SUNBURST (Success Using Neuromodulation With BURST) Study

Not Applicable

Completed

Conditions: Chronic Pain

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

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

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): Newport Beach Headache and Pain
🇺🇸
Mission Viejo, California, United States
Napa Biomedical Services
🇺🇸
Napa, California, United States
Eisenhower Desert Orthopedic Center
🇺🇸
Rancho Mirage, California, United States
IPM Medical Group
🇺🇸
Walnut Creek, California, United States
Goodman Campbell Brain and Spine
🇺🇸
Indianapolis, Indiana, United States
Bronson Neuroscience Center
🇺🇸
Kalamazoo, Michigan, United States
The Neuroscience Center
🇺🇸
Biloxi, Mississippi, United States
Jackson Pain Center
🇺🇸
Jackson, Mississippi, United States
Comprehensive Pain & Rehabilitation
🇺🇸
Pascagoula, Mississippi, United States
Midwest Neurosurgery Associates
🇺🇸
Kansas City, Missouri, United States
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Newport Beach Headache and Pain
🇺🇸Mission Viejo, California, United States