Integrated Treatment Program for Osteoarthritis of the Knee

NCT02200107 | Unknown

• 1 other identifier: OA-knee 015/2014
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 1

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

Conditions

Osteoarthritis Knee

Keywords

Osteoarthritis Knee; Self Care; Treatment Outcome; Patient Education as Topic; Physical Therapy Modalities

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• 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

• 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

Other Outcomes (1)

• Patient satisfaction with treatment

  6 months after enrollment

Study Arms (2)

self management education

EXPERIMENTAL

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

Behavioral: self management education

control

NO INTERVENTION

Routine follow up according to standard practice

Interventions

self management education BEHAVIORAL

self management education

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Meir Medical Center: lead

Study Sites (1)

Clalit Health Service

Jerusalem, Israel

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Ohad Avny, MD

  Clalit Health Service

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2014
• First Posted: July 25, 2014
• Study Start: September 1, 2014
• Primary Completion: December 1, 2015
• Last Updated: April 14, 2015

Record last verified: 2014-07

Locations

IL (1)