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Status:

COMPLETED

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

Lead Sponsor:

Boston Scientific Corporation

Conditions:

Chronic Pain

Eligibility:

All Genders

22+ years

Phase:

NA

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 w...

Eligibility Criteria

Inclusion

  • Key
  • 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

  • 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)

Key Trial Info

Start Date :

March 26 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

February 21 2025

Estimated Enrollment :

241 Patients enrolled

Trial Details

Trial ID

NCT04676022

Start Date

March 26 2021

End Date

February 21 2025

Last Update

March 6 2025

Active Locations (23)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 6 (23 locations)

1

Vitamed Research

Palm Desert, California, United States, 92260

2

Summit Pain Alliance

Santa Rosa, California, United States, 95401

3

Denver Back Pain Specialists

Greenwood Village, Colorado, United States, 80111

4

South Lake Pain Institute, Inc

Clermont, Florida, United States, 34711