Back to resultsIntegrated Treatment Program for Osteoarthritis of the Knee
Primary Purpose
Osteoarthritis Knee
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
self management education
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis Knee focused on measuring Osteoarthritis Knee, Self Care, Treatment Outcome, Patient Education as Topic, Physical Therapy Modalities
Eligibility Criteria
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
Sites / Locations
- Clalit Health ServiceRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
self management education
control
Arm Description
self management education program delivered by family doctor in primary care clinics and during and physical therapy design
Routine follow up according to standard practice
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02200107
Brief Title
Integrated Treatment Program for Osteoarthritis of the Knee
Official Title
Implementing and Evaluating Integrated Medical and Physiotherapy Treatment Program for Osteoarthritis of the Knee by Family Doctors in Primary Care Clinics
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meir Medical Center
4. Oversight
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis Knee
Keywords
Osteoarthritis Knee, Self Care, Treatment Outcome, Patient Education as Topic, Physical Therapy Modalities
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
155 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
self management education
Arm Type
Experimental
Arm Description
self management education program delivered by family doctor in primary care clinics and during and physical therapy design
Arm Title
control
Arm Type
No Intervention
Arm Description
Routine follow up according to standard practice
Intervention Type
Behavioral
Intervention Name(s)
self management education
Primary Outcome Measure Information:
Title
Change in WOMAC ( Western Ontario and McMaster Universities Arthritis Index ) score during participating in the program
Description
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.
Time Frame
0, 6 weeks, for intervention group after completing physical therapy program, for the control group after 6 months
Secondary Outcome Measure Information:
Title
Change in VAS pain score during participating in the program
Description
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.
Time Frame
0, 6 weeks, for intervention group after completing physical therapy program, for the control group after 6 months
Title
Change in the consumption of drugs during participating in the program
Description
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.
Time Frame
0, 6 weeks, for intervention group after completing physical therapy program, for the control group after 6 months
Title
Changes in Referrals to specialists doctors during participating in the program
Description
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.
Time Frame
after 6 weeks since enrollment, and then for intervention group after completing physical therapy program, and for the control group after 6 months
Other Pre-specified Outcome Measures:
Title
Patient satisfaction with treatment
Description
Satisfaction Questionnaire
Time Frame
6 months after enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ohad Avny, MD
Organizational Affiliation
Clalit Health Service
Official's Role
Study Chair
Facility Information:
Facility Name
Clalit Health Service
City
Jerusalem
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keren Cohen-Nahum, MD
Phone
+972523834141
Email
kercona@gmail.com
First Name & Middle Initial & Last Name & Degree
Ohad Avny, MD
12. IPD Sharing Statement
Learn more about this trial
Integrated Treatment Program for Osteoarthritis of the Knee
We'll reach out to this number within 24 hrs