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Educational Program Associated With a Conventional Spa Therapy of Knee Osteoarthritis Patients

NCT ID: NCT03550547

Last Updated: 2020-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-11

Study Completion Date

2022-05-28

Brief Summary

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The main objective of this work is to measure the efficiency of 18 days SPA Therapy in orientation rheumatology associated with an educational intervention in patients with knee osteoarthritis on a priority objective, personalized and determined by the patient, chosen in the list of 5 objectives determined during the educational assessment.

Detailed Description

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This program begin with a shared educational balance assessment allowing to set up the individual program adapted to the objectives personalized by the patients. The objectives to achieve are to allow the patients to acquire knowledge and skills (attitudes, behavior) concerning their pathology and the existing treatment. A multidisciplinary team trained in the therapeutic education of the patient assure the educational interventions. The proposed educational activities (7 educational workshops) concern major axes of the care of the knee osteoarthritis: knowledge of the pathology, the adapted physical exercise, the dietetics, the management of the pain, the articular hygiene and the technical helps.

Conditions

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Knee Osteoarthritis

Keywords

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Physical Activity Education Dietary Self-management

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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7 educational workshops

Intervention: 7 educational workshops in addition to spa therapy :

Knowledge of the pathology ; Educational physical activity ( 2 workshops); Dietary; Management of pain, fatigue and the medical treatments; Articular hygiene and ergonomics; Technical assistance, an adaptation of the living condition

Group Type EXPERIMENTAL

Educational workshops

Intervention Type OTHER

1 workshop : Knowledge of the pathology ; 2a workshop: Educational physical activity; 2b workshop : Educational physical activity; 4 workshop : Dietary; 5 workshop : Management of pain, fatigue and the medical treatments; 6 workshop : Articular hygiene and ergonomics; 7 workshop : Technical assistance, an adaptation of the living condition

Spa Therapy

Intervention Type OTHER

Approved Spa therapy of knee osteoarthritis patients

spa therapy

Approved Spa therapy

Group Type ACTIVE_COMPARATOR

Spa Therapy

Intervention Type OTHER

Approved Spa therapy of knee osteoarthritis patients

Interventions

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Educational workshops

1 workshop : Knowledge of the pathology ; 2a workshop: Educational physical activity; 2b workshop : Educational physical activity; 4 workshop : Dietary; 5 workshop : Management of pain, fatigue and the medical treatments; 6 workshop : Articular hygiene and ergonomics; 7 workshop : Technical assistance, an adaptation of the living condition

Intervention Type OTHER

Spa Therapy

Approved Spa therapy of knee osteoarthritis patients

Intervention Type OTHER

Other Intervention Names

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Non pharmacological intervention Non pharmacological intervention

Eligibility Criteria

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Inclusion Criteria

* Patients, male or female, aged 50 to 75 years
* Patients with knee osteoarthritis clinical criteria of the American College of Rheumatology (ACR)
* Patient affiliated to a social security scheme (beneficiary entitled)
* Patient registered spa
* Pain intensity equal or more than "3" at the Visual Analogical Scale
* Patient has given its consent in writing to

Exclusion Criteria

* Contraindication to the spa therapy
* Trouble behavior or understanding making it impossible to assess
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Clermont-Ferrand

OTHER

Sponsor Role collaborator

Association Francaise pour la Recherche Thermale

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Emmanuel COUDEYRE, MD-PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

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Etablissement thermal

Dax, Aquitaine, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Emmanuel COUDEYRE, MD-PhD

Role: CONTACT

Phone: +33473750900

Email: [email protected]

Anna GOLDSTEIN

Role: CONTACT

Phone: +33473750839

Email: [email protected]

Facility Contacts

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Karine Dubourg, Dr

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 19734131 (View on PubMed)

Mendelson AD, McCullough C, Chan A. Integrating self-management and exercise for people living with arthritis. Health Educ Res. 2011 Feb;26(1):167-77. doi: 10.1093/her/cyq077. Epub 2010 Dec 1.

Reference Type BACKGROUND
PMID: 21123844 (View on PubMed)

Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW. Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol. 1988 Dec;15(12):1833-40.

Reference Type BACKGROUND
PMID: 3068365 (View on PubMed)

Krasny-Pacini A, Evans J, Sohlberg MM, Chevignard M. Proposed Criteria for Appraising Goal Attainment Scales Used as Outcome Measures in Rehabilitation Research. Arch Phys Med Rehabil. 2016 Jan;97(1):157-70. doi: 10.1016/j.apmr.2015.08.424. Epub 2015 Sep 4.

Reference Type BACKGROUND
PMID: 26343173 (View on PubMed)

Rockwood K, Joyce B, Stolee P. Use of goal attainment scaling in measuring clinically important change in cognitive rehabilitation patients. J Clin Epidemiol. 1997 May;50(5):581-8. doi: 10.1016/s0895-4356(97)00014-0.

Reference Type BACKGROUND
PMID: 9180650 (View on PubMed)

Goldstein A, Lanhers C, Gay C, Dubourg K, Grange L, Roques CF, Pereira B, Coudeyre E. Efficacy of self-management program associated with a spa therapy for knee osteoarthritis patients (GETT 2): a research protocol for a randomized trial. Trials. 2023 Jan 19;24(1):45. doi: 10.1186/s13063-022-06879-5.

Reference Type DERIVED
PMID: 36658607 (View on PubMed)

Other Identifiers

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2017-A03323-50

Identifier Type: -

Identifier Source: org_study_id