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

Status unconfirmed

Conditions studied: Lumbar Facet Joint Pain

In brief

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.

Key facts

Study ID

NCT01590004

Run by

Mehul Desai

People needed

10

Starts

2012-08-01

Last updated by the study team

2015-05-19

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Literate
• 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

You may not qualify if…

• 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
• Neurologic deficits
• 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
• Spondylolysis
• Spondylolisthesis
• More than 75% narrowing of a disc space on plain radiographs
• Spondyloarthropathy
• 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

Where it is running

• MAPS Applied Research Center, Inc. — Edina, Minnesota, United States (enrolling)

Full record on ClinicalTrials.gov

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