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

Not Applicable

Completed

Conditions: Chronic Low Back Pain
Chronic Leg Pain

Interventions: Device: Therapy A spinal cord stimulation parameter set using BIO-RNA system and associated components
Device: Therapy B spinal cord stimulation parameter set using BIO-RNA system and associated components

Registration Number: NCT03594266

Lead Sponsor: Biotronik, Inc.

Brief Summary: 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.

Detailed Description: The study population will consist of patients with chronic low back and/or leg pain who have been identified as candidates for trial testing of a commercially available SCS system including percutaneous SCS trial lead(s), but have not yet undergone trial lead implant. The commercial trial test period will be conducted independently from the study according to standard of care. The commercial trial period is referred to as the "trial" and the BENEFIT-02 interventional study stimulation period is referred to as the "study".

Potential subjects will be identified by the investigator from their general patient population and must meet all of the study inclusion and none of the study exclusion criteria evaluated at the time of enrollment. Once study eligibility is confirmed, written informed consent is obtained, after which enrollment visit data will be collected. Subjects will be considered fully enrolled after being randomly assigned to receive one of two study SCS therapies.

To participate in this study, subjects must be willing to undergo an extended 14 day testing period following the conclusion of their commercial trial, where their existing SCS trial lead(s) will be connected to a BIOTRONIK study stimulator and one of two randomly assigned study SCS therapies will be administered for an additional 12 days after a two day washout period. After completion of the 12 day study testing period, the subject's participation in the study ends, the study stimulator will be disconnected, and the commercial SCS trial lead(s) will be removed according to the standard clinical routine.

This feasibility study includes the assessment of two primary endpoints and two secondary endpoints that are designed to provide preliminary information regarding the effectiveness and safety of the two study SCS therapies under investigation in the study.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 136

Inclusion Criteria

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%

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Therapy A Spinal Cord Stimulation Parameter Set	Therapy A spinal cord stimulation parameter set using BIO-RNA system and associated components	-
Therapy B Spinal Cord Stimulation Parameter Set	Therapy B spinal cord stimulation parameter set using BIO-RNA system and associated components	-

Primary Outcome Measures

Name	Time	Method
Change Since Baseline in Numerical Rating Scale (NRS) for Pain (Overall) Evaluated Separately for Each Study SCS Therapy	Baseline and in-office visit 3, average of 21 days	The purpose of primary endpoint 1 is to evaluate the change since baseline in Numerical Rating Scale (NRS) for pain (overall) for each study SCS therapy. The evaluation of primary endpoint 1 is based on the NRS for pain (overall) obtained at the final study testing visit compared with the baseline measurement obtained prior to initiation of the commercial trial period, for subjects randomized to each study SCS therapy. Numerical Rating Scale (NRS) was collected for overall pain experienced over the past 24 hours on a scale of 0-10, with 0 being No Pain and 10 being Worst Possible Pain.
Inter-therapy Comparison of Change Since Baseline in Numerical Rating Scale (NRS) for Pain (Overall)	Baseline and in-office visit 3, average of 21 days	The purpose of primary endpoint 2 is to provide an inter-therapy comparison of change since baseline in Numerical Rating Scale (NRS) for pain (overall). Primary endpoint 2 analyses includes all participants included in primary endpoint 1 analyses. Numerical Rating Scale (NRS) was collected for overall pain experienced over the past 24 hours on a scale of 0-10, with 0 being No Pain and 10 being Worst Possible Pain.

Secondary Outcome Measures

Name	Time	Method
Change Since Conclusion of Commercial Trial in Numerical Rating Scale (NRS) for Pain (Overall) Evaluated Separately for Each Study SCS Therapy	In-office visit 1 at approximately 7 days and in-office visit 3 at approximately 21 days, average of 14 days	The evaluation of secondary endpoint 1 will be based on Numerical Rating Scale (NRS) for overall pain experienced over the past 24 hours (scale of 0-10, with 0 being No Pain and 10 being Worst Possible Pain) obtained at conclusion of commercial trial compared to NRS for overall pain at the final study testing visit
Investigational Device-related Adverse Event-free Rate	Baseline and in-office visit 3, average of 21 days	The evaluation of secondary endpoint 2 will be based on the number of subjects free from investigational device-related adverse events assessed at in-office visit 1 (randomization visit) through in-office visit 3 (study completion). The investigational device-related adverse event-free rate was pre-defined within the protocol as the overall rate from all implanted Prospera SCS devices, regardless of randomized therapy output setting (Therapy A or Therapy B).

Trial Locations

Locations (18): Neuroscience Research Center DBA Kansas Pain Management
🇺🇸
Overland Park, Kansas, United States
Integrated Pain Solutions
🇺🇸
Columbus, Ohio, United States
St. Louis Pain Consultants
🇺🇸
Chesterfield, Missouri, United States
Arizona Pain
🇺🇸
Scottsdale, Arizona, United States
Delaware Valley Pain and Spine Institute
🇺🇸
Trevose, Pennsylvania, United States
Kansas University Medical Center
🇺🇸
Kansas City, Kansas, United States
Hope Research Institute
🇺🇸
Peoria, Arizona, United States
Integrated Pain Management (IPM) Medical Group
🇺🇸
Walnut Creek, California, United States
Coastal Orthopedics
🇺🇸
Bradenton, Florida, United States
Center for Interventional Pain and Spine
🇺🇸
Wilmington, Delaware, United States
Pain Care, LLC
🇺🇸
Stockbridge, Georgia, United States
Brigham and Women's Hospital
🇺🇸
Chestnut Hill, Massachusetts, United States
KC Pain Centers
🇺🇸
Lee's Summit, Missouri, United States
Ainsworth Institute of Pain Management
🇺🇸
New York, New York, United States
Premier Pain Centers
🇺🇸
Shrewsbury, New Jersey, United States
Nevada Advanced Pain Specialists
🇺🇸
Reno, Nevada, United States
The Center for Clinical Research
🇺🇸
Winston-Salem, North Carolina, United States
Northwest Pain Care, Inc.
🇺🇸
Spokane, Washington, United States