Integrated Treatment Program for Osteoarthritis of the Knee

Sponsor

Meir Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT02200107

Collaborator

(none)

155

Enrollment

Location

Arms

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis Knee	Behavioral: self management education	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

155 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2014

Anticipated Primary Completion Date :

Dec 1, 2015

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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.
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.

Other Outcome Measures

Patient satisfaction with treatment [6 months after enrollment]
Satisfaction Questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clalit Health Service	Jerusalem		Israel

Sponsors and Collaborators

Meir Medical Center

Investigators

Study Chair: Ohad Avny, MD, Clalit Health Service

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Meir Medical Center

ClinicalTrials.gov Identifier:

NCT02200107

Other Study ID Numbers:

OA-knee 015/2014

First Posted:

Jul 25, 2014

Last Update Posted:

Apr 14, 2015

Last Verified:

Jul 1, 2014

Keywords provided by Meir Medical Center

Osteoarthritis Knee

Self Care

Treatment Outcome

Patient Education as Topic

Physical Therapy Modalities

Additional relevant MeSH terms:

Osteoarthritis

Osteoarthritis, Knee

Study Results

No Results Posted as of Apr 14, 2015