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Completed

NCT Number: NCT00348777

THERMARTHROSE: Gonarthrosis and Water Cure

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Cabinet médical, Balaruc-les-Bains, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

thermal cure

Drug

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

Drug

access to watering place for movement in swimming pool, sauna and hammam.

Primary outcomes

  1. the more small change clinically relevant of the WOMAC indice and/or of pain.

    Time frame: at 6 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Association Francaise pour la Recherche Thermale

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jul 6, 2006
Registry last updated
Jun 22, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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