- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01457742
Effectiveness Study of the Ivivi SofPulse for Pain Amelioration in Adults With Mild to Moderate Knee Osteoarthritis
July 6, 2012 updated by: Amp Orthopedics, Inc.
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.
Study Overview
Status
Terminated
Conditions
Intervention / 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 Type
Interventional
Enrollment (Actual)
45
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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San Francisco, California, United States, 94104
- Mytrus, Inc.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Pulsed Radio Frequency (PRF)
|
15 minute Pulsed Radio Frequency (PRF) treatment twice per day
15 minute simulated treatment using Sham Device twice per day
|
SHAM_COMPARATOR: Sham
Use of Sham device for 15 minutes simulated treatment twice per day
|
15 minute Pulsed Radio Frequency (PRF) treatment twice per day
15 minute simulated treatment using Sham Device twice per day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Four weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in knee pain severity and duration of clinical benefit following treatment.
Time Frame: Four weeks
|
"Maximum" knee pain severity assessed on a 10 cm VAS and pain improvement
|
Four weeks
|
EuroQol EQ-5D
Time Frame: Four weeks
|
Improvement of quality of life
|
Four weeks
|
OMERACT-OARSI Responder Rate
Time Frame: Four weeks
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Change in need of pain medications and modalities due to knee pain
|
Four weeks
|
Adverse events
Time Frame: Four weeks
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Occurance of Adverse Events during treatment period
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Four weeks
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Treatment compliance
Time Frame: Four weeks
|
Improvement of pain and decrease in pain medication with compliant use of the PRF study device as compared to the Sham device.
|
Four weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Nancy Lane, M.D., Mytrus, Inc.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2011
Primary Completion (ACTUAL)
July 1, 2012
Study Completion (ACTUAL)
July 1, 2012
Study Registration Dates
First Submitted
October 19, 2011
First Submitted That Met QC Criteria
October 20, 2011
First Posted (ESTIMATE)
October 24, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
July 10, 2012
Last Update Submitted That Met QC Criteria
July 6, 2012
Last Verified
July 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Ivivi-OAPain-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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