SUNBURST (Success Using Neuromodulation With BURST) Study
- Conditions
- Chronic Pain
- Interventions
- Device: Burst StimulationDevice: Tonic Stimulation
- Registration Number
- NCT02011893
- Lead Sponsor
- Abbott Medical Devices
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 173
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Burst Stimulation Burst Stimulation Burst Stimulation using the Prodigy system Tonic Stimulation Tonic Stimulation Tonic Stimulation using the Prodigy system
- Primary Outcome Measures
Name Time Method Visual Analog Scale (VAS) Pain Diary Scores for Average Overall Pain 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.
- Secondary Outcome Measures
Name Time Method Percentage of Paresthesia Coverage During in-office visit after 3 months of treatment while utilizing burst or tonic stimulation 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.
Number of Subjects With Response as Measured by Overall Daily Visual Analog Scale (VAS) Over 7 days at baseline and after 3 months of treatment of burst or tonic stimulation 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.
Test for Superiority of Overall Daily Visual Analog Scale (VAS) Score With Burst Stimulation 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 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.
Trial Locations
- Locations (20)
Eisenhower Desert Orthopedic Center
🇺🇸Rancho Mirage, California, United States
Jackson Pain Center
🇺🇸Jackson, Mississippi, United States
Utah Spine Care
🇺🇸Ogden, Utah, United States
The Center for Pain Relief
🇺🇸Charleston, West Virginia, United States
Houston Pain Centers
🇺🇸Houston, Texas, United States
Goodman Campbell Brain and Spine
🇺🇸Indianapolis, Indiana, United States
Oklahoma Pain Physicians
🇺🇸Oklahoma City, Oklahoma, United States
Napa Biomedical Services
🇺🇸Napa, California, United States
Newport Beach Headache and Pain
🇺🇸Mission Viejo, California, United States
IPM Medical Group
🇺🇸Walnut Creek, California, United States
The Neuroscience Center
🇺🇸Biloxi, Mississippi, United States
The Montana Center for Wellness & Pain Management
🇺🇸Kalispell, Montana, United States
Bronson Neuroscience Center
🇺🇸Kalamazoo, Michigan, United States
Midwest Neurosurgery Associates
🇺🇸Kansas City, Missouri, United States
Comprehensive Pain & Rehabilitation
🇺🇸Pascagoula, Mississippi, United States
Albany Medical Center
🇺🇸Albany, New York, United States
NeuroSpine Institute
🇺🇸Eugene, Oregon, United States
New York Spine & Wellness Center
🇺🇸North Syracuse, New York, United States
St. Luke's Hospital
🇺🇸Bethlehem, Pennsylvania, United States
Clinical Trials of South Carolina
🇺🇸North Charleston, South Carolina, United States