Burst Neurostimulation for Discogenic Low Back Pain

Rijnstate Hospital16 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Pain severity

Pain severity, assessed by an 11 point (0-10) numerical pain rating scale 0=no pain, 10 very severe pain

Time frame: 1 year

Secondary Outcomes

Treatment satisfaction

Patient's Global Impression of Change, a 7-point Likert scale ( 1 =very much improved and 7 is very much worse

Time frame: 1 year

Disability

Physical function will be assessed using the Oswestry Disability Index

Time frame: 1 year

Quality of Life utility score

EuroQol-5D-5L

Time frame: 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).

Time frame: 1 year

Pain type

PainDETECT® questionnaire which is designed to differentiate between neuropathic and non-neuropathic pain.

Time frame: 1 year

Burst Neurostimulation for Discogenic Low Back Pain

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes