Study Stopped
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Effectiveness Study of the Ivivi SofPulse for Pain Amelioration in Adults With Mild to Moderate Knee Osteoarthritis
Non-thermal Pulsed Radio Frequency for Pain Amelioration in Adults With Knee Osteoarthritis: A Double-blind, Randomized, Sham-controlled Trial
1 other identifier
interventional
45
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 knee-osteoarthritis
Started Oct 2011
Shorter than P25 for phase_4 knee-osteoarthritis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 19, 2011
CompletedFirst Posted
Study publicly available on registry
October 24, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedJuly 10, 2012
July 1, 2012
9 months
October 19, 2011
July 6, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Four weeks
Secondary Outcomes (5)
Change in knee pain severity and duration of clinical benefit following treatment.
Four weeks
EuroQol EQ-5D
Four weeks
OMERACT-OARSI Responder Rate
Four weeks
Adverse events
Four weeks
Treatment compliance
Four weeks
Study Arms (2)
Pulsed Radio Frequency (PRF)
ACTIVE COMPARATORSham
SHAM COMPARATORUse of Sham device for 15 minutes simulated treatment twice per day
Interventions
15 minute Pulsed Radio Frequency (PRF) treatment twice per day
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mytrus, Inc.
San Francisco, California, 94104, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nancy Lane, M.D.
Mytrus, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 19, 2011
First Posted
October 24, 2011
Study Start
October 1, 2011
Primary Completion
July 1, 2012
Study Completion
July 1, 2012
Last Updated
July 10, 2012
Record last verified: 2012-07