Osteoarthritis, KneeOANCT01490606
Knee Osteoarthritis (OA) Project Treatment Versus Conventional Physical Therapy in the Treatment of Knee OA Patients
A study testing knee OA project and conventional PT in people with Osteoarthritis, Knee, run by Meir Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- knee OA project and conventional PT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2012to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Clalit Health Service
Jerusalem, Israel, 97802
Shimi Fatal, BPT, 0504021514, shimifatal@gmail.com
Yair Barzilay, MD, 0508573279, dbar@hadassah.org.il
About this study
Official title: A Comparative, Non Randomized Trial of Knee Osteoarthritis (OA) Project Treatment Versus Conventional Physical Therapy in the Treatment of Knee OA Patients
- 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.
Read more
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.
- 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 .
- 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.
- 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.
Read the 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
- Being tested
- knee OA project, conventional PT
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
knee OA projectOther
physical therapy in "OA Knee project", total of 12 sessions, 6 group therapies amd 6 one on one therapy.
conventional PTOther
12 SESSIONS OF CONVENTIONAL PHYSICAL THERAPY
| Study group | Role | What they receive |
|---|---|---|
| knee OA project | Experimental | 12 sessions of PT, 6 INDIVIDUAL AND 6 GROUP TREATMENTS Receives: Other: knee OA project; Other: conventional PT |
| conventional PT | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: On the first week- first session of PT and on last session- 12 weeks Average
WOMAC questionaire
Measured: On the first week- first session of PT and on last session- 12 weeks Average
EQ-5D questionaire
Measured: On the first week- first session of PT and on last session- 12 weeks Average
Secondary outcomes (1)
Body Mass index
Measured: Up to the first week- on the first session of PT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2011 (estimated)
- Study startJan 2012
- Primary completionSep 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shemtov Fatal, Meir Medical Center
- Investigators
- Yair Barzilai, M.D., Principal investigator, Clalit health service, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01490606
- Sponsor's protocol ID
- MMC11191/2011KCTIL
- Acronym
- OA
- Status last verified
- Mar 2012
- First submitted
- 8 Dec 2011
- Last updated
- 5 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative, Non Randomized Trial of Knee Osteoarthritis (OA) Project Treatment Versus Conventional Physical Therapy in the Treatment of Knee OA Patients
- ClinicalTrials.gov ID
- NCT01490606
- Acronym / sponsor ID
- OA / MMC11191/2011KCTIL
- Conditions
- Osteoarthritis, Knee
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Sep 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 13 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
- 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 .
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| knee OA project | Experimental | Other: knee OA project, Other: conventional PT12 sessions of PT, 6 INDIVIDUAL AND 6 GROUP TREATMENTS |
| conventional PT | No intervention | – |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| knee OA projectphysical therapy in "OA Knee project", total of 12 sessions, 6 group therapies amd 6 one on one therapy. | Other | knee OA project |
| conventional PT12 SESSIONS OF CONVENTIONAL PHYSICAL THERAPY | Other | knee OA project |
Primary outcome
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.
WOMAC questionaire
Time frame: On the first week- first session of PT and on last session- 12 weeks Average
EQ-5D questionaire
Time frame: On the first week- first session of PT and on last session- 12 weeks Average
1 secondary outcome
Body Mass index
Time frame: Up to the first week- on the first session of PT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yair Barzilai, M.D. principal investigator
Clalit health service, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing knee OA project and conventional PT in people with Osteoarthritis, Knee, run by Meir Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shimi Fatal, BPT (0504021514, shimifatal@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time up and go test (time frame: On the first week- first session of PT and on last session- 12 weeks Average). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2012.