Osteoarthritis, KneeNCT02600702
A Study of Siriraj Home Exercises Protocol for Primary Osteoarthritis of the Knee
A study testing Siriraj knee exercise and Physical modalities in people with Osteoarthritis, Knee, run by Mahidol University at 1 site in Thailand.
Trial summary
The purpose of this study is to compare the exercise protocol called "Siriraj home base exercise program for OA knee" to usual care and physical modalities for conservative treatment in patients with 1st OA knee. 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?
- Siriraj knee exercise and Physical modalities
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteThailand
- Study dates
- Oct 2014to Jun 2016
- 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
- 1st osteoarthritis of the knee Age >/= 50 yrs
Who cannot join
- Previous knee surgery for OA knee treatment
- Has plan or schedule for knee surgery
- Severe degree of OA knee.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Control Study of Siriraj Home Exercises Protocol for Primary Knee Osteoarthritis Patients Versus Usual Orthopedic Outpatient Consultation in Primary Knee Osteoarthritis Patients
The purpose of this study is to compare the exercise protocol called "Siriraj home base exercise program for OA knee" to usual care and physical modalities for conservative treatment in patients with 1st OA knee.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Siriraj knee exercise, Physical modalities
- Keywords
- Home base exercise
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Siriraj knee exerciseOther
Siriraj knee exercise, 12 position of exercise protocol
Physical modalitiesOther
| Study group | Role | What they receive |
|---|---|---|
| usual care | No intervention | quadricep exercise |
| Siriraj home base exercise | Experimental | Knee exercise protocol for 12 position for 3 months with low-impact aerobic exercise Receives: Other: Siriraj knee exercise |
| Modalities and exercise | Active comparator | Physical modalities for 6 weeks and Knee exercise protocol for 12 position for 3 months with low-impact aerobic exercise Receives: Other: Siriraj knee exercise; Other: Physical modalities |
What is being measured
The primary outcome is the main question the study is designed to answer.
WOMAC score
Measured: 3 months
Secondary outcomes (1)
6 mins walk test
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2015 (estimated)
- Study startOct 2014
- Primary completionFeb 2016
- Study completionJun 2016
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.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02600702
- Sponsor's protocol ID
- 444/2557(EC4)
- Status last verified
- Dec 2016
- First submitted
- 6 Nov 2015
- Last updated
- 2 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Control Study of Siriraj Home Exercises Protocol for Primary Knee Osteoarthritis Patients Versus Usual Orthopedic Outpatient Consultation in Primary Knee Osteoarthritis Patients
- ClinicalTrials.gov ID
- NCT02600702
- Acronym / sponsor ID
- 444/2557(EC4)
- Conditions
- Osteoarthritis, Knee
- Keywords
- Home base exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Feb 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 9 Nov 2015 (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 compare the exercise protocol called "Siriraj home base exercise program for OA knee" to usual care and physical modalities for conservative treatment in patients with 1st OA knee.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| usual care | No intervention | –quadricep exercise |
| Siriraj home base exercise | Experimental | Other: Siriraj knee exerciseKnee exercise protocol for 12 position for 3 months with low-impact aerobic exercise |
| Modalities and exercise | Active comparator | Other: Siriraj knee exercise, Other: Physical modalitiesPhysical modalities for 6 weeks and Knee exercise protocol for 12 position for 3 months with low-impact aerobic exercise |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1st osteoarthritis of the knee Age >/= 50 yrs
Key exclusion criteria (3 listed)
- Previous knee surgery for OA knee treatment
- Has plan or schedule for knee surgery
- Severe degree of OA knee.
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 |
|---|---|---|
| Siriraj knee exerciseSiriraj knee exercise, 12 position of exercise protocol | Other | Modalities and exercise, Siriraj home base exercise |
| Physical modalities | Other | Modalities and exercise |
Primary outcome
WOMAC score
Time frame: 3 months
1 secondary outcome
6 mins walk test
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Siriraj knee exercise and Physical modalities in people with Osteoarthritis, Knee, run by Mahidol University at 1 site in Thailand.
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 1 inclusion and 3 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: finished, as of the sponsor's last update on 2 Dec 2016. 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 Thailand. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WOMAC score (time frame: 3 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 2 Dec 2016.