SCS as an Option for Chronic Low Back and/or Leg Pain Instead of Surgery

Not Applicable

Completed

Conditions: Chronic Pain

Interventions: Other: Conventional Medical Managament
Device: WaveWriter

Registration Number: NCT04676022

Lead Sponsor: Boston Scientific Corporation

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 241

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional Medical Management	Conventional Medical Managament	To receive conventional medical management
Spinal Cord Stimulation	WaveWriter	To receive Spinal Cord Stimulation programming

Primary Outcome Measures

Name	Time	Method
Responder Rate	3 months post-activation	Proportion of subjects with 50% or greater reduction in overall pain relief

Secondary Outcome Measures

Name	Time	Method
Change in Disability (Oswestry Disability Index)	3-Months post activation	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.

Trial Locations

Locations (23): Goodman Campbell Brain and Spine
🇺🇸
Carmel, Indiana, United States
Crimson Pain Management
🇺🇸
Overland Park, Kansas, United States
Willis-Knighton River Cities Clinical Research Center
🇺🇸
Shreveport, Louisiana, United States
Saint Louis Pain Consultants
🇺🇸
Chesterfield, Missouri, United States
MedPharmics, LLC
🇺🇸
Metairie, Louisiana, United States
South Lake Pain Institute, Inc
🇺🇸
Clermont, Florida, United States
Forest Health Medical Center
🇺🇸
Ypsilanti, Michigan, United States
Weill Cornell Medical University
🇺🇸
New York, New York, United States
Pacific Sports and Spine, LLC
🇺🇸
Eugene, Oregon, United States
Vitamed Research
🇺🇸
Palm Desert, California, United States
Summit Pain Alliance
🇺🇸
Santa Rosa, California, United States
Denver Back Pain Specialists
🇺🇸
Greenwood Village, Colorado, United States
The Toledo Clinic
🇺🇸
Toledo, Ohio, United States
University of Utah Orthopaedic Center
🇺🇸
Salt Lake City, Utah, United States
University of Chicago Hospital
🇺🇸
Chicago, Illinois, United States
The Center for Clinical Research
🇺🇸
Winston-Salem, North Carolina, United States
Ochsner Clinic Foundation
🇺🇸
New Orleans, Louisiana, United States
Novant Health-Hawthorne
🇺🇸
Winston-Salem, North Carolina, United States
Precision Spine Care
🇺🇸
Tyler, Texas, United States
Delaware Valley Pain and Spine Institute
🇺🇸
Trevose, Pennsylvania, United States
Institute of Precision Pain Medicine
🇺🇸
Corpus Christi, Texas, United States
PCPMG Clinical Research Unit, LLC
🇺🇸
Greenville, South Carolina, United States
Carolinas Research Institute, PLLC
🇺🇸
Huntersville, North Carolina, United States