Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-27 @ 10:53 PM
Study NCT ID:
NCT00370994
Status:
COMPLETED
Last Update Posted:
2020-03-10
First Post:
2006-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effectiveness of Percutaneous Lumbar Epidural Adhesiolysis and Neurolysis on Low Back Pain
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': 'drlm@thepainmd.com', 'phone': '270-554-8373', 'title': 'Dr. Laxmaiah Manchikanti', 'phoneExt': '101', 'organization': 'Pain Management Center of Paducah'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'The results of this study are limited by potentially inadequate double blinding, by the lack of a placebo group.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Caudal Epidural Injection', 'description': 'Caudal epidural with placement of catheter in sacral canal with injection of 5 mL of 2% preservative-free lidocaine, followed by 6 mL of 0.9% sodium chloride solution and 6 mg of non-particulate Betamethasone and 1 mL of sodium chloride solution', 'otherNumAtRisk': 60, 'otherNumAffected': 0, 'seriousNumAtRisk': 60, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Pecutaneous Adhesiolysis', 'description': 'Pecutaneous adhesiolysis and targeted placement of Racz catheter with injection of 5 mL of 2% preservative-free lidocaine, followed by 6 mL of 10% sodium chloride solution and 6 mg of non-particulate Betamethasone and 1 mL of sodium chloride solution', 'otherNumAtRisk': 60, 'otherNumAffected': 0, 'seriousNumAtRisk': 60, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Numeric Pain Rating Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'caudal epidural injections since no adhesiolysis was performed and there was no injection of 10% sodium chloride solution.'}, {'id': 'OG001', 'title': 'Intervention Group', 'description': 'adhesiolysis and targeted placement of Racz catheter with injection of 5 mL of 2% preservative-free lidocaine, followed by 6 mL of 10% sodium chloride solution and 6 mg of non-particulate Betamethasone and 1 mL of sodium chloride solution'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '7.9', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '8.1', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': '3 months', 'categories': [{'measurements': [{'value': '4.9', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '5.8', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '3.7', 'spread': '1.1', 'groupId': 'OG001'}]}]}, {'title': '12 months', 'categories': [{'measurements': [{'value': '6.1', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '4.0', 'spread': '1.2', 'groupId': 'OG001'}]}]}, {'title': '18 months', 'categories': [{'measurements': [{'value': '6.1', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '1.2', 'groupId': 'OG001'}]}]}, {'title': '24 months', 'categories': [{'measurements': [{'value': '6.2', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '1.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'Comparisons were made between groups and within the group between baseline and different time points.', 'statisticalMethod': 'Repeated measures ANOVA.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': '3, 6, 12, 18 and 24 months post treatment.', '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', 'populationDescription': 'Sample size is calculated based on reduction of NRS. A 25% clinical difference change of 1.15.'}, {'type': 'SECONDARY', 'title': 'Functional Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'caudal epidural injections since no adhesiolysis was performed and there was no injection of 10% sodium chloride solution.'}, {'id': 'OG001', 'title': 'Intervention Group', 'description': 'adhesiolysis and targeted placement of Racz catheter with injection of 5 mL of 2% preservative-free lidocaine, followed by 6 mL of 10% sodium chloride solution and 6 mg of non-particulate Betamethasone and 1 mL of sodium chloride solution'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '28.6', 'spread': '4.1', 'groupId': 'OG000'}, {'value': '31.2', 'spread': '4.1', 'groupId': 'OG001'}]}]}, {'title': '3 months', 'categories': [{'measurements': [{'value': '20.2', 'spread': '6.6', 'groupId': 'OG000'}, {'value': '15.2', 'spread': '4.1', 'groupId': 'OG001'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '22.3', 'spread': '6.1', 'groupId': 'OG000'}, {'value': '15.2', 'spread': '5.2', 'groupId': 'OG001'}]}]}, {'title': '12 months', 'categories': [{'measurements': [{'value': '23.3', 'spread': '5.8', 'groupId': 'OG000'}, {'value': '15.8', 'spread': '5.6', 'groupId': 'OG001'}]}]}, {'title': '18 months', 'categories': [{'measurements': [{'value': '23.3', 'spread': '5.7', 'groupId': 'OG000'}, {'value': '14.6', 'spread': '4.6', 'groupId': 'OG001'}]}]}, {'title': '24 months', 'categories': [{'measurements': [{'value': '23.2', 'spread': '6.7', 'groupId': 'OG000'}, {'value': '13.9', 'spread': '5.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'There were significant differences in Oswestry Disability Index between both groups', 'statisticalMethod': 'Repeated measures of ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': '3, 6, 12, 18 and 24 months post treatment.', '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': 'Caudal Epidural Injection', 'description': 'Caudal epidural with placement of catheter in sacral canal with injection of 5 mL of 2% preservative-free lidocaine, followed by 6 mL of 0.9% sodium chloride solution and 6 mg of non-particulate Betamethasone and 1 mL of sodium chloride solution.'}, {'id': 'FG001', 'title': 'Pecutaneous Adhesiolysis', 'description': 'Pecutaneous adhesiolysis and targeted placement of Racz catheter with injection of 5 mL of 2% preservative-free lidocaine, followed by 6 mL of 10% sodium chloride solution and 6 mg of non-particulate Betamethasone and 1 mL of sodium chloride solution'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Sample size was 200, due to the difficulties of recruiting we changed to 120', 'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '60'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '60'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'An interventional pain management practice, a specialty referral center, a private practice setting in the United States'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Caudal Epidural Injection', 'description': 'Caudal epidural with placement of catheter in sacral canal with injection of 5 mL of 2% preservative-free lidocaine, followed by 6 mL of 0.9% sodium chloride solution and 6 mg of non-particulate Betamethasone and 1 mL of sodium chloride solution'}, {'id': 'BG001', 'title': 'Pecutaneous Adhesiolysis', 'description': 'Pecutaneous adhesiolysis and targeted placement of Racz catheter with injection of 5 mL of 2% preservative-free lidocaine, followed by 6 mL of 10% sodium chloride solution and 6 mg of non-particulate Betamethasone and 1 mL of sodium chloride solution'}, {'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': '44', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52', 'spread': '13.9', 'groupId': 'BG000'}, {'value': '52', 'spread': '12.5', 'groupId': 'BG001'}, {'value': '52', 'spread': '13.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-02', 'studyFirstSubmitDate': '2006-08-30', 'resultsFirstSubmitDate': '2012-03-21', 'studyFirstSubmitQcDate': '2006-08-30', 'lastUpdatePostDateStruct': {'date': '2020-03-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-10-20', 'studyFirstPostDateStruct': {'date': '2006-09-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-11-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Numeric Pain Rating Score', 'timeFrame': '3, 6, 12, 18 and 24 months post treatment.', 'description': 'Numeric rating scale represented 0 with no pain and 10 with the worst pain imaginable'}], 'secondaryOutcomes': [{'measure': 'Functional Status', 'timeFrame': '3, 6, 12, 18 and 24 months post treatment.', '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': ['post-lumbar surgery syndrome', 'percutaneous lumbar epidural adhesiolysis', 'hypertonic saline neurolysis'], 'conditions': ['Low Back Pain']}, 'referencesModule': {'references': [{'pmid': '23293536', 'type': 'RESULT', 'citation': 'Manchikanti L, Singh V, Cash KA, Pampati V. Assessment of effectiveness of percutaneous adhesiolysis and caudal epidural injections in managing post lumbar surgery syndrome: 2-year follow-up of a randomized, controlled trial. J Pain Res. 2012;5:597-608. doi: 10.2147/JPR.S38999. Epub 2012 Dec 20.'}, {'pmid': '19935992', 'type': 'DERIVED', 'citation': 'Manchikanti L, Singh V, Cash KA, Pampati V, Datta S. A comparative effectiveness evaluation of percutaneous adhesiolysis and epidural steroid injections in managing lumbar post surgery syndrome: a randomized, equivalence controlled trial. Pain Physician. 2009 Nov-Dec;12(6):E355-68.'}, {'pmid': '19935991', 'type': 'DERIVED', 'citation': 'Manchikanti L, Cash KA, McManus CD, Pampati V, Singh V, Benyamin R. The preliminary results of a comparative effectiveness evaluation of adhesiolysis and caudal epidural injections in managing chronic low back pain secondary to spinal stenosis: a randomized, equivalence controlled trial. Pain Physician. 2009 Nov-Dec;12(6):E341-54.'}], 'seeAlsoLinks': [{'url': 'https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3533727/', 'label': 'Assessment of effectiveness of percutaneous adhesiolysis and caudal epidural injections in managing post lumbar surgery syndrome: 2-year follow-up of a randomized, controlled trial.'}]}, 'descriptionModule': {'briefSummary': 'Clinically significant improvements in the percutaneous adhesiolysis patients with hypertonic neurolysis compared to those patients randomized to the control group who did not receive adhesiolysis and hypertonic saline neurolysis. Improvement will be assessed in relation to the clinical outcome measures of pain and function.\n\nImprovements among patients with adhesiolysis and hypertonic saline neurolysis and compare to control group.\n\nCompare adverse event profile in both groups', 'detailedDescription': "Patients with chronic low back pain and lower extremity pain secondary to spinal stenosis or post lumbar laminectomy syndrome, non responsive to conservative therapy with physical therapy or chiropractic and medical therapy and fluoroscopically directed epidural steroid injections.\n\nSingle-center, prospective, controlled, double blind, randomized study. If non-responsive or at patient's request, the patient may be unblinded anytime after 3 months, and will be offered adhesiolysis and hypertonic saline neurolysis if the patient was in the control group. All patients will be unblinded at 24 months."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Over 18 years of age\n* History of chronic, function limiting low back pain of at least 6 months in duration\n* Able to give voluntary, written informed consent\n* Able to understand investigational procedures and willing to return for follow-ups\n* No recent surgical procedures within last 3 months\n\nExclusion Criteria:\n\n* Large contained or sequestered herniation\n* Cauda Equina symptoms and/or compressive radiculopathy\n* Narcotic use of no greater than 100mg/day Hydrocodone, 60mg Methadone, or 100mg Morphine\n* Uncontrolled major depression or psychiatric disorder\n* Uncontrolled or acute medical illness\n* Chronic sever conditions that could interfere with outcome assessments\n* Women who are pregnant or lactating\n* Subjects who have participated in a clinical study with an investigational product within 30 days of enrollment'}, 'identificationModule': {'nctId': 'NCT00370994', 'briefTitle': 'Effectiveness of Percutaneous Lumbar Epidural Adhesiolysis and Neurolysis on Low Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'Pain Management Center of Paducah'}, 'officialTitle': 'A Randomized, Prospective, Double-blind Controlled Evaluation of the Effectiveness of Percutaneous Lumbar Epidural Adhesiolysis and Hypertonic Saline Neurolysis', 'orgStudyIdInfo': {'id': 'protocol 11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Caudal epidural injection', 'description': 'Caudal epidural with placement of catheter in sacral canal with injection of 5 mL of 2% preservative-free lidocaine, followed by 6 mL of 0.9% sodium chloride solution and 6 mg of non-particulate Betamethasone and 1 mL of sodium chloride solution', 'interventionNames': ['Procedure: Caudal epidural injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Percutaneous adhesiolysis', 'description': 'Pecutaneous adhesiolysis and targeted placement of Racz catheter with injection of 5 mL of 2% preservative-free lidocaine, followed by 6 mL of 10% sodium chloride solution and 6 mg of non-particulate Betamethasone and 1 mL of sodium chloride solution', 'interventionNames': ['Procedure: Percutaneous adhesiolysis']}], 'interventions': [{'name': 'Caudal epidural injection', 'type': 'PROCEDURE', 'description': 'Caudal epidural injection with catheterization', 'armGroupLabels': ['Caudal epidural injection']}, {'name': 'Percutaneous adhesiolysis', 'type': 'PROCEDURE', 'description': 'Percutaneous adhesiolysis with hypertonic saline neurolysis', 'armGroupLabels': ['Percutaneous adhesiolysis']}]}, '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'}}}}