Burst Neurostimulation for Discogenic Low Back Pain

Study Overview
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Brief Summary
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The purpose of this prospective post market pilot study is to evaluate the effect of Burst Spinal Cord Stimulation(B-SCS) 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 SCS as routinely utilized in the study centers. Results from this pilot study will inform current clinical practice and future comparative studies in this specific population. Eligible subjects for B-SCS will be asked to participate in this study. If they decide to participate, they will be treated with the Prodigy TM and Proclaim TM (Abbott Laboratories) SCS system and prospectively followed for 12 months following implantation.

Detailed Description
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This is a prospective, single-arm, single-center, post-market, pilot study to collect data on back pain relief, subject satisfaction, quality of life, physical functioning and safety. Chronic discogenic pain(CDP) suffering patients will be followed for 12 months with follow-up visits at 3, 6, and 12 months. In line with standard practice the system will be implanted in two stages. The first stage is the Trial Burst spinal cord Neurostimulation (TBNS) phase during which epidural leads are implanted and temporarily tunnelled to an external trial stimulation device. Subjects will then utilize the temporary system for a period in line with usual practice (typically 10-14 days). If, at the end of this TBNS phase a reduction of ≥50% is achieved the device will be permanently implanted (the second stage) and subjects will be followed-up during 12 months. Patients who do not have at least 50% pain relief during TBNS will receive a Trial Tonic Neurostimulator(TTNS) targeting the dorsal root ganglion(DRG). Similarly, these patients will be followed-up during 12 months.

Official Title
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Prospective Post Market Pilot Study to Evaluate the Effectiveness of Burst Spinal Cord Stimulation in the Treatment of Discogenic Low Back Pain

Conditions
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Discogenic Pain, Low Back Pain

Intervention / Treatment
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* Procedure: Neurostimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Subject has a negative test block of facet joints in the sacroiliac joint. Neurologic exam without marked motor deficit. Definite/Highly Probable/Discogenic Pain as confirmed by provocative discography according to International Association for the Study of Pain (IASP/ISIS) guidelines Low Back Pain intensity should be 6 or higher measured on a Numeric Pain Rating Scale(NPRS) at baseline Meets all the inclusion criteria for the implantation of a neurostimulation system as typically utilized in the study center 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 Body Mass Index ≥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 Internal Cardioverter Defibrillator(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 of ComputoTomography (CT)/Magnetic Resonance Imaging(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(SCS) 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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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Burst neurostimulation for discogenic low back pain. If this fails to provide pain relief of at least 50%, tonic stimulation targeting the DRG will be the second treatment potential. Follow-up during one year.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Burst Spinal Cord Neurostimulation<br>Burst spinal cord stimulation. When this fails, tonic stimulation targeting the DRG wil be applied | Procedure: Neurostimulation<br>* Spinal cord stimulation with burst modality for discogenic low back pain<br>* Other names: ProclaimTM Abbott Laboratories;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain severity | Pain severity, assessed by an 11 point (0-10) numerical pain rating scale 0=no pain, 10 very severe pain | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment satisfaction | Patient's Global Impression of Change, a 7-point Likert scale ( 1 =very much improved and 7 is very much worse | 1 year | 
| Disability | Physical function will be assessed using the Oswestry Disability Index | 1 year | 
| Quality of Life utility score | EuroQol-5D-5L | 1 year | 
| Safety; Serious and Adverse events | Safety will be monitored by the collection and reporting of device related adverse events, device related serious adverse events and any unanticipated serious adverse events (regardless of device relatedness). | 1 year | 
| Pain type | PainDETECT® questionnaire which is designed to differentiate between neuropathic and non-neuropathic pain. | 1 year |