- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03594266
Comparison of the Effects of Two Spinal Cord Stimulation (SCS) Therapies on Subject Reported Pain (BENEFIT-02)
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Arizona
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Peoria, Arizona, United States, 85381
- Hope Research Institute
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Scottsdale, Arizona, United States, 85258
- Arizona Pain
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California
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Walnut Creek, California, United States, 94598
- Integrated Pain Management (IPM) Medical Group
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Delaware
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Wilmington, Delaware, United States, 19711
- Center for Interventional Pain and Spine
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Florida
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Bradenton, Florida, United States, 34209
- Coastal Orthopedics
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Georgia
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Stockbridge, Georgia, United States, 30281
- Pain Care, LLC
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Kansas
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Kansas City, Kansas, United States, 66160
- Kansas University Medical Center
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Overland Park, Kansas, United States, 66210
- Neuroscience Research Center DBA Kansas Pain Management
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Massachusetts
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Chestnut Hill, Massachusetts, United States, 02467
- Brigham and Women's Hospital
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Missouri
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Chesterfield, Missouri, United States, 63017
- St. Louis Pain Consultants
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Lee's Summit, Missouri, United States, 64086
- KC Pain Centers
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Nevada
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Reno, Nevada, United States, 89511
- Nevada Advanced Pain Specialists
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New Jersey
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Shrewsbury, New Jersey, United States, 07702
- Premier Pain Centers
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New York
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New York, New York, United States, 10022
- Ainsworth Institute of Pain Management
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North Carolina
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Winston-Salem, North Carolina, United States, 27103
- The Center for Clinical Research
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Ohio
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Columbus, Ohio, United States, 43240
- Integrated Pain Solutions
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Pennsylvania
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Trevose, Pennsylvania, United States, 19053
- Delaware Valley Pain and Spine Institute
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Washington
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Spokane, Washington, United States, 99201
- Northwest Pain Care, Inc.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Therapy A Spinal Cord Stimulation Parameter Set
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Therapy A stimulation patterns
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Experimental: Therapy B Spinal Cord Stimulation Parameter Set
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Therapy B stimulation patterns
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change Since Baseline in Numerical Rating Scale (NRS) for Pain (Overall) Evaluated Separately for Each Study SCS Therapy
Time Frame: Baseline and in-office visit 3, average of 21 days
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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.
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Baseline and in-office visit 3, average of 21 days
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Inter-therapy Comparison of Change Since Baseline in Numerical Rating Scale (NRS) for Pain (Overall)
Time Frame: Baseline and in-office visit 3, average of 21 days
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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.
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Baseline and in-office visit 3, average of 21 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change Since Conclusion of Commercial Trial in Numerical Rating Scale (NRS) for Pain (Overall) Evaluated Separately for Each Study SCS Therapy
Time Frame: In-office visit 1 at approximately 7 days and in-office visit 3 at approximately 21 days, average of 14 days
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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
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In-office visit 1 at approximately 7 days and in-office visit 3 at approximately 21 days, average of 14 days
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Investigational Device-related Adverse Event-free Rate
Time Frame: Baseline and in-office visit 3, average of 21 days
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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).
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Baseline and in-office visit 3, average of 21 days
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Leonardo Kapural, MD, Carolinas Pain Institute
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BENEFIT-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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