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Burst Neurostimulation for Discogenic Low Back Pain

NCT03958604 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2024-11-19

No results posted yet for this study

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

Interventions

PROCEDURE

Neurostimulation

Spinal cord stimulation with burst modality for discogenic low back pain

Sponsors & Collaborators

  • Abbott Medical Devices

    collaborator INDUSTRY

  • Rijnstate Hospital

    lead OTHER

Principal Investigators

  • Jan Willem Kallewaard, MD · Rijnstate Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-28
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03958604 on ClinicalTrials.gov