Clinical trial NCT03594266: Comparison of the Effects of Two Spinal Cord Stimulation (SCS) Therapies on Subject Reported Pain (BENEFIT-02)
Official title: Comparison of the Effects of Two Spinal Cord Stimulation (SCS) Therapies on Subject Reported Pain (BENEFIT-02)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low Back Pain
Chronic Leg Pain
Lead sponsor: Biotronik, Inc.
Sponsor class: INDUSTRY
First posted: 2018-07-20
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change Since Baseline in Numerical Rating Scale (NRS) for Pain (Overall) Evaluated Separately for Each Study SCS Therapy
timeFrame: Baseline and in-office visit 3, average of 21 days
measure: Inter-therapy Comparison of Change Since Baseline in Numerical Rating Scale (NRS) for Pain (Overall)
timeFrame: Baseline and in-office visit 3, average of 21 days
Secondary outcomes:
measure: Change Since Conclusion of Commercial Trial in Numerical Rating Scale (NRS) for Pain (Overall) Evaluated Separately for Each Study SCS Therapy
timeFrame: In-office visit 1 at approximately 7 days and in-office visit 3 at approximately 21 days, average of 14 days
measure: Investigational Device-related Adverse Event-free Rate
timeFrame: Baseline and in-office visit 3, average of 21 days
Other outcomes:
Locations:
city: Peoria
country: United States
facility: Hope Research Institute
state: Arizona
city: Scottsdale
country: United States
facility: Arizona Pain
state: Arizona
city: Walnut Creek
country: United States
facility: Integrated Pain Management (IPM) Medical Group
state: California
city: Wilmington
country: United States
facility: Center for Interventional Pain and Spine
state: Delaware
city: Bradenton
country: United States
facility: Coastal Orthopedics
state: Florida
city: Stockbridge
country: United States
facility: Pain Care, LLC
state: Georgia
city: Kansas City
country: United States
facility: Kansas University Medical Center
state: Kansas
city: Overland Park
country: United States
facility: Neuroscience Research Center DBA Kansas Pain Management
state: Kansas
city: Chestnut Hill
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Chesterfield
country: United States
facility: St. Louis Pain Consultants
state: Missouri
city: Lee's Summit
country: United States
facility: KC Pain Centers
state: Missouri
city: Reno
country: United States
facility: Nevada Advanced Pain Specialists
state: Nevada
city: Shrewsbury
country: United States
facility: Premier Pain Centers
state: New Jersey
city: New York
country: United States
facility: Ainsworth Institute of Pain Management
state: New York
city: Winston-Salem
country: United States
facility: The Center for Clinical Research
state: North Carolina
city: Columbus
country: United States
facility: Integrated Pain Solutions
state: Ohio
city: Trevose
country: United States
facility: Delaware Valley Pain and Spine Institute
state: Pennsylvania
city: Spokane
country: United States
facility: Northwest Pain Care, Inc.
state: Washington
Study officials:
affiliation: Carolinas Pain Institute
name: Leonardo Kapural, MD
role: STUDY_CHAIR
References: