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

Completed · Not applicable

Conditions studied: Chronic Low Back Pain, Chronic Leg Pain

In brief

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.

Key facts

Study ID

NCT03594266

Run by

Biotronik, Inc.

People needed

136

Starts

2018-08-01

Expected to finish

2020-03-27

Last updated by the study team

2023-07-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age greater than or equal to 18 years
• Able to understand the nature of the study and provide written 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 T8 or 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%

You may not qualify if…

• 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

Where it is running

• Hope Research Institute — Peoria, Arizona, United States
• Arizona Pain — Scottsdale, Arizona, United States
• Integrated Pain Management (IPM) Medical Group — Walnut Creek, California, United States
• Center for Interventional Pain and Spine — Wilmington, Delaware, United States
• Coastal Orthopedics — Bradenton, Florida, United States
• Pain Care, LLC — Stockbridge, Georgia, United States
• Kansas University Medical Center — Kansas City, Kansas, United States
• Neuroscience Research Center DBA Kansas Pain Management — Overland Park, Kansas, United States
• Brigham and Women's Hospital — Chestnut Hill, Massachusetts, United States
• St. Louis Pain Consultants — Chesterfield, Missouri, United States
• KC Pain Centers — Lee's Summit, Missouri, United States
• Nevada Advanced Pain Specialists — Reno, Nevada, United States
• Premier Pain Centers — Shrewsbury, New Jersey, United States
• Ainsworth Institute of Pain Management — New York, New York, United States
• The Center for Clinical Research — Winston-Salem, North Carolina, United States
• Integrated Pain Solutions — Columbus, Ohio, United States
• Delaware Valley Pain and Spine Institute — Trevose, Pennsylvania, United States
• Northwest Pain Care, Inc. — Spokane, Washington, United States

Full record on ClinicalTrials.gov

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