Chronic Low Back PainNCT03594266
Comparison of the Effects of Two Spinal Cord Stimulation (SCS) Therapies on Subject Reported Pain (BENEFIT-02)
A study testing Therapy A spinal cord stimulation parameter set using BIO-RNA system and associated components and Therapy B spinal cord stimulation parameter set using BIO-RNA system and associated components in people with Chronic Low Back Pain and Chronic Leg Pain, run by Biotronik, Inc. at 18 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Low Back Pain, Chronic Leg Pain
- What is being tested?
- Therapy A spinal cord stimulation parameter set using BIO-RNA system and associated components and Therapy B spinal cord stimulation parameter set using BIO-RNA system and associated components
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 18 sitesUnited States
- Study dates
- 1 Aug 2018to 27 Mar 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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%
Who cannot join
- 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
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- 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
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Coastal Orthopedics
Bradenton, Florida, 34209
St. Louis Pain Consultants
Chesterfield, Missouri, 63017
Brigham and Women's Hospital
Chestnut Hill, Massachusetts, 02467
Integrated Pain Solutions
Columbus, Ohio, 43240
Kansas University Medical Center
Kansas City, Kansas, 66160
KC Pain Centers
Lee's Summit, Missouri, 64086
Ainsworth Institute of Pain Management
New York, New York, 10022
Neuroscience Research Center DBA Kansas Pain Management
Overland Park, Kansas, 66210
Hope Research Institute
Peoria, Arizona, 85381
Nevada Advanced Pain Specialists
Reno, Nevada, 89511
Arizona Pain
Scottsdale, Arizona, 85258
Premier Pain Centers
Shrewsbury, New Jersey, 07702
Northwest Pain Care, Inc.
Spokane, Washington, 99201
Pain Care, LLC
Stockbridge, Georgia, 30281
Delaware Valley Pain and Spine Institute
Trevose, Pennsylvania, 19053
Integrated Pain Management (IPM) Medical Group
Walnut Creek, California, 94598
Center for Interventional Pain and Spine
Wilmington, Delaware, 19711
The Center for Clinical Research
Winston-Salem, North Carolina, 27103
About this study
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.
Read the 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.
- Conditions
- Chronic Low Back Pain, Chronic Leg Pain
- Being tested
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapy A spinal cord stimulation parameter set using BIO-RNA system and associated componentsDevice
Therapy A stimulation patterns
Therapy B spinal cord stimulation parameter set using BIO-RNA system and associated componentsDevice
Therapy B stimulation patterns
| Study group | Role | What they receive |
|---|---|---|
| Therapy A Spinal Cord Stimulation Parameter Set | Experimental | Not described Receives: Device: Therapy A spinal cord stimulation parameter set using BIO-RNA system and associated components |
| Therapy B Spinal Cord Stimulation Parameter Set | Experimental | Not described Receives: Device: Therapy B spinal cord stimulation parameter set using BIO-RNA system and associated components |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and in-office visit 3, average of 21 days
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.
Measured: Baseline and in-office visit 3, average of 21 days
Secondary outcomes (2)
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
Measured: In-office visit 1 at approximately 7 days and in-office visit 3 at approximately 21 days, average of 14 days
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).
Measured: Baseline and in-office visit 3, average of 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2018
- Study start1 Aug 2018
- Primary completion20 Mar 2020
- Study completion27 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotronik, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Leonardo Kapural, MD, Study chair, Carolinas Pain Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03594266
- Sponsor's protocol ID
- BENEFIT-02
- Status last verified
- Jul 2023
- First submitted
- 9 Jul 2018
- Last updated
- 10 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Kapural L, Patterson DG, Li S, Hatheway J, Hunter C, Rosen S, Fishman M, Gupta M, Sayed D, Christopher A, Burgher A, McJunkin T, Ross EL, Provenzano D, Amirdelfan K. Multiphase Spinal Cord Stimulation in Participants With Chronic Back or Leg Pain: Results of the BENEFIT-02 Randomized Clinical Trial. Neuromodulation. 2023 Oct;26(7):1400-1411. doi: 10.1016/j.neurom.2023.05.006. Epub 2023 Aug 16.
PubMed 37589641
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Two Spinal Cord Stimulation (SCS) Therapies on Subject Reported Pain (BENEFIT-02)
- ClinicalTrials.gov ID
- NCT03594266
- Acronym / sponsor ID
- BENEFIT-02
- Conditions
- Chronic Low Back Pain, Chronic Leg Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Biotronik, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 20 Mar 2020 (actual)
- Study completion
- 27 Mar 2020 (actual)
- First posted
- 20 Jul 2018 (actual)
- Results
- Posted 10 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapy A Spinal Cord Stimulation Parameter Set | Experimental | Device: Therapy A spinal cord stimulation parameter set using BIO-RNA system and associated components |
| Therapy B Spinal Cord Stimulation Parameter Set | Experimental | Device: Therapy B spinal cord stimulation parameter set using BIO-RNA system and associated components |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapy A spinal cord stimulation parameter set using BIO-RNA system and associated componentsTherapy A stimulation patterns | Device | Therapy A Spinal Cord Stimulation Parameter Set |
| Therapy B spinal cord stimulation parameter set using BIO-RNA system and associated componentsTherapy B stimulation patterns | Device | Therapy B Spinal Cord Stimulation Parameter Set |
Primary outcome
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
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)
Time frame: 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.
2 secondary outcomes
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
Investigational Device-related Adverse Event-free Rate
Time frame: Baseline and in-office visit 3, average of 21 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37589641Kapural L, Patterson DG, Li S, Hatheway J, Hunter C, Rosen S, Fishman M, Gupta M, Sayed D, Christopher A, Burgher A, McJunkin T, Ross EL, Provenzano D, Amirdelfan K. Multiphase Spinal Cord Stimulation in Participants With Chronic Back or Leg Pain: Results of the BENEFIT-02 Randomized Clinical Trial. Neuromodulation. 2023 Oct;26(7):1400-1411. doi: 10.1016/j.neurom.2023.05.006. Epub 2023 Aug 16.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leonardo Kapural, MD study chair
Carolinas Pain Institute
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapy A spinal cord stimulation parameter set using BIO-RNA system and associated components and Therapy B spinal cord stimulation parameter set using BIO-RNA system and associated components in people with Chronic Low Back Pain and Chronic Leg Pain, run by Biotronik, Inc. at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03594266, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2023.