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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01507818
Recruitment Status : Terminated (Sponsor decision)
First Posted : January 11, 2012
Last Update Posted : July 9, 2012
Information provided by (Responsible Party):
Amp Orthopedics, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Rotator Cuff Tear Device: Ivivi Torino II Device: Inactive Sham device Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : December 2011
Estimated Primary Completion Date : September 2012
Estimated Study Completion Date : October 2012

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Average daily narcotic consumption (oxycodone mg) [ Time Frame: week-1 post surgery ]
    Average, daily, patient-reported narcotic consumption (converted to oxycodone equivalents in mg) during Week 1.

Secondary Outcome Measures :
  1. Average daily narcotic consumption (oxycodone mg) [ Time Frame: Weeks 2-6 post surgery ]
    Average, daily, patient-reported narcotic consumption during Weeks 2-6

  2. Visual Analogue Scale (VAS) pain [ Time Frame: Weeks 2-6 post surgery ]
    Daily VAS pain (daily "current" and "maximum") during Week 1, VAS pain (daily "current" and "maximum") during Weeks 2-6

  3. Patient-reported general health-related quality of life score (EQ-5D) [ Time Frame: On the last day of Weeks 1-6 ]
    The EQ-5D will be completed by the subject on the last day of each week (Weeks 1-6)

  4. Adverse Events [ Time Frame: Weeks 1-6 post surgery ]
    Adverse events will be recorded daily following randomization and analyzed for confirmation of device safety

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01507818

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.
Principal Investigator: Felix Savoie, M.D. Tulane University Schol of Medicine

Responsible Party: Amp Orthopedics, Inc. Identifier: NCT01507818     History of Changes
Other Study ID Numbers: Amp-PostOpShoulder-Pain-001
First Posted: January 11, 2012    Key Record Dates
Last Update Posted: July 9, 2012
Last Verified: July 2012

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

Additional relevant MeSH terms:
Rotator Cuff Injuries
Wounds and Injuries
Shoulder Injuries
Tendon Injuries
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents