Chronic PainSUNBURSTNCT02011893
SUNBURST (Success Using Neuromodulation With BURST) Study
A study testing Tonic Stimulation and Burst Stimulation in people with Chronic Pain, run by Abbott Medical Devices at 20 sites in United States.
Trial summary
The purpose of the study is to demonstrate the safety and efficacy of the Prodigy system for the treatment of chronic intractable pain of the trunk and/or limbs. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Tonic Stimulation and Burst Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 173 participants
- Where
- 20 sitesUnited States
- Study dates
- Dec 2013to Jan 2017
- 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 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 intractable pain of the trunk and/or limbs
- Subject has a average score of 60 or higher for average daily overall pain on the Visual Analog Scale (VAS) 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 from activation through the 24 week follow-up visit
Who cannot join
- Subject is currently participating in a clinical investigation that includes an active treatment arm
- Subject has been implanted with a previous neurostimulation system or participated in a trial period for a neurostimulation 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 screening visit
- Subject has an infusion pump or any implantable neurostimulator device
- Subjects with concurrent clinically significant or disabling chronic pain problem that requires additional treatment
- Subject has an existing medical condition that is likely to require repetitive Magnetic Resonance Imaging (MRI) evaluation in the future (i.e. epilepsy, stroke, multiple sclerosis, acoustic neuroma, tumor)
Show all 12Show fewer
- Subject has an existing medical condition that is likely to require the use of diathermy in the future
- Subject's pain originates from 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 urine/blood pregnancy test)
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Albany Medical Center
Albany, New York, 12208
St. Luke's Hospital
Bethlehem, Pennsylvania, 18015
The Neuroscience Center
Biloxi, Mississippi, 39531
The Center for Pain Relief
Charleston, West Virginia, 25301
NeuroSpine Institute
Eugene, Oregon, 97401
Houston Pain Centers
Houston, Texas, 77030
Goodman Campbell Brain and Spine
Indianapolis, Indiana, 46202
Jackson Pain Center
Jackson, Mississippi, 39202
Bronson Neuroscience Center
Kalamazoo, Michigan, 49007
The Montana Center for Wellness & Pain Management
Kalispell, Montana, 25301
Midwest Neurosurgery Associates
Kansas City, Missouri, 64132
Newport Beach Headache and Pain
Mission Viejo, California, 92691
Napa Biomedical Services
Napa, California, 94558
Clinical Trials of South Carolina
North Charleston, South Carolina, 29406
New York Spine & Wellness Center
North Syracuse, New York, 13212
Utah Spine Care
Ogden, Utah, 84403
Oklahoma Pain Physicians
Oklahoma City, Oklahoma, 73120
Comprehensive Pain & Rehabilitation
Pascagoula, Mississippi, 39581
Eisenhower Desert Orthopedic Center
Rancho Mirage, California, 92270
IPM Medical Group
Walnut Creek, California, 94598
About this study
Official title: Success Using Neuromodulation With BURST (SUNBURST™) Study
The purpose of the study is to demonstrate the safety and efficacy of the Prodigy system for the treatment of chronic intractable pain of the trunk and/or limbs.
- Conditions
- Chronic Pain
- Being tested
- Tonic Stimulation, Burst Stimulation
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tonic StimulationDevice
Prodigy Neurostimulation System with associated components
Burst StimulationDevice
Prodigy Neurostimulation System with associated components
| Study group | Role | What they receive |
|---|---|---|
| Burst Stimulation | Experimental | Burst Stimulation using the Prodigy system Receives: Device: Burst Stimulation |
| Tonic Stimulation | Active comparator | Tonic Stimulation using the Prodigy system Receives: Device: Tonic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS) Pain Diary Scores for Average Overall Pain
Differences for average daily overall pain using the Visual Analog Scale (VAS) pain diary between Burst and Tonic Stimulation. Visual Analog Scale (VAS) scores were averaged using a 7 day diary where the subject rates his/her pain on a horizontal line, from 0 mm to 100mm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher level of pain.
Measured: Over 7 days after 3 months of treatment of burst or tonic stimulation
Secondary outcomes (3)
Number of Subjects With Response as Measured by Overall Daily Visual Analog Scale (VAS)
Number of subjects responding to Burst and Tonic Stimulation defined as 30% or greater decrease in overall Visual Analog Scale (VAS) score from baseline. Visual Analog Scale (VAS) scores were averaged using a 7 day diary where the subject rates his/her pain on a horizontal line, 100mm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher level of pain.
Measured: Over 7 days at baseline and after 3 months of treatment of burst or tonic stimulation
Percentage of Paresthesia Coverage
Paresthesia mapping (percentage of paresthesia coverage) analyzed to demonstrate the differences between Burst and Tonic Stimulation. Data is presented as areas of paresthesia reported while utilizing either Burst or Tonic Stimulation as a percentage of the total number of areas possible.
Measured: During in-office visit after 3 months of treatment while utilizing burst or tonic stimulation
Test for Superiority of Overall Daily Visual Analog Scale (VAS) Score With Burst Stimulation
Differences for average daily overall pain using the Visual Analog Scale (VAS) pain diary between Burst and Tonic Stimulation to evaluate for superiority of Burst Stimulation. Differences for average daily overall pain using the Visual Analog Scale (VAS) pain diary between Burst and Tonic Stimulation. Visual Analog Scale (VAS) scores were averaged using a 7 day diary where the subject rates his/her pain on a horizontal line, 100mm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher level of pain.
Measured: Over 7 days after 3 months of treatment of burst or tonic stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionJan 2016
- Study completionJan 2017
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 PainStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Timothy Deer, MD, Study chair, The Center for Pain Relief
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02011893
- Sponsor's protocol ID
- C-12-07
- Acronym
- SUNBURST
- Status last verified
- Jan 2019
- First submitted
- 10 Dec 2013
- Last updated
- 30 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated device
- Yes
Publications
Slavin KV, North RB, Deer TR, Staats P, Davis K, Diaz R. Tonic and burst spinal cord stimulation waveforms for the treatment of chronic, intractable pain: study protocol for a randomized controlled trial. Trials. 2016 Dec 1;17(1):569. doi: 10.1186/s13063-016-1706-5.
PubMed 27906080
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Success Using Neuromodulation With BURST (SUNBURST™) Study
- ClinicalTrials.gov ID
- NCT02011893
- Acronym / sponsor ID
- SUNBURST / C-12-07
- Conditions
- Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 13 Dec 2013 (estimated)
- Results
- Posted 18 May 2017
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 the safety and efficacy of the Prodigy system for the treatment of chronic intractable pain of the trunk and/or limbs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Burst Stimulation | Experimental | Device: Burst StimulationBurst Stimulation using the Prodigy system |
| Tonic Stimulation | Active comparator | Device: Tonic StimulationTonic Stimulation using the Prodigy system |
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 intractable pain of the trunk and/or limbs
- Subject has a average score of 60 or higher for average daily overall pain on the Visual Analog Scale (VAS) 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 (12 listed)
- Subject is currently participating in a clinical investigation that includes an active treatment arm
- Subject has been implanted with a previous neurostimulation system or participated in a trial period for a neurostimulation 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 screening visit
- Subject has an infusion pump or any implantable neurostimulator device
- Subjects with concurrent clinically significant or disabling chronic pain problem that requires additional treatment
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 |
|---|---|---|
| Tonic StimulationProdigy Neurostimulation System with associated components | Device | Tonic Stimulation |
| Burst StimulationProdigy Neurostimulation System with associated components | Device | Burst Stimulation |
Primary outcome
Visual Analog Scale (VAS) Pain Diary Scores for Average Overall Pain
Time frame: Over 7 days after 3 months of treatment of burst or tonic stimulation
Differences for average daily overall pain using the Visual Analog Scale (VAS) pain diary between Burst and Tonic Stimulation. Visual Analog Scale (VAS) scores were averaged using a 7 day diary where the subject rates his/her pain on a horizontal line, from 0 mm to 100mm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher level of pain.
3 secondary outcomes
Number of Subjects With Response as Measured by Overall Daily Visual Analog Scale (VAS)
Time frame: Over 7 days at baseline and after 3 months of treatment of burst or tonic stimulation
Percentage of Paresthesia Coverage
Time frame: During in-office visit after 3 months of treatment while utilizing burst or tonic stimulation
Test for Superiority of Overall Daily Visual Analog Scale (VAS) Score With Burst Stimulation
Time frame: Over 7 days after 3 months of treatment of burst or tonic stimulation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27906080Slavin KV, North RB, Deer TR, Staats P, Davis K, Diaz R. Tonic and burst spinal cord stimulation waveforms for the treatment of chronic, intractable pain: study protocol for a randomized controlled trial. Trials. 2016 Dec 1;17(1):569. doi: 10.1186/s13063-016-1706-5.
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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.
Timothy Deer, MD study chair
The Center for Pain Relief
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tonic Stimulation and Burst Stimulation in people with Chronic Pain, run by Abbott Medical Devices at 20 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 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 30 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 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 18 May 2017). 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?
Visual Analog Scale (VAS) Pain Diary Scores for Average Overall Pain (time frame: Over 7 days after 3 months of treatment of burst or tonic stimulation). 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 NCT02011893, 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 30 Jan 2019.