A Prospective Post Market Observational Pilot Study to Evaluate the Effectiveness of DRG Stimulation in the Treatment of Discogenic Low Back Pain; Protocol 28-SMI-2015 - 28-SMI-2015

St. Jude Medical0 个研究点目标入组 20 人开始时间: 待定最近更新: 2024年4月23日

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•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

•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

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