chronische lage rugpijn vanuit de tussenwervelschijf chronic discogenic low back pain
Conditions
Interventions
Burst spinal cord neurostimulation. If this type of stimulation proofs
unsuccessful after a trial period, Dorsal root ganglion(DRG) stimulation of
level L2 is optionally available for the patients a
Sponsors
Rijnstate Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the number (percentage) of subjects who achieve a sustained and clinically meaningful pain reduction compared to baseline(at least 30%) or 2 points on a numerical pain rating scale (NPRS) in the by burst stimulation treated subjects at 12 months follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| * Subject Satisfaction with treatment will be assessed using the Pat ent GlobalImpression of Change (PGIC), a 7 point Likert scale * Number (percentage) of subjects who achieve a 250% reduction in the intensity of the LBP at 6 and 12 months FU * Pain relief (230% and | — |
Countries
Netherlands
Outcome results
None listed