Chronic Pain
Conditions
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.
Interventions
DEVICETonic Stimulation
Prodigy Neurostimulation System with associated components
DEVICEBurst Stimulation
Prodigy Neurostimulation System with associated components
Sponsors
Abbott Medical Devices
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Subjects All subjects who were enrolled in the SUNBURST clinical study | 141 |
| Total | 141 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Enrollment to Randomization | Adverse Event | 2 | 0 | 0 |
| Enrollment to Randomization | Insurance/Financial Reasons | 2 | 0 | 0 |
| Enrollment to Randomization | Physician Decision | 10 | 0 | 0 |
| Enrollment to Randomization | Screening Failure | 29 | 0 | 0 |
| Enrollment to Randomization | Temporary Trial Stimulation Failure | 9 | 0 | 0 |
| Enrollment to Randomization | Withdrawal by Subject | 21 | 0 | 0 |
| Period 1 (Randomization to 12 Weeks) | Physician Decision | 0 | 0 | 1 |
| Period 1 (Randomization to 12 Weeks) | Withdrawal by Subject | 0 | 0 | 2 |
| Period 2 (12 Weeks to 24 Weeks) | Physician Decision | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | All Subjects |
|---|---|
| Age, Continuous | 59.1 years STANDARD_DEVIATION 13.5 |
| Sex: Female, Male Female | 85 Participants |
| Sex: Female, Male Male | 56 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 13 / 100 |
| serious Total, serious adverse events | 12 / 173 |
Outcome results
Primary
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
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Burst Stimulation | Visual Analog Scale (VAS) Pain Diary Scores for Average Overall Pain | 43.5 mm | Standard Deviation 25.6 |
| Tonic Stimulation | Visual Analog Scale (VAS) Pain Diary Scores for Average Overall Pain | 48.7 mm | Standard Deviation 23.9 |
p-value: <0.001t-distribution
Secondary
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
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Burst Stimulation | Number of Subjects With Response as Measured by Overall Daily Visual Analog Scale (VAS) | 60 participants |
| Tonic Stimulation | Number of Subjects With Response as Measured by Overall Daily Visual Analog Scale (VAS) | 51 participants |
p-value: 0.083McNemar
Secondary
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
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Burst Stimulation | Percentage of Paresthesia Coverage | 4.5 Percentage of paresthesia areas | Standard Deviation 8.7 |
| Tonic Stimulation | Percentage of Paresthesia Coverage | 22.7 Percentage of paresthesia areas | Standard Deviation 16.3 |
Secondary
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
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Burst Stimulation | Test for Superiority of Overall Daily Visual Analog Scale (VAS) Score With Burst Stimulation | 43.5 mm | Standard Deviation 25.6 |
| Tonic Stimulation | Test for Superiority of Overall Daily Visual Analog Scale (VAS) Score With Burst Stimulation | 48.7 mm | Standard Deviation 23.9 |
p-value: 0.017t-distribution