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

This study has been terminated.
(Sponsor decision)
Sponsor:
Information provided by (Responsible Party):
Amp Orthopedics, Inc.
ClinicalTrials.gov Identifier:
NCT01457742
First received: October 19, 2011
Last updated: July 6, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Knee Osteoarthritis
Device: Ivivi SofPulse
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Non-thermal Pulsed Radio Frequency for Pain Amelioration in Adults With Knee Osteoarthritis: A Double-blind, Randomized, Sham-controlled Trial

Resource links provided by NLM:


Further study details as provided by Amp Orthopedics, Inc.:

Primary Outcome Measures:
  • A comparison of changes in VAS pain scores at 4 weeks over baseline. [ Time Frame: Four weeks ] [ Designated as safety issue: No ]
    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. [ Time Frame: Four weeks ] [ Designated as safety issue: No ]
    "Maximum" knee pain severity assessed on a 10 cm VAS and pain improvement

  • EuroQol EQ-5D [ Time Frame: Four weeks ] [ Designated as safety issue: No ]
    Improvement of quality of life

  • OMERACT-OARSI Responder Rate [ Time Frame: Four weeks ] [ Designated as safety issue: No ]
    Change in need of pain medications and modalities due to knee pain

  • Adverse events [ Time Frame: Four weeks ] [ Designated as safety issue: No ]
    Occurance of Adverse Events during treatment period

  • Treatment compliance [ Time Frame: Four weeks ] [ Designated as safety issue: No ]
    Improvement of pain and decrease in pain medication with compliant use of the PRF study device as compared to the Sham device.


Enrollment: 45
Study Start Date: October 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Pulsed Radio Frequency (PRF) Device: Ivivi SofPulse
15 minute Pulsed Radio Frequency (PRF) treatment twice per day
Sham Comparator: Sham
Use of Sham device for 15 minutes simulated treatment twice per day
Device: Ivivi SofPulse
15 minute simulated treatment using Sham Device twice per day

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.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01457742

Locations
United States, California
Mytrus, Inc.
San Francisco, California, United States, 94104
Sponsors and Collaborators
Amp Orthopedics, Inc.
Investigators
Principal Investigator: Nancy Lane, M.D. Mytrus, Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Amp Orthopedics, Inc.
ClinicalTrials.gov Identifier: NCT01457742     History of Changes
Other Study ID Numbers: Ivivi-OAPain-001
Study First Received: October 19, 2011
Last Updated: July 6, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Amp Orthopedics, Inc.:
Osteoarthritis

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on November 25, 2014