Chronic discogenic low back pain Effect of neurostimulation on chronic discogenic low back pain
Conditions
Interventions
Subjects enrolled will be asked to complete several questionnaires prior to
their procedure and at routine follow up visits for 12 months.
Sponsors
St. Jude Medical
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. Neurologic exam without marked motor deficit. 7. Definite/Highly Probable/Discogenic Pain as confirmed by provocative discography according to IASP/ISIS 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 neurostimulation system as typically utilised in the study centre 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 within the 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 height loss 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 reduction in the intensity of LBP of >=30% or 2 points on a numerical pain rating scale (NPRS)22 in the implanted subjects at 6 and 12 month follow up visits as compared to baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Subject Satisfaction with treatment will be assessed using the Patient Global Impression of Change (PGIC), a 7 point Likert scale • Number (percentage) of subjects who achieve a >=50% reduction in the intensity of the LBP at 6 and 12 months FU • Pain relief (>=30% and >=50%) in other painful anatomy related to the back pain (e.g. Leg, buttock or foot) • Functional improvements will be assessed using the Oswestry Disability Index (ODI) at the 6 and 12 month follow up as compared to baseline • Reduction in analgesia intake will be assessed by a comprehensive inventory of medication used at the 6 and 12 month FU as compared to baseline. • Quality of Life (QOL) improvements will be assessed at all visits using the EQ-5D as compared to baseline values • Change in psychological disposition assessed using the Profile of Mood States (POMS) at 6 and 12 month FU visits as compared to baseline • Characterisation of LBP will be assessed at baseline; then at the 6 month and 12 month FU visits using the painDETECT® questionnaire which is designed to differentiate neuropathic and non-neuropathic pain states. This may provide interesting data in post hoc analysis of responders and non-responders to the therapy • Safety will be monitored by the collection and reporting (as required) of device related adverse events (AE*s), device related serious adverse events (SAE*s) and any unanticipated SAE*s (regardless of device relatedness) | — |
Countries
Netherlands
Outcome results
None listed