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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Burst Stimulation | Experimental | Burst Stimulation using the Prodigy system |
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| Tonic Stimulation | Active Comparator | Tonic Stimulation using the Prodigy system |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tonic Stimulation | Device | Prodigy Neurostimulation System with associated components |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Over 7 days after 3 months of treatment of burst or tonic stimulation |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Timothy Deer, MD | The Center for Pain Relief | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Newport Beach Headache and Pain | Mission Viejo | California | 92691 | United States | ||
| Napa Biomedical Services |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27906080 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Enrolled | All subjects enrolled through device activation/randomization |
| FG001 | Arm 1 | Tonic stimulation first, then Burst |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Enrollment to Randomization |
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| Burst Stimulation |
| Device |
Prodigy Neurostimulation System with associated components |
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| Over 7 days at baseline and after 3 months of treatment of burst or tonic stimulation |
| 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. | During in-office visit after 3 months of treatment while utilizing burst or tonic stimulation |
| 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. | Over 7 days after 3 months of treatment of burst or tonic stimulation |
| 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 |
| FG002 | Arm 2 | Burst stimulation first, then Tonic |
| Baseline |
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| Trial Stimulation Implant |
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| Permanent Stimulation Implant |
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| Randomization |
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| COMPLETED |
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| NOT COMPLETED |
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| Period 1 (Randomization to 12 Weeks) |
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| Period 2 (12 Weeks to 24 Weeks) |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects | All subjects who were enrolled in the SUNBURST clinical study |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| 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. | 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. | Posted | Mean | Standard Deviation | mm | Over 7 days after 3 months of treatment of burst or tonic stimulation |
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| 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. | 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. | Posted | Number | participants | Over 7 days at baseline and after 3 months of treatment of burst or tonic stimulation |
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| 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. | 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. | Posted | Mean | Standard Deviation | Percentage of paresthesia areas | During in-office visit after 3 months of treatment while utilizing burst or tonic stimulation |
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| 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. | 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. | Posted | Mean | Standard Deviation | mm | Over 7 days after 3 months of treatment of burst or tonic stimulation |
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following enrollment through 6 months of treatment
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).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Subjects | All subjects who were enrolled in the SUNBURST clinical study | 12 | 173 | 13 | 100 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Persistent pain and/or numbness | Injury, poisoning and procedural complications | Categorized as Procedure-Related |
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| Unsuccessful lead placement | Injury, poisoning and procedural complications | Categorized as Procedure-Related |
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| Abdominal pain | Hepatobiliary disorders | Categorized as neither Device- nor Procedure-Related |
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| Bowel obstruction | Gastrointestinal disorders | Categorized as neither Device- nor Procedure-Related |
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| Femur fracture | Injury, poisoning and procedural complications | Categorized as neither Device- nor Procedure-Related |
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| Hip pain/hip replacement | Surgical and medical procedures | Categorized as neither Device- nor Procedure-Related |
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| Low Potassium Levels | General disorders | Categorized as neither Device- nor Procedure-Related |
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| Persistent pain and/or numbness | Injury, poisoning and procedural complications | Categorized as neither Device- nor Procedure-Related |
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| Cancerous tumor on vocal chords | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Categorized as neither Device- nor Procedure-Related |
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| Infection | Infections and infestations | Categorized as neither Device- nor Procedure-Related |
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| Loss of speech and memory, and headache | Nervous system disorders | Categorized as neither Device- nor Procedure-Related |
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| Scheduled right total knee arthroplasty | Surgical and medical procedures | Categorized as neither Device- nor Procedure-Related |
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| Shortness of breath | Cardiac disorders | Categorized as neither Device- nor Procedure-Related |
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| Somnolence | General disorders | Categorized as neither Device- nor Procedure-Related |
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| Temporary paralysis | Nervous system disorders | Categorized as neither Device- nor Procedure-Related |
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| Withdrawal symptoms from tapering off oxymorphone | General disorders | Categorized as neither Device- nor Procedure-Related |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diminished or loss of symptom relief (Burst Stimulation) | General disorders | Categorized as Device-Related |
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| Diminished or loss of symptom relief (Tonic Stimulation) | General disorders | Categorized as Device-Related |
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| Persistent pain and/or numbness | General disorders | Categorized as neither Device- nor Procedure-Related |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roni Diaz, Director Clinical Studies | St. Jude Medical | 972-309-8601 | RDiaz@sjm.com |
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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