Lumbar Facet Joint Pain
Conditions
Keywords
LumbarCool system, Cooled radiofrequency medial ablation, Cooled-RF neurotomy
Brief summary
This study aims to develop a technical description of lumbar medial branch ablation using the LumbarCool system. The procedure uses cooled radiofrequency (cooled-RF) technology in treating patients with diagnosed lumbar facet joint pain.
Detailed description
This is a prospective, open-label, single center clinical study to be enrolled at George Washington University Medical Center. This study will consist of 10 patients and each patient will be assessed at pre-treatment, pre-discharge, and at 1 and 3 months post treatment. Outcomes to be evaluated include: pain severity, disability, and the occurrence of adverse events.
Interventions
None listed
Sponsors
Halyard Health
Mehul Desai
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Literate 2. Aged between 18 and 75 years 3. Chronic lumbar pain for \> 6 months 4. 3-day average NRS score at least 4 and not greater than 8 5. Clinical features consistent with possible lumbar z-joint pain (such as pain and tenderness over not more than three segments unilaterally) 6. No adequate relief with conservative management, including physical therapy, chiropractic manipulation, exercises, and drug therapy 7. Understand and tolerate lumbar medial branch diagnostic blocks 8. Positive for lumbar zygapophyseal joint pain after comparative diagnostic blocks (≥ 80% pain relief) per standard of care. 9. Understands study protocol and provides voluntary written consent to participate in study and outcome measurements 10. Normal neurological exam 11. Understands and agrees to use an acceptable form of birth control
Exclusion criteria
1. Current pregnancy, currently breast feeding or the intent of becoming pregnant during the study period 2. Prior posterior lumbar fusion 3. Prior low back surgery 4. Concurrent cervical or thoracic pain or pain in these regions lasting longer than 2 weeks during the last 6 months 5. Compensable disability or work injury or ongoing litigation 6. Prior treatment with radiofrequency neurotomy in the lumbar region within 3 months 7. Discogenic pain verified by controlled discography 8. Sources of pain not in the lumbar spine 9. Leg pain greater than back pain 10. Obvious inappropriate pain behavior during physical exam 11. Neurologic deficits 12. Positive straight leg raising result 13. Any features of upper motor neuron lesion 14. Gait abnormality not attributable to spinal pain 15. Severe Central Spinal Canal Stenosis (\> 50%) evident on prior computed tomogram or magnetic resonance image 16. Spondylolysis 17. Spondylolisthesis 18. More than 75% narrowing of a disc space on plain radiographs 19. Spondyloarthropathy 20. Score higher than 20 on the Beck Depression Inventory 21. Patients addicted to alcohol, narcotics or other illegal substances 22. Dependence on opioids 23. Uncontrolled acute/chronic illness that may confound interpretation of outcome measures 24. Allergy to injectants, medication or anesthetics to be used 25. Active or uncontrolled rheumatoid arthritis or other autoimmune diseases 26. Patients with a history of mental instability or diagnosed with a mental disorder 27. Patient unwilling or unable to comply with study procedures or follow-up visits 28. The presence of a pacemaker in the patient
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Confirm acute safety of the procedure | Baseline to 3 months post procedure. | The primary outcome is to confirm acute safety of the procedure utilizing the neurological exam. The following outcome measures will also be used to confirm there are no safety concerns at one month and 3 months follow-up visits: * Pain intensity using the Numerical Rating Scale (NRS) * Change in medication usage * Assessment of adverse device effects, including neurological exam (light touch/pin prick, strength, straight leg test, gait, heel to toe/straight-line walking, heel to shin) (immediately post procedure, 1 month and 3 months). |
Countries
United States
Contacts
Primary ContactMehul J Desai, MD
Backup ContactNicholas J Peterson, BS
Outcome results
None listed