NCT03550547

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for not_applicable knee-osteoarthritis

Timeline
Completed

Started Mar 2019

Longer than P75 for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 28, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 8, 2018

Completed
9 months until next milestone

Study Start

First participant enrolled

March 11, 2019

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2022

Completed
Last Updated

November 30, 2020

Status Verified

November 1, 2020

Enrollment Period

2.7 years

First QC Date

May 28, 2018

Last Update Submit

November 27, 2020

Conditions

Knee Osteoarthritis

Keywords

Physical ActivityEducationDietarySelf-management

Outcome Measures

Primary Outcomes (1)

  • Measuring effectiveness of the educational workshops, personalized and determined for every patient.

    Average change from effectiveness of the educational workshops, personalized and determined for every patient, measured by a GAS GAS (Goal Attainment Scaling in Rehabilitation) is a method of scoring the extent to which patient's individual goals are achieved in the course of intervention. In effect, each patient has their own outcome measure but this is scored in a standardized way as to allow statistical analysis. Each goal is rated on a 5-point scale, with the degree of attainment captured for each goal area: * If the patient achieves the expected level, this is scored at 0. * If they achieve a better than expected outcome this is scored at: +1 (more than expected), +2 (much more than expected) * If they achieve a worse than expected outcome this is scored at: -1 (less than expected) or -2 (much less than expected) GAS depends on two things - the patient's ability to achieve their goals and the clinician's ability to predict outcome, which requires knowledge and experience.

    Month 06

Secondary Outcomes (5)

  • Functional status

    Day 01, Day 18, Month 03, Month 06, Month 09, Month 12.

  • Pain intensity

    Day 01, Day 18, Month 03, Month 06, Month 09, Month 12.

  • Life quality

    Day 01, Day 18, Month 03, Month 06, Month 09, Month 12.

  • Comprehensive evaluation of patient education programs

    Day 18, Month 03, Month 06, Month 09, Month 12

  • Measuring effectiveness of the educational workshops, personalized and determined for every patient.

    Day 01, Day 18, Month 03, Month 09, Month 12.

Study Arms (2)

7 educational workshops

EXPERIMENTAL

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

Other: Educational workshopsOther: Spa Therapy

spa therapy

ACTIVE COMPARATOR

Approved Spa therapy

Other: Spa Therapy

Interventions

Educational workshopsOTHER

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

Also known as: Non pharmacological intervention
7 educational workshops
Spa TherapyOTHER

Approved Spa therapy of knee osteoarthritis patients

Also known as: Non pharmacological intervention
7 educational workshopsspa therapy

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Contraindication to the spa therapy
  • Trouble behavior or understanding making it impossible to assess

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Etablissement thermal

Dax, Aquitaine, 40100, France

RECRUITING

Related Publications (6)

  • 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: 19734131BACKGROUND

  • 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.

    PMID: 21123844BACKGROUND

  • 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.

    PMID: 3068365BACKGROUND

  • 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.

    PMID: 26343173BACKGROUND

  • 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.

    PMID: 9180650BACKGROUND

  • 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.

    PMID: 36658607DERIVED

MeSH Terms

Conditions

Osteoarthritis, KneeMotor Activity

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesBehavior

Study Officials

  • Emmanuel COUDEYRE, MD-PhD

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Emmanuel COUDEYRE, MD-PhD

CONTACT

+33473750900ecoudeyre@chu-clermontferrand.fr

Anna GOLDSTEIN

CONTACT

+33473750839agoldstein@chu-clermontferrand.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2018

First Posted

June 8, 2018

Study Start

March 11, 2019

Primary Completion

November 28, 2021

Study Completion

May 28, 2022

Last Updated

November 30, 2020

Record last verified: 2020-11

Locations

FR(1)