Effectiveness Study of the Ivivi SofPulse for Pain Amelioration in Adults With Mild to Moderate Knee Osteoarthritis
| Status: | Archived |
|---|---|
| Conditions: | Arthritis, Osteoarthritis (OA) |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | October 2011 |
| End Date: | October 2012 |
| Contact: | Nancy Lane, M.D. |
| Phone: | 877-448-6987 |
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.
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.
We found this trial at
1
site
Click here to add this to my saved trials
