THERMARTHROSE: Gonarthrosis and Water Cure

NCT00348777 | Completed Phase 3

• 1 other identifier: DCIC 06 06
• Study Type: interventional
• Target: 462
• Locations: 1 country
• Sites: 3

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.

Conditions

Osteoarthritis, Knee; Pain

Keywords

Visual analogic Scale of pain; Womac indice; SF-36 quality of life; Hydrotherapy

Outcome Measures

Primary Outcomes (1)

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

  at 6 months

Secondary Outcomes (6)

• 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

Study Arms (2)

1

ACTIVE COMPARATOR

group with 18 days thermal cure

Drug: thermal cure

2

SHAM COMPARATOR

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

Interventions

thermal cure DRUG

thermal cure of 18 days including movement in swimming pool, mud-bath, shower, massage and thermal steam

1

3 days access to watering place at 6 months DRUG

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

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Association Francaise pour la Recherche Thermale: lead

Study Sites (3)

Cabinet médical

Balaruc-les-Bains, 34540, France

Location

Cabinet Médical

Chambéry, 73000, France

Location

Hôpital thermal

Dax, 40107, France

Location

Related Publications (7)

• 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.

  PMID: 14644851 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.

  PMID: 15140778 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.

  PMID: 15208174 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.

  PMID: 10796385 BACKGROUND

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

  PMID: 2218168 BACKGROUND

• 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.

  PMID: 24745692 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.

  PMID: 19734131 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Pain

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Romain FORESTIER, Dr

  Président du Centre de Recherches Rhumatologiques et Thermales, Aix-les-Bains, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 4, 2006
• First Posted: July 6, 2006
• Study Start: June 1, 2006
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: June 22, 2011

Record last verified: 2011-06

Locations

FR (3)