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

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.

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