SCS as an Option for Chronic Low Back and/or Leg Pain Instead of Surgery
NCT ID: NCT04676022
Last Updated: 2025-03-06
Study Results
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View full resultsBasic Information
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COMPLETED
NA
241 participants
INTERVENTIONAL
2021-03-26
2025-02-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Spinal Cord Stimulation
To receive Spinal Cord Stimulation programming
WaveWriter
To receive Spinal Cord Stimulation programming
Conventional Medical Management
To receive conventional medical management
Conventional Medical Managament
To receive conventional medical management
Interventions
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WaveWriter
To receive Spinal Cord Stimulation programming
Conventional Medical Managament
To receive conventional medical management
Eligibility Criteria
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Inclusion Criteria
* Received at least 90 days of documented pain management care to address the primary pain complaint, prior to Screening (e.g. medication, physical therapy)
* If female of childbearing potential: not pregnant, as evidenced by a negative pregnancy test at Screening
* Subject signed a valid, IRB-approved informed consent form (ICF) provided in English
Exclusion Criteria
* Require implantation of lead(s) in the cervical epidural space
* Significant cognitive impairment at Screening that, in the opinion of the Investigator, would reasonably be expected to impair the study candidate's ability to assess pain intensity
* Previous failed spinal cord stimulation trial or is already implanted with an active implantable device(s) (e.g. pacemaker, drug pump, implantable pulse generator)
22 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Natalie Bloom Lyons
Role: STUDY_DIRECTOR
Boston Scientific Corporation
Locations
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Vitamed Research
Palm Desert, California, United States
Summit Pain Alliance
Santa Rosa, California, United States
Denver Back Pain Specialists
Greenwood Village, Colorado, United States
South Lake Pain Institute, Inc
Clermont, Florida, United States
University of Chicago Hospital
Chicago, Illinois, United States
Goodman Campbell Brain and Spine
Carmel, Indiana, United States
Crimson Pain Management
Overland Park, Kansas, United States
MedPharmics, LLC
Metairie, Louisiana, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Willis-Knighton River Cities Clinical Research Center
Shreveport, Louisiana, United States
Forest Health Medical Center
Ypsilanti, Michigan, United States
Saint Louis Pain Consultants
Chesterfield, Missouri, United States
Weill Cornell Medical University
New York, New York, United States
Carolinas Research Institute, PLLC
Huntersville, North Carolina, United States
Novant Health-Hawthorne
Winston-Salem, North Carolina, United States
The Center for Clinical Research
Winston-Salem, North Carolina, United States
The Toledo Clinic
Toledo, Ohio, United States
Pacific Sports and Spine, LLC
Eugene, Oregon, United States
Delaware Valley Pain and Spine Institute
Trevose, Pennsylvania, United States
PCPMG Clinical Research Unit, LLC
Greenville, South Carolina, United States
Institute of Precision Pain Medicine
Corpus Christi, Texas, United States
Precision Spine Care
Tyler, Texas, United States
University of Utah Orthopaedic Center
Salt Lake City, Utah, United States
Countries
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References
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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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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A4077
Identifier Type: -
Identifier Source: org_study_id
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