Failed Back Surgery SyndromeSENSENCT01990287
SENSE (Subcutaneous and Epidural Neuromodulation System Evaluation) Study
A study testing SCS and PNfS and SCS Alone in people with Failed Back Surgery Syndrome and Post-Laminectomy Syndrome, run by Abbott Medical Devices at 28 sites in United States.
Trial summary
The purpose of the study is to demonstrate safety and efficacy of spinal cord stimulation with peripheral nerve field stimulation for the treatment of chronic low back and leg pain. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Failed Back Surgery Syndrome, Post-Laminectomy Syndrome, Low Back Pain
- What is being tested?
- SCS and PNfS and SCS Alone
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 28 sitesUnited States
- Study dates
- Nov 2013to Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is 22 years of age or older
- Subject has chronic low back and leg pain secondary to Failed Back Surgery Syndrome (FBSS)
- Subject has an average score of 6 or higher for average daily overall pain on the Numerical Rating Scale (NRS) based on the 7 day pain diary
- Subject has attempted "best" medical therapy and has tried and failed at least three documented medically supervised treatments (including, but not limited to physical therapy, acupuncture, etc.) and has failed medication treatment from at least two different classes
- Subject's pain-related medication regimen is stable 4 weeks prior to the baseline evaluation
- Subject agrees not to add or increase pain-related medication throughout the 12 week randomized evaluation phase of the study (starting at activation)
Who cannot join
- Subject currently participating in a clinical investigation that includes an active treatment arm
- Subject has been implanted with a previous neuromodulation system (PNfS, SCS-PNfS or SCS) or participated in a trial for a neuromodulation system
- Subject's overall Beck Depression Inventory II Score is > 24 or has a score of 3 on question 9 relating to suicidal thoughts or wishes at the baseline visit
- Subject with an infusion pump or any implantable neurostimulator device
- Subject has an existing medical condition that is likely to require repetitive MRI evaluation in the future (i.e. epilepsy, stroke, multiple sclerosis, acoustic neuroma, tumor)
- Subject has an existing medical condition that is likely to require the use of diathermy in the future
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- Subject has peripheral vascular disease
- Subject is immunocompromised
- Subject has documented history of allergic response to titanium or silicone
- Subject has a documented history of substance abuse (narcotics, alcohol, etc.) or substance dependency in the 6 months prior to baseline data collection
- Female candidates of child bearing potential that are pregnant (confirmed by positive pregnancy test)
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
United States28 sites
Michigan Pain Specialists
Brighton, Michigan, 48114
Comprehensive Pain Specialists
Broomfield, Colorado, 80020
Comprehensive Pain Management Center
Campbell, California, 95008
Coastal Pain & Spinal Diagnostics Medical Group
Carlsbad, California, 92009
The Center for Pain Relief
Charleston, West Virginia, 25301
Integrated Pain Solutions
Columbus, Ohio, 43219
Pain and Spine Center
Dayton, Ohio, 45417
Duke University Medical Center
Durham, North Carolina, 27710
Mid Atlantic Spine and Pain Physicians
Elkton, Maryland, 21921
Holy Cross Orthopedics
Fort Lauderdale, Florida, 33301
Vertex Spine and Pain
Franklin, Tennessee, 37067
Neurological Surgery, P.C.
Lake Success, New York, 11042
The Mocek Spine Clinic
Little Rock, Arkansas, 72202
Bluegrass Pain
Louisville, Kentucky, 40241
Interventional Pain Care
Muncie, Indiana, 47302
Pacific Pain Medicine Consultants
Oceanside, California, 92056
Pasadena Rehabilitation Institute
Pasadena, California, 91105
Comprehensive Pain & Rehabilitation
Pascagoula, Mississippi, 39581
The Pain Center of Arizona
Phoenix, Arizona, 85027
Performance Spine and Sports Physicians, P.C.
Pottstown, Pennsylvania, 19403
Valley Pain Consultants - N. Scottsdale
Scottsdale, Arizona, 85254
Arizona Pain Specialists
Scottsdale, Arizona, 85255
Pain Care LLC
Stockbridge, Georgia, 30281
H. Lee Moffitt Cancer and Research Institute
Tampa, Florida, 33612
Montefiore Medical Center
The Bronx, New York, 10467
Granger Pain and Spine
West Jordan, Utah, 84088
Bright Health Physicians of PIH
Whittier, California, 90602
Carolina Pain Institute
Winston-Salem, North Carolina, 27103
About this study
Official title: SENSE (Subcutaneous and Epidural Neuromodulation System Evaluation)Study for the Treatment of Chronic Low Back and Leg Pain
The purpose of the study is to demonstrate safety and efficacy of spinal cord stimulation with peripheral nerve field stimulation for the treatment of chronic low back and leg pain.
- Being tested
- SCS and PNfS, SCS Alone
- Keywords
- Low Back Pain, Failed Back surgery Syndrome, Post-Laminectomy Syndrome, Spinal Cord Stimulation, Peripheral Nerve field Stimulation, Pain
- Medical subject headings
- Failed Back Surgery Syndrome, post laminectomy syndrome, Low Back Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCS and PNfSDevice
Also called Eon or Eon Mini IPG neurostimulation system with associated components
Spinal Cord Stimulation (SCS) in combination with Peripheral Nerve Field Stimulation (PNfS). The SCS leads will be placed in the Thoracolumbar region and the PNfS lead will be placed subcutaneously in the area of pain.
SCS AloneDevice
Also called Eon or Eon Mini IPG neurostimulation system with associated components
Spinal Cord Stimulation (SCS) only. The SCS leads will be placed in the Thoracolumbar region only.
| Study group | Role | What they receive |
|---|---|---|
| SCS and PNfS | Experimental | Eon or Eon Mini IPG with epidural leads in the spinal column and subcutaneous leads in the peripheral field Receives: Device: SCS and PNfS |
| SCS Alone | Active comparator | Eon or Eon Mini IPG with epidural leads in the spinal column Receives: Device: SCS Alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Evaluation of device or procedure related adverse events
Measured: 6 months
Efficacy
Responder rate in SCS-PNfS vs SCS alone
Measured: 3 months
Secondary outcomes (4)
Quality of Life
Measured: 3 months
Functional Disability
Measured: 3 months
Worst pain
Measured: 3 months
Rescue medication usage
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionFeb 2016
- Study completionFeb 2016
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Failed Back Surgery SyndromeStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Porter McRoberts, MD, Principal investigator, Holy Cross Orthopedic Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01990287
- Sponsor's protocol ID
- C-11-12
- Acronym
- SENSE
- Status last verified
- Apr 2016
- First submitted
- 15 Nov 2013
- Last updated
- 13 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SENSE (Subcutaneous and Epidural Neuromodulation System Evaluation)Study for the Treatment of Chronic Low Back and Leg Pain
- ClinicalTrials.gov ID
- NCT01990287
- Acronym / sponsor ID
- SENSE / C-11-12
- Keywords
- Low Back Pain, Failed Back surgery Syndrome, Post-Laminectomy Syndrome, Spinal Cord Stimulation, Peripheral Nerve field Stimulation, Pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 21 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to demonstrate safety and efficacy of spinal cord stimulation with peripheral nerve field stimulation for the treatment of chronic low back and leg pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SCS and PNfS | Experimental | Device: SCS and PNfSEon or Eon Mini IPG with epidural leads in the spinal column and subcutaneous leads in the peripheral field |
| SCS Alone | Active comparator | Device: SCS AloneEon or Eon Mini IPG with epidural leads in the spinal column |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject is 22 years of age or older
- Subject has chronic low back and leg pain secondary to Failed Back Surgery Syndrome (FBSS)
- Subject has an average score of 6 or higher for average daily overall pain on the Numerical Rating Scale (NRS) based on the 7 day pain diary
- Subject has attempted "best" medical therapy and has tried and failed at least three documented medically supervised treatments (including, but not limited to physical therapy, acupuncture, etc.) and has failed medication treatment from at least two different classes
- Subject's pain-related medication regimen is stable 4 weeks prior to the baseline evaluation
Key exclusion criteria (11 listed)
- Subject currently participating in a clinical investigation that includes an active treatment arm
- Subject has been implanted with a previous neuromodulation system (PNfS, SCS-PNfS or SCS) or participated in a trial for a neuromodulation system
- Subject's overall Beck Depression Inventory II Score is > 24 or has a score of 3 on question 9 relating to suicidal thoughts or wishes at the baseline visit
- Subject with an infusion pump or any implantable neurostimulator device
- Subject has an existing medical condition that is likely to require repetitive MRI evaluation in the future (i.e. epilepsy, stroke, multiple sclerosis, acoustic neuroma, tumor)
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 |
|---|---|---|
| SCS and PNfSAlso: Eon or Eon Mini IPG neurostimulation system with associated componentsSpinal Cord Stimulation (SCS) in combination with Peripheral Nerve Field Stimulation (PNfS). The SCS leads will be placed in the Thoracolumbar region and the PNfS lead will be placed subcutaneously in the area of pain. | Device | SCS and PNfS |
| SCS AloneAlso: Eon or Eon Mini IPG neurostimulation system with associated componentsSpinal Cord Stimulation (SCS) only. The SCS leads will be placed in the Thoracolumbar region only. | Device | SCS Alone |
Primary outcome
Safety
Time frame: 6 months
Evaluation of device or procedure related adverse events
Efficacy
Time frame: 3 months
Responder rate in SCS-PNfS vs SCS alone
4 secondary outcomes
Quality of Life
Time frame: 3 months
Functional Disability
Time frame: 3 months
Worst pain
Time frame: 3 months
Rescue medication usage
Time frame: 3 months
Results and safety
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2016.
Related trials for Failed Back Surgery Syndrome
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Open and Closed Loop DTM SCS in Patients With PSPS Type 2: ENDLESS Study
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Success Rates and Safety of Steroid Injections in Managing Spinal and Sacro-Iliac Pain (CORTisone Injection Spine Study)
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SPINE-RISK VE: Multimodal Predictive Model for Failed Back Surgery Syndrome in Venezuelan Surgical Patients
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Restoring Segmental Lumbar Lordosis After Failed Previous Fusion at the Same Level
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Improvement of Gait by Spinal Stimulation in Patients With Postoperative Chronic Lumbosciatalgia: Pilot Study (GaitStim)
Failed Back Surgery Syndrome
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.
Porter McRoberts, MD principal investigator
Holy Cross Orthopedic Institute
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SCS and PNfS and SCS Alone in people with Failed Back Surgery Syndrome and Post-Laminectomy Syndrome, run by Abbott Medical Devices at 28 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 6 inclusion and 11 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: stopped early, as of the sponsor's last update on 13 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 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?
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
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?
Safety (time frame: 6 months). 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?
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 13 Apr 2016.