Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To evaluate the safety and effectiveness of Spinal Cord Stimulation (SCS) with multiple modalities compared to Conventional Medical Management (CMM) in patients with chronic low back and/or leg pain who have not undergone spinal surgery when using the Boston Scientific WaveWriter SCS Systems.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spinal Cord Stimulation | Experimental | To receive Spinal Cord Stimulation programming |
|
| Conventional Medical Management | Other | To receive conventional medical management |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WaveWriter | Device | To receive Spinal Cord Stimulation programming |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Responder Rate | Proportion of subjects with 50% or greater reduction in overall pain relief | 3 months post-activation |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Disability (Oswestry Disability Index) | Change in Disability (Oswestry Disability Index). The Oswestry Disability Index (ODI) is a validated questionnaire of pain-related disability with total score on a scale of 0 (no disability) to 100 (complete disability). Categories for ODI total score are 0-20 (minimal disability), 21-40 (moderate disability), 41-60 (severe disability), 61-80 (crippling back pain), and 81-100 (bed-bound or exaggerating). The published minimally clinically important difference for change in ODI is 10 points. |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Natalie Bloom Lyons | Boston Scientific Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vitamed Research | Palm Desert | California | 92260 | United States | ||
| Summit Pain Alliance |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41047246 | Derived | North J, Calodney A, Trainor D, McCormick ZL, Paez J, Loudermilk E, Christopher A, Noles J, Phillips G, Jolly S, Yang MI, Guirguis M, Kloster D, Pak DJ, Peacock J, Engle M, Shah B, Wilson D, Anitescu M, Atallah J, Chatas J, Leier T, Rosen S, Goldberg E. Spinal cord stimulation plus conventional medical management versus conventional medical management alone for severe, non-surgical, refractory back pain: a randomized clinical trial followed by crossover. Reg Anesth Pain Med. 2025 Oct 5:rapm-2024-106335. doi: 10.1136/rapm-2024-106335. Online ahead of print. | |
| 34854473 |
Not provided
Not provided
After subjects were consented and enrolled, they were evaluated per study eligibility criteria. Only those who met criteria proceeded to randomization.
241 subjects provided informed consent.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Spinal Cord Stimulation | Randomized to receive Spinal Cord Stimulation programming WaveWriter: To receive Spinal Cord Stimulation programming |
| FG001 | Conventional Medical Management |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| 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 | Apr 5, 2022 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Conventional Medical Managament |
| Other |
To receive conventional medical management |
|
| 3-Months post activation |
| Santa Rosa |
| California |
| 95401 |
| United States |
| Denver Back Pain Specialists | Greenwood Village | Colorado | 80111 | United States |
| South Lake Pain Institute, Inc | Clermont | Florida | 34711 | United States |
| University of Chicago Hospital | Chicago | Illinois | 60637 | United States |
| Goodman Campbell Brain and Spine | Carmel | Indiana | 46032 | United States |
| Crimson Pain Management | Overland Park | Kansas | 66210 | United States |
| MedPharmics, LLC | Metairie | Louisiana | 70006 | United States |
| Ochsner Clinic Foundation | New Orleans | Louisiana | 70115 | United States |
| Willis-Knighton River Cities Clinical Research Center | Shreveport | Louisiana | 71105 | United States |
| Forest Health Medical Center | Ypsilanti | Michigan | 48198 | United States |
| Saint Louis Pain Consultants | Chesterfield | Missouri | 63017 | United States |
| Weill Cornell Medical University | New York | New York | 10022 | United States |
| Carolinas Research Institute, PLLC | Huntersville | North Carolina | 28078 | United States |
| Novant Health-Hawthorne | Winston-Salem | North Carolina | 27103 | United States |
| The Center for Clinical Research | Winston-Salem | North Carolina | 27103 | United States |
| The Toledo Clinic | Toledo | Ohio | 43623 | United States |
| Pacific Sports and Spine, LLC | Eugene | Oregon | 97401 | United States |
| Delaware Valley Pain and Spine Institute | Trevose | Pennsylvania | 19053 | United States |
| PCPMG Clinical Research Unit, LLC | Greenville | South Carolina | 29601 | United States |
| Institute of Precision Pain Medicine | Corpus Christi | Texas | 78414 | United States |
| Precision Spine Care | Tyler | Texas | 75701 | United States |
| University of Utah Orthopaedic Center | Salt Lake City | Utah | 84132 | United States |
| Derived |
| O'Connell NE, Ferraro MC, Gibson W, Rice AS, Vase L, Coyle D, Eccleston C. Implanted spinal neuromodulation interventions for chronic pain in adults. Cochrane Database Syst Rev. 2021 Dec 2;12(12):CD013756. doi: 10.1002/14651858.CD013756.pub2. |
Randomized to receive conventional medical management
Conventional Medical Managament: To receive conventional medical management
| FG002 | Non-randomized Subjects | Consented subjects who were not randomized in the study. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All Randomized subjects
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Randomized to Spinal Cord Stimulation (SCS) Treatment Activated | Baseline demographics and clinical characteristics for subjects in the SCS arm |
| BG001 | Randomized to Conventional Medical Management (CMM) Treatment Activated | Baseline demographics and clinical characteristics for subjects in the CMM arm |
| 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 |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Duration of Low Back Pain | Mean | Standard Deviation | years |
| |||||||||||||||
| Average low back pain (VRS) | Pain intensity is expressed on a 0 - 10 verbal rating scale (VRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine". | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Average overall pain (VRS) | Pain intensity is expressed on a 0 - 10 verbal rating scale (VRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine". | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Oswestry Disability Index (ODI) Summary Score | Change in Disability (Oswestry Disability Index). The Oswestry Disability Index (ODI) is a validated questionnaire of pain-related disability with total score on a scale of 0 (no disability) to 100 (complete disability). Categories for ODI total score are 0-20 (minimal disability), 21-40 (moderate disability), 41-60 (severe disability), 61-80 (crippling back pain), and 81-100 (bed-bound or exaggerating). The published minimally clinically important difference for change in ODI is 10 points. | Mean | Standard Deviation | units on a scale |
|
| 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 | Responder Rate | Proportion of subjects with 50% or greater reduction in overall pain relief | Intent to Treat population | Posted | Count of Participants | Participants | 3 months post-activation |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Change in Disability (Oswestry Disability Index) | Change in Disability (Oswestry Disability Index). The Oswestry Disability Index (ODI) is a validated questionnaire of pain-related disability with total score on a scale of 0 (no disability) to 100 (complete disability). Categories for ODI total score are 0-20 (minimal disability), 21-40 (moderate disability), 41-60 (severe disability), 61-80 (crippling back pain), and 81-100 (bed-bound or exaggerating). The published minimally clinically important difference for change in ODI is 10 points. | Intent to treat population | Posted | Mean | Standard Deviation | score on a scale | 3-Months post activation |
|
|
Randomized subjects through 3-Months post-Activation, an average of 6 months.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Randomized to SCS | Subjects Randomized to SCS Arm through 3 Months post-Activation. | 0 | 79 | 8 | 79 | 9 | 79 |
| EG001 | Randomized to CMM | Subjects Randomized to CMM Arm through 3 Months post-Activation. | 1 | 68 | 1 | 68 | 4 | 68 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hiatus hernia | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Oesophageal food impaction | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Renal Mass | Renal and urinary disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Alcohol Use Disorder | Psychiatric disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (23.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA (23.0) | Systematic Assessment |
|
A contractual agreement is in place between the PI and the Sponsor that restricts the rights to discuss or publish trial results without prior review by the sponsor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. Director, Clinical Operations | Boston Scientific Corporation | 855-213-9890 | BSNClinicalTrials@bsci.com |
| Sep 13, 2023 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| Male |
|
| Race and Ethnicity : Black, of African heritage |
|
| Race and Ethnicity : Caucasian |
|
| Race and Ethnicity : Not disclosed |
|
| Race and Ethnicity : Hispanic or Latino |
|
|