Study to Evaluate the Effectiveness of DRG Stimulation for Discogenic Low Back Pain
CompletedNot applicableNCT02587637
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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 prospective post market observational pilot study is to evaluate the effect of DRG stimulation in the management of chronic discogenic pain in subjects who are refractory to other available treatments. Selected subjects will not be suitable candidates for lumbar spinal surgery and will meet the standard selection process for DRG stimulation as routinely utilised in the study centre. Results from this pilot study will inform current clinical practice and future comparative studies in this specific population.
Study details
- Official title
- A Prospective Post Market Observational Pilot Study to Evaluate the Effectiveness of DRG Stimulation in the Treatment of Discogenic Low Back Pain
- Conditions
- Interventions
- Device: Dorsal root ganglion (DRG) stimulation
- Sponsor
- Abbott Medical Devices
- Start date
- 2015-10-01
- Primary completion
- 2017-12
- Sex
- All
- Age range
- from 18 Years to 65 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- Netherlands
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Subject of either gender between 18 and 65 years of age 2. Subject is able and willing to comply with the follow-up schedule and protocol 3. Subject is able to provide written informed consent 4. Chronic low back pain of at least 6 months 5. History consistent with discogenic low back pain (e.g. Pain produced on lumbar motion, significant functional limitation in sitting duration and tolerance) 6. Neurologic exam without marked motor deficit. 7. Definite/Highly Probable/Discogenic Pain as confirmed by provocative discography according to IASP/ISIS guidelines\* 8. Low Back Pain intensity should be 6 or higher measured on a NPRS at baseline 9. Meets all the inclusion criteria for the implantation of a neurostimulation system as typically utilised in the study centre 10. Subject has been screened by a multi-disciplinary panel including a psychologist and deemed suitable for implantation 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. BMI ≥35 4. Subject has had injection therapy or radiofrequency treatment for their low back pain 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. Severe disc degeneration at the affected level as evidenced by \>50% disc height loss on plain anteroposterior and lateral lumbar radiographs or CT/MRI. 8. Extruded or sequestered herniated nucleus pulposus at the affected level(s). 9. Previous lumbar back surgery (e.g. Laminectomy, discectomy or fusion) at the affected level(s) 10. Moderate to severe spinal stenosis due to osteophyte and/or ligamentous overgrowth as evidenced by MRI or CT in the previous 6 months 11. Moderate to severe endplate degenerative changes at the affected levels 12. Grade 1-2 spondylolisthesis 13. Previous Neurostimulation therapy
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02587637