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Spinal Cord Stimulation With Precision® System Versus Reoperation for Failed Back Surgery Syndrome

NCT01036529 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2020-11-16

Study results available
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Summary

The EVIDENCE trial is a randomized controlled trial comparing the therapeutic effectiveness and cost-effectiveness of the Precision® Spinal Cord Stimulation with that of reoperation as a treatment of pain in patients with Failed Back Surgery Syndrome (FBSS). FBSS is defined as persistent or recurrent pain following one or more lumbosacral spine surgical procedures. Surgical procedures that can result in FBSS can be categorized as either decompression or decompression followed by fusion with or without instrumentation. The pain of FBSS is categorized as neuropathic, which involves pathological nerve activity and is commonly characterized by patients as shooting or burning and/or nociceptive, which signals actual or impending tissue damage or inflammation.

Conditions

Interventions

DEVICE

Precision Spinal Cord Stimulator

Programming settings will be specific to the individual needs in accordance with the labeling

PROCEDURE

Back Surgery

Different types of back surgery may be performed

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Richard North, M.D. · The Sandra and Malcolm Berman Brain & Spine Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2013-05-31
Completion
2013-05-31

Countries

  • United States
  • Canada
  • France
  • 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 NCT01036529 on ClinicalTrials.gov