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

Primary Purpose

Osteoarthritis, Knee

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
knee OA project
conventional PT
Sponsored by
Meir Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clalit Health ServiceRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

knee OA project

conventional PT

Arm Description

12 sessions of PT, 6 INDIVIDUAL AND 6 GROUP TREATMENTS

Outcomes

Primary Outcome Measures

Time up and go test
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
EQ-5D questionaire

Secondary Outcome Measures

Body Mass index

Full Information

First Posted
December 8, 2011
Last Updated
March 2, 2012
Sponsor
Meir Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01490606
Brief Title
Knee Osteoarthritis (OA) Project Treatment Versus Conventional Physical Therapy in the Treatment of Knee OA Patients
Acronym
OA
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 Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
September 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Meir Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
knee OA project
Arm Type
Experimental
Arm Description
12 sessions of PT, 6 INDIVIDUAL AND 6 GROUP TREATMENTS
Arm Title
conventional PT
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
knee OA project
Intervention Description
physical therapy in "OA Knee project", total of 12 sessions, 6 group therapies amd 6 one on one therapy.
Intervention Type
Other
Intervention Name(s)
conventional PT
Intervention Description
12 SESSIONS OF CONVENTIONAL PHYSICAL THERAPY
Primary Outcome Measure Information:
Title
Time up and go test
Description
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.
Time Frame
On the first week- first session of PT and on last session- 12 weeks Average
Title
WOMAC questionaire
Time Frame
On the first week- first session of PT and on last session- 12 weeks Average
Title
EQ-5D questionaire
Time Frame
On the first week- first session of PT and on last session- 12 weeks Average
Secondary Outcome Measure Information:
Title
Body Mass index
Time Frame
Up to the first week- on the first session of PT

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shimi Fatal, BPT
Phone
0504021514
Email
shimifatal@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yair barzilai, M.D
Phone
0508573279
Email
dbar@hadassah.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yair Barzilai, M.D.
Organizational Affiliation
Clalit health service, Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clalit Health Service
City
Jerusalem
ZIP/Postal Code
97802
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shimi Fatal, BPT
Phone
0504021514
Email
shimifatal@gmail.com
First Name & Middle Initial & Last Name & Degree
Yair Barzilay, MD
Phone
0508573279
Email
dbar@hadassah.org.il
First Name & Middle Initial & Last Name & Degree
Shimi Fatal, BPT
First Name & Middle Initial & Last Name & Degree
Yair Barzilai, MD
First Name & Middle Initial & Last Name & Degree
Ehud Lebel, MD
First Name & Middle Initial & Last Name & Degree
Esti voltz, BPT
First Name & Middle Initial & Last Name & Degree
Basma Hasan, BPT
First Name & Middle Initial & Last Name & Degree
Yaron Milul, M.A
First Name & Middle Initial & Last Name & Degree
Goni Miron, M.A
First Name & Middle Initial & Last Name & Degree
Tal Shemesh, M.A
First Name & Middle Initial & Last Name & Degree
Lisa Cohen, M.A
First Name & Middle Initial & Last Name & Degree
Alexandra Maximov, BPT

12. IPD Sharing Statement

Learn more about this trial

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

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