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To evaluate the effectiveness of Spinal Cord Stimulation (SCS) with multiple modalities as compared to conventional SCS in patients with chronic pain when using the Boston Scientific Spectra WaveWriter SCS System.
To evaluate the effectiveness of Spinal Cord Stimulation (SCS) with multiple modalities as compared to conventional SCS in patients with chronic pain when using the Boston Scientific Spectra WaveWriter SCS System.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WaveWriter Settings | Active Comparator | WaveWriter Programming |
|
| Conventional Settings | Active Comparator | Conventional Programming |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Boston Scientific Spectra WaveWriter™ Spinal Cord Stimulation (SCS) System | Device | The Spectra WaveWriter Spinal Cord Stimulator (SCS) System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, Complex Regional Pain Syndrome (CRPS) Types I and II, intractable low back pain and leg pain. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Pain Responder Rate | Percentage of subjects with 50% or greater reduction from Baseline Visit in average overall pain intensity at 3 months post-randomization with no increase in opioid medications | 3 months post-randomization |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Wallace, M.D. | University of California, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Pain and Supportive Care | Phoenix | Arizona | 85028 | United States | ||
| UCSD Medical Center - Jacobs Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36866658 | Derived | Wallace MS, North JM, Phillips GM, Calodney AK, Scowcroft JA, Popat-Lewis BU, Lee JM, Washabaugh EP 3rd, Paez J, Bolash RB, Noles J, Atallah J, Shah B, Ahadian FM, Trainor DM, Chen L, Jain R. Combination therapy with simultaneous delivery of spinal cord stimulation modalities: COMBO randomized controlled trial. Pain Manag. 2023 Mar;13(3):171-184. doi: 10.2217/pmt-2022-0101. Epub 2023 Mar 3. |
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After subjects were enrolled, they were evaluated per study eligibility criteria. Only those who met all criteria proceeded to receive implant and randomized in the study (as applicable).
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| ID | Title | Description |
|---|---|---|
| FG000 | WaveWriter Settings | WaveWriter Programming Boston Scientific Spectra WaveWriter™ Spinal Cord Stimulation (SCS) System: The Spectra WaveWriter Spinal Cord Stimulator (SCS) System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, Complex Regional Pain Syndrome (CRPS) Types I and II, intractable low back pain and leg pain. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Jan 31, 2020 |
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|
| La Jolla |
| California |
| 92037 |
| United States |
| Denver Back Pain Specialists | Greenwood Village | Colorado | 80111 | United States |
| South Lake Pain Institute, Inc | Clermont | Florida | 34711 | United States |
| Willis-Knighton River Cities Clinical Research Center | Shreveport | Louisiana | 71105 | United States |
| Michigan Pain Consultants | Grand Rapids | Michigan | 49546 | United States |
| Forest Health Medical Center | Ypsilanti | Michigan | 48198 | United States |
| KC Pain Centers | Lee's Summit | Missouri | 64086 | United States |
| Carolinas Research Institute, LLC | Huntersville | North Carolina | 28078 | United States |
| The Center for Clinical Research, LLC | Winston-Salem | North Carolina | 27103 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Toledo Clinic | Toledo | Ohio | 43623 | United States |
| Pacific Sports and Spine, LLC | Eugene | Oregon | 97401 | United States |
| Precision Spine Care | Tyler | Texas | 75701 | United States |
| EvergreenHealth Pain Care | Kirkland | Washington | 98034 | United States |
| FG001 | Conventional Settings | Conventional Programming Boston Scientific Spectra WaveWriter™ Spinal Cord Stimulation (SCS) System: The Spectra WaveWriter Spinal Cord Stimulator (SCS) System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, Complex Regional Pain Syndrome (CRPS) Types I and II, intractable low back pain and leg pain. |
| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | WaveWriter Settings | WaveWriter Programming Boston Scientific Spectra WaveWriter™ Spinal Cord Stimulation (SCS) System: The Spectra WaveWriter Spinal Cord Stimulator (SCS) System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, Complex Regional Pain Syndrome (CRPS) Types I and II, intractable low back pain and leg pain. |
| BG001 | Conventional Settings | Conventional Programming Boston Scientific Spectra WaveWriter™ Spinal Cord Stimulation (SCS) System: The Spectra WaveWriter Spinal Cord Stimulator (SCS) System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, Complex Regional Pain Syndrome (CRPS) Types I and II, intractable low back pain and leg pain. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | 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 | Overall Pain Responder Rate | Percentage of subjects with 50% or greater reduction from Baseline Visit in average overall pain intensity at 3 months post-randomization with no increase in opioid medications | Posted | Count of Participants | Participants | 3 months post-randomization |
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Adverse Events were collected up to end of randomized phase (3 months post-randomization)
Adverse Events including Serious Adverse Events were collected up to end of randomized phase (3 months post-randomization)
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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 | WaveWriter Settings | WaveWriter Programming Boston Scientific Spectra WaveWriter™ Spinal Cord Stimulation (SCS) System: The Spectra WaveWriter Spinal Cord Stimulator (SCS) System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, Complex Regional Pain Syndrome (CRPS) Types I and II, intractable low back pain and leg pain. | 0 | 41 | 4 | 41 | 0 | 41 |
| EG001 | Conventional Settings | Conventional Programming Boston Scientific Spectra WaveWriter™ Spinal Cord Stimulation (SCS) System: The Spectra WaveWriter Spinal Cord Stimulator (SCS) System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, Complex Regional Pain Syndrome (CRPS) Types I and II, intractable low back pain and leg pain. | 0 | 48 | 5 | 48 | 0 | 48 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Obesity | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Carotid Artery Stenosis | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Ischaemic Stroke | Nervous system disorders | MedDRA | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Sciences | Boston Scientific | 661-949-4350 | roshini.jain@bsci.com |
| Nov 4, 2020 |
| Prot_SAP_000.pdf |
| 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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| ID | Term |
|---|---|
| D062187 | Spinal Cord Stimulation |
| D016503 | Drug Delivery Systems |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D004358 | Drug Therapy |
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| Male |
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| Caucasian |
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| Hispanic or Latino |
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| Other |
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