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NCT03958604

Burst Neurostimulation for Discogenic Low Back Pain

Completed NA Last updated 19 November 2024
What this trial tests

NA trial testing Neurostimulation in Discogenic Pain in 16 participants. Completed in 31 December 2021.

Timeline
28 May 2019
Primary endpoint
31 December 2021
31 December 2021

Quick facts

Lead sponsorRijnstate Hospital
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment16
Start date28 May 2019
Primary completion31 December 2021
Estimated completion31 December 2021
Sites1 location across Netherlands

Drugs / interventions tested

Conditions studied

Sponsor

Rijnstate Hospital

Who can join

Adults 18 to 65, any sex, with Discogenic Pain or Low Back Pain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. 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.
    Mons MR, Chapman KB, Terwiel C, Joosten EA, et al · · 2024 · cited 3× · PMID 37191612 · DOI 10.1016/j.neurom.2023.04.464

Verify or expand the search:

Other trials of Neurostimulation

Trials testing the same drug.

Other recruiting trials for Discogenic Pain

Currently open trials in the same condition.

Other Rijnstate Hospital trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03958604.

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