A Post Market ObServational StudY on the Effect of DRG StiMulation in PATients witH Chronic Pain Following Surgical Lumbar DiscectomY (Failed Back Surgery Syndrome): SYMPATHY

Abbott Medical Devices1 site in 1 countryDecember 2015

ConditionsFailed Back Surgery Syndrome

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Failed Back Surgery Syndrome
Sponsor: Abbott Medical Devices
Locations: 1
Primary Endpoint: Pain Relief
Status: Withdrawn
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this Post Market Observational Study is to monitor the effect of the Axium® SCS System in the management of chronic pain following surgical lumbar discectomy in subjects whom are routinely scheduled for treatment with the Axium® SCS System.

Registry

clinicaltrials.gov

Start Date

December 2015

End Date

November 2016

Last Updated

7 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Abbott Medical Devices

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subject is at least 18 years old
•Subject is able and willing to comply with the follow-up schedule and protocol
•Chronic pain following surgical lumbar discectomy for at least 6 months
•Failed conservative treatments for chronic pain including but not limited to pharmacological therapy, physical therapy and interventional pain procedures for chronic pain
•Minimum baseline pain rating of 60 mm on the VAS in the subjects' primary area of pain
•Subject is able to provide written informed consent

Exclusion Criteria

•Female subject of childbearing potential is pregnant/nursing or plans to become pregnant during the course of the study
•Escalating or changing pain condition within the past month as evidenced by investigator examination
•Subject has had corticosteroid therapy at an intended site of stimulation within the past 30 days
•Subject has had radiofrequency treatment of an intended target DRG within the past 3 months
•Subject currently has an active implantable device including ICD, pacemaker, spinal cord stimulator or intrathecal drug pump
•Subject is unable to operate the device
•Subjects with indwelling devices that may pose an increased risk of infection
•Subjects currently has an active infection
•Subject has participated in another clinical investigation within 30 days
•Subject has a coagulation disorder or uses anticoagulants that, in the opinion of the investigator, precludes participation