Integrated Treatment Program for Osteoarthritis of the Knee

Implementing and Evaluating Integrated Medical and Physiotherapy Treatment Program for Osteoarthritis of the Knee by Family Doctors in Primary Care Clinics

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

Study Overview

• Status: Unknown
• Conditions: Osteoarthritis Knee
• Intervention / Treatment: Behavioral: self management education

• Study Type: Interventional
• Enrollment (Anticipated): 155
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Jerusalem, Israel
    • Recruiting
    • Clalit Health Service
    • Contact: Keren Cohen-Nahum, MD; Phone Number: +972523834141; Email: kercona@gmail.com
    • Principal Investigator: Ohad Avny, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: self management education; self management education program delivered by family doctor in primary care clinics and during and physical therapy design	Behavioral: self management education
No Intervention: control; Routine follow up according to standard practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in WOMAC ( Western Ontario and McMaster Universities Arthritis Index ) score during participating in the program	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.	0, 6 weeks, for intervention group after completing physical therapy program, for the control group after 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in VAS pain score during participating in the program	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.	0, 6 weeks, for intervention group after completing physical therapy program, for the control group after 6 months
Change in the consumption of drugs during participating in the program	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.	0, 6 weeks, for intervention group after completing physical therapy program, for the control group after 6 months
Changes in Referrals to specialists doctors during participating in the program	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.	after 6 weeks since enrollment, and then for intervention group after completing physical therapy program, and for the control group after 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction with treatment	Satisfaction Questionnaire	6 months after enrollment

Collaborators and Investigators

• Sponsor: Meir Medical Center
• Investigators: Study Chair: Ohad Avny, MD, Clalit Health Service

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: July 17, 2014
• First Submitted That Met QC Criteria: July 23, 2014
• First Posted (Estimate): July 25, 2014

Study Record Updates

• Last Update Posted (Estimate): April 14, 2015
• Last Update Submitted That Met QC Criteria: April 12, 2015
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: Physical Therapy Modalities; Treatment Outcome; Self Care; Patient Education as Topic; Osteoarthritis Knee
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: OA-knee 015/2014