Clinical trial NCT04676022: SCS as an Option for Chronic Low Back and/or Leg Pain Instead of Surgery
Official title: A Randomized Controlled Study to Evaluate the Safety and Effectiveness of Boston Scientific Spinal Cord Stimulation (SCS) Systems in the Treatment of Chronic Low Back and/or Leg Pain With No Prior Surgeries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: Spinal Cord Stimulation
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2020-12-19
Enrollment: 241
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Key Inclusion Criteria:

* Chronic low back pain, with or without leg pain, for at least 6 months
* 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

Key Exclusion Criteria:

* Primary pain complaint of vascular origin (e.g. peripheral vascular disease)
* 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)

Primary outcomes:
measure: Responder Rate
timeFrame: 3 months post-activation
Secondary outcomes:
measure: Change in Disability (Oswestry Disability Index)
timeFrame: 3-Months post activation
Other outcomes:
Locations:
city: Palm Desert
country: United States
facility: Vitamed Research
state: California
city: Santa Rosa
country: United States
facility: Summit Pain Alliance
state: California
city: Greenwood Village
country: United States
facility: Denver Back Pain Specialists
state: Colorado
city: Clermont
country: United States
facility: South Lake Pain Institute, Inc
state: Florida
city: Chicago
country: United States
facility: University of Chicago Hospital
state: Illinois
city: Carmel
country: United States
facility: Goodman Campbell Brain and Spine
state: Indiana
city: Overland Park
country: United States
facility: Crimson Pain Management
state: Kansas
city: Metairie
country: United States
facility: MedPharmics, LLC
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Shreveport
country: United States
facility: Willis-Knighton River Cities Clinical Research Center
state: Louisiana
city: Ypsilanti
country: United States
facility: Forest Health Medical Center
state: Michigan
city: Chesterfield
country: United States
facility: Saint Louis Pain Consultants
state: Missouri
city: New York
country: United States
facility: Weill Cornell Medical University
state: New York
city: Huntersville
country: United States
facility: Carolinas Research Institute, PLLC
state: North Carolina
city: Winston-Salem
country: United States
facility: Novant Health-Hawthorne
state: North Carolina
city: Winston-Salem
country: United States
facility: The Center for Clinical Research
state: North Carolina
city: Toledo
country: United States
facility: The Toledo Clinic
state: Ohio
city: Eugene
country: United States
facility: Pacific Sports and Spine, LLC
state: Oregon
city: Trevose
country: United States
facility: Delaware Valley Pain and Spine Institute
state: Pennsylvania
city: Greenville
country: United States
facility: PCPMG Clinical Research Unit, LLC
state: South Carolina
city: Corpus Christi
country: United States
facility: Institute of Precision Pain Medicine
state: Texas
city: Tyler
country: United States
facility: Precision Spine Care
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Orthopaedic Center
state: Utah
Study officials:
affiliation: Boston Scientific Corporation
name: Natalie Bloom Lyons
role: STUDY_DIRECTOR
References:
citation: 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.