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SubQStim: A Post-market Study of Subcutaneous Nerve Stimulation in Failed Back Surgery Syndrome (FBSS) Patients

NCT01711619 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 162

Last updated 2018-10-22

Study results available
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Summary

The purpose of this study is to compare the effectiveness of peripheral nerve stimulation utilizing a subcutaneous lead implant technique (SQS) plus optimized medical management (OMM) versus OMM alone in patients suffering from back pain due to Failed Back Surgery Syndrome (FBSS).

Conditions

  • Failed Back Surgery Syndrome

Interventions

DEVICE

subcutaneous nerve stimulation

subcutaneous nerve stimulation plus optimized medical management

OTHER

Optimized Medical Management

Optimized medical management

Sponsors & Collaborators

  • MedtronicNeuro

    lead INDUSTRY

Principal Investigators

  • Sam Eldabe, MD · The James Cook Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2016-02-29
Completion
2016-02-29

Countries

  • Australia
  • Austria
  • Belgium
  • France
  • Germany
  • Israel
  • Netherlands
  • Spain
  • Switzerland
  • United Kingdom

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 NCT01711619 on ClinicalTrials.gov