Burst Neurostimulation for Discogenic Low Back Pain

NCT03958604 | Completed

• 1 other identifier: NL 67172.091.18
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Discogenic Pain; Low Back Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Treatment satisfaction

  1 year

• Disability

  1 year

• Quality of Life utility score

  1 year

• Safety; Serious and Adverse events

  1 year

• Pain type

  1 year

Study Arms (1)

Burst Spinal Cord Neurostimulation

EXPERIMENTAL

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

Procedure: Neurostimulation

Interventions

Neurostimulation PROCEDURE

Spinal cord stimulation with burst modality for discogenic low back pain

Also known as: spinal cord burst stimulation, spinal cord stimulation, ProdigyTM Abbott Laboratories, ProclaimTM Abbott Laboratories

Burst Spinal Cord Neurostimulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rijnstate Hospital: lead
• Abbott Medical Devices: collaborator

Study Sites (1)

Rijnstate hospital Pain Management Centre Velp

Arnhem, Gelderland, 6883 AZ, Netherlands

Location

Related Publications (4)

• Courtney P, Espinet A, Mitchell B, Russo M, Muir A, Verrills P, Davis K. Improved Pain Relief With Burst Spinal Cord Stimulation for Two Weeks in Patients Using Tonic Stimulation: Results From a Small Clinical Study. Neuromodulation. 2015 Jul;18(5):361-6. doi: 10.1111/ner.12294. Epub 2015 Apr 16.

  PMID: 25879884 BACKGROUND

• Kallewaard JW, Terheggen MA, Groen GJ, Sluijter ME, Derby R, Kapural L, Mekhail N, van Kleef M. 15. Discogenic low back pain. Pain Pract. 2010 Nov-Dec;10(6):560-79. doi: 10.1111/j.1533-2500.2010.00408.x. Epub 2010 Sep 6.

  PMID: 20825564 BACKGROUND

• Mons MR, Chapman KB, Terwiel C, Joosten EA, Kallewaard JW. Burst Spinal Cord Stimulation as Compared With L2 Dorsal Root Ganglion Stimulation in Pain Relief for Nonoperated Discogenic Low Back Pain: Analysis of Two Prospective Studies. Neuromodulation. 2024 Jan;27(1):172-177. doi: 10.1016/j.neurom.2023.04.464. Epub 2023 May 16.

  PMID: 37191612 DERIVED

• Mons MR, Chapman KB, Terwiel C, Joosten EA, Kallewaard JW. A prospective study of BurstDR spinal cord stimulation for non-operated discogenic low back pain. Pain Pract. 2023 Mar;23(3):234-241. doi: 10.1111/papr.13181. Epub 2022 Nov 23.

  PMID: 36373868 DERIVED

MeSH Terms

Conditions

Low Back Pain

Interventions

Spinal Cord Stimulation

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Jan Willem Kallewaard, MD

  Rijnstate Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 20, 2019
• First Posted: May 22, 2019
• Study Start: May 28, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: November 19, 2024

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)