Effectiveness Study of the Ivivi SofPulse for Pain Amelioration in Adults With Mild to Moderate Knee Osteoarthritis

Amp Orthopedics

Status and phase

Terminated

Phase 4

Conditions

Knee Osteoarthritis

Treatments

Device: Ivivi SofPulse

Study type

Interventional

Funder types

Industry

Identifiers

NCT01457742

Ivivi-OAPain-001

Details and patient eligibility

About

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.

Full description

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.

Enrollment

45 patients

Sex

All

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

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