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Osteoarthritis, KneePhase 3NCT00348777

THERMARTHROSE: Gonarthrosis and Water Cure

A Phase 3 study testing thermal cure and 3 days access to watering place at 6 months in people with Osteoarthritis, Knee and Pain, run by Association Francaise pour la Recherche Thermale at 3 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Osteoarthritis, Knee, Pain
What is being tested?
thermal cure and 3 days access to watering place at 6 months
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
462 participants
Where
3 sitesFrance
Study dates
Jun 2006to Jan 2008
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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:
Show all 11Show fewer
  • 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.

Trial locations and contacts

3 sites in 1 country.

France3 sites

  • Cabinet médical

    Balaruc-les-Bains, 34540

  • Cabinet Médical

    Chambéry, 73000

  • Hôpital thermal

    Dax, 40107

Other trials in France

About this 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

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.

Read the 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.

Being tested
thermal cure, 3 days access to watering place at 6 months
Keywords
Visual analogic Scale of pain, Womac indice, SF-36 quality of life, Hydrotherapy
Medical subject headings
Osteoarthritis, Knee, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • thermal cureDrug

    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 monthsDrug

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

Study groups in NCT00348777
Study groupRoleWhat they receive
1Active comparatorgroup with 18 days thermal cure
Receives: Drug: thermal cure
2Sham comparatorgroup with no thermal cure but only access 3 days to watering place 6 months after inclusion
Receives: Drug: 3 days access to watering place at 6 months

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: at 6 months

Secondary outcomes (6)

  1. WOMAC indice and pain (EVA)

    Measured: at inclusion and 1, 3, 6 and 9 months

  2. The clinically acceptable symptom for the patient

    Measured: at 6 months

  3. Clinical evaluation

    Measured: at inclusion and 1, 3 and 6 months

  4. Opinion of the patient and the physician

    Measured: at 1, 3 and 6 months

  5. Quality of life: questionnaire SF-36

    Measured: 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)

    Measured: inclusion and 1,3,6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2006 (estimated)
  2. Study startJun 2006
  3. Primary completionJan 2008
  4. Study completionJan 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
462 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00348777
Sponsor's protocol ID
DCIC 06 06
Status last verified
Jun 2011
First submitted
4 Jul 2006
Last updated
22 Jun 2011
Results posted
No
Data monitoring committee
No

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. doi: 10.1136/ard.2003.011742.

    PubMed 14644851

  • 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.

    PubMed 15140778

  • 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.

    PubMed 15208174

  • 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.

    PubMed 10796385

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

    PubMed 2218168

  • 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.

    PubMed 24745692

  • 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.

    PubMed 19734131

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing thermal cure and 3 days access to watering place at 6 months in people with Osteoarthritis, Knee and Pain, run by Association Francaise pour la Recherche Thermale at 3 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the more small change clinically relevant of the WOMAC indice and/or of pain. (time frame: at 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00348777, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2011.

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