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

Stopped early · Not applicable · Has a placebo group

Conditions studied: Rotator Cuff Tear

In brief

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).

Key facts

Study ID

NCT01507818

Run by

Amp Orthopedics, Inc.

People needed

37

Starts

2011-12-01

Expected to finish

2012-10-01

Last updated by the study team

2012-07-09

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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.)

Where it is running

• Tulane University School of Medicine — New Orleans, Louisiana, United States
• Mississippi sports Medicine and Orthopaedic Center — Jackson, Mississippi, United States
• Taos Orthopaedic Institue — Taos, New Mexico, United States

Full record on ClinicalTrials.gov

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