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

Amp Orthopedics

Status

Terminated

Conditions

Rotator Cuff Tear

Treatments

Device: Inactive Sham device

Device: Ivivi Torino II

Study type

Interventional

Funder types

Industry

Identifiers

NCT01507818

Amp-PostOpShoulder-Pain-001

Details and patient eligibility

About

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).

Enrollment

37 patients

Sex

All

Ages

40 to 80 years old

Volunteers

No 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.)