NCT01507818

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 9, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 11, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

July 9, 2012

Status Verified

July 1, 2012

Enrollment Period

9 months

First QC Date

January 9, 2012

Last Update Submit

July 6, 2012

Conditions

Rotator Cuff Tear

Keywords

Arthroscopic Rotator Cuff RepairElectromagnetic field treatmentPulsed Radio Frequency treatmentNon-invasiveNon-thermal

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • Average daily narcotic consumption (oxycodone mg)

    Weeks 2-6 post surgery

  • Visual Analogue Scale (VAS) pain

    Weeks 2-6 post surgery

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

    On the last day of Weeks 1-6

  • Adverse Events

    Weeks 1-6 post surgery

Study Arms (2)

Ivivi Torino II

ACTIVE COMPARATOR

Active treatment with Non-thermal Pulsed Radio Frequency device

Device: Ivivi Torino II

Inactive Sham

SHAM COMPARATOR

Sham treatment

Device: Inactive Sham device

Interventions

Ivivi Torino IIDEVICE

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\>

Ivivi Torino II
Inactive Sham deviceDEVICE

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

Inactive Sham

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Tulane University School of Medicine

New Orleans, Louisiana, 70112, United States

Location

Mississippi sports Medicine and Orthopaedic Center

Jackson, Mississippi, 39202, United States

Location

Taos Orthopaedic Institue

Taos, New Mexico, 87571, United States

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon Injuries

Study Officials

  • Felix Savoie, M.D.

    Tulane University Schol of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2012

First Posted

January 11, 2012

Study Start

December 1, 2011

Primary Completion

September 1, 2012

Study Completion

October 1, 2012

Last Updated

July 9, 2012

Record last verified: 2012-07

Locations

US(3)