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In >9 months only 1 patient enrolled. Study stopped because design was too cumbersome and subjects not willing to participate
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The purpose of this study is to investigate the effects of varying programming parameters in subthreshold spinal cord stimulation therapy for pain relief.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham Stimulation | Placebo Comparator | Sham subthreshold spinal cord stimulation therapy |
|
| Treatment 1 | Active Comparator | subthreshold spinal cord stimulation therapy |
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| Treatment 2 | Experimental | subthreshold spinal cord stimulation therapy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Boston Scientific Precision Plus spinal cord stimulation therapy | Device | Epidural spinal cord stimulation (SCS) using the Boston Scientific Precision Plus SCS system |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Relief | Mean within-patient difference in average back pain intensity among treatment groups | 4,8,and 12 days post temporary lead(s) implantation |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Relief Responder Rate | Difference in the proportion of subjects with ≥50% reduction in average back pain intensity among treatment groups | 4,8,and 12 days post temporary lead(s) implantation |
| Leg Pain Reduction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kay Adair | Boston Scientific Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hunter Pain Clinic | Newcastle | New South Wales | 2292 | Australia |
1 subject was enrolled in this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Randomized | Eligible patients who were randomized in a 1:1:1:1:1:1 ratio to one of the six sequences of three treatment groups (sham stimulation, subthreshold spinal cord stimulation therapy 1, and subthreshold spinal cord stimulation therapy 2). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention, 4 - 5 Days |
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| Second Intervention, 4 - 5 Days |
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| Third Intervention, 4 - 5 Days |
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| ID | Title | Description |
|---|---|---|
| BG000 | Randomized | Eligible patients who were randomized in a 1:1:1:1:1:1 ratio to one of the six sequences of three treatment groups (sham stimulation, subthreshold spinal cord stimulation therapy 1, and subthreshold spinal cord stimulation therapy 2). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pain Relief | Mean within-patient difference in average back pain intensity among treatment groups | No study data are available. | Posted | 4,8,and 12 days post temporary lead(s) implantation |
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|
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No study data are available
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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 | Randomized | Eligible patients who were randomized in a 1:1:1:1:1:1 ratio to one of the six sequences of three treatment groups (sham stimulation, subthreshold spinal cord stimulation therapy 1, and subthreshold spinal cord stimulation therapy 2). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Research Sciences | Boston Scientific | 6619494350 | roshini.jain@bsci.com |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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Mean within-patient difference in average leg pain intensity among treatment groups
| 4,8,and 12 days post temporary lead(s) implantation |
| Disability | Mean within-patient difference in disability among treatment groups | 4,8,and 12 days post temporary lead(s) implantation |
| Percent Pain Relief | Mean within-patient difference in overall percent pain relief among treatment groups | 4,8,and 12 days post temporary lead(s) implantation |
| Quality of Life, as Measured by EQ-5D-5L | Mean within-patient difference in quality of life among treatment groups | 4,8,and 12 days post temporary lead(s) implantation |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Secondary | Pain Relief Responder Rate | Difference in the proportion of subjects with ≥50% reduction in average back pain intensity among treatment groups | No study data are available. | Posted | 4,8,and 12 days post temporary lead(s) implantation |
|
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| Secondary | Leg Pain Reduction | Mean within-patient difference in average leg pain intensity among treatment groups | No study data are available. | Posted | 4,8,and 12 days post temporary lead(s) implantation |
|
|
| Secondary | Disability | Mean within-patient difference in disability among treatment groups | No study data are available. | Posted | 4,8,and 12 days post temporary lead(s) implantation |
|
|
| Secondary | Percent Pain Relief | Mean within-patient difference in overall percent pain relief among treatment groups | No study data are available. | Posted | 4,8,and 12 days post temporary lead(s) implantation |
|
|
| Secondary | Quality of Life, as Measured by EQ-5D-5L | Mean within-patient difference in quality of life among treatment groups | No study data are available. | Posted | 4,8,and 12 days post temporary lead(s) implantation |
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| 0 |
| 1 |
| 0 |
| 1 |
| 0 |
| 1 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |