Technical Description of Cooled Radiofrequency Ablation of Lumbar Medial Branches for the Treatment of Lumbar Facet Pain
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Purpose
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 |
|---|
|
Lumbar Facet Joint Pain |
| Study Type: | Observational |
| Study Design: | 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 |
- Confirm acute safety of the procedure [ Time Frame: Baseline to 3 months post procedure. ] [ Designated as safety issue: Yes ]
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).
| Estimated Enrollment: | 10 |
| Study Start Date: | August 2012 |
| Estimated Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Patients of the George Washington Spine and Pain Center
Inclusion Criteria:
- Literate
- Aged between 18 and 60 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
Exclusion Criteria:
- 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
- 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
Contacts and Locations| Contact: Mehul J Desai, MD | (202) 715-4599 | mdesai@mfa.gwu.edu |
| Contact: Margot I Kern, MS | (202) 715-4269 | mkern@mfa.gwu.edu |
| United States, District of Columbia | |
| GW Spine and Pain Center | Recruiting |
| Washington, District of Columbia, United States, 20037 | |
| Principal Investigator: | Mehul J Desai, MD | George Washington University |
More Information
No publications provided
| Responsible Party: | George Washington University |
| ClinicalTrials.gov Identifier: | NCT01590004 History of Changes |
| Other Study ID Numbers: | lumbar01 |
| Study First Received: | April 30, 2012 |
| Last Updated: | May 14, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by George Washington University:
|
LumbarCool system Cooled radiofrequency medial ablation Cooled-RF neurotomy |
Additional relevant MeSH terms:
|
Arthralgia Joint Diseases Musculoskeletal Diseases Pain Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013