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

Overview

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)

Full Title of Study: “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”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: January 2017

Interventions

  • Device: Implantation with the commercially available Axium neurostimulator

Arms, Groups and Cohorts

  • Treated Subjects
    • All subjects recruited and treated with the Axium neurostimulator

Clinical Trial Outcome Measures

Primary Measures

  • Change in Pain Intensity for Overall Pain From Pre-treatment Baseline
    • Time Frame: 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
    • Time Frame: 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).

Participating in This Clinical Trial

Inclusion Criteria

1. Subject is at least 18 years old 2. Subject is able and willing to comply with the follow-up schedule and protocol 3. Chronic pain following surgical lumbar discectomy for at least 6 months 4. Failed conservative treatments for chronic pain including but not limited to pharmacological therapy, physical therapy and interventional pain procedures for chronic pain 5. Minimum baseline pain rating of 60 mm on the Visual Analog Scale in the subjects primary area of pain 6. Subject is able to provide written informed consent Exclusion Criteria:

1. Female subject of childbearing potential is pregnant/nursing or plans to become pregnant during the course of the study 2. Escalating or changing pain condition within the past month as evidenced by investigator examination 3. Subject has had corticosteroid therapy at an intended site of stimulation within the past 30 days 4. Subject has had radiofrequency treatment of an intended target Dorsal Root Ganglion within the past 3 months 5. Subject currently has an active implantable device including implantable cardioverter defibrillator, pacemaker, spinal cord stimulator or intrathecal drug pump 6. Subject is unable to operate the device 7. Subjects with indwelling devices that may pose an increased risk of infection 8. Subjects currently has an active infection 9. Subject has participated in another clinical investigation within 30 days 10. Subject has a coagulation disorder or uses anticoagulants that, in the opinion of the investigator, precludes participation 11. Subject has been diagnosed with cancer in the past 2 years. 12. Subject has an anatomical spinal abnormality which is anticipated to require further surgery

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Abbott Medical Devices
  • Provider of Information About this Clinical Study
    • Sponsor

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