clinically relevant of the WOMAC indice and/or of pain. [ Time Frame: at 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

WOMAC indice and pain (EVA) [ Time Frame: at inclusion and 1, 3, 6 and 9 months ] [ Designated as safety issue: No ]
The clinically acceptable symptom for the patient [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
Clinical evaluation [ Time Frame: at inclusion and 1, 3 and 6 months ] [ Designated as safety issue: Yes ]
Opinion of the patient and the physician [ Time Frame: at 1, 3 and 6 months ] [ Designated as safety issue: No ]
Quality of life: questionnaire SF-36 [ Time Frame: inclusion and 1, 3, 6 and 9 months ] [ Designated as safety issue: No ]
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) [ Time Frame: inclusion and 1,3,6 months ] [ Designated as safety issue: Yes ]

Enrollment:	462
Study Start Date:	June 2006
Study Completion Date:	January 2008
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator group with 18 days thermal cure	Drug: thermal cure thermal cure of 18 days including movement in swimming pool, mud-bath, shower, massage and thermal steam
2: Sham Comparator group with no thermal cure but only access 3 days to watering place 6 months after inclusion	Drug: 3 days access to watering place at 6 months access to watering place for movement in swimming pool, sauna and hammam.

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00348777

Locations

France
Cabinet Médical
Chambery, France, 73000
Cabinet médical
Balaruc-les-Bains, France, 34540
Hôpital thermal
DAX, France, 40107

Sponsors and Collaborators

Association Francaise pour la Recherche Thermale

Investigators

Principal Investigator:

Romain FORESTIER, Dr

Président du Centre de Recherches Rhumatologiques et Thermales, Aix-les-Bains, France

More Information

Publications:

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.

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.

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.

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.

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

Responsible Party:	Association Francaise pour la Recherche Thermale ( Pr Roques Christian )
Study ID Numbers:	DCIC 06 06
Study First Received:	July 4, 2006
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00348777
Health Authority:	France: Ministry of Health

Keywords provided by Association Francaise pour la Recherche Thermale:

Visual analogic Scale of pain
Womac indice
SF-36 quality of life
Hydrotherapy

Study placed in the following topic categories:

Osteoarthritis, Knee
Musculoskeletal Diseases
Osteoarthritis
Joint Diseases

Arthritis
Quality of Life
Pain
Rheumatic Diseases

ClinicalTrials.gov processed this record on February 09, 2009