THERMARTHROSE: Gonarthrosis and Water Cure

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

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.

Study Overview

• Status: Completed
• Conditions: Pain; Osteoarthritis, Knee
• Intervention / Treatment: Drug: thermal cure; Drug: 3 days access to watering place at 6 months

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.

• Study Type: Interventional
• Enrollment (Actual): 462
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Balaruc-les-Bains, France, 34540
    • Cabinet Médical
  • Chambery, France, 73000
    • Cabinet Médical
  • DAX, France, 40107
    • Hopital thermal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 1; 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
SHAM_COMPARATOR: 2; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
the more small change clinically relevant of the WOMAC indice and/or of pain.	at 6 months

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Association Francaise pour la Recherche Thermale
• Investigators: Principal Investigator: Romain FORESTIER, Dr, Président du Centre de Recherches Rhumatologiques et Thermales, Aix-les-Bains, France

Publications and helpful links

General Publications

• Zelen M. Randomized consent designs for clinical trials: an update. Stat Med. 1990 Jun;9(6):645-56. doi: 10.1002/sim.4780090611.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2006
• Primary Completion (ACTUAL): January 1, 2008
• Study Completion (ACTUAL): January 1, 2008

Study Registration Dates

• First Submitted: July 4, 2006
• First Submitted That Met QC Criteria: July 5, 2006
• First Posted (ESTIMATE): July 6, 2006

Study Record Updates

• Last Update Posted (ESTIMATE): June 22, 2011
• Last Update Submitted That Met QC Criteria: June 21, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Keywords: Hydrotherapy; Visual analogic Scale of pain; Womac indice; SF-36 quality of life
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: DCIC 06 06