Ignite Creation Date:
2025-12-26 @ 4:00 PM
Ignite Modification Date:
2025-12-28 @ 11:56 PM
Study NCT ID:
NCT00355706
Status:
COMPLETED
Last Update Posted:
2020-03-10
First Post:
2006-07-24
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effectiveness of Thoracic Facet Joint Nerve Blocks
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}], 'ancestors': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'drm@asipp.org', 'phone': '2705548373', 'title': 'Laxmaiah Manchikanti, MD', 'phoneExt': '100', 'organization': 'Pain Management Center of Paducah'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Group I - With Local Anesthetics', 'description': 'Group I - Thoracic medial branch blocks with local anesthetics', 'otherNumAtRisk': 50, 'otherNumAffected': 0, 'seriousNumAtRisk': 50, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Group II - With Bupivacaine and Steroid', 'description': 'Group II - Thoracic medial branch blocks with bupivacaine and steroid', 'otherNumAtRisk': 50, 'otherNumAffected': 0, 'seriousNumAtRisk': 50, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Numeric Rating Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group I Without Steroids', 'description': 'Thoracic Facet Joint Nerve Blocks with Local Anesthetic (0.25% Bupivacaine)'}, {'id': 'OG001', 'title': 'Group II With Steroid', 'description': 'Thoracic Facet Joint Nerve Blocks with Local Anesthetic (0.25% Bupivacaine) and Steroids (0.15 mg of non-particulate betamethasone)'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '7.9', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '7.8', 'spread': '1.0', 'groupId': 'OG001'}]}]}, {'title': '3 months', 'categories': [{'measurements': [{'value': '3.1', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '0.7', 'groupId': 'OG001'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '3.0', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '3.2', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': '12 months', 'categories': [{'measurements': [{'value': '3.2', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '1.0', 'groupId': 'OG001'}]}]}, {'title': '18 months', 'categories': [{'measurements': [{'value': '3.0', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '1.0', 'groupId': 'OG001'}]}]}, {'title': '24 months', 'categories': [{'measurements': [{'value': '3.1', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '1.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.964', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': '2 years', 'description': 'Numeric rating scale represented 0 with no pain and 10 with the worst pain imaginable.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Opioid Intake', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group I - Without Steroids', 'description': 'Thoracic medial branch blocks with local anesthetics'}, {'id': 'OG001', 'title': 'Group II - With Steroids', 'description': 'Thoracic medial branch blocks with bupivacaine and steroid'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '48.0', 'spread': '53.75', 'groupId': 'OG000'}, {'value': '47.9', 'spread': '48.6', 'groupId': 'OG001'}]}]}, {'title': '3 months', 'categories': [{'measurements': [{'value': '38.0', 'spread': '44.2', 'groupId': 'OG000'}, {'value': '40.3', 'spread': '33.9', 'groupId': 'OG001'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '38.2', 'spread': '46.1', 'groupId': 'OG000'}, {'value': '39.3', 'spread': '34.8', 'groupId': 'OG001'}]}]}, {'title': '12 months', 'categories': [{'measurements': [{'value': '37.6', 'spread': '38.4', 'groupId': 'OG000'}, {'value': '37.8', 'spread': '33.2', 'groupId': 'OG001'}]}]}, {'title': '18 months', 'categories': [{'measurements': [{'value': '37.6', 'spread': '46.4', 'groupId': 'OG000'}, {'value': '38.7', 'spread': '35.2', 'groupId': 'OG001'}]}]}, {'title': '24 months', 'categories': [{'measurements': [{'value': '37.6', 'spread': '46.4', 'groupId': 'OG000'}, {'value': '38.7', 'spread': '35.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.892', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': '24 months', 'description': 'Opioid intake(morphine equivalence mg)', 'unitOfMeasure': 'mg/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Oswestry Disability Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group I - Without Steroids', 'description': 'Thoracic medial branch blocks with local anesthetics'}, {'id': 'OG001', 'title': 'Group II - With Steroids', 'description': 'Thoracic medial branch blocks with bupivacaine and steroid'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '27.1', 'spread': '6.6', 'groupId': 'OG000'}, {'value': '27.5', 'spread': '5.8', 'groupId': 'OG001'}]}]}, {'title': '3 months', 'categories': [{'measurements': [{'value': '13.0', 'spread': '4.9', 'groupId': 'OG000'}, {'value': '11.6', 'spread': '3.7', 'groupId': 'OG001'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '13.0', 'spread': '4.2', 'groupId': 'OG000'}, {'value': '11.9', 'spread': '3.8', 'groupId': 'OG001'}]}]}, {'title': '12 months', 'categories': [{'measurements': [{'value': '12.0', 'spread': '4.0', 'groupId': 'OG000'}, {'value': '11.8', 'spread': '3.9', 'groupId': 'OG001'}]}]}, {'title': '18 months', 'categories': [{'measurements': [{'value': '12.0', 'spread': '4.9', 'groupId': 'OG000'}, {'value': '11.7', 'spread': '3.9', 'groupId': 'OG001'}]}]}, {'title': '24 months', 'categories': [{'measurements': [{'value': '11.7', 'spread': '4.9', 'groupId': 'OG000'}, {'value': '11.0', 'spread': '4.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.560', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': '24 months', 'description': 'Oswestry Disability Index (ODI) - ODI score is ranged from 0 to 50. Total score is converted in to percent disability. ODI Scoring: 0% to 20% (minimal disability), 21%-40% (moderate disability), 41%-60% (severe disability), 61%-80% (crippled) and 81%-100 (these patients are either bed-bound or exaggerating their symptoms).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group I - Without Steroids', 'description': 'Group I - Thoracic medial branch blocks with local anesthetics'}, {'id': 'FG001', 'title': 'Group II - With Steroids', 'description': 'Group II - Thoracic medial branch blocks with bupivacaine and steroid'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Group I - With Local Anesthetics', 'description': 'Group I - Thoracic medial branch blocks with local anesthetics'}, {'id': 'BG001', 'title': 'Group II - With Bupivacaine and Steroid', 'description': 'Group II - Thoracic medial branch blocks with bupivacaine and steroid'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '97', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44.7', 'spread': '11.7', 'groupId': 'BG000'}, {'value': '42.8', 'spread': '12.3', 'groupId': 'BG001'}, {'value': '43.8', 'spread': '12.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-02', 'studyFirstSubmitDate': '2006-07-24', 'resultsFirstSubmitDate': '2012-12-06', 'studyFirstSubmitQcDate': '2006-07-24', 'lastUpdatePostDateStruct': {'date': '2020-03-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-09-27', 'studyFirstPostDateStruct': {'date': '2006-07-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-11-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Opioid Intake', 'timeFrame': '24 months', 'description': 'Opioid intake(morphine equivalence mg)'}], 'primaryOutcomes': [{'measure': 'Numeric Rating Scale', 'timeFrame': '2 years', 'description': 'Numeric rating scale represented 0 with no pain and 10 with the worst pain imaginable.'}, {'measure': 'Oswestry Disability Index', 'timeFrame': '24 months', 'description': 'Oswestry Disability Index (ODI) - ODI score is ranged from 0 to 50. Total score is converted in to percent disability. ODI Scoring: 0% to 20% (minimal disability), 21%-40% (moderate disability), 41%-60% (severe disability), 61%-80% (crippled) and 81%-100 (these patients are either bed-bound or exaggerating their symptoms).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['chronic low back pain', 'thoracic facet joint', 'nerve block'], 'conditions': ['Low Back Pain']}, 'referencesModule': {'references': [{'pmid': '22851967', 'type': 'RESULT', 'citation': 'Manchikanti L, Singh V, Falco FJ, Cash KA, Pampati V, Fellows B. The role of thoracic medial branch blocks in managing chronic mid and upper back pain: a randomized, double-blind, active-control trial with a 2-year followup. Anesthesiol Res Pract. 2012;2012:585806. doi: 10.1155/2012/585806. Epub 2012 Jul 19.'}, {'pmid': '21102966', 'type': 'DERIVED', 'citation': 'Manchikanti L, Singh V, Falco FJ, Cash KA, Pampati V, Fellows B. Comparative effectiveness of a one-year follow-up of thoracic medial branch blocks in management of chronic thoracic pain: a randomized, double-blind active controlled trial. Pain Physician. 2010 Nov-Dec;13(6):535-48.'}, {'pmid': '18690278', 'type': 'DERIVED', 'citation': 'Manchikanti L, Singh V, Falco FJ, Cash KA, Pampati V. Effectiveness of thoracic medial branch blocks in managing chronic pain: a preliminary report of a randomized, double-blind controlled trial. Pain Physician. 2008 Jul-Aug;11(4):491-504.'}], 'seeAlsoLinks': [{'url': 'http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3407605/pdf/ARP2012-585806.pdf', 'label': 'The Role of Thoracic Medial Branch Blocks in Managing Chronic Mid and Upper Back Pain: A Randomized, Double-Blind, Active-Control Trial with a 2-Year Followup'}]}, 'descriptionModule': {'briefSummary': '1. To demonstrate whether:\n\n i. Facet joint nerve blocks have therapeutic value beyond the duration of local anesthetic effect.\n\n ii. Addition of Depo-steroid provides additional relief of thoracic facet joint pain when used with facet joint nerve blocks.\n2. To demonstrate whether or not there are clinically significant improvements in function of patients who receive thoracic facet joint nerve block with Depo-steroid compared to patients randomized to Group I who receive only local anesthetic blocks.\n3. To determine the adverse event profile in both groups', 'detailedDescription': 'Participants Study participants were recruited at the interventional pain management practice from consecutive new patients presenting with thoracic pain. One hundred patients were included and randomly assigned to one of 2 groups; either a local anesthetic only group (Group I) or a local anesthetic with steroid group (Group II), with 50 patients in each group. Patients meeting the inclusion criteria were eligible to undergo diagnostic thoracic facet joint nerve blocks. Only patients positive for controlled comparative local anesthetic blocks met the criteria for inclusion for thoracic medial branch blocks.\n\nInclusion and Exclusion Criteria Only patients with nonspecific mid-back or upper back pain without suspected disc herniation, radiculitis, thoracic fracture, stenosis, or intercostal neuritis were included. Further, patients suspected of disc-related pain with radicular symptoms were also excluded, based on radiologic testing and symptomatology involving radicular or chest wall pain. Patients also should have previously received conservative management with physical therapy, chiropractic manipulation exercises, drug therapy, and bed rest, and so forth, but continued to have pain.\n\nFurther inclusion criteria were a diagnosis of thoracic facet joint pain by means of controlled comparative local anesthetic blocks; patients who were over 18 years of age; patients with a history of chronic function-limiting mid-back or upper back pain of at least 6 months duration; and patients who where competent to understand the study protocol and provide voluntary, written informed consent, and participate in the outcome measurements. A negative or false-positive response to controlled comparative local anesthetic blocks, uncontrollable to heavy opioid use (morphine equivalent of 300 mg), uncontrolled'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPositive for facet joint pain with comparative local anesthetic blocks\n\nCandidates are over 18 years of age\n\nSubjects with a history of chronic, function limiting neck pain of at least six months in duration Subjects who are able to give voluntary, written informed consent to participate in this investigation Subjects who, in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the center for all the required post-operative follow-ups The subject has not had recent surgical procedures within the last three months.\n\n\\-\n\nExclusion Criteria:\n\n* Negative or false-positive response to controlled comparative local anesthetic blocks\n\nNarcotic use of greater than Hydrocodone 100 mg/day, Methadone 80 mg or Morphine 100 mg, or dose equivalent\n\nUncontrolled major Depression or uncontrolled psychiatric disorders\n\nUncontrolled or acute medical illnesses including coagulopathy, renal insufficiency, chronic liver dysfunction, progressive neurological deficit, urinary sphincter dysfunction, infection, increased intercranial pressure, pseudotumor cerebri, intercranial tumors, unstable angina, and severe chronic obstructive pulmonary disease.\n\nChronic severe conditions that could interfere with the interpretations of the outcome assessments for pain and bodily function\n\nWomen who are pregnant or lactating\n\nSubjects who have participated in a clinical study with an investigational product within 30 days of enrollment\n\nPatients with multiple complaints involving concomitant hip osteoarthritis, will not be amenable to study due to the overlap of pain complaints.\n\nInability to achieve appropriate positioning and inability to understand informed consent and protocol History of adverse reaction to local anesthetic or anti-inflammatory drugs'}, 'identificationModule': {'nctId': 'NCT00355706', 'briefTitle': 'Effectiveness of Thoracic Facet Joint Nerve Blocks', 'organization': {'class': 'OTHER', 'fullName': 'Pain Management Center of Paducah'}, 'officialTitle': 'Effectiveness of Thoracic Facet Joint Nerve Blocks: A Randomized, Prospective, Double-Blind Controlled Evaluation', 'orgStudyIdInfo': {'id': 'protocol 5'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group I - without Steroids', 'description': 'Thoracic Facet Joint Nerve Blocks with Local Anesthetic(0.25% Bupivacaine)', 'interventionNames': ['Procedure: Thoracic facet joint nerve blocks']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group II - with steroid', 'description': 'Thoracic Facet Joint Nerve Blocks with Local Anesthetic (0.25% Bupivacaine) and Sterioids(0.15 mg of non-particulate betamethasone)', 'interventionNames': ['Procedure: Thoracic facet joint nerve blocks']}], 'interventions': [{'name': 'Thoracic facet joint nerve blocks', 'type': 'PROCEDURE', 'otherNames': ['Thoracic medial branch blocks'], 'description': 'Thoracic medial branch blocks', 'armGroupLabels': ['Group I - without Steroids', 'Group II - with steroid']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42003', 'city': 'Paducah', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Ambulatory Surgery Center', 'geoPoint': {'lat': 37.08339, 'lon': -88.60005}}], 'overallOfficials': [{'name': 'Laxmaiah Manchikanti, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ambulatory Surgery Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pain Management Center of Paducah', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Director', 'investigatorFullName': 'Laxmaiah Manchikanti, MD', 'investigatorAffiliation': 'Pain Management Center of Paducah'}}}}