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Subcutaneous Nerve Stimulation for Failed Back Surgery Syndrome (FBSS) Patients

NCT01818297 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 137

Last updated 2017-09-21

Study results available
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Summary

The purpose of this study is to assess the safety and efficacy of Subcutaneous Nerve Stimulation (SQS) (also known as Peripheral Nerve Stimulation \[PNS\]) in the reduction of chronic, intractable post-surgical back pain in adults.

Conditions

  • Failed Back Surgery Syndrome
  • Post-laminectomy Syndrome

Interventions

DEVICE

PrimeAdvanced® neurostimulator system

Neurostimulator and associated components

Sponsors & Collaborators

  • MedtronicNeuro

    lead INDUSTRY

Principal Investigators

  • George Mandybur, MD · Mayfield Clinic, University of Cincinnati

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2016-03-31
Completion
2016-03-31

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 NCT01818297 on ClinicalTrials.gov