N/A
Completed N=173
SUNBURST (Success Using Neuromodulation With BURST) Study
Source: ClinicalTrials.gov NCT02011893 ↗Enrolled (actual)
173
Serious AEs
6.9%
Results posted
May 2017
Primary outcomePrimary: Visual Analog Scale (VAS) Pain Diary Scores for Average Overall Pain — 43.5; 48.7 mm — p=<0.001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Analog Scale (VAS) Pain Diary Scores for Average Overall Pain |
43.5; 48.7 | <0.001 sig |
| SECONDARY Number of Subjects With Response as Measured by Overall Daily Visual Analog Scale (VAS) |
60; 51 | 0.083 |
| SECONDARY Percentage of Paresthesia Coverage |
4.5; 22.7 | — |
| SECONDARY Test for Superiority of Overall Daily Visual Analog Scale (VAS) Score With Burst Stimulation |
43.5; 48.7 | 0.017 sig |
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)
Data sourced from ClinicalTrials.gov (NCT02011893). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.