Burst Neurostimulation for Discogenic Low Back Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-28

Study Completion Date

2021-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT02587637

Chronic Pain

COMPLETED NA

Spinal Cord Stimulation for Low Back Pain

NCT00205868

Chronic Pain

COMPLETED PHASE4

Bone Marrow Concentrate Intradiscal Injection for Chronic Discogenic Low Back Pain

NCT03340818

Discogenic Pain

COMPLETED NA

An Implantable Spinal Cord Stimulation Pain Management System

NCT00205855

Chronic Pain Pain, Intractable Pain +2 more

COMPLETED PHASE3

Study Of Disc Anaesthesia For The Preoperative Diagnosis Of Chronic Lower Back Pain

NCT00443781

Low Back Pain

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Discogenic Pain Low Back Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Burst Spinal Cord Neurostimulation

Burst spinal cord stimulation. When this fails, tonic stimulation targeting the DRG wil be applied

Group Type EXPERIMENTAL

Neurostimulation

Intervention Type PROCEDURE

Spinal cord stimulation with burst modality for discogenic low back pain

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Neurostimulation

Spinal cord stimulation with burst modality for discogenic low back pain

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

spinal cord burst stimulation spinal cord stimulation ProdigyTM Abbott Laboratories ProclaimTM Abbott Laboratories

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No