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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
45
15 minute Pulsed Radio Frequency (PRF) treatment twice per day
15 minute simulated treatment using Sham Device twice per day
Mytrus, Inc.
San Francisco, California, United States
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.
Time frame: Four weeks
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
Time frame: Four weeks
EuroQol EQ-5D
Improvement of quality of life
Time frame: Four weeks
OMERACT-OARSI Responder Rate
Change in need of pain medications and modalities due to knee pain
Time frame: Four weeks
Adverse events
Occurance of Adverse Events during treatment period
Time frame: 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.
Time frame: Four weeks
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