Integrated Treatment Program for Osteoarthritis of the Knee

Osteoarthritis Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02200107
• Other study ID #: OA-knee 015/2014
• Status: Recruiting
• Phase: N/A
• First received: July 17, 2014
• Last updated: April 12, 2015
• Start date: September 2014

Study information

• Verified date: July 2014
• Source: Meir Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 155
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis Knee
• Osteoarthritis, Knee

Intervention

Behavioral:
• self management education

Locations

Country	Name	City	State
Israel	Clalit Health Service	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient satisfaction with treatment	Satisfaction Questionnaire	6 months after enrollment	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No