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SENSE (Subcutaneous and Epidural Neuromodulation System Evaluation) Study

NCT01990287 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2016-04-13

No results posted yet for this study

Summary

The purpose of the study is to demonstrate safety and efficacy of spinal cord stimulation with peripheral nerve field stimulation for the treatment of chronic low back and leg pain.

Conditions

  • Failed Back Surgery Syndrome
  • Post-Laminectomy Syndrome
  • Low Back Pain

Interventions

DEVICE

SCS and PNfS

Spinal Cord Stimulation (SCS) in combination with Peripheral Nerve Field Stimulation (PNfS). The SCS leads will be placed in the Thoracolumbar region and the PNfS lead will be placed subcutaneously in the area of pain.

DEVICE

SCS Alone

Spinal Cord Stimulation (SCS) only. The SCS leads will be placed in the Thoracolumbar region only.

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Porter McRoberts, MD · Holy Cross Orthopedic Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2016-02-29
Completion
2016-02-29

Countries

  • United States

Study Locations

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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 NCT01990287 on ClinicalTrials.gov