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

Boston Scientific Corporation23 sites in 1 country241 target enrollmentMarch 26, 2021

ConditionsChronic Pain

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Chronic Pain
Sponsor: Boston Scientific Corporation
Enrollment: 241
Locations: 23
Primary Endpoint: Responder Rate
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 26, 2021

End Date

February 21, 2025

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Boston Scientific Corporation

Responsible Party

Sponsor

Eligibility Criteria

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

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)