Integrated Treatment Program for Osteoarthritis of the Knee

Not Applicable

• Conditions: Osteoarthritis Knee
• Interventions: Behavioral: self management education

• Registration Number: NCT02200107
• Lead Sponsor: Meir Medical Center

Brief Summary

The purpose of this study is to determine the ability to assimilate and implement an integrated treatment program osteoarthritis of the knee, including the diagnosis and follow-up by a family physician in primary care clinics, combined with patient self-care training and physiotherapy program

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2014-07
• Study First Submitted: 2014-07-17
• Study First Submitted QC: 2014-07-23
• Study First Posted: 2014-07-25
• Study Start: 2014-09
• Last Update Submitted: 2015-04-12
• Last Update Posted: 2015-04-14
• Primary Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 155

Inclusion Criteria

• Active complaint of knee pain
• Diagnosis of knee osteoarthritis according to X-ray
• Morning stiffness of less than 30 minutes AND/OR crepitus in active movement
• Ability to read Hebrew

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Exclusion Criteria

• Previous participation in physiotherapy treatment program
• Gout in knee, rheumatoid arthritis, fibromyalgia
• Complaints that appear in a knee which was operated in the past
• Dementia
• Severe limitations in mobility

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
self management education	self management education	self management education program delivered by family doctor in primary care clinics and during and physical therapy design

Primary Outcome Measures

Name	Time	Method
Change in WOMAC ( Western Ontario and McMaster Universities Arthritis Index ) score during participating in the program	0, 6 weeks, for intervention group after completing physical therapy program, for the control group after 6 months	WOMAC score will be evaluated through a questionnaire (validated to Hebrew) at baseline and after a constant time period. For both groups (intervention and control) after 6 weeks from enrollment and then for the control group after 6 months, and for the intervention group after completing physical therapy program. we will assess the change from baseline.

Secondary Outcome Measures

Name	Time	Method
Change in the consumption of drugs during participating in the program	0, 6 weeks, for intervention group after completing physical therapy program, for the control group after 6 months	Prescriptions given by family doctor, for treating patient's knee complaints. It will be evaluated by the medical record registration of the patients, at baseline and after a constant time period. For both groups (intervention and control) after 6 weeks from enrollment and then for the control group after 6 months, and for the intervention group after completing physical therapy program.
Changes in Referrals to specialists doctors during participating in the program	after 6 weeks since enrollment, and then for intervention group after completing physical therapy program, and for the control group after 6 months	Referrals given by family doctor. It will be evaluated by the medical record registration of the patients, for both groups (intervention and control) after 6 weeks from enrollment and then for the control group after 6 months, and for the intervention group after completing physical therapy program.
Change in VAS pain score during participating in the program	0, 6 weeks, for intervention group after completing physical therapy program, for the control group after 6 months	VAS score will be evaluated through a questionnaire (validated to Hebrew) at baseline and after a constant time period. For both groups (intervention and control) after 6 weeks from enrollment and then for the control group after 6 months, and for the intervention group after completing physical therapy program. we will assess the change from baseline.

Trial Locations

Locations (1)

Clalit Health Service; 🇮🇱 Jerusalem, Israel