Effectiveness of the Ivivi Torino II, Pulsed Radio Frequency Device, on Narcotic Use, Pain and Quality of Life Following Shoulder Arthroscopic Rotator Cuff Repair.

This study has been terminated.
(Sponsor decision)
Sponsor:
Information provided by (Responsible Party):
Amp Orthopedics, Inc.
ClinicalTrials.gov Identifier:
NCT01507818
First received: January 9, 2012
Last updated: July 6, 2012
Last verified: July 2012
  Purpose

To determine the effectiveness of non-thermal PRF delivered with the Ivivi Torino II on narcotic use, pain, and health-related quality of life following shoulder arthroscopic rotator cuff surgery comparing: Active treatment versus placebo (Sham).


Condition Intervention
Rotator Cuff Tear
Device: Ivivi Torino II
Device: Inactive Sham device

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Impact of Non-thermal Pulsed Radio Frequency (PRF)on Narcotic Use, Pain, and Health-related Quality of Life Following Shoulder Arthroscopic Rotator Cuff Repair: A Double-Blind, Randomized Sham-Controlled Trial

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

Primary Outcome Measures:
  • Average daily narcotic consumption (oxycodone mg) [ Time Frame: week-1 post surgery ] [ Designated as safety issue: No ]
    Average, daily, patient-reported narcotic consumption (converted to oxycodone equivalents in mg) during Week 1.


Secondary Outcome Measures:
  • Average daily narcotic consumption (oxycodone mg) [ Time Frame: Weeks 2-6 post surgery ] [ Designated as safety issue: No ]
    Average, daily, patient-reported narcotic consumption during Weeks 2-6

  • Visual Analogue Scale (VAS) pain [ Time Frame: Weeks 2-6 post surgery ] [ Designated as safety issue: No ]
    Daily VAS pain (daily "current" and "maximum") during Week 1, VAS pain (daily "current" and "maximum") during Weeks 2-6

  • Patient-reported general health-related quality of life score (EQ-5D) [ Time Frame: On the last day of Weeks 1-6 ] [ Designated as safety issue: No ]
    The EQ-5D will be completed by the subject on the last day of each week (Weeks 1-6)

  • Adverse Events [ Time Frame: Weeks 1-6 post surgery ] [ Designated as safety issue: Yes ]
    Adverse events will be recorded daily following randomization and analyzed for confirmation of device safety


Enrollment: 37
Study Start Date: December 2011
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ivivi Torino II
Active treatment with Non-thermal Pulsed Radio Frequency device
Device: Ivivi Torino II
Emits a PRF generated specific electromagnetic signal consisting of a 27.12 MHz radio frequency carrier pulse-modulated with a burst duration of 3 milliseconds repeating at 2 times per second (2Hza0>
Sham Comparator: Inactive Sham
Sham treatment
Device: Inactive Sham device
The inactive control device (Sham) identical to the Active device with the exception that a PRF signal is not delivered.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • MRI diagnosis of rotator cuff tear
  • Persistent symptoms despite a minimum of 6 months of failed non-operative management
  • Scheduled for primary or revision arthroscopic rotator cuff repair (with or without any of the following: debridement, subacromial decompression, distal clavicle resection, treatment of biceps tendon and /or glenoid labrum pathology, release of capsule).
  • Age 40 to 80 years
  • Able to read and complete English-language surveys
  • Ability of the participant to comprehend the full nature and purpose of the study including possible risks and side effects
  • Willingness and ability to comply with study product and methods

Exclusion Criteria:

  • Diagnosis of adhesive capsulitis requiring global capsular release, instability, fracture, or arthritis
  • Any implanted metallic leads, wires, or systems (e.g. pacemaker, implantable cardioverter-defibrillator)
  • Known narcotic allergy, hepatitis, nephritis, or gastrointestinal ulcer
  • Chronic narcotic pain medication dependency
  • Vulnerable populations including prisoners, pregnant women, nursing home residents, the Investigator's students and employees, employees of sponsor, those unable to consent for themselves, uninsured subjects or others who could be subject coercion
  • Worker's compensation claimant
  • Medical condition, in the judgement of the patient's physician, which may interfere with the shoulder surgery or the effectiveness or safety of the study treatment
  • Use of oral prednisone in the past 30 days
  • Use of any investigational drug or participation in another research study within the past 30 days
  • Self-reported diagnosis of autoimmune or inflammatory arthritis (e.g. Rheumatoid Arthritis, Lupus, ets.)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01507818

Locations
United States, Louisiana
Tulane University School of Medicine
New Orleans, Louisiana, United States, 70112
United States, Mississippi
Mississippi sports Medicine and Orthopaedic Center
Jackson, Mississippi, United States, 39202
United States, New Mexico
Taos Orthopaedic Institue
Taos, New Mexico, United States, 87571
Sponsors and Collaborators
Amp Orthopedics, Inc.
Investigators
Principal Investigator: Felix Savoie, M.D. Tulane University Schol of Medicine
  More Information

No publications provided

Responsible Party: Amp Orthopedics, Inc.
ClinicalTrials.gov Identifier: NCT01507818     History of Changes
Other Study ID Numbers: Amp-PostOpShoulder-Pain-001
Study First Received: January 9, 2012
Last Updated: July 6, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Amp Orthopedics, Inc.:
Arthroscopic Rotator Cuff Repair
Electromagnetic field treatment
Pulsed Radio Frequency treatment
Non-invasive
Non-thermal

Additional relevant MeSH terms:
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 21, 2014