Rotator Cuff TearNCT01507818
Effectiveness of the Ivivi Torino II, Pulsed Radio Frequency Device, on Narcotic Use, Pain and Quality of Life Following Shoulder Arthroscopic Rotator Cuff Repair.
A study testing Ivivi Torino II in people with Rotator Cuff Tear, run by Amp Orthopedics, Inc. at 3 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Rotator Cuff Tear
- What is being tested?
- Ivivi Torino II
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 3 sitesUnited States
- Study dates
- Dec 2011to Oct 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Mississippi sports Medicine and Orthopaedic Center
Jackson, Mississippi, 39202
Tulane University School of Medicine
New Orleans, Louisiana, 70112
Taos Orthopaedic Institue
Taos, New Mexico, 87571
About this study
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
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).
- Conditions
- Rotator Cuff Tear
- Being tested
- Ivivi Torino II, Inactive Sham device
- Keywords
- Arthroscopic Rotator Cuff Repair, Electromagnetic field treatment, Pulsed Radio Frequency treatment, Non-invasive, Non-thermal
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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>
Inactive Sham deviceDevice
The inactive control device (Sham) identical to the Active device with the exception that a PRF signal is not delivered.
| Study group | Role | What they receive |
|---|---|---|
| Ivivi Torino II | Active comparator | Active treatment with Non-thermal Pulsed Radio Frequency device Receives: Device: Ivivi Torino II |
| Inactive Sham | Sham comparator | Sham treatment Receives: Device: Inactive Sham device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average daily narcotic consumption (oxycodone mg)
Average, daily, patient-reported narcotic consumption (converted to oxycodone equivalents in mg) during Week 1.
Measured: week-1 post surgery
Secondary outcomes (4)
Average daily narcotic consumption (oxycodone mg)
Average, daily, patient-reported narcotic consumption during Weeks 2-6
Measured: Weeks 2-6 post surgery
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
Measured: Weeks 2-6 post surgery
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)
Measured: On the last day of Weeks 1-6
Adverse Events
Adverse events will be recorded daily following randomization and analyzed for confirmation of device safety
Measured: Weeks 1-6 post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2012 (estimated)
- Study startDec 2011
- Primary completionSep 2012 (estimated)
- Study completionOct 2012 (estimated)
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amp Orthopedics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Felix Savoie, M.D., Principal investigator, Tulane University Schol of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01507818
- Sponsor's protocol ID
- Amp-PostOpShoulder-Pain-001
- Status last verified
- Jul 2012
- First submitted
- 9 Jan 2012
- Last updated
- 9 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01507818
- Acronym / sponsor ID
- Amp-PostOpShoulder-Pain-001
- Conditions
- Rotator Cuff Tear
- Keywords
- Arthroscopic Rotator Cuff Repair, Electromagnetic field treatment, Pulsed Radio Frequency treatment, Non-invasive, Non-thermal
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Amp Orthopedics, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Sep 2012 (estimated)
- Study completion
- Oct 2012 (estimated)
- First posted
- 11 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ivivi Torino II | Active comparator | Device: Ivivi Torino IIActive treatment with Non-thermal Pulsed Radio Frequency device |
| Inactive Sham | Sham comparator | Device: Inactive Sham deviceSham treatment |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ivivi Torino IIEmits 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> | Device | Ivivi Torino II |
| Inactive Sham deviceThe inactive control device (Sham) identical to the Active device with the exception that a PRF signal is not delivered. | Device | Inactive Sham |
Primary outcome
Average daily narcotic consumption (oxycodone mg)
Time frame: week-1 post surgery
Average, daily, patient-reported narcotic consumption (converted to oxycodone equivalents in mg) during Week 1.
4 secondary outcomes
Average daily narcotic consumption (oxycodone mg)
Time frame: Weeks 2-6 post surgery
Visual Analogue Scale (VAS) pain
Time frame: Weeks 2-6 post surgery
Patient-reported general health-related quality of life score (EQ-5D)
Time frame: On the last day of Weeks 1-6
Adverse Events
Time frame: Weeks 1-6 post surgery
Results and safety
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Felix Savoie, M.D. principal investigator
Tulane University Schol of Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ivivi Torino II in people with Rotator Cuff Tear, run by Amp Orthopedics, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average daily narcotic consumption (oxycodone mg) (time frame: week-1 post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2012.