Technical Description of Cooled Radiofrequency Ablation of Lumbar Medial Branches for the Treatment of Lumbar Facet Pain

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.

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