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The study is a prospective, on-label, multi-center, blinded, randomized controlled trial with a cross-over design to evaluate the effect of Precision Spectraâ„¢ SCS System's programming features and lead options.
The study is a sub-study of RELIEF - A Global Registry to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for Pain (NCT01719055). The treatment will consist of permanent implant of a Precision Spectraâ„¢ SCS IPG with either a 32 contact CoverEdgeâ„¢ Surgical Lead or with more than 2 percutaneous leads after a successful trial. Programming features and lead options of the Precision Spectraâ„¢ SCS System will be evaluated up to 3 months post-IPG activation. Following completion of the 3 month visit, subjects will continue to be followed for up to 36 months per the study requirements of the RELIEF Registry.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional Programming, then Advanced Programming | Active Comparator | Precision Spectra SCS System with CoverEdge Surgical Lead or more than 2 percutaneous leads. Subjects first received conventional single source programming followed by Precision Spectra SCS System advanced programming. |
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| Advanced Programming, then Conventional Programming | Active Comparator | Precision Spectra SCS System with CoverEdge Surgical Lead or more than 2 percutaneous leads. Subjects first received Precision Spectra SCS System advanced programming followed by conventional single source programming. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional single source programming | Device | Precision Spectra SCS System using conventional single source programming. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Paresthesia Coverage ≥50% | Paresthesia Coverage assesses how much of the subject's painful areas are covered by SCS-induced paresthesia. The number of subjects reporting paresthesia coverage ≥50% is reported. | 7, 14 days post activation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kristen Lechleiter, M.S. | Boston Scientific Neuromodulation Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Physicians Research Group, LLC | Phoenix | Arizona | 85016 | United States | ||
| Albany Medical Center |
17 subjects were enrolled in the study. 5 were withdrawn prior to randomization: 4 were withdrawn as failing to meet inclusion criteria and 1 at the subject's request prior to randomization. 12 were randomized, but 1 was randomized in error and was withdrawn same day. Statistically relevant conclusions cannot be made from this small sample size.
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| ID | Title | Description |
|---|---|---|
| FG000 | Conventional Programming, Then Advanced Programming | Precision Spectra SCS System with CoverEdge Surgical Lead. Subjects were randomized to first receive conventional single source programming followed by Precision Spectra SCS System advanced programming. Conventional single source programming: Precision Spectra SCS System using conventional single source programming. Precision Spectra SCS System advanced programming: Precision Spectra SCS System using advanced programming. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| First Intervention (7 Days) |
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| Precision Spectra SCS System advanced programming | Device | Precision Spectra SCS System using advanced programming |
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| Albany |
| New York |
| 12208 |
| United States |
| PCPMG Clinical Research Unit, LLC | Greenville | South Carolina | 29601 | United States |
| Spine Team Texas | Rockwall | Texas | 75032 | United States |
| FG001 | Advanced Programming, Then Conventional Programming | Precision Spectra SCS System with CoverEdge Surgical Lead. Subjects were randomized to first receive Precision Spectra SCS System advanced programming followed by conventional single source programming. Conventional single source programming: Precision Spectra SCS System using conventional single source programming. Precision Spectra SCS System advanced programming: Precision Spectra SCS System using advanced programming. |
| COMPLETED |
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| NOT COMPLETED |
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| Second Intervention (7 Days) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Conventional Programming, Then Advanced Programming | Precision Spectra SCS System with CoverEdge Surgical Lead. Subjects were randomized to first receive conventional single source programming followed by Precision Spectra SCS System advanced programming. Conventional single source programming: Precision Spectra SCS System using conventional single source programming. Precision Spectra SCS System advanced programming: Precision Spectra SCS System using advanced programming. |
| BG001 | Advanced Programming, Then Conventional Programming | Precision Spectra SCS System with CoverEdge Surgical Lead. Subjects were randomized to first receive Precision Spectra SCS System advanced programming followed by conventional single source programming. Conventional single source programming: Precision Spectra SCS System using conventional single source programming. Precision Spectra SCS System advanced programming: Precision Spectra SCS System using advanced programming. |
| BG002 | Total | Total of all reporting groups |
| 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, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | 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 | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Paresthesia Coverage ≥50% | Paresthesia Coverage assesses how much of the subject's painful areas are covered by SCS-induced paresthesia. The number of subjects reporting paresthesia coverage ≥50% is reported. | All subjects who completed the day 7 and day 14 post-activation study visits were included. Statistical analysis was not performed as the sample size is too small to draw any statistically relevant conclusions. | Posted | Number | Participants | 7, 14 days post activation |
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From informed consent through completion of study (approximately 3 months)
Arms/groups are combined instead of reported per intervention because subjects received both programming types (arms) in this crossover study. Additionally, adverse events did not necessarily occur when a subject was receiving one of the two programming types.
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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 Enrolled Subjects | Rate of device-related adverse events (AEs) and Serious Adverse Events (SAEs) are reported for 17 enrolled subjects from informed consent through completion of study. | 0 | 17 | 2 | 17 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection | Infections and infestations | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Mid back muscle cramps | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Sciences and Scientific Communication | Boston Scientific Neuromodulation | Roshini.Jain@bsci.com |
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D001416 | Back Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| >=65 years |
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| Male |
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| Conventional Programming |
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