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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | group with 18 days thermal cure |
|
| 2 | Sham Comparator | group with no thermal cure but only access 3 days to watering place 6 months after inclusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| thermal cure | Drug | thermal cure of 18 days including movement in swimming pool, mud-bath, shower, massage and thermal steam |
|
| Measure | Description | Time Frame |
|---|---|---|
| the more small change clinically relevant of the WOMAC indice and/or of pain. | at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| WOMAC indice and pain (EVA) | at inclusion and 1, 3, 6 and 9 months | |
| The clinically acceptable symptom for the patient | at 6 months | |
| Clinical evaluation |
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Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Romain FORESTIER, Dr | Président du Centre de Recherches Rhumatologiques et Thermales, Aix-les-Bains, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cabinet médical | Balaruc-les-Bains | 34540 | France | |||
| Cabinet Médical |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14644851 | Background | 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. doi: 10.1136/ard.2003.011742. | |
| 15140778 |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010146 | Pain |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| 3 days access to watering place at 6 months | Drug | access to watering place for movement in swimming pool, sauna and hammam. |
|
| at inclusion and 1, 3 and 6 months |
| Opinion of the patient and the physician | at 1, 3 and 6 months |
| Quality of life: questionnaire SF-36 | inclusion and 1, 3, 6 and 9 months |
| 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 |
| Chambéry |
| 73000 |
| France |
| Hôpital thermal | Dax | 40107 | France |
| Background |
| 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. doi: 10.1136/ard.2003.009803. |
| 15208174 | 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 changes in patient reported outcomes in knee and hip osteoarthritis: the minimal clinically important improvement. Ann Rheum Dis. 2005 Jan;64(1):29-33. doi: 10.1136/ard.2004.022905. Epub 2004 Jun 18. |
| 10796385 | 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. |
| 2218168 | Background | Zelen M. Randomized consent designs for clinical trials: an update. Stat Med. 1990 Jun;9(6):645-56. doi: 10.1002/sim.4780090611. |
| 24745692 | Derived | Forestier R, Genty C, Waller B, Francon A, Desfour H, Rolland C, Roques CF, Bosson JL. Crenobalneotherapy (spa therapy) in patients with knee and generalized osteoarthritis: a post-hoc subgroup analysis of a large multicentre randomized trial. Ann Phys Rehabil Med. 2014 Jun;57(4):213-27. doi: 10.1016/j.rehab.2014.03.001. Epub 2014 Mar 27. |
| 19734131 | Derived | 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. |
| D012216 |
| Rheumatic Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |