Burst Neurostimulation for Discogenic Low Back Pain

Rijnstate Hospital

Status

Completed

Conditions

Discogenic Pain

Low Back Pain

Treatments

Procedure: Neurostimulation

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03958604

NL 67172.091.18

Details and patient eligibility

About

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.

Full description

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.

Enrollment

16 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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