Spinal Cord Stimulation in Chronic Refractory Pain Associated With Failed Back Surgery Syndrome, Epidural Fibrosis, Peripheral Causalgia, Complex Regional Pain Syndrome - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Chronic Refractory Pain Associated With Failed Back Surgery Syndrome, Epidural Fibrosis, Peripheral Causalgia, Complex Regional Pain Syndrome

Intervention / Treatment

Device: Spinal Cord Stimulation

Study Type

Interventional

Enrollment

100

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Illinois
  - Chicago, Illinois, United States
    - Contact Medtronic for exact location
- Indiana
  - Indianapolis, Indiana, United States
    - Contact Medtronic for exact location
- Missouri
  - Kansas City, Missouri, United States
    - Contact Medtronic for exact location
- New York
  - Syosset, New York, United States
    - Contact Medtronic for exact location
- Oregon
  - Eugene, Oregon, United States
    - Contact Medtronic for exact location
- Texas
  - Dallas, Texas, United States
    - Contact Medtronic for exact location
  - San Antonio, Texas, United States
    - Contact Medtronic for exact location
- West Virginia
  - Huntington, West Virginia, United States
    - Contact Medtronic for exact location

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Has chronic refractory pain associated with one of the conditions currently approved for spinal cord stimulation as follows: Failed Back Syndrome, Degenerative Disk Disease (DDD), Herniated Disk pain refractory to conservative and surgical interventions, Peripheral Causalgia, Complex Regional Pain Syndrome (CRPS) or Reflex Sympathetic Dystrophy (RSD).
Primary pain in the lower half of the body.

Exclusion Criteria:

Requires, or will in the future, diathermy treatments.
Had implanted spinal cord stimulation system within the last six months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The primary endpoint is to assesses the pain coverage capability of the RESTORE SCS system.

Secondary Outcome Measures

Outcome Measure
Secondary outcome measures include pain relief, quality of life, function, patient and physician acceptance.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MedtronicNeuro

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

O'Connell NE, Ferraro MC, Gibson W, Rice AS, Vase L, Coyle D, Eccleston C. Implanted spinal neuromodulation interventions for chronic pain in adults. Cochrane Database Syst Rev. 2021 Dec 2;12(12):CD013756. doi: 10.1002/14651858.CD013756.pub2.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria