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CompletedNCT02011893SUNBURSTUpdated Jan 30, 2019Results posted

SUNBURST (Success Using Neuromodulation With BURST) Study

An interventional study of Tonic Stimulation and Burst Stimulation in Chronic Pain, sponsored by Abbott Medical Devices. Completed at 20 sites in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2019-01-30.

Sponsored by Abbott Medical Devices · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
173
Allocation
Randomized
Ages
22 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Pain

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03

In context

Chronic Pain

2,930 studies on the registry are indexed under Chronic Pain; 701 are open to participants now.

This study's enrollment of 173 is above the median of 60 across 2,161 interventional studies indexed under Chronic Pain.

Browse Chronic Pain studies →

Lead sponsor

Abbott Medical Devices is the lead sponsor of 525 studies on the registry; 35 are open to participants now.

Of its 52 completed or terminated interventional studies of FDA-regulated products, 43 (83%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
173 participants (actual)

Study arms

  • Experimental
    Burst Stimulation

    Burst Stimulation using the Prodigy system

    Device: Burst Stimulation

  • Active comparator
    Tonic Stimulation

    Tonic Stimulation using the Prodigy system

    Device: Tonic Stimulation

Interventions

  • DeviceTonic Stimulation

    Prodigy Neurostimulation System with associated components

  • DeviceBurst Stimulation

    Prodigy Neurostimulation System with associated components

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Over 7 days after 3 months of treatment of burst or tonic stimulation

Secondary outcomes

  1. 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.

    Time frame: Over 7 days at baseline and after 3 months of treatment of burst or tonic stimulation

  2. 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.

    Time frame: During in-office visit after 3 months of treatment while utilizing burst or tonic stimulation

  3. 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.

    Time frame: Over 7 days after 3 months of treatment of burst or tonic stimulation

07

Results

Posted May 18, 2017

Participant flow

Enrollment to Randomization
Participant flow — Enrollment to Randomization
MilestoneEnrolledArm 1Arm 2
Started17300
Baseline14100
Trial stimulation implant12100
Permanent stimulation implant10100
Randomization10000
Completed10000
Not completed7300
Withdrew: Adverse event200
Withdrew: Physician decision1000
Withdrew: Withdrawal by subject2100
Withdrew: Screening failure2900
Withdrew: Temporary trial stimulation failure900
Withdrew: Insurance/financial reasons200
Period 1 (Randomization to 12 Weeks)
Participant flow — Period 1 (Randomization to 12 Weeks)
MilestoneEnrolledArm 1Arm 2
Started04555
6 week follow-up04552
12 week follow-up04552
Completed04552
Not completed003
Withdrew: Physician decision001
Withdrew: Withdrawal by subject002
Period 2 (12 Weeks to 24 Weeks)
Participant flow — Period 2 (12 Weeks to 24 Weeks)
MilestoneEnrolledArm 1Arm 2
Started04552
18 week follow-up04451
24 week follow-up04551
Completed04551
Not completed001
Withdrew: Physician decision001

Outcome measures

PrimaryVisual 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.

Time frame:
Over 7 days after 3 months of treatment of burst or tonic stimulation
Reported as:
Mean · mm
Visual Analog Scale (VAS) Pain Diary Scores for Average Overall Pain
mmBurst StimulationTonic Stimulation
Visual Analog Scale (VAS) Pain Diary Scores for Average Overall Pain43.5 ± 25.648.7 ± 23.9
Statistical analysis
  • Burst Stimulation vs Tonic Stimulation · t-distribution · p = <0.00195% UCB and p-value for non-inferiority are based on t-distribution with n1 + n2-2 degrees of freedom where n1 and n2 are number of subjects per arm.
SecondaryNumber 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.

Time frame:
Over 7 days at baseline and after 3 months of treatment of burst or tonic stimulation
Reported as:
Number · participants
Number of Subjects With Response as Measured by Overall Daily Visual Analog Scale (VAS)
participantsBurst StimulationTonic Stimulation
Number of Subjects With Response as Measured by Overall Daily Visual Analog Scale (VAS)6051
Statistical analysis
  • Burst Stimulation vs Tonic Stimulation · McNemar · p = 0.083 (Superiority analysis performed)
SecondaryPercentage 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.

Time frame:
During in-office visit after 3 months of treatment while utilizing burst or tonic stimulation
Reported as:
Mean · Percentage of paresthesia areas
Percentage of Paresthesia Coverage
Percentage of paresthesia areasBurst StimulationTonic Stimulation
Percentage of Paresthesia Coverage4.5 ± 8.722.7 ± 16.3
SecondaryTest 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.

Time frame:
Over 7 days after 3 months of treatment of burst or tonic stimulation
Reported as:
Mean · mm
Test for Superiority of Overall Daily Visual Analog Scale (VAS) Score With Burst Stimulation
mmBurst StimulationTonic Stimulation
Test for Superiority of Overall Daily Visual Analog Scale (VAS) Score With Burst Stimulation43.5 ± 25.648.7 ± 23.9
Statistical analysis
  • Burst Stimulation vs Tonic Stimulation · t-distribution · p = 0.017 (Superiority analysis performed)95% UCB and p-value for superiority are based on t-distribution with n1 + n2-2 degrees of freedom where n1 and n2 are number of subjects per arm.

Adverse events

Collected over following enrollment through 6 months of treatment. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
All Subjects—12/173 (6.9%)13/100 (13%)
Most frequent serious events
Showing 10 of 16
Most frequent serious events
EventAll Subjects
Cancerous tumor on vocal chordsNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/100
InfectionInfections and infestations1/100
Loss of speech and memory, and headacheNervous system disorders1/100
Scheduled right total knee arthroplastySurgical and medical procedures1/100
Shortness of breathCardiac disorders1/100
SomnolenceGeneral disorders1/100
Temporary paralysisNervous system disorders1/100
Withdrawal symptoms from tapering off oxymorphoneGeneral disorders1/100
Persistent pain and/or numbnessInjury, poisoning and procedural complications1/173
Unsuccessful lead placementInjury, poisoning and procedural complications1/173
Most frequent other events
Most frequent other events
EventAll Subjects
Persistent pain and/or numbnessGeneral disorders8/100
Diminished or loss of symptom relief (Tonic Stimulation)General disorders6/97
Diminished or loss of symptom relief (Burst Stimulation)General disorders5/100

Baseline characteristics

Age, Continuous
Age, Continuous(years)All Subjects
Mean59.1 ± 13.5
Sex: Female, Male
Sex: Female, Male(Participants)All Subjects
Female85
Male56
08

Study locations

20 sites
  • Newport Beach Headache and Pain
    Mission Viejo, California 92691, United States
  • Napa Biomedical Services
    Napa, California 94558, United States
  • Eisenhower Desert Orthopedic Center
    Rancho Mirage, California 92270, United States
  • IPM Medical Group
    Walnut Creek, California 94598, United States
  • Goodman Campbell Brain and Spine
    Indianapolis, Indiana 46202, United States
  • Bronson Neuroscience Center
    Kalamazoo, Michigan 49007, United States
  • The Neuroscience Center
    Biloxi, Mississippi 39531, United States
  • Jackson Pain Center
    Jackson, Mississippi 39202, United States
  • Comprehensive Pain & Rehabilitation
    Pascagoula, Mississippi 39581, United States
  • Midwest Neurosurgery Associates
    Kansas City, Missouri 64132, United States
  • The Montana Center for Wellness & Pain Management
    Kalispell, Montana 25301, United States
  • Albany Medical Center
    Albany, New York 12208, United States
  • New York Spine & Wellness Center
    North Syracuse, New York 13212, United States
  • Oklahoma Pain Physicians
    Oklahoma City, Oklahoma 73120, United States
  • NeuroSpine Institute
    Eugene, Oregon 97401, United States
  • St. Luke's Hospital
    Bethlehem, Pennsylvania 18015, United States
  • Clinical Trials of South Carolina
    North Charleston, South Carolina 29406, United States
  • Houston Pain Centers
    Houston, Texas 77030, United States
  • Utah Spine Care
    Ogden, Utah 84403, United States
  • The Center for Pain Relief
    Charleston, West Virginia 25301, United States
09

References and documents

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 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 30, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02011893
Lead sponsor
Abbott Medical Devices
Responsible party
Sponsor
First posted
Dec 13, 2013
Start date
Dec 2013
Primary completion
Jan 2016
Completion
Jan 2017
Results posted
May 18, 2017
Last update
Jan 30, 2019

Study contacts

Timothy Deer, MD
study chair · The Center for Pain Relief

Oversight

Data monitoring committee
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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