Effectiveness Study of the Ivivi SofPulse for Pain Amelioration in Adults With Mild to Moderate Knee Osteoarthritis
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 Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Non-thermal Pulsed Radio Frequency for Pain Amelioration in Adults With Knee Osteoarthritis: A Double-blind, Randomized, Sham-controlled Trial|
- A comparison of changes in VAS pain scores at 4 weeks over baseline. [ Time Frame: Four weeks ] [ Designated as safety issue: No ]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.
- Change in knee pain severity and duration of clinical benefit following treatment. [ Time Frame: Four weeks ] [ Designated as safety issue: No ]"Maximum" knee pain severity assessed on a 10 cm VAS and pain improvement
- EuroQol EQ-5D [ Time Frame: Four weeks ] [ Designated as safety issue: No ]Improvement of quality of life
- OMERACT-OARSI Responder Rate [ Time Frame: Four weeks ] [ Designated as safety issue: No ]Change in need of pain medications and modalities due to knee pain
- Adverse events [ Time Frame: Four weeks ] [ Designated as safety issue: No ]Occurance of Adverse Events during treatment period
- Treatment compliance [ Time Frame: Four weeks ] [ Designated as safety issue: No ]Improvement of pain and decrease in pain medication with compliant use of the PRF study device as compared to the Sham device.
|Study Start Date:||October 2011|
|Study Completion Date:||July 2012|
|Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
|Active Comparator: Pulsed Radio Frequency (PRF)||
Device: Ivivi SofPulse
15 minute Pulsed Radio Frequency (PRF) treatment twice per day
Sham Comparator: Sham
Use of Sham device for 15 minutes simulated treatment twice per day
Device: Ivivi SofPulse
15 minute simulated treatment using Sham Device twice per day
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01457742
|United States, California|
|San Francisco, California, United States, 94104|
|Principal Investigator:||Nancy Lane, M.D.||Mytrus, Inc.|