Comparison of the Effects of Two Spinal Cord Stimulation (SCS) Therapies on Subject Reported Pain (BENEFIT-02)



Status:Recruiting
Conditions:Back Pain, Back Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:18 - Any
Updated:4/5/2019
Start Date:August 1, 2018
End Date:July 2019
Contact:Clinical Study Project Manager
Email:benefit02@biotronik.com
Phone:800-547-0394

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The BENEFIT-02 Study

A BIOTRONIK wearable stimulator will be utilized in order to investigate the effects of two
study spinal cord stimulation (SCS) therapies on subject reported pain and paresthesia
perception observed over 12 days of study stimulation testing following the conclusion of a
successful SCS commercial trial.


Inclusion Criteria:

- Age greater than or equal to 18 years

- Able to understand the nature of the study and provide informed consent

- Able to read, understand, and speak English

- Willing and able to comply with all study requirements, including all required
procedures, phone calls and study visits

- Planned to undergo a commercial SCS trial of standard duration for the treatment of
low back and/or leg pain with a commercially available SCS system as prescribed by a
physician(s) according to FDA approved indications for use

- Planned utilization of preoperative antibiotics for SCS commercial trial

- Planned placement of two eight-electrode SCS trial leads (or at least one 16-
electrode SCS trial lead) using a suitable technique for an extended trial (e.g.
tunneling approach of a minimum of 3-4 cm, or buried lead trial) with at least one
lead covering the T9 vertebral level

- Incoming Numerical Rating Scale (NRS) for pain (overall) of at least 6 (collected
prior to the commercial trial)

- Passed psychological evaluation

- Negative MRSA screening result

- Negative MSSA screening result or documentation of subsequent decolonization routine
if MSSA positive

- For diabetic patients: minimum of one HbA1c test within the last 6 months, with most
recent result ≤ 7.5%

Exclusion Criteria:

- Enrolled in any investigational SCS stimulation trial, for which the SCS system is not
commercially available

- Presence of any life-threatening, underlying illness separate from their indication
for SCS therapy

- Patients reporting pregnancy at the time of enrollment

- Patients with poor compliance for pain management regimen

- Patients currently involved in an active workers compensation claim and/or active
litigation related to injury associated with indication for SCS

- Patients with a documented history of substance abuse (narcotics, alcohol, etc.) or
substance dependency (other than prescribed) in the 6 months prior to baseline data
collection

- Patients with an implanted pacemaker, defibrillator, or other medical
contraindications for SCS therapy

- Patients with a medical condition or pain in other area(s), not intended to be treated
with SCS, that could interfere with study procedures, accurate pain reporting, and/or
confound evaluation of study endpoints, as determined by the investigator

- Patients immunocompromised and/or at high risk for infection

- Patients with morphine equivalent dose > 120 units

- Patients with documented history of allergic response or sensitivity to material(s)
required for the study (e.g. silver impregnated antibacterial dressing, adhesives,
titanium, silicone, etc.)

- Patients with a documented history of clostridium difficile
We found this trial at
15
sites
Chesterfield, Missouri 63017
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Chestnut Hill, Massachusetts 02467
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Columbus, Ohio 43219
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Columbus, OH
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Kansas City, Kansas
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New York, New York 10022
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New York, NY
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Overland Park, KS
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Peoria, Arizona 85381
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Peoria, AZ
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5578 Longley Lane
Reno, Nevada 89511
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Reno, NV
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Scottsdale, Arizona 85258
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Scottsdale, AZ
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Shrewsbury, New Jersey 07702
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Shrewsbury, NJ
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Spokane, Washington 99201
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Spokane, WA
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Trevose, Pennsylvania 19053
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Trevose, PA
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Walnut Creek, California 94598
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Walnut Creek, CA
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Wilmington, Delaware 19803
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Wilmington, DE
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Winston-Salem, North Carolina 27103
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Winston-Salem, NC
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