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.
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Locations near you
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Full eligibility criteria for NCT01590004
Ages eligible for Study
18 Years to 75 Years
Genders eligible for Study
Accepts Healthy Volunteers
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
The presence of a pacemaker in the patient
All locations for NCT01590004
United States (1)
MAPS Applied Research Center, Inc.
Edina, Minnesota, United States, 55435
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View full eligibility
Tris trial is registered with FDA with number: NCT01590004. The sponsor of the trial is Mehul Desai and it is looking for 10 volunteers for the current phase.
Official trial title: Technical Description of Cooled Radiofrequency Ablation of Lumbar Medial Branches for the Treatment of Lumbar Facet Pain
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