- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01590004
Technical Description of Cooled Radiofrequency Ablation of Lumbar Medial Branches for the Treatment of Lumbar Facet Pain
May 18, 2015 updated by: Mehul Desai
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.
Study Overview
Status
Unknown
Conditions
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
Enrollment (Anticipated)
10
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mehul J Desai, MD
- Phone Number: (301)588-7888
- Email: mehuljdesaimd@gmail.com
Study Contact Backup
- Name: Nicholas J Peterson, BS
- Phone Number: (414) 325-3724
- Email: nicholas.peterson@apmhealth.com
Study Locations
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Minnesota
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Edina, Minnesota, United States, 55435
- Recruiting
- MAPS Applied Research Center, Inc.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients of Medical Advanced Pain Specialists, PA (MAPS)
Description
Inclusion Criteria:
- 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
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Confirm acute safety of the procedure
Time Frame: Baseline to 3 months post procedure.
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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:
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Baseline to 3 months post procedure.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Mehul J Desai, MD, MAPS Applied Research Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2012
Primary Completion (Anticipated)
March 1, 2016
Study Registration Dates
First Submitted
April 30, 2012
First Submitted That Met QC Criteria
May 1, 2012
First Posted (Estimate)
May 2, 2012
Study Record Updates
Last Update Posted (Estimate)
May 19, 2015
Last Update Submitted That Met QC Criteria
May 18, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- lumbar01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Lumbar Facet Joint Pain
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Complejo Hospitalario Universitario de GranadaUnknownFacet Joint Pain | Facet Syndrome of Lumbar Spine | Facet Joints; DegenerationSpain
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Stanford UniversityWithdrawnLumbar Facet Joint PainUnited States
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Instituto de Investigación Hospital Universitario...CompletedLumbar Facet Joint Pain | Lumbar Medial Branch NeurotomySpain
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Erasme University HospitalUnknownLow Back Pain | Chronic Low Back Pain | Facet Joint Pain | Facet Syndrome of Lumbar SpineBelgium
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University of AarhusAarhus University HospitalActive, not recruitingChronic Low-back Pain | Facet Joint Pain | Back Pain Lower Back Chronic | Degeneration Lumbar Spine | Facet Joint SyndromeDenmark
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Johns Hopkins UniversityWalter Reed National Military Medical Center; Uniformed Services University...CompletedLow Back Pain | Lumbar Facet Joint PainUnited States
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Assiut UniversityRecruitingLumbar Facet Joint PainEgypt
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Seoul National University Bundang HospitalUnknownLow Back Pain | Arthropathy | Lumbar Facet Joint PainKorea, Republic of
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Balgrist University HospitalUniversity of ZurichCompletedPain, Back | Arthropathy of Lumbar FacetSwitzerland
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Interventional Spine, Inc.Withdrawn