SUNBURST (Success Using Neuromodulation With BURST) Study

• Sponsor: Abbott Medical Devices (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02011893
• Collaborator: (none)
• Enrollment: 173
• Locations: 20
• Arms: 2
• Duration (Months): 37
• Patients Per Site: 8.7
• Patients Per Site Per Month: 0.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Pain	Device: Tonic Stimulation; Device: Burst Stimulation	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 173 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Success Using Neuromodulation With BURST (SUNBURST™) Study
• Study Start Date: Dec 1, 2013
• Actual Primary Completion Date: Jan 1, 2016
• Actual Study Completion Date: Jan 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Burst Stimulation Burst Stimulation using the Prodigy system	Device: Burst Stimulation; Prodigy Neurostimulation System with associated components
Active Comparator: Tonic Stimulation Tonic Stimulation using the Prodigy system	Device: Tonic Stimulation; Prodigy Neurostimulation System with associated components

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. 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.

3. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years and Older
• Sexes Eligible for Study: 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:

• 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Newport Beach Headache and Pain	Mission Viejo	California	United States	92691
2	Napa Biomedical Services	Napa	California	United States	94558
3	Eisenhower Desert Orthopedic Center	Rancho Mirage	California	United States	92270
4	IPM Medical Group	Walnut Creek	California	United States	94598
5	Goodman Campbell Brain and Spine	Indianapolis	Indiana	United States	46202
6	Bronson Neuroscience Center	Kalamazoo	Michigan	United States	49007
7	The Neuroscience Center	Biloxi	Mississippi	United States	39531
8	Jackson Pain Center	Jackson	Mississippi	United States	39202
9	Comprehensive Pain & Rehabilitation	Pascagoula	Mississippi	United States	39581
10	Midwest Neurosurgery Associates	Kansas City	Missouri	United States	64132
11	The Montana Center for Wellness & Pain Management	Kalispell	Montana	United States	25301
12	Albany Medical Center	Albany	New York	United States	12208
13	New York Spine & Wellness Center	North Syracuse	New York	United States	13212
14	Oklahoma Pain Physicians	Oklahoma City	Oklahoma	United States	73120
15	NeuroSpine Institute	Eugene	Oregon	United States	97401
16	St. Luke's Hospital	Bethlehem	Pennsylvania	United States	18015
17	Clinical Trials of South Carolina	North Charleston	South Carolina	United States	29406
18	Houston Pain Centers	Houston	Texas	United States	77030
19	Utah Spine Care	Ogden	Utah	United States	84403
20	The Center for Pain Relief	Charleston	West Virginia	United States	25301

Sponsors and Collaborators

• Abbott Medical Devices

Investigators

• Study Chair: Timothy Deer, MD, The Center for Pain Relief

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT02011893
• Other Study ID Numbers: C-12-07
• First Posted: Dec 13, 2013
• Last Update Posted: Jan 30, 2019
• Last Verified: Jan 1, 2019

• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Chronic Pain

Study Results

Participant Flow

Arm/Group Title	Enrolled	Arm 1	Arm 2
Arm/Group Description	All subjects enrolled through device activation/randomization	Tonic stimulation first, then Burst	Burst stimulation first, then Tonic
Period Title: Enrollment to Randomization
STARTED	173	0	0
Baseline	141	0	0
Trial Stimulation Implant	121	0	0
Permanent Stimulation Implant	101	0	0
Randomization	100	0	0
COMPLETED	100	0	0
NOT COMPLETED	73	0	0
Period Title: Enrollment to Randomization
STARTED	0	45	55
6 Week Follow-up	0	45	52
12 Week Follow-up	0	45	52
COMPLETED	0	45	52
NOT COMPLETED	0	0	3
Period Title: Enrollment to Randomization
STARTED	0	45	52
18 Week Follow-up	0	44	51
24 Week Follow-up	0	45	51
COMPLETED	0	45	51
NOT COMPLETED	0	0	1

Baseline Characteristics

Arm/Group Title	All Subjects
Arm/Group Description	All subjects who were enrolled in the SUNBURST clinical study
Overall Participants	141
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	59.1 (13.5)
Sex: Female, Male (Count of Participants)
Female	85 60.3%
Male	56 39.7%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

All subjects randomized were analyzed for this outcome measure. Statistical measures were used to impute Visual Analog Scale (VAS) scores according the study Statistical Analysis Plan (SAP) if data was not available.

Arm/Group Title	Burst Stimulation	Tonic Stimulation
Arm/Group Description	Burst Stimulation using the Prodigy system Burst Stimulation: Prodigy Neurostimulation System with associated components	Tonic Stimulation using the Prodigy system Tonic Stimulation: Prodigy Neurostimulation System with associated components
Measure Participants	100	100
Mean (Standard Deviation) [mm]	43.5 (25.6)	48.7 (23.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Burst Stimulation, Tonic Stimulation
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority margin is 7.5 points, where the Visual Analog Scale (VAS) scores were measured on a scale of 0 to 100. Testing was carried out at a 5% significance level.
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	t-distribution
	Comments	95% 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.

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All subjects randomized were analyzed for this outcome measure. Statistical measures were used to impute Visual Analog Scale (VAS) scores according the study Statistical Analysis Plan (SAP) if data was not available.

Arm/Group Title	Burst Stimulation	Tonic Stimulation
Arm/Group Description	Burst Stimulation using the Prodigy system Burst Stimulation: Prodigy Neurostimulation System with associated components	Tonic Stimulation using the Prodigy system Tonic Stimulation: Prodigy Neurostimulation System with associated components
Measure Participants	100	100
Number [participants]	60 42.6%	51 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Burst Stimulation, Tonic Stimulation
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.083
	Comments	Superiority analysis performed
	Method	McNemar
	Comments

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

There were 73 subjects in whom paresthesia coverage data at both the 12 and 24 week visits were available and included in the analysis. The remaining 23 subjects were excluded due to questionnaire completion errors at the time of data collection.

Arm/Group Title	Burst Stimulation	Tonic Stimulation
Arm/Group Description	Burst Stimulation using the Prodigy system Burst Stimulation: Prodigy Neurostimulation System with associated components	Tonic Stimulation using the Prodigy system Tonic Stimulation: Prodigy Neurostimulation System with associated components
Measure Participants	73	73
Mean (Standard Deviation) [Percentage of paresthesia areas]	4.5 (8.7)	22.7 (16.3)

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All subjects randomized were analyzed for this outcome measure. Statistical measures were used to impute Visual Analog Scale (VAS) scores according the study Statistical Analysis Plan (SAP) if data was not available.

Arm/Group Title	Burst Stimulation	Tonic Stimulation
Arm/Group Description	Burst Stimulation using the Prodigy system Burst Stimulation: Prodigy Neurostimulation System with associated components	Tonic Stimulation using the Prodigy system Tonic Stimulation: Prodigy Neurostimulation System with associated components
Measure Participants	100	100
Mean (Standard Deviation) [mm]	43.5 (25.6)	48.7 (23.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Burst Stimulation, Tonic Stimulation
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.017
	Comments	Superiority analysis performed
	Method	t-distribution
	Comments	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

Time Frame	following enrollment through 6 months of treatment
Adverse Event Reporting Description	Subjects at risk (denominators for risk %) are defined as follows: enrollment to device activation (randomization) is 173, device activation (randomization) to 24 weeks is 100. The only events identified as device (stimulation) related are reported per intervention, by therapy (Burst and Tonic Stimulation). The subjects at risk (denominators for risk %) for are defined as follows: subjects active through 12 weeks (100) or subjects active through 24 weeks (97).
Arm/Group Title	All Subjects
Arm/Group Description	All subjects who were enrolled in the SUNBURST clinical study
All Cause Mortality
	All Subjects
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	All Subjects
	Affected / at Risk (%)	# Events
Total	12/173 (6.9%)
Cardiac disorders
Shortness of breath	1/100 (1%)	1
Gastrointestinal disorders
Bowel obstruction	1/173 (0.6%)	1
General disorders
Low Potassium Levels	1/173 (0.6%)	1
Somnolence	1/100 (1%)	1
Withdrawal symptoms from tapering off oxymorphone	1/100 (1%)	1
Hepatobiliary disorders
Abdominal pain	1/173 (0.6%)	1
Infections and infestations
Infection	1/100 (1%)	1
Injury, poisoning and procedural complications
Persistent pain and/or numbness	1/173 (0.6%)	1
Unsuccessful lead placement	1/173 (0.6%)	1
Femur fracture	1/173 (0.6%)	1
Persistent pain and/or numbness	1/173 (0.6%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancerous tumor on vocal chords	1/100 (1%)	1
Nervous system disorders
Loss of speech and memory, and headache	1/100 (1%)	1
Temporary paralysis	1/100 (1%)	1
Surgical and medical procedures
Hip pain/hip replacement	1/173 (0.6%)	1
Scheduled right total knee arthroplasty	1/100 (1%)	1
Other (Not Including Serious) Adverse Events
	All Subjects
	Affected / at Risk (%)	# Events
Total	13/100 (13%)
General disorders
Diminished or loss of symptom relief (Burst Stimulation)	5/100 (5%)	5
Diminished or loss of symptom relief (Tonic Stimulation)	6/97 (6.2%)	8
Persistent pain and/or numbness	8/100 (8%)	8

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.