OsteoarthritisPhase 4KC-01NCT00858416
Combined Vibrations, Passive Motion and Thermotherapy for Knee Osteoarthritis
A Phase 4 study of Osteoarthritis and Knee Pain, run by Kineticure at 1 site in United States.
Trial summary
The study evaluated the efficacy of combined mechanical vibrations, continuous passive motion and heat on the severity of pain in management of osteoarthritis of the knee Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Osteoarthritis, Knee Pain
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2006to Mar 2007
- Phase
- Phase 4
- 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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of OA of the knee by ACR criteria
- symptoms consistent with radiographic OA grades 2, 3 or 4 by Kellgren and Lawrence criteria
- moderate to severe knee pain (≥35mm on a 100mm visual analog pain scale (VAS)).
Who cannot join
- knee or hip surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
Jacksonville Orthopedic Institute
Jacksonville, Florida, 32207
About this study
Official title: Efficacy of Combined Local Mechanical Vibrations, Continuous Passive Motion and Thermotherapy in the Management of Osteoarthritis of the Knee
The study evaluated the efficacy of combined mechanical vibrations, continuous passive motion and heat on the severity of pain in management of osteoarthritis of the knee
- Conditions
- Osteoarthritis, Knee Pain
- Being tested
- "Kineticure System" followed by sham, sham followed by "Kineticure System"
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Kineticure System" followed by shamDevice
Also called Kineticure System
20 minutes sessions with knee brace (integrated heating pad, a vibration unit and a foot pedal that delivers continuous passive motion) during the first 4 weeks followed by 2 weeks wash out and 4 weeks of sham device
sham followed by "Kineticure System"Device
Also called kineticure system
sham device during the first 4 weeks then 2 weeks wash out period followed by 4 weeks for 20 minutes sessions with knee brace (integrated heating pad, a vibration unit and a foot pedal that delivers continuous passive motion)
| Study group | Role | What they receive |
|---|---|---|
| AB | Experimental | First active then Sham Receives: Device: "Kineticure System" followed by sham |
| BA | Sham comparator | First sham then active Receives: Device: sham followed by "Kineticure System" |
What is being measured
The primary outcome is the main question the study is designed to answer.
intensity of pain as measured on a 100 mm non-marked VAS and the total Western Ontario McMaster (WOMAC) OA index using a Likert scale,
Measured: 10 weeks
Secondary outcomes (2)
satisfaction of use of the Kineticure device as measured on a 0-100 mm non-marked scale
Measured: 10 weeks
range of motion (ROM) of the knee (using goniometer)
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2009 (estimated)
- Study startApr 2006
- Primary completionMar 2007
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kineticure
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Gary S Kitay, MD, Principal investigator, Jacksonville Orthopedic Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00858416
- Sponsor's protocol ID
- KC-01
- Acronym
- KC-01
- Status last verified
- Mar 2009
- First submitted
- 2 Mar 2009
- Last updated
- 9 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Kitay GS, Koren MJ, Helfet DL, Parides MK, Markenson JA. Efficacy of combined local mechanical vibrations, continuous passive motion and thermotherapy in the management of osteoarthritis of the knee. Osteoarthritis Cartilage. 2009 Oct;17(10):1269-74. doi: 10.1016/j.joca.2009.04.015. Epub 2009 May 4.
PubMed 19433134
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Combined Local Mechanical Vibrations, Continuous Passive Motion and Thermotherapy in the Management of Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT00858416
- Acronym / sponsor ID
- KC-01 / KC-01
- Conditions
- Osteoarthritis, Knee Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- KineticureIndustry (pharma, biotech, devices)
- Study start
- Apr 2006
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 9 Mar 2009 (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 study evaluated the efficacy of combined mechanical vibrations, continuous passive motion and heat on the severity of pain in management of osteoarthritis of the knee
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AB | Experimental | Device: "Kineticure System" followed by shamFirst active then Sham |
| BA | Sham comparator | Device: sham followed by "Kineticure System"First sham then active |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diagnosis of OA of the knee by ACR criteria
- symptoms consistent with radiographic OA grades 2, 3 or 4 by Kellgren and Lawrence criteria
- moderate to severe knee pain (≥35mm on a 100mm visual analog pain scale (VAS)).
Key exclusion criteria (1 listed)
- knee or hip surgery
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 |
|---|---|---|
| "Kineticure System" followed by shamAlso: Kineticure System20 minutes sessions with knee brace (integrated heating pad, a vibration unit and a foot pedal that delivers continuous passive motion) during the first 4 weeks followed by 2 weeks wash out and 4 weeks of sham device | Device | AB |
| sham followed by "Kineticure System"Also: kineticure systemsham device during the first 4 weeks then 2 weeks wash out period followed by 4 weeks for 20 minutes sessions with knee brace (integrated heating pad, a vibration unit and a foot pedal that delivers continuous passive motion) | Device | BA |
Primary outcome
intensity of pain as measured on a 100 mm non-marked VAS and the total Western Ontario McMaster (WOMAC) OA index using a Likert scale,
Time frame: 10 weeks
2 secondary outcomes
satisfaction of use of the Kineticure device as measured on a 0-100 mm non-marked scale
Time frame: 10 weeks
range of motion (ROM) of the knee (using goniometer)
Time frame: 10 weeks
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 9 Mar 2009.
- Derived from this study: PubMed 19433134Kitay GS, Koren MJ, Helfet DL, Parides MK, Markenson JA. Efficacy of combined local mechanical vibrations, continuous passive motion and thermotherapy in the management of osteoarthritis of the knee. Osteoarthritis Cartilage. 2009 Oct;17(10):1269-74. doi: 10.1016/j.joca.2009.04.015. Epub 2009 May 4.
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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.
Gary S Kitay, MD principal investigator
Jacksonville Orthopedic Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study of Osteoarthritis and Knee Pain, run by Kineticure at 1 site in United States.
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 3 inclusion and 1 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 9 Mar 2009. 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 United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
intensity of pain as measured on a 100 mm non-marked VAS and the total Western Ontario McMaster (WOMAC) OA index using a Likert scale, (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00858416, which also lists 1 linked publication.
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 9 Mar 2009.