Knee OsteoarthritisPhase 4NCT01457742
Effectiveness Study of the Ivivi SofPulse for Pain Amelioration in Adults With Mild to Moderate Knee Osteoarthritis
A Phase 4 study testing Ivivi SofPulse in people with Knee Osteoarthritis, run by Amp Orthopedics, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to determine the effectiveness of non-thermal Pulsed Radio Frequency (PRF) treatment with the Ivivi SofPulse for amelioration of knee pain in patients with mild to moderate Osteoarthritis and to determine the duration of clinical benefit following discontinuation of treatment. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Ivivi SofPulse
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Jul 2012
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 40 to 80 years
- Bilateral weight-bearing anteroposterior x-ray of each knee taken within the last 12 months and radiographs submitted to the Principal Investigator for evaluation
- Radiographic evidence of mild to moderate (Kellgren/Lawrence grade 2 or 3) OA in at least one knee based on a weight-bearing anteroposterior x-ray taken within the last 12 months
- Self-reported persistent knee pain severity of 4.0 to 8.0 cm on a 10 cm VAS for most days in the previous 2 months in at least one knee, with grade 2 or 3 OA
- Able to read and complete English-language surveys
- Daily access to the internet
- Ability of the participant to comprehend the full nature and purpose of the study including possible risks and side effects
- Consent to the study and willing to comply with study methods
Who cannot join
- Subjects who have any implanted metallic leads, wires, or systems (e.g. pacemaker, implantable cardioverterdefibrillator)
- Self-reported persistent knee pain severity > 8.0 cm on a 10 cm VAS in either knee for most days in the previous 2 months
- Radiographic evidence of severe (Kellgren/Lawrence grade 4) OA in either knee based on a weight-bearing anteroposterior x-ray taken within the last 12 months
- Self-reported diagnosis of autoimmune or inflammatory arthritis (e.g. Rheumatoid Arthritis, Lupus, etc.)
- More than 8 days of narcotic pain medication in the last 30 days
- Joint surgery, tidal lavage, or arthroscopy of either knee in the past 6 months
Show all 20Show fewer
- Intra-articular corticosteroid or hyaluronic acid injections of either knee in the past 6 months
- Oral prednisone use in the past 30 days
- Participation in any clinical trial in the past 30 days
- Knee OA associated with worker's compensation or accident litigation
- Regular use of a walker or wheelchair
- Vulnerable populations including prisoners and nursing home residents
- Anticipated move away from immediate area in next 6 months
- Any medical condition that, in the opinion of the investigator, may compromise patient safety or confound the assessment of treatment effectiveness
- After 1-week Run-in Period
- Daily average of "current" knee pain severity < 4.0 cm, assessed on a 10 cm VAS, during the 1-week run-in period in both knees
- Daily average of "current" knee pain severity > 8.0 cm, assessed on a 10 cm VAS, during the 1-week run-in period in either knee
- Daily average of "current" knee pain severity of 4.0 to 8.0 cm, assessed on a 10 cm VAS, during the 1-week run-in period in any knee with Kellgren/Lawrence grades of 0 or 1 in the same knees
- Narcotic use of more than 2 days during the 1-week runin period
- Noncompliance with online symptom reporting requirements
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-thermal Pulsed Radio Frequency for Pain Amelioration in Adults With Knee Osteoarthritis: A Double-blind, Randomized, Sham-controlled Trial
The purpose of this study is to determine the effectiveness of non-thermal Pulsed Radio Frequency (PRF) treatment with the Ivivi SofPulse for amelioration of knee pain in patients with mild to moderate Osteoarthritis and to determine the duration of clinical benefit following discontinuation of treatment.
Read the detailed description
This prospective, double-blind, randomized, sham-controlled clinical trial will investigate the effectiveness of PRF using the Ivivi SofPulse on knee pain severity in adults with mild to moderate knee OA. Potential subjects will complete questions related to medical history, inclusion / exclusion criteria, and OA symptom severity. Knee radiographs will be evaluated by the Principal Investigator (PI) or co-investigator for determination of knee OA severity based on the Kellgren/Lawrence criteria. Eligible subjects will enter a 1-week run-in period. After successful completion of the run-in period, subjects will be randomized to PRF treatment twice a day (Active) or sham treatment twice a day (Sham). All subjects will be followed for 4 weeks for purposes of the primary endpoint evaluation. Thereafter, the subjects initially allocated to Active will be equally allocated to Active or Sham and will be followed through 26 or 8 weeks, respectively. The subjects originally assigned to Sham will maintain this treatment regimen through 26 weeks.
- Conditions
- Knee Osteoarthritis
- Being tested
- Ivivi SofPulse
- Keywords
- Osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ivivi SofPulseDevice
15 minute Pulsed Radio Frequency (PRF) treatment twice per day
Ivivi SofPulseDevice
15 minute simulated treatment using Sham Device twice per day
| Study group | Role | What they receive |
|---|---|---|
| Pulsed Radio Frequency (PRF) | Active comparator | Not described Receives: Device: Ivivi SofPulse |
| Sham | Sham comparator | Use of Sham device for 15 minutes simulated treatment twice per day Receives: Device: Ivivi SofPulse |
What is being measured
The primary outcome is the main question the study is designed to answer.
A comparison of changes in VAS pain scores at 4 weeks over baseline.
Comparison of changes in "current" knee pain severity at 4 wks over baseline. Between-group difference of at least 25 percentage points considered clinically significant. "Current" knee pain severity assessed on a 10 cm visual analogue scale, 0 (no pain) and 10 (pain as bad as it can be). The knee that meets radiographic criteria for mild or moderate knee OA and has the highest knee pain severity based on the average daily severity score during the 1-wk run-in period will be selected for the primary endpoint analysis.
Measured: Four weeks
Secondary outcomes (5)
Change in knee pain severity and duration of clinical benefit following treatment.
"Maximum" knee pain severity assessed on a 10 cm VAS and pain improvement
Measured: Four weeks
EuroQol EQ-5D
Improvement of quality of life
Measured: Four weeks
OMERACT-OARSI Responder Rate
Change in need of pain medications and modalities due to knee pain
Measured: Four weeks
Adverse events
Occurance of Adverse Events during treatment period
Measured: Four weeks
Treatment compliance
Improvement of pain and decrease in pain medication with compliant use of the PRF study device as compared to the Sham device.
Measured: Four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionJul 2012
- Study completionJul 2012
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amp Orthopedics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nancy Lane, M.D., Principal investigator, Mytrus, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01457742
- Sponsor's protocol ID
- Ivivi-OAPain-001
- Status last verified
- Jul 2012
- First submitted
- 19 Oct 2011
- Last updated
- 10 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-thermal Pulsed Radio Frequency for Pain Amelioration in Adults With Knee Osteoarthritis: A Double-blind, Randomized, Sham-controlled Trial
- ClinicalTrials.gov ID
- NCT01457742
- Acronym / sponsor ID
- Ivivi-OAPain-001
- Conditions
- Knee Osteoarthritis
- Keywords
- Osteoarthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Amp Orthopedics, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 24 Oct 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.
The purpose of this study is to determine the effectiveness of non-thermal Pulsed Radio Frequency (PRF) treatment with the Ivivi SofPulse for amelioration of knee pain in patients with mild to moderate Osteoarthritis and to determine the duration of clinical benefit following discontinuation of treatment.
Detailed description
This prospective, double-blind, randomized, sham-controlled clinical trial will investigate the effectiveness of PRF using the Ivivi SofPulse on knee pain severity in adults with mild to moderate knee OA. Potential subjects will complete questions related to medical history, inclusion / exclusion criteria, and OA symptom severity. Knee radiographs will be evaluated by the Principal Investigator (PI) or co-investigator for determination of knee OA severity based on the Kellgren/Lawrence criteria. Eligible subjects will enter a 1-week run-in period. After successful completion of the run-in period, subjects will be randomized to PRF treatment twice a day (Active) or sham treatment twice a day (Sham). All subjects will be followed for 4 weeks for purposes of the primary endpoint evaluation. Thereafter, the subjects initially allocated to Active will be equally allocated to Active or Sham and will be followed through 26 or 8 weeks, respectively. The subjects originally assigned to Sham will maintain this treatment regimen through 26 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulsed Radio Frequency (PRF) | Active comparator | Device: Ivivi SofPulse |
| Sham | Sham comparator | Device: Ivivi SofPulseUse of Sham device for 15 minutes simulated treatment twice per day |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 40 to 80 years
- Bilateral weight-bearing anteroposterior x-ray of each knee taken within the last 12 months and radiographs submitted to the Principal Investigator for evaluation
- Radiographic evidence of mild to moderate (Kellgren/Lawrence grade 2 or 3) OA in at least one knee based on a weight-bearing anteroposterior x-ray taken within the last 12 months
- Self-reported persistent knee pain severity of 4.0 to 8.0 cm on a 10 cm VAS for most days in the previous 2 months in at least one knee, with grade 2 or 3 OA
- Able to read and complete English-language surveys
Key exclusion criteria (20 listed)
- Subjects who have any implanted metallic leads, wires, or systems (e.g. pacemaker, implantable cardioverterdefibrillator)
- Self-reported persistent knee pain severity > 8.0 cm on a 10 cm VAS in either knee for most days in the previous 2 months
- Radiographic evidence of severe (Kellgren/Lawrence grade 4) OA in either knee based on a weight-bearing anteroposterior x-ray taken within the last 12 months
- Self-reported diagnosis of autoimmune or inflammatory arthritis (e.g. Rheumatoid Arthritis, Lupus, etc.)
- More than 8 days of narcotic pain medication in the last 30 days
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 |
|---|---|---|
| Ivivi SofPulse15 minute Pulsed Radio Frequency (PRF) treatment twice per day | Device | Pulsed Radio Frequency (PRF) |
| Ivivi SofPulse15 minute simulated treatment using Sham Device twice per day | Device | Sham |
Primary outcome
A comparison of changes in VAS pain scores at 4 weeks over baseline.
Time frame: Four weeks
Comparison of changes in "current" knee pain severity at 4 wks over baseline. Between-group difference of at least 25 percentage points considered clinically significant. "Current" knee pain severity assessed on a 10 cm visual analogue scale, 0 (no pain) and 10 (pain as bad as it can be). The knee that meets radiographic criteria for mild or moderate knee OA and has the highest knee pain severity based on the average daily severity score during the 1-wk run-in period will be selected for the primary endpoint analysis.
5 secondary outcomes
Change in knee pain severity and duration of clinical benefit following treatment.
Time frame: Four weeks
EuroQol EQ-5D
Time frame: Four weeks
OMERACT-OARSI Responder Rate
Time frame: Four weeks
Adverse events
Time frame: Four weeks
Treatment compliance
Time frame: Four weeks
Results and safety
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2012.
- website for MytrusLink provided by the sponsor.
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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.
Nancy Lane, M.D. principal investigator
Mytrus, Inc.
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 testing Ivivi SofPulse in people with Knee Osteoarthritis, run by Amp Orthopedics, Inc. 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 8 inclusion and 20 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: stopped early, as of the sponsor's last update on 10 Jul 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 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 was stopped early (reason given: Sponsor decision). Results are not available in the source record.
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?
A comparison of changes in VAS pain scores at 4 weeks over baseline. (time frame: Four weeks). 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 10 Jul 2012.