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

Primary Purpose

Chronic Low Back Pain, Chronic Leg Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Therapy A spinal cord stimulation parameter set using BIO-RNA system and associated components
Therapy B spinal cord stimulation parameter set using BIO-RNA system and associated components
Sponsored by
Biotronik, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low Back Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hope Research Institute
  • Arizona Pain
  • Integrated Pain Management (IPM) Medical Group
  • Center for Interventional Pain and Spine
  • Coastal Orthopedics
  • Pain Care, LLC
  • Kansas University Medical Center
  • Neuroscience Research Center DBA Kansas Pain Management
  • Brigham and Women's Hospital
  • St. Louis Pain Consultants
  • KC Pain Centers
  • Nevada Advanced Pain Specialists
  • Premier Pain Centers
  • Ainsworth Institute of Pain Management
  • The Center for Clinical Research
  • Integrated Pain Solutions
  • Delaware Valley Pain and Spine Institute
  • Northwest Pain Care, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Therapy A Spinal Cord Stimulation Parameter Set

Therapy B Spinal Cord Stimulation Parameter Set

Arm Description

Outcomes

Primary Outcome Measures

Change Since Baseline in Numerical Rating Scale (NRS) for Pain (Overall) Evaluated Separately for Each Study SCS Therapy
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)
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

Change Since Conclusion of Commercial Trial in Numerical Rating Scale (NRS) for Pain (Overall) Evaluated Separately for Each Study SCS Therapy
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
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).

Full Information

First Posted
July 9, 2018
Last Updated
July 6, 2023
Sponsor
Biotronik, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03594266
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
March 20, 2020 (Actual)
Study Completion Date
March 27, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biotronik, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain, Chronic Leg Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
136 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Therapy A Spinal Cord Stimulation Parameter Set
Arm Type
Experimental
Arm Title
Therapy B Spinal Cord Stimulation Parameter Set
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Therapy A spinal cord stimulation parameter set using BIO-RNA system and associated components
Intervention Description
Therapy A stimulation patterns
Intervention Type
Device
Intervention Name(s)
Therapy B spinal cord stimulation parameter set using BIO-RNA system and associated components
Intervention Description
Therapy B stimulation patterns
Primary Outcome Measure Information:
Title
Change Since Baseline in Numerical Rating Scale (NRS) for Pain (Overall) Evaluated Separately for Each Study SCS Therapy
Description
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.
Time Frame
Baseline and in-office visit 3, average of 21 days
Title
Inter-therapy Comparison of Change Since Baseline in Numerical Rating Scale (NRS) for Pain (Overall)
Description
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.
Time Frame
Baseline and in-office visit 3, average of 21 days
Secondary Outcome Measure Information:
Title
Change Since Conclusion of Commercial Trial in Numerical Rating Scale (NRS) for Pain (Overall) Evaluated Separately for Each Study SCS Therapy
Description
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
Time Frame
In-office visit 1 at approximately 7 days and in-office visit 3 at approximately 21 days, average of 14 days
Title
Investigational Device-related Adverse Event-free Rate
Description
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).
Time Frame
Baseline and in-office visit 3, average of 21 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leonardo Kapural, MD
Organizational Affiliation
Carolinas Pain Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Hope Research Institute
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Facility Name
Arizona Pain
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
Integrated Pain Management (IPM) Medical Group
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Center for Interventional Pain and Spine
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19711
Country
United States
Facility Name
Coastal Orthopedics
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34209
Country
United States
Facility Name
Pain Care, LLC
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Facility Name
Kansas University Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Neuroscience Research Center DBA Kansas Pain Management
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66210
Country
United States
Facility Name
Brigham and Women's Hospital
City
Chestnut Hill
State/Province
Massachusetts
ZIP/Postal Code
02467
Country
United States
Facility Name
St. Louis Pain Consultants
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
KC Pain Centers
City
Lee's Summit
State/Province
Missouri
ZIP/Postal Code
64086
Country
United States
Facility Name
Nevada Advanced Pain Specialists
City
Reno
State/Province
Nevada
ZIP/Postal Code
89511
Country
United States
Facility Name
Premier Pain Centers
City
Shrewsbury
State/Province
New Jersey
ZIP/Postal Code
07702
Country
United States
Facility Name
Ainsworth Institute of Pain Management
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Facility Name
The Center for Clinical Research
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Integrated Pain Solutions
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43240
Country
United States
Facility Name
Delaware Valley Pain and Spine Institute
City
Trevose
State/Province
Pennsylvania
ZIP/Postal Code
19053
Country
United States
Facility Name
Northwest Pain Care, Inc.
City
Spokane
State/Province
Washington
ZIP/Postal Code
99201
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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