Technical Description of Cooled Radiofrequency Ablation of Lumbar Medial Branches for the Treatment of Lumbar Facet Pain
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ClinicalTrials.gov Identifier: NCT01590004
Verified May 2015 by Mehul Desai, MAPS Applied Research Center. Recruitment status was: Recruiting
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
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.
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).
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Ages Eligible for Study:
18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients of Medical Advanced Pain Specialists, PA (MAPS)
Aged between 18 and 75 years
Chronic lumbar pain for > 6 months
3-day average NRS score at least 4 and not greater than 8
Clinical features consistent with possible lumbar z-joint pain (such as pain and tenderness over not more than three segments unilaterally)
No adequate relief with conservative management, including physical therapy, chiropractic manipulation, exercises, and drug therapy
Understand and tolerate lumbar medial branch diagnostic blocks
Positive for lumbar zygapophyseal joint pain after comparative diagnostic blocks (≥ 80% pain relief) per standard of care.
Understands study protocol and provides voluntary written consent to participate in study and outcome measurements
Normal neurological exam
Understands and agrees to use an acceptable form of birth control
Current pregnancy, currently breast feeding or the intent of becoming pregnant during the study period
Prior posterior lumbar fusion
Prior low back surgery
Concurrent cervical or thoracic pain or pain in these regions lasting longer than 2 weeks during the last 6 months
Compensable disability or work injury or ongoing litigation
Prior treatment with radiofrequency neurotomy in the lumbar region within 3 months
Discogenic pain verified by controlled discography
Sources of pain not in the lumbar spine
Leg pain greater than back pain
Obvious inappropriate pain behavior during physical exam
Positive straight leg raising result
Any features of upper motor neuron lesion
Gait abnormality not attributable to spinal pain
Severe Central Spinal Canal Stenosis (> 50%) evident on prior computed tomogram or magnetic resonance image
More than 75% narrowing of a disc space on plain radiographs
Score higher than 20 on the Beck Depression Inventory
Patients addicted to alcohol, narcotics or other illegal substances
Dependence on opioids
Uncontrolled acute/chronic illness that may confound interpretation of outcome measures
Allergy to injectants, medication or anesthetics to be used
Active or uncontrolled rheumatoid arthritis or other autoimmune diseases
Patients with a history of mental instability or diagnosed with a mental disorder
Patient unwilling or unable to comply with study procedures or follow-up visits