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

Primary Purpose

Knee Osteoarthritis

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ivivi SofPulse
Ivivi SofPulse
Sponsored by
Amp Orthopedics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Osteoarthritis

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Mytrus, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Pulsed Radio Frequency (PRF)

Sham

Arm Description

Use of Sham device for 15 minutes simulated treatment twice per day

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
EuroQol EQ-5D
Improvement of quality of life
OMERACT-OARSI Responder Rate
Change in need of pain medications and modalities due to knee pain
Adverse events
Occurance of Adverse Events during treatment period
Treatment compliance
Improvement of pain and decrease in pain medication with compliant use of the PRF study device as compared to the Sham device.

Full Information

First Posted
October 19, 2011
Last Updated
July 6, 2012
Sponsor
Amp Orthopedics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01457742
Brief Title
Effectiveness Study of the Ivivi SofPulse for Pain Amelioration in Adults With Mild to Moderate Knee Osteoarthritis
Official Title
Non-thermal Pulsed Radio Frequency for Pain Amelioration in Adults With Knee Osteoarthritis: A Double-blind, Randomized, Sham-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Terminated
Why Stopped
Sponsor decision
Study Start Date
October 2011 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amp Orthopedics, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pulsed Radio Frequency (PRF)
Arm Type
Active Comparator
Arm Title
Sham
Arm Type
Sham Comparator
Arm Description
Use of Sham device for 15 minutes simulated treatment twice per day
Intervention Type
Device
Intervention Name(s)
Ivivi SofPulse
Intervention Description
15 minute Pulsed Radio Frequency (PRF) treatment twice per day
Intervention Type
Device
Intervention Name(s)
Ivivi SofPulse
Intervention Description
15 minute simulated treatment using Sham Device twice per day
Primary Outcome Measure Information:
Title
A comparison of changes in VAS pain scores at 4 weeks over baseline.
Description
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
Secondary Outcome Measure Information:
Title
Change in knee pain severity and duration of clinical benefit following treatment.
Description
"Maximum" knee pain severity assessed on a 10 cm VAS and pain improvement
Time Frame
Four weeks
Title
EuroQol EQ-5D
Description
Improvement of quality of life
Time Frame
Four weeks
Title
OMERACT-OARSI Responder Rate
Description
Change in need of pain medications and modalities due to knee pain
Time Frame
Four weeks
Title
Adverse events
Description
Occurance of Adverse Events during treatment period
Time Frame
Four weeks
Title
Treatment compliance
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy Lane, M.D.
Organizational Affiliation
Mytrus, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mytrus, Inc.
City
San Francisco
State/Province
California
ZIP/Postal Code
94104
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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