MedTrace Logo

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

NCT01457742 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2012-07-10

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

Ivivi SofPulse

15 minute Pulsed Radio Frequency (PRF) treatment twice per day

DEVICE

Ivivi SofPulse

15 minute simulated treatment using Sham Device twice per day

Sponsors & Collaborators

  • Amp Orthopedics, Inc.

    lead INDUSTRY

Principal Investigators

  • Nancy Lane, M.D. · Mytrus, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2012-07-31
Completion
2012-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01457742 on ClinicalTrials.gov