Osteoarthritis KneeNCT02200107
Integrated Treatment Program for Osteoarthritis of the Knee
A study testing self management education in people with Osteoarthritis Knee, run by Meir Medical Center at 1 site in Israel.
Trial summary
The purpose of this study is to determine the ability to assimilate and implement an integrated treatment program osteoarthritis of the knee, including the diagnosis and follow-up by a family physician in primary care clinics, combined with patient self-care training and physiotherapy program Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoarthritis Knee
- What is being tested?
- self management education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2014to Dec 2015
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Active complaint of knee pain
- Diagnosis of knee osteoarthritis according to X-ray
- Morning stiffness of less than 30 minutes AND/OR crepitus in active movement
- Ability to read Hebrew
Who cannot join
- Previous participation in physiotherapy treatment program
- Gout in knee, rheumatoid arthritis, fibromyalgia
- Complaints that appear in a knee which was operated in the past
- Dementia
- Severe limitations in mobility
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Clalit Health Service
Jerusalem
Keren Cohen-Nahum, MD, +972523834141, kercona@gmail.com
Ohad Avny, MD
About this study
Official title: Implementing and Evaluating Integrated Medical and Physiotherapy Treatment Program for Osteoarthritis of the Knee by Family Doctors in Primary Care Clinics
The purpose of this study is to determine the ability to assimilate and implement an integrated treatment program osteoarthritis of the knee, including the diagnosis and follow-up by a family physician in primary care clinics, combined with patient self-care training and physiotherapy program
- Conditions
- Osteoarthritis Knee
- Being tested
- self management education
- Keywords
- Osteoarthritis Knee, Self Care, Treatment Outcome, Patient Education as Topic, Physical Therapy Modalities
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self management educationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| self management education | Experimental | self management education program delivered by family doctor in primary care clinics and during and physical therapy design Receives: Behavioral: self management education |
| control | No intervention | Routine follow up according to standard practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in WOMAC ( Western Ontario and McMaster Universities Arthritis Index ) score during participating in the program
WOMAC score will be evaluated through a questionnaire (validated to Hebrew) at baseline and after a constant time period. For both groups (intervention and control) after 6 weeks from enrollment and then for the control group after 6 months, and for the intervention group after completing physical therapy program. we will assess the change from baseline.
Measured: 0, 6 weeks, for intervention group after completing physical therapy program, for the control group after 6 months
Secondary outcomes (3)
Change in VAS pain score during participating in the program
VAS score will be evaluated through a questionnaire (validated to Hebrew) at baseline and after a constant time period. For both groups (intervention and control) after 6 weeks from enrollment and then for the control group after 6 months, and for the intervention group after completing physical therapy program. we will assess the change from baseline.
Measured: 0, 6 weeks, for intervention group after completing physical therapy program, for the control group after 6 months
Change in the consumption of drugs during participating in the program
Prescriptions given by family doctor, for treating patient's knee complaints. It will be evaluated by the medical record registration of the patients, at baseline and after a constant time period. For both groups (intervention and control) after 6 weeks from enrollment and then for the control group after 6 months, and for the intervention group after completing physical therapy program.
Measured: 0, 6 weeks, for intervention group after completing physical therapy program, for the control group after 6 months
Changes in Referrals to specialists doctors during participating in the program
Referrals given by family doctor. It will be evaluated by the medical record registration of the patients, for both groups (intervention and control) after 6 weeks from enrollment and then for the control group after 6 months, and for the intervention group after completing physical therapy program.
Measured: after 6 weeks since enrollment, and then for intervention group after completing physical therapy program, and for the control group after 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2014 (estimated)
- Study startSep 2014
- Primary completionDec 2015 (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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 155 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ohad Avny, MD, Study chair, Clalit Health Service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02200107
- Sponsor's protocol ID
- OA-knee 015/2014
- Status last verified
- Jul 2014
- First submitted
- 17 Jul 2014
- Last updated
- 14 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing and Evaluating Integrated Medical and Physiotherapy Treatment Program for Osteoarthritis of the Knee by Family Doctors in Primary Care Clinics
- ClinicalTrials.gov ID
- NCT02200107
- Acronym / sponsor ID
- OA-knee 015/2014
- Conditions
- Osteoarthritis Knee
- Keywords
- Osteoarthritis Knee, Self Care, Treatment Outcome, Patient Education as Topic, Physical Therapy Modalities
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 155 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Dec 2015 (estimated)
- First posted
- 25 Jul 2014 (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.
The purpose of this study is to determine the ability to assimilate and implement an integrated treatment program osteoarthritis of the knee, including the diagnosis and follow-up by a family physician in primary care clinics, combined with patient self-care training and physiotherapy program
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| self management education | Experimental | Behavioral: self management educationself management education program delivered by family doctor in primary care clinics and during and physical therapy design |
| control | No intervention | –Routine follow up according to standard practice |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Active complaint of knee pain
- Diagnosis of knee osteoarthritis according to X-ray
- Morning stiffness of less than 30 minutes AND/OR crepitus in active movement
- Ability to read Hebrew
Key exclusion criteria (5 listed)
- Previous participation in physiotherapy treatment program
- Gout in knee, rheumatoid arthritis, fibromyalgia
- Complaints that appear in a knee which was operated in the past
- Dementia
- Severe limitations in mobility
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 |
|---|---|---|
| self management education | Behavioural | self management education |
Primary outcome
Change in WOMAC ( Western Ontario and McMaster Universities Arthritis Index ) score during participating in the program
Time frame: 0, 6 weeks, for intervention group after completing physical therapy program, for the control group after 6 months
WOMAC score will be evaluated through a questionnaire (validated to Hebrew) at baseline and after a constant time period. For both groups (intervention and control) after 6 weeks from enrollment and then for the control group after 6 months, and for the intervention group after completing physical therapy program. we will assess the change from baseline.
3 secondary outcomes
Change in VAS pain score during participating in the program
Time frame: 0, 6 weeks, for intervention group after completing physical therapy program, for the control group after 6 months
Change in the consumption of drugs during participating in the program
Time frame: 0, 6 weeks, for intervention group after completing physical therapy program, for the control group after 6 months
Changes in Referrals to specialists doctors during participating in the program
Time frame: after 6 weeks since enrollment, and then for intervention group after completing physical therapy program, and for the control group after 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2015.
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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.
Ohad Avny, MD study chair
Clalit Health Service
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing self management education 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 4 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 14 Apr 2015. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in WOMAC ( Western Ontario and McMaster Universities Arthritis Index ) score during participating in the program (time frame: 0, 6 weeks, for intervention group after completing physical therapy program, for the control group after 6 months). 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 14 Apr 2015.