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

Lumbar Facet Joint Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01590004
• Other study ID #: lumbar01
• Status: Recruiting
• Phase: N/A
• First received: April 30, 2012
• Last updated: May 18, 2015
• Start date: August 2012

Study information

• Verified date: May 2015
• Source: MAPS Applied Research Center
• Contact: Mehul J Desai, MD
• Phone: (301)588-7888
• Email: mehuljdesaimd[@]gmail.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Lumbar Facet Joint Pain

Locations

Country	Name	City	State
United States	MAPS Applied Research Center, Inc.	Edina	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mehul Desai	Halyard Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Confirm acute safety of the 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).	Baseline to 3 months post procedure.	Yes