Study to Evaluate the Effectiveness of DRG Stimulation for Discogenic Low Back Pain

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective Post Market Observational Pilot Study to Evaluate the Effectiveness of DRG Stimulation in the Treatment of Discogenic Low Back Pain

Conditions
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Discogenic Low Back Pain

Intervention / Treatment
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* Device: Dorsal Root Ganglion Stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject of either gender between 18 and 65 years of age Subject is able and willing to comply with the follow-up schedule and protocol Subject is able to provide written informed consent Chronic low back pain of at least 6 months History consistent with discogenic low back pain (e.g. Pain produced on lumbar motion, significant functional limitation in sitting duration and tolerance) Neurologic exam without marked motor deficit. Definite/Highly Probable/Discogenic Pain as confirmed by provocative discography according to IASP/ISIS guidelines* Low Back Pain intensity should be 6 or higher measured on a NPRS at baseline Meets all the inclusion criteria for the implantation of a neurostimulation system as typically utilised in the study centre Subject has been screened by a multi-disciplinary panel including a psychologist and deemed suitable for implantation 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 BMI ≥35 Subject has had injection therapy or radiofrequency treatment for their low back pain within the past 3 months Subject currently has an active implantable device including ICD, pacemaker, spinal cord stimulator or intrathecal drug pump Subject is unable to operate the device Severe disc degeneration at the affected level as evidenced by >50% disc height loss on plain anteroposterior and lateral lumbar radiographs or CT/MRI. Extruded or sequestered herniated nucleus pulposus at the affected level(s). Previous lumbar back surgery (e.g. Laminectomy, discectomy or fusion) at the affected level(s) Moderate to severe spinal stenosis due to osteophyte and/or ligamentous overgrowth as evidenced by MRI or CT in the previous 6 months Moderate to severe endplate degenerative changes at the affected levels Grade 1-2 spondylolisthesis Previous Neurostimulation therapy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Dorsal Root Ganglion Stimulation|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Relief | To determine the number (percentage) of subjects who achieve a sustained and clinically meaningful reduction in the intensity of LBP of ≥30% or 2 points on a numerical pain rating scale (NPRS) in the implanted subjects at 6 and 12 month follow up visits as compared to baseline. | Change in pain intensity at 6 and 12 months post implantation of the stimulation device as compared to baseline scores |