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Spinal Cord Stimulation for Predominant Low Back Pain

NCT01697358 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 278

Last updated 2017-07-21

Study results available
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Summary

The purpose of this study is to compare the effectiveness of spinal cord stimulation (SCS) using the Medtronic Specify® 5-6-5 multicolumn surgical lead plus optimal medical management (OMM) versus OMM alone in patients suffering from predominant low back pain due to failed back surgery syndrome (FBSS).

Conditions

  • Failed Back Surgery Syndrome
  • Back Pain
  • Pain in Leg, Unspecified

Interventions

DEVICE

Spinal Cord Stimulation (SCS)

Spinal Cord Stimulation (SCS) using the Medtronic Specify 5-6-5 multicolumn surgical lead. Subjects will undergo an SCS screening test and, if successful, an implantable neurostimulation system implant. Any SCS group subject not implanted will continue to be treated with OMM and will be followed as part of the SCS group.

DRUG

Optimal Medical Management (OMM)

The investigator and subject will determine an individual OMM treatment plan, which should include non-investigational pharmacologic agents and/or therapies.

Sponsors & Collaborators

  • MedtronicNeuro

    lead INDUSTRY

Principal Investigators

  • Philippe Rigoard, MD, PhD · University of Poitiers

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-08
Primary Completion
2016-03-12
Completion
2017-06-20

Countries

  • United States
  • Belgium
  • Canada
  • Colombia
  • France
  • Germany
  • Netherlands
  • Spain
  • United Kingdom

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 NCT01697358 on ClinicalTrials.gov