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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01590004
Recruitment Status : Unknown
Verified May 2015 by Mehul Desai, MAPS Applied Research Center.
Recruitment status was:  Recruiting
First Posted : May 2, 2012
Last Update Posted : May 19, 2015
Halyard Health
Information provided by (Responsible Party):
Mehul Desai, MAPS Applied Research Center

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.

Condition or disease
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.

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Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Technical Description of Cooled Radiofrequency Ablation of Lumbar Medial Branches for the Treatment of Lumbar Facet Pain
Study Start Date : August 2012
Estimated Primary Completion Date : March 2016

Primary Outcome Measures :
  1. Confirm acute safety of the procedure [ Time Frame: 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).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients of Medical Advanced Pain Specialists, PA (MAPS)

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01590004

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Contact: Mehul J Desai, MD (301)588-7888
Contact: Nicholas J Peterson, BS (414) 325-3724

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United States, Minnesota
MAPS Applied Research Center, Inc. Recruiting
Edina, Minnesota, United States, 55435
Sponsors and Collaborators
Mehul Desai
Halyard Health
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Principal Investigator: Mehul J Desai, MD MAPS Applied Research Center

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Responsible Party: Mehul Desai, Principal Investigator, MAPS Applied Research Center Identifier: NCT01590004     History of Changes
Other Study ID Numbers: lumbar01
First Posted: May 2, 2012    Key Record Dates
Last Update Posted: May 19, 2015
Last Verified: May 2015
Keywords provided by Mehul Desai, MAPS Applied Research Center:
LumbarCool system
Cooled radiofrequency medial ablation
Cooled-RF neurotomy
Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases
Neurologic Manifestations
Signs and Symptoms