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

NCT ID: NCT01490606

Last Updated: 2012-03-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2012-12-31

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.

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.

Conditions

Osteoarthritis, Knee

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

knee OA project

12 sessions of PT, 6 INDIVIDUAL AND 6 GROUP TREATMENTS

Group Type: EXPERIMENTAL

knee OA project

Intervention Type: OTHER

physical therapy in "OA Knee project", total of 12 sessions, 6 group therapies amd 6 one on one therapy.

conventional PT

Intervention Type: OTHER

12 SESSIONS OF CONVENTIONAL PHYSICAL THERAPY

conventional PT

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

knee OA project

physical therapy in "OA Knee project", total of 12 sessions, 6 group therapies amd 6 one on one therapy.

Intervention Type: OTHER

conventional PT

12 SESSIONS OF CONVENTIONAL PHYSICAL THERAPY

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Meir Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Shemtov Fatal

physical therapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yair Barzilai, M.D.

Role: PRINCIPAL_INVESTIGATOR

Clalit health service, Israel

Locations

Clalit Health Service

Jerusalem, Israel, Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Shimi Fatal, BPT

Role: CONTACT

shimifatal@gmail.com

0504021514

Yair barzilai, M.D

Role: CONTACT

dbar@hadassah.org.il

0508573279

Facility Contacts

Shimi Fatal, BPT

Role: primary

shimifatal@gmail.com

0504021514

Yair Barzilay, MD

Role: backup

dbar@hadassah.org.il

0508573279

Other Identifiers

MMC11191/2011KCTIL

Identifier Type: -

Identifier Source: org_study_id