A Post Market Study on DRG Stimulation in FBSS (SYMPATHY)
WithdrawnNCT02634398
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- 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
- Conditions
- Sponsor
- Abbott Medical Devices
- Start date
- 2015-12
- Primary completion
- 2016-11
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- Switzerland
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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 VAS 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 DRG within the past 3 months 5. Subject currently has an active implantable device including ICD, 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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02634398