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

Primary Purpose

Rotator Cuff Tear

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Ivivi Torino II

Inactive Sham device

About this trial

This is an interventional treatment trial for Rotator Cuff Tear focused on measuring Arthroscopic Rotator Cuff Repair, Electromagnetic field treatment, Pulsed Radio Frequency treatment, Non-invasive, Non-thermal

Eligibility Criteria

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

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.)

Sites / Locations

Tulane University School of Medicine
Mississippi sports Medicine and Orthopaedic Center
Taos Orthopaedic Institue

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Ivivi Torino II

Inactive Sham

Arm Description

Active treatment with Non-thermal Pulsed Radio Frequency device

Sham treatment

Outcomes

Primary Outcome Measures

Average daily narcotic consumption (oxycodone mg)

Average, daily, patient-reported narcotic consumption (converted to oxycodone equivalents in mg) during Week 1.

Secondary Outcome Measures

Average daily narcotic consumption (oxycodone mg)

Average, daily, patient-reported narcotic consumption during Weeks 2-6

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

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)

Adverse Events

Adverse events will be recorded daily following randomization and analyzed for confirmation of device safety

Full Information

NCT ID

NCT01507818

First Posted

January 9, 2012

Last Updated

July 6, 2012

Sponsor

Amp Orthopedics, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01507818

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

July 2012

Overall Recruitment Status

Terminated

Why Stopped

Sponsor decision

Study Start Date

December 2011 (undefined)

Primary Completion Date

September 2012 (Anticipated)

Study Completion Date

October 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Amp Orthopedics, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

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

Rotator Cuff Tear

Keywords

Arthroscopic Rotator Cuff Repair, Electromagnetic field treatment, Pulsed Radio Frequency treatment, Non-invasive, Non-thermal

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

37 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ivivi Torino II

Arm Type

Active Comparator

Arm Description

Active treatment with Non-thermal Pulsed Radio Frequency device

Arm Title

Inactive Sham

Arm Type

Sham Comparator

Arm Description

Sham treatment

Intervention Type

Device

Intervention Name(s)

Ivivi Torino II

Intervention Description

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>

Intervention Type

Device

Intervention Name(s)

Inactive Sham device

Intervention Description

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

Primary Outcome Measure Information:

Title

Average daily narcotic consumption (oxycodone mg)

Description

Average, daily, patient-reported narcotic consumption (converted to oxycodone equivalents in mg) during Week 1.

Time Frame

week-1 post surgery

Secondary Outcome Measure Information:

Title

Average daily narcotic consumption (oxycodone mg)

Description

Average, daily, patient-reported narcotic consumption during Weeks 2-6

Time Frame

Weeks 2-6 post surgery

Title

Visual Analogue Scale (VAS) pain

Description

Daily VAS pain (daily "current" and "maximum") during Week 1, VAS pain (daily "current" and "maximum") during Weeks 2-6

Time Frame

Weeks 2-6 post surgery

Title

Patient-reported general health-related quality of life score (EQ-5D)

Description

The EQ-5D will be completed by the subject on the last day of each week (Weeks 1-6)

Time Frame

On the last day of Weeks 1-6

Title

Adverse Events

Description

Adverse events will be recorded daily following randomization and analyzed for confirmation of device safety

Time Frame

Weeks 1-6 post surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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.)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Felix Savoie, M.D.

Organizational Affiliation

Tulane University Schol of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Tulane University School of Medicine

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70112

Country

United States

Facility Name

Mississippi sports Medicine and Orthopaedic Center

City

Jackson

State/Province

Mississippi

ZIP/Postal Code

39202

Country

United States

Facility Name

Taos Orthopaedic Institue

City

Taos

State/Province

New Mexico

ZIP/Postal Code

87571

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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