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Efficacy Study of the Octapolar Lead in Patients With Failed Back Surgery Syndrome (FBSS) With Chronic Pain

NCT01096147 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2013-11-04

No results posted yet for this study

Summary

Spinal cord stimulation (SCS) has been used for over 40 years to treat neuropathic pain. Various clinical studies have shown a beneficial effect of SCS on pain in patients with Failed Back Surgery Syndrome (FBSS). Since more than 2 years the 8-contact points Octad lead has been used and replaced the 4-contact points Quad lead. Even though it seems that eight electrodes has potential advantage over the four electrodes in case of lead migration or disease progress, no clinical data have been published on the effectiveness of SCS using the octopolar epidural lead. The Octad study intents to assess the effectiveness and technical performance of SCS with the Octad® lead for treatment of chronic pain. This study is not set up as a comparison study between the Octad lead and other SCS leads, such as the Quad lead, because the Octad lead is used in most eligible FBSS patients as the standard of care lead.

The study intends to:

1. evaluate the effectiveness of SCS with the Octad® lead on chronic pain in Failed Back Surgery Syndrome patients after 12 months of treatment.
2. collect safety data for SCS with the Octad® lead in patients with refractory chronic pain.

Conditions

  • Failed Back Surgery Syndrome

Interventions

DEVICE

Spinal cord stimulation with eight polar electrode

In SCS a lead is positioned in the epidural space on the dorsal aspect of the spinal cord as to produce electrically induced paraesthesia in the painful area.

Sponsors & Collaborators

  • Rik Buschman, PhD

    lead INDUSTRY

Principal Investigators

  • Ann Ver Donck, MD PhD · Hospital St Jan, Brugge, Belgium

  • Kliment P Gatzinsky, MD PhD · Sahlgrenska University Hospital

  • Roald Baardsen, MD PhD · University hospital Stavanger, Stavanger, Norway

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2013-03-31
Completion
2013-11-30

Countries

  • Belgium
  • Norway
  • Sweden

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 NCT01096147 on ClinicalTrials.gov