Knee Osteoarthritis (OA) Project Treatment Versus Conventional Physical Therapy in the Treatment of Knee OA Patients (OA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01490606
Recruitment Status : Unknown
Verified March 2012 by Shemtov Fatal, Meir Medical Center.
Recruitment status was:  Recruiting
First Posted : December 13, 2011
Last Update Posted : March 5, 2012
Information provided by (Responsible Party):
Shemtov Fatal, Meir Medical Center

Brief Summary:

A. Background.

Patients with osteoarthritis (OA) of the knee, suffer from a combination of pain, stiffness, joint instability, swelling and muscles weakness. This leads to decrease in quality of life, Active Daily living (ADL) and increase of medical services consumption in the community. OA of the knee, Is one of the world's common musculoskeletal disorder (18% among women and 10% among men). 80% of patients with OA of the knee suffer from decrease in mobility and 20% of them suffer an inability to perform everyday activities.

Physical therapy training includes exercises for OA patients (Mild to Severe degree) is the cornerstone of non medicinal treatment. This training aimed to pain reduction, improved functioning and participation in family and working social life. Physical training with exercises can enhance physical capabilities such as: muscular strength, range of motion, balance, proprioception and cardiovascular performance. Other benefits are improving mobility, reducing risk of falls and body weight and improvement in psychological condition.

B. Purpose

The purpose of this research is to check the effectiveness of treatment in the framework of "knee Osteoarthritis project" compared to conventional Physical therapy in physical functioning, pain and quality of life scales, among patients over the age of 60 who suffer from OA of the knee .

C. Research method

A comparative non blinded, clinical trial will be conducted. This research will include 60 independent patients divided into equal groups: Intervention group will be trained in "knee Osteoarthritis project" (in which patients receive 6 individual treatments and 6 Group treatments). Control group will be treated with conventional physical therapy, which includes 12 individual treatments. Effect of the treatment will be evaluated by: 1. WOMAC questionnaire- used to evaluate function and pain. 2. EQ-5D questionnaire for evaluating the quality of life. 3. Time up and go test- a Common functional test. This Questionnaires and test will be Performed before and after the study.

D. Study hypothesis

Physical therapy treatment within the framework of "knee Osteoarthritis project" is favor than the treatment of the conventional Physical therapy. Therefore the investigators expect much improvement in terms of pain, physical functioning and quality of life among intervention group compared to control groups.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Other: knee OA project Other: conventional PT Not Applicable

Detailed Description:

This research is divided into o Intervention and control groups. Research Population is 60 Patients (30 patients to each arm), aged 60 and above suffering from OA of the knees and admitted to physical therapy .Intervention group patients were treated by the concept of "Knee Osteoarthritis Project". This was first applied in middle of 2010 and its effectiveness was never tested.

The main idea was to make patients more active, to encourage them to do exercise at home, increase their motivation and self efficacy. In addition, patients received prescription for TENS device (Transcutaneous electrical nerve stimulator) for home use.

Individual sessions include: muscle strengthening, proprioception exercise, taping, soft tissue stretching, joint and soft tissue mobilization, electrotherapy, aerobic exercise (bicycle, treadmill), functional exercise. Group session include: muscle strengthening, stairs exercise, balance exercise and education about the disease and treatment (lecture about knee OA and recommendations for changes in life style).

In Intervention group were given 12 session. 6 individual treatments and 6 group treatments Control group patients were given 12 individual sessions of conventional physical therapy.

The Outcome measures that were mention above will be performed in the beginning and the end of 12 sessions.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Comparative, Non Randomized Trial of Knee Osteoarthritis (OA) Project Treatment Versus Conventional Physical Therapy in the Treatment of Knee OA Patients
Study Start Date : January 2012
Estimated Primary Completion Date : September 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: knee OA project
Other: knee OA project
physical therapy in "OA Knee project", total of 12 sessions, 6 group therapies amd 6 one on one therapy.

Other: conventional PT

No Intervention: conventional PT

Primary Outcome Measures :
  1. Time up and go test [ Time Frame: On the first week- first session of PT and on last session- 12 weeks Average ]
    Patient sits on a chair with handles. by order "go", patient will stand up and walk 3 meters forward circle a Conus and return to the chair. a time watch will count time.

  2. WOMAC questionaire [ Time Frame: On the first week- first session of PT and on last session- 12 weeks Average ]
  3. EQ-5D questionaire [ Time Frame: On the first week- first session of PT and on last session- 12 weeks Average ]

Secondary Outcome Measures :
  1. Body Mass index [ Time Frame: Up to the first week- on the first session of PT ]

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 60+ years old independent men and women,who suffer from OA in the knee and was referred to Physiotherapy.
  • ability to write and read properly in Hebrew

Exclusion Criteria:

  • OA secondary to systematic disease (Rheumatoid arthritis)
  • steroids injections to the knee in the past 3 months.
  • orthopaedic surgery to lower limbs.
  • neurological deficit.
  • symptomatic OA in the hip or ankle

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01490606

Contact: Shimi Fatal, BPT 0504021514
Contact: Yair barzilai, M.D 0508573279

Clalit Health Service Recruiting
Jerusalem, Israel, 97802
Contact: Shimi Fatal, BPT    0504021514   
Contact: Yair Barzilay, MD    0508573279   
Sub-Investigator: Shimi Fatal, BPT         
Principal Investigator: Yair Barzilai, MD         
Sub-Investigator: Ehud Lebel, MD         
Sub-Investigator: Esti voltz, BPT         
Sub-Investigator: Basma Hasan, BPT         
Sub-Investigator: Yaron Milul, M.A         
Sub-Investigator: Goni Miron, M.A         
Sub-Investigator: Tal Shemesh, M.A         
Sub-Investigator: Lisa Cohen, M.A         
Sub-Investigator: Alexandra Maximov, BPT         
Sponsors and Collaborators
Meir Medical Center
Principal Investigator: Yair Barzilai, M.D. Clalit health service, Israel

Responsible Party: Shemtov Fatal, physical therapist, Meir Medical Center Identifier: NCT01490606     History of Changes
Other Study ID Numbers: MMC11191/2011KCTIL
First Posted: December 13, 2011    Key Record Dates
Last Update Posted: March 5, 2012
Last Verified: March 2012

Additional relevant MeSH terms:
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases