Clinical trial NCT01507818: 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
Overall status: TERMINATED
Phase: NA
Conditions: Rotator Cuff Tear
Keywords: Arthroscopic Rotator Cuff Repair
Electromagnetic field treatment
Pulsed Radio Frequency treatment
Non-invasive
Non-thermal
Lead sponsor: Amp Orthopedics, Inc.
Sponsor class: INDUSTRY
First posted: 2012-01-11
Enrollment: 37
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.)

Primary outcomes:
measure: Average daily narcotic consumption (oxycodone mg)
timeFrame: week-1 post surgery
Secondary outcomes:
measure: Average daily narcotic consumption (oxycodone mg)
timeFrame: Weeks 2-6 post surgery
measure: Visual Analogue Scale (VAS) pain
timeFrame: Weeks 2-6 post surgery
measure: Patient-reported general health-related quality of life score (EQ-5D)
timeFrame: On the last day of Weeks 1-6
measure: Adverse Events
timeFrame: Weeks 1-6 post surgery
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Tulane University School of Medicine
state: Louisiana
city: Jackson
country: United States
facility: Mississippi sports Medicine and Orthopaedic Center
state: Mississippi
city: Taos
country: United States
facility: Taos Orthopaedic Institue
state: New Mexico
Study officials:
affiliation: Tulane University Schol of Medicine
name: Felix Savoie, M.D.
role: PRINCIPAL_INVESTIGATOR
References: