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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

Tracking Information
First Submitted Date April 30, 2012
First Posted Date May 2, 2012
Last Update Posted Date May 19, 2015
Study Start Date August 2012
Estimated Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 14, 2013)
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).
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT01590004 on Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title Technical Description of Cooled Radiofrequency Ablation of Lumbar Medial Branches for the Treatment of Lumbar Facet Pain
Official Title Technical Description of Cooled Radiofrequency Ablation of Lumbar Medial Branches for the Treatment of Lumbar Facet Pain
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.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients of Medical Advanced Pain Specialists, PA (MAPS)
Condition Lumbar Facet Joint Pain
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: May 1, 2012)
Original Estimated Enrollment Same as current
Study Completion Date Not Provided
Estimated Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sexes Eligible for Study: All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
Administrative Information
NCT Number NCT01590004
Other Study ID Numbers lumbar01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Mehul Desai, MAPS Applied Research Center
Study Sponsor Mehul Desai
Collaborators Halyard Health
Principal Investigator: Mehul J Desai, MD MAPS Applied Research Center
PRS Account MAPS Applied Research Center
Verification Date May 2015