Burst Neurostimulation for Discogenic Low Back Pain

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

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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain; Discogenic Pain
• Intervention / Treatment: Procedure: Neurostimulation

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Gelderland
    • Arnhem, Gelderland, Netherlands, 6883 AZ
      • Rijnstate hospital Pain Management Centre Velp

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Rijnstate Hospital
• Collaborators: Abbott Medical Devices
• Investigators: Principal Investigator: Jan Willem Kallewaard, MD, Rijnstate Hospital

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2019
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: May 20, 2019
• First Submitted That Met QC Criteria: May 20, 2019
• First Posted (Actual): May 22, 2019

Study Record Updates

• Last Update Posted (Estimated): November 19, 2024
• Last Update Submitted That Met QC Criteria: November 15, 2024
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: NL 67172.091.18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No