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THERMARTHROSE: Gonarthrosis and Water Cure

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ClinicalTrials.gov Identifier: NCT00348777
Recruitment Status : Completed
First Posted : July 6, 2006
Last Update Posted : June 22, 2011
Sponsor:
Information provided by:

Study Description
Brief 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.

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

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 462 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Evaluation of the Effects of a Water Cure on Gonarthrosis: Randomized Clinical Study Including Water Cure Versus Continuation of the Usual Treatment
Study Start Date : June 2006
Primary Completion Date : January 2008
Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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.


Outcome Measures

Primary Outcome Measures :
  1. the more small change clinically relevant of the WOMAC indice and/or of pain. [ Time Frame: at 6 months ]

Secondary Outcome Measures :
  1. WOMAC indice and pain (EVA) [ Time Frame: at inclusion and 1, 3, 6 and 9 months ]
  2. The clinically acceptable symptom for the patient [ Time Frame: at 6 months ]
  3. Clinical evaluation [ Time Frame: at inclusion and 1, 3 and 6 months ]
  4. Opinion of the patient and the physician [ Time Frame: at 1, 3 and 6 months ]
  5. Quality of life: questionnaire SF-36 [ Time Frame: inclusion and 1, 3, 6 and 9 months ]
  6. 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 ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00348777


Locations
France
Cabinet médical
Balaruc-les-Bains, France, 34540
Cabinet Médical
Chambery, France, 73000
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:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pr Roques Christian, Association Francaise pour la Recherche Thermale
ClinicalTrials.gov Identifier: NCT00348777     History of Changes
Other Study ID Numbers: DCIC 06 06
First Posted: July 6, 2006    Key Record Dates
Last Update Posted: June 22, 2011
Last Verified: June 2011

Keywords provided by Association Francaise pour la Recherche Thermale:
Visual analogic Scale of pain
Womac indice
SF-36 quality of life
Hydrotherapy

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases