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To evaluate programming modalities at various targets for focal foot, knee pain, and groin pain relief.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dorsal Column (DC) Perception | Active Comparator | Use of DC Perception based programming |
|
| Dorsal Root (DR) Perception | Active Comparator | Use of DR Perception based programming |
|
| Dorsal Root (DR) Sub-perception | Active Comparator | Use of DR sub-perception based programming |
|
| Dorsal Column (DC) Sub-perception | Active Comparator | Use of DC sub-perception based programming |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spinal Cord Stimulation | Device | Patients eligible for SCS |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Intensity | Change in pain intensity from Baseline to end of each Period (knee/foot). Pain scores are measured on a scale of 0 - 10 where 0 is no pain and 10 is maximum pain possible. | up to 6 weeks |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roshini Jain | Boston Scientific Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AZ Nikolaas | Sint-Niklaas | Belgium |
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3 subjects were enrolled. However 2 were implanted and proceeded to crossover phase
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| ID | Title | Description |
|---|---|---|
| FG000 | Subjects Received All Interventions (4 Programs) | Four Programs utilized included DC perception and sub-perception; DR perception and subperception based programming |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Subjects Received 4 Interventions (4 Programs) | Four Programs utilized included DC perception and sub-perception; DR perception and subperception based programming |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change in Pain Intensity | Change in pain intensity from Baseline to end of each Period (knee/foot). Pain scores are measured on a scale of 0 - 10 where 0 is no pain and 10 is maximum pain possible. | Posted | Mean | Full Range | units on a scale | up to 6 weeks |
|
Adverse events were collected and reported up to end of crossover phase (approximately 18 weeks)
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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 | Dorsal Column (DC) Perception | Use of DC Perception based programming Spinal Cord Stimulation: Patients eligible for SCS |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Shoulder Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fasciculation | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roshini Jain, Sr. Director Clinical Sciences | Boston Scientific | 16619494350 | roshini.jain@bsci.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 24, 2021 | Mar 27, 2023 | Prot_SAP_004.pdf |
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| 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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| ID | Term |
|---|---|
| D062187 | Spinal Cord Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Use of DR sub-perception based programming Spinal Cord Stimulation: Patients eligible for SCS |
| OG003 | Dorsal Column (DC) Sub-perception | Use of DC sub-perception based programming Spinal Cord Stimulation: Patients eligible for SCS |
|
|
| 0 |
| 2 |
| 0 |
| 2 |
| 0 |
| 2 |
| EG001 | Dorsal Root (DR) Perception | Use of DR Perception based programming Spinal Cord Stimulation: Patients eligible for SCS | 0 | 2 | 0 | 2 | 1 | 2 |
| EG002 | Dorsal Column (DC) Sub-perception | Use of DC sub-perception based programming Spinal Cord Stimulation: Patients eligible for SCS | 0 | 1 | 0 | 1 | 1 | 1 |
| EG003 | Dorsal Root (DR) Sub-perception | Use of DR sub-perception based programming Spinal Cord Stimulation: Patients eligible for SCS | 0 | 2 | 1 | 2 | 0 | 2 |
| No bowel movements | Gastrointestinal disorders | Systematic Assessment |
|
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