Knee Osteoarthritis (OA) Project Treatment Versus Conventional Physical Therapy in the Treatment of Knee OA Patients
OA
A Comparative, Non Randomized Trial of Knee Osteoarthritis (OA) Project Treatment Versus Conventional Physical Therapy in the Treatment of Knee OA Patients
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 8, 2011
CompletedFirst Posted
Study publicly available on registry
December 13, 2011
CompletedStudy Start
First participant enrolled
January 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedMarch 5, 2012
March 1, 2012
8 months
December 8, 2011
March 2, 2012
Conditions
Outcome Measures
Primary Outcomes (3)
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.
On the first week- first session of PT and on last session- 12 weeks Average
WOMAC questionaire
On the first week- first session of PT and on last session- 12 weeks Average
EQ-5D questionaire
On the first week- first session of PT and on last session- 12 weeks Average
Secondary Outcomes (1)
Body Mass index
Up to the first week- on the first session of PT
Study Arms (2)
knee OA project
EXPERIMENTAL12 sessions of PT, 6 INDIVIDUAL AND 6 GROUP TREATMENTS
conventional PT
NO INTERVENTIONInterventions
physical therapy in "OA Knee project", total of 12 sessions, 6 group therapies amd 6 one on one therapy.
Eligibility Criteria
You may qualify if:
- + 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clalit Health Service
Jerusalem, Israel, 97802, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yair Barzilai, M.D.
Clalit health service, Israel
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- physical therapist
Study Record Dates
First Submitted
December 8, 2011
First Posted
December 13, 2011
Study Start
January 1, 2012
Primary Completion
September 1, 2012
Study Completion
December 1, 2012
Last Updated
March 5, 2012
Record last verified: 2012-03