Clinical trial NCT02011893: SUNBURST (Success Using Neuromodulation With BURST) Study
Official title: Success Using Neuromodulation With BURST (SUNBURST™) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2013-12-13
Enrollment: 173
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)
* 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)

Primary outcomes:
measure: Visual Analog Scale (VAS) Pain Diary Scores for Average Overall Pain
timeFrame: Over 7 days after 3 months of treatment of burst or tonic stimulation
Secondary outcomes:
measure: Number of Subjects With Response as Measured by Overall Daily Visual Analog Scale (VAS)
timeFrame: Over 7 days at baseline and after 3 months of treatment of burst or tonic stimulation
measure: Percentage of Paresthesia Coverage
timeFrame: During in-office visit after 3 months of treatment while utilizing burst or tonic stimulation
measure: Test for Superiority of Overall Daily Visual Analog Scale (VAS) Score With Burst Stimulation
timeFrame: Over 7 days after 3 months of treatment of burst or tonic stimulation
Other outcomes:
Locations:
city: Mission Viejo
country: United States
facility: Newport Beach Headache and Pain
state: California
city: Napa
country: United States
facility: Napa Biomedical Services
state: California
city: Rancho Mirage
country: United States
facility: Eisenhower Desert Orthopedic Center
state: California
city: Walnut Creek
country: United States
facility: IPM Medical Group
state: California
city: Indianapolis
country: United States
facility: Goodman Campbell Brain and Spine
state: Indiana
city: Kalamazoo
country: United States
facility: Bronson Neuroscience Center
state: Michigan
city: Biloxi
country: United States
facility: The Neuroscience Center
state: Mississippi
city: Jackson
country: United States
facility: Jackson Pain Center
state: Mississippi
city: Pascagoula
country: United States
facility: Comprehensive Pain & Rehabilitation
state: Mississippi
city: Kansas City
country: United States
facility: Midwest Neurosurgery Associates
state: Missouri
city: Kalispell
country: United States
facility: The Montana Center for Wellness & Pain Management
state: Montana
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: North Syracuse
country: United States
facility: New York Spine & Wellness Center
state: New York
city: Oklahoma City
country: United States
facility: Oklahoma Pain Physicians
state: Oklahoma
city: Eugene
country: United States
facility: NeuroSpine Institute
state: Oregon
city: Bethlehem
country: United States
facility: St. Luke's Hospital
state: Pennsylvania
city: North Charleston
country: United States
facility: Clinical Trials of South Carolina
state: South Carolina
city: Houston
country: United States
facility: Houston Pain Centers
state: Texas
city: Ogden
country: United States
facility: Utah Spine Care
state: Utah
city: Charleston
country: United States
facility: The Center for Pain Relief
state: West Virginia
Study officials:
affiliation: The Center for Pain Relief
name: Timothy Deer, MD
role: STUDY_CHAIR
References:
citation: 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.