Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2026-01-03 @ 12:47 PM
Study NCT ID:
NCT01590004
Status:
UNKNOWN
Last Update Posted:
2015-05-19
First Post:
2012-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Technical Description of Cooled Radiofrequency Ablation of Lumbar Medial Branches for the Treatment of Lumbar Facet Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'lastUpdateSubmitDate': '2015-05-18', 'studyFirstSubmitDate': '2012-04-30', 'studyFirstSubmitQcDate': '2012-05-01', 'lastUpdatePostDateStruct': {'date': '2015-05-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Confirm acute safety of the procedure', 'timeFrame': 'Baseline to 3 months post procedure.', 'description': 'The primary outcome is to confirm acute safety of the procedure utilizing the neurological exam.\n\nThe following outcome measures will also be used to confirm there are no safety concerns at one month and 3 months follow-up visits:\n\n* Pain intensity using the Numerical Rating Scale (NRS)\n* Change in medication usage\n* 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).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['LumbarCool system', 'Cooled radiofrequency medial ablation', 'Cooled-RF neurotomy'], 'conditions': ['Lumbar Facet Joint Pain']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients of Medical Advanced Pain Specialists, PA (MAPS)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Literate\n2. Aged between 18 and 75 years\n3. Chronic lumbar pain for \\> 6 months\n4. 3-day average NRS score at least 4 and not greater than 8\n5. Clinical features consistent with possible lumbar z-joint pain (such as pain and tenderness over not more than three segments unilaterally)\n6. No adequate relief with conservative management, including physical therapy, chiropractic manipulation, exercises, and drug therapy\n7. Understand and tolerate lumbar medial branch diagnostic blocks\n8. Positive for lumbar zygapophyseal joint pain after comparative diagnostic blocks (≥ 80% pain relief) per standard of care.\n9. Understands study protocol and provides voluntary written consent to participate in study and outcome measurements\n10. Normal neurological exam\n11. Understands and agrees to use an acceptable form of birth control\n\nExclusion Criteria:\n\n1. Current pregnancy, currently breast feeding or the intent of becoming pregnant during the study period\n2. Prior posterior lumbar fusion\n3. Prior low back surgery\n4. Concurrent cervical or thoracic pain or pain in these regions lasting longer than 2 weeks during the last 6 months\n5. Compensable disability or work injury or ongoing litigation\n6. Prior treatment with radiofrequency neurotomy in the lumbar region within 3 months\n7. Discogenic pain verified by controlled discography\n8. Sources of pain not in the lumbar spine\n9. Leg pain greater than back pain\n10. Obvious inappropriate pain behavior during physical exam\n11. Neurologic deficits\n12. Positive straight leg raising result\n13. Any features of upper motor neuron lesion\n14. Gait abnormality not attributable to spinal pain\n15. Severe Central Spinal Canal Stenosis (\\> 50%) evident on prior computed tomogram or magnetic resonance image\n16. Spondylolysis\n17. Spondylolisthesis\n18. More than 75% narrowing of a disc space on plain radiographs\n19. Spondyloarthropathy\n20. Score higher than 20 on the Beck Depression Inventory\n21. Patients addicted to alcohol, narcotics or other illegal substances\n22. Dependence on opioids\n23. Uncontrolled acute/chronic illness that may confound interpretation of outcome measures\n24. Allergy to injectants, medication or anesthetics to be used\n25. Active or uncontrolled rheumatoid arthritis or other autoimmune diseases\n26. Patients with a history of mental instability or diagnosed with a mental disorder\n27. Patient unwilling or unable to comply with study procedures or follow-up visits\n28. The presence of a pacemaker in the patient'}, 'identificationModule': {'nctId': 'NCT01590004', 'briefTitle': 'Technical Description of Cooled Radiofrequency Ablation of Lumbar Medial Branches for the Treatment of Lumbar Facet Pain', 'organization': {'class': 'INDUSTRY', 'fullName': 'MAPS Applied Research Center'}, 'officialTitle': 'Technical Description of Cooled Radiofrequency Ablation of Lumbar Medial Branches for the Treatment of Lumbar Facet Pain', 'orgStudyIdInfo': {'id': 'lumbar01'}}, 'contactsLocationsModule': {'locations': [{'zip': '55435', 'city': 'Edina', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'MAPS Applied Research Center, Inc.', 'geoPoint': {'lat': 44.88969, 'lon': -93.34995}}], 'centralContacts': [{'name': 'Mehul J Desai, MD', 'role': 'CONTACT', 'email': 'mehuljdesaimd@gmail.com', 'phone': '(301)588-7888'}, {'name': 'Nicholas J Peterson, BS', 'role': 'CONTACT', 'email': 'nicholas.peterson@apmhealth.com', 'phone': '(414) 325-3724'}], 'overallOfficials': [{'name': 'Mehul J Desai, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MAPS Applied Research Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mehul Desai', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Halyard Health', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mehul Desai', 'investigatorAffiliation': 'MAPS Applied Research Center'}}}}