Ignite Creation Date:
2025-12-24 @ 1:49 PM
Ignite Modification Date:
2026-01-24 @ 5:02 PM
Study NCT ID:
NCT02748395
Status:
WITHDRAWN
Last Update Posted:
2016-12-05
First Post:
2016-04-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lidocaine and Triamcinolone vs Saline Trigger Point Injection for Treatment of Chronic Abdominal Wall Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014221', 'term': 'Triamcinolone'}, {'id': 'D008012', 'term': 'Lidocaine'}], 'ancestors': [{'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'No IRB approval', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2016-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'lastUpdateSubmitDate': '2016-12-02', 'studyFirstSubmitDate': '2016-04-20', 'studyFirstSubmitQcDate': '2016-04-21', 'lastUpdatePostDateStruct': {'date': '2016-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-04-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain score', 'timeFrame': 'Baseline and 1 month', 'description': 'Questionnaire to assess change in pain score'}], 'secondaryOutcomes': [{'measure': 'Pain score', 'timeFrame': 'Baseline and 1 week', 'description': 'Questionnaire to assess change in pain score'}, {'measure': 'Pain score', 'timeFrame': 'Baseline and 2 months', 'description': 'Questionnaire to assess change in pain score'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Abdominal Wall Pain', 'Abdominal Cutaneous Nerve Entrapment Syndrome']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether the injection of triamcinolone and lidocaine is effective in relieving chronic abdominal wall pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of chronic abdominal wall pain\n* Prior ultrasound or cross-sectional imaging of the abdomen to exclude other causes\n* Baseline Brief Pain Inventory score ≥ 5\n\nExclusion Criteria:\n\n* Multiple trigger points\n* Abdominal wall hernia on exam\n* Weight loss\n* Rectal bleeding\n* Recent change in bowel habits\n* Decompensated cirrhosis or recurrent ascites\n* Allergy or contraindication to study medications\n* Known thrombocytopenia with platelet count \\< 50,000\n* Other diagnosis of chronic pain syndromes including fibromyalgia\n* Unable to provide informed consent\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT02748395', 'briefTitle': 'Lidocaine and Triamcinolone vs Saline Trigger Point Injection for Treatment of Chronic Abdominal Wall Pain', 'organization': {'class': 'OTHER', 'fullName': 'Temple University'}, 'officialTitle': 'Lidocaine and Triamcinolone vs Saline Trigger Point Injection for Treatment of Chronic Abdominal Wall Pain', 'orgStudyIdInfo': {'id': '23417'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Injection of 3.5mL of normal saline into the point of maximal tenderness in the abdomen', 'interventionNames': ['Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'Injection of 20mg triamcinolone and 1% lidocaine into the point of maximal tenderness in the abdomen', 'interventionNames': ['Drug: Triamcinolone', 'Drug: Lidocaine']}], 'interventions': [{'name': 'Triamcinolone', 'type': 'DRUG', 'armGroupLabels': ['Treatment']}, {'name': 'Placebo', 'type': 'OTHER', 'armGroupLabels': ['Placebo']}, {'name': 'Lidocaine', 'type': 'DRUG', 'armGroupLabels': ['Treatment']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Temple University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Medicine', 'investigatorFullName': 'Adam Ehrlich', 'investigatorAffiliation': 'Temple University'}}}}