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

Completed

• Conditions: chronische lage rugpijn vanuit de tussenwervelschijf; chronic discogenic low back pain; low back pain

• Registration Number: NL-OMON48334
• Lead Sponsor: Rijnstate Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

1. Subject of either gender between 18 and 65 years of age
2. Subject is able and willing to comply with the follow-up schedule and protocol
3. Subject is able to provide written informed consent
4. Chronic low back pain of at least 6 months
5. History consistent with discogenic low back pain (e.g. Pain produced on lumbar motion, significant functional limitation in sitting duration and tolerance)
6. Neurolog1c exam without marked motor deficit
7 Definite/Highly Probable/Discogenic Pam as confirmed by provocative discography according to IASPllSI S guidelines*
8. Low Back Pain intensity should be 6 or higher measured on a NPRS at baseline
9 Meets all the inclusion criteria for the implantation of a neurostimulallon system as typically utilised in the study centre for patients with discogenic low back pain
10. Subject has been screened by a multi-disciplinary panel including a psychologist and deemed suitable for implantation

Exclusion Criteria

1. Female subject of childbearing potential is pregnant/nursing or plans to become pregnant during the course of the study
2. Escalating or changing pain condition within the past month as evidenced by investigator examination
3. BMI 35
4. Subject has had injection therapy or radiofrequency treatment for their low back pain withinthe past 3 months 5.Subject currently has an active implantable device including ICD,pacemaker , spinal cord stimulator or
intrathecal drug pump
6. Subject is unable to operate the device
7. Severe disc degeneration at the affected level as evidenced by >50% disc heightl on plain anteroposterior and lateral lumbar radiographs or CT/MRI.
8. Extruded or sequestered herniated nucleus pulposus at the affected level(s).
9. Previous lumbar back surgery (e.g. Laminectomy, discectomy or fusion) at the affected level(s)
10. Moderate to severe spinal stenosis due to osteophyte and/or ligamentous overgrowth as evidenced by MRI or CT in the previous 6 months
11. Moderate to severe endplate degenerative changes at the affected levels
12. Grade 1-2 spondylolisthesis
13. Previous Neurostimulation therapy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To determine the number (percentage) of subjects who achieve a sustained and<br /><br>clinically meaningful pain reduction compared to baseline(at least 30%) or 2<br /><br>points on a numerical pain rating scale (NPRS) in the by burst stimulation<br /><br>treated subjects at 12 months follow-up.</p><br>