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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Meir Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Shemtov Fatal, Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01490606
First received: December 8, 2011
Last updated: March 2, 2012
Last verified: March 2012
  Purpose

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 Intervention
Osteoarthritis, Knee
Other: knee OA project
Other: conventional PT

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • Time up and go test [ Time Frame: On the first week- first session of PT and on last session- 12 weeks Average ] [ Designated as safety issue: No ]
    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.

  • WOMAC questionaire [ Time Frame: On the first week- first session of PT and on last session- 12 weeks Average ] [ Designated as safety issue: No ]
  • EQ-5D questionaire [ Time Frame: On the first week- first session of PT and on last session- 12 weeks Average ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Body Mass index [ Time Frame: Up to the first week- on the first session of PT ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: January 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: knee OA project
12 sessions of PT, 6 INDIVIDUAL AND 6 GROUP TREATMENTS
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
12 SESSIONS OF CONVENTIONAL PHYSICAL THERAPY
No Intervention: conventional PT

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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01490606

Contacts
Contact: Shimi Fatal, BPT 0504021514 shimifatal@gmail.com
Contact: Yair barzilai, M.D 0508573279 dbar@hadassah.org.il

Locations
Israel
Clalit Health Service Recruiting
Jerusalem, Israel, 97802
Contact: Shimi Fatal, BPT    0504021514    shimifatal@gmail.com   
Contact: Yair Barzilay, MD    0508573279    dbar@hadassah.org.il   
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
Investigators
Principal Investigator: Yair Barzilai, M.D. Clalit health service, Israel
  More Information

No publications provided

Responsible Party: Shemtov Fatal, physical therapist, Meir Medical Center
ClinicalTrials.gov Identifier: NCT01490606     History of Changes
Other Study ID Numbers: MMC11191/2011KCTIL
Study First Received: December 8, 2011
Last Updated: March 2, 2012
Health Authority: Israel:Clalit Health Services

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

ClinicalTrials.gov processed this record on October 16, 2014