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

NCT04676022 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 241

Last updated 2025-03-06

Study results available
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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.

Conditions

Interventions

DEVICE

WaveWriter

To receive Spinal Cord Stimulation programming

OTHER

Conventional Medical Managament

To receive conventional medical management

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Natalie Bloom Lyons · Boston Scientific Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-26
Primary Completion
2022-08-25
Completion
2025-02-21
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04676022 on ClinicalTrials.gov