A Post Market Study on Dorsal Root Ganglion (DRG) Stimulation in Failed Back Surgery Syndrome (FBSS)

Terminated

Interventions: Device: Implantation with the commercially available Axium neurostimulator

Brief Summary: 18-SMI-2013 is a post market, observational, questionnaire based study to assess the effectiveness of the commercially available Axium neurostimulator in the management of chronic pain following lumbar discectomy (Failed Back Surgery Syndrome)

Recruitment & Eligibility

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 Visual Analog Scale 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 Dorsal Root Ganglion within the past 3 months
Subject currently has an active implantable device including implantable cardioverter defibrillator, 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
Subject has been diagnosed with cancer in the past 2 years.
Subject has an anatomical spinal abnormality which is anticipated to require further surgery

Arm && Interventions

Group	Intervention	Description
Treated Subjects	Implantation with the commercially available Axium neurostimulator	All subjects recruited and treated with the Axium neurostimulator

Primary Outcome Measures

Name	Time	Method
Change in Pain Intensity for Overall Pain From Pre-treatment Baseline	Baseline, 3, 6 and 12 Months	The Visual Analog Scale (VAS) is self-administered instrument assessing average pain intensity. Subjects rated their pain on a horizontal line, 10 cm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher pain level. The values range from 0 (minimum pain) to 10 (maximum pain).
Percentage of Subjects With at Least 50% Pain Reduction	3, 6 and 12-Month Visits	Percent of subjects with at least a 50% reduction. The Visual Analog Scale (VAS) is self-administered instrument assessing average pain intensity. Subjects rated their pain on a horizontal line, 10 cm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher pain level. The values range from 0 (minimum) to 10 (maximum).

Secondary Outcome Measures