SUNBURST (Success Using Neuromodulation With BURST) Study (SUNBURST)
Primary Purpose
Chronic Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tonic Stimulation
Burst Stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain
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)
Sites / Locations
- Newport Beach Headache and Pain
- Napa Biomedical Services
- Eisenhower Desert Orthopedic Center
- IPM Medical Group
- Goodman Campbell Brain and Spine
- Bronson Neuroscience Center
- The Neuroscience Center
- Jackson Pain Center
- Comprehensive Pain & Rehabilitation
- Midwest Neurosurgery Associates
- The Montana Center for Wellness & Pain Management
- Albany Medical Center
- New York Spine & Wellness Center
- Oklahoma Pain Physicians
- NeuroSpine Institute
- St. Luke's Hospital
- Clinical Trials of South Carolina
- Houston Pain Centers
- Utah Spine Care
- The Center for Pain Relief
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Burst Stimulation
Tonic Stimulation
Arm Description
Burst Stimulation using the Prodigy system
Tonic Stimulation using the Prodigy system
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT02011893
First Posted
December 10, 2013
Last Updated
January 28, 2019
Sponsor
Abbott Medical Devices
1. Study Identification
Unique Protocol Identification Number
NCT02011893
Brief Title
SUNBURST (Success Using Neuromodulation With BURST) Study
Acronym
SUNBURST
Official Title
Success Using Neuromodulation With BURST (SUNBURST™) Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices
4. Oversight
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
173 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Burst Stimulation
Arm Type
Experimental
Arm Description
Burst Stimulation using the Prodigy system
Arm Title
Tonic Stimulation
Arm Type
Active Comparator
Arm Description
Tonic Stimulation using the Prodigy system
Intervention Type
Device
Intervention Name(s)
Tonic Stimulation
Intervention Description
Prodigy Neurostimulation System with associated components
Intervention Type
Device
Intervention Name(s)
Burst Stimulation
Intervention Description
Prodigy Neurostimulation System with associated components
Primary Outcome Measure Information:
Title
Visual Analog Scale (VAS) Pain Diary Scores for Average Overall Pain
Description
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.
Time Frame
Over 7 days after 3 months of treatment of burst or tonic stimulation
Secondary Outcome Measure Information:
Title
Number of Subjects With Response as Measured by Overall Daily Visual Analog Scale (VAS)
Description
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.
Time Frame
Over 7 days at baseline and after 3 months of treatment of burst or tonic stimulation
Title
Percentage of Paresthesia Coverage
Description
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.
Time Frame
During in-office visit after 3 months of treatment while utilizing burst or tonic stimulation
Title
Test for Superiority of Overall Daily Visual Analog Scale (VAS) Score With Burst Stimulation
Description
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.
Time Frame
Over 7 days after 3 months of treatment of burst or tonic stimulation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy Deer, MD
Organizational Affiliation
The Center for Pain Relief
Official's Role
Study Chair
Facility Information:
Facility Name
Newport Beach Headache and Pain
City
Mission Viejo
State/Province
California
ZIP/Postal Code
92691
Country
United States
Facility Name
Napa Biomedical Services
City
Napa
State/Province
California
ZIP/Postal Code
94558
Country
United States
Facility Name
Eisenhower Desert Orthopedic Center
City
Rancho Mirage
State/Province
California
ZIP/Postal Code
92270
Country
United States
Facility Name
IPM Medical Group
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Goodman Campbell Brain and Spine
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Bronson Neuroscience Center
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007
Country
United States
Facility Name
The Neuroscience Center
City
Biloxi
State/Province
Mississippi
ZIP/Postal Code
39531
Country
United States
Facility Name
Jackson Pain Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
Facility Name
Comprehensive Pain & Rehabilitation
City
Pascagoula
State/Province
Mississippi
ZIP/Postal Code
39581
Country
United States
Facility Name
Midwest Neurosurgery Associates
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States
Facility Name
The Montana Center for Wellness & Pain Management
City
Kalispell
State/Province
Montana
ZIP/Postal Code
25301
Country
United States
Facility Name
Albany Medical Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
New York Spine & Wellness Center
City
North Syracuse
State/Province
New York
ZIP/Postal Code
13212
Country
United States
Facility Name
Oklahoma Pain Physicians
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
NeuroSpine Institute
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
St. Luke's Hospital
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
Clinical Trials of South Carolina
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Houston Pain Centers
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Utah Spine Care
City
Ogden
State/Province
Utah
ZIP/Postal Code
84403
Country
United States
Facility Name
The Center for Pain Relief
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25301
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
27906080
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.
Results Reference
derived
Learn more about this trial
SUNBURST (Success Using Neuromodulation With BURST) Study
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