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

Rotator Cuff Tear Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01507818
• Other study ID #: Amp-PostOpShoulder-Pain-001
• Status: Terminated
• Phase: N/A
• First received: January 9, 2012
• Last updated: July 6, 2012
• Start date: December 2011
• Est. completion date: October 2012

Study information

• Verified date: July 2012
• Source: Amp Orthopedics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 37
• Est. completion date: October 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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.)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rotator Cuff Tear

Intervention

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>
• Inactive Sham device
The inactive control device (Sham) identical to the Active device with the exception that a PRF signal is not delivered.

Locations

Country	Name	City	State
United States	Mississippi sports Medicine and Orthopaedic Center	Jackson	Mississippi
United States	Tulane University School of Medicine	New Orleans	Louisiana
United States	Taos Orthopaedic Institue	Taos	New Mexico

Sponsors (1)

Lead Sponsor	Collaborator
Amp Orthopedics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average daily narcotic consumption (oxycodone mg)	Average, daily, patient-reported narcotic consumption (converted to oxycodone equivalents in mg) during Week 1.	week-1 post surgery	No
Secondary	Average daily narcotic consumption (oxycodone mg)	Average, daily, patient-reported narcotic consumption during Weeks 2-6	Weeks 2-6 post surgery	No
Secondary	Visual Analogue Scale (VAS) pain	Daily VAS pain (daily "current" and "maximum") during Week 1, VAS pain (daily "current" and "maximum") during Weeks 2-6	Weeks 2-6 post surgery	No
Secondary	Patient-reported general health-related quality of life score (EQ-5D)	The EQ-5D will be completed by the subject on the last day of each week (Weeks 1-6)	On the last day of Weeks 1-6	No
Secondary	Adverse Events	Adverse events will be recorded daily following randomization and analyzed for confirmation of device safety	Weeks 1-6 post surgery	Yes