Ignite Creation Date:
2025-12-24 @ 12:16 PM
Ignite Modification Date:
2026-01-16 @ 9:11 AM
Study NCT ID:
NCT05324761
Status:
COMPLETED
Last Update Posted:
2023-05-01
First Post:
2022-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Management of Pain Associated With Failed Back Surgery Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055111', 'term': 'Failed Back Surgery Syndrome'}, {'id': 'D009437', 'term': 'Neuralgia'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069583', 'term': 'Pregabalin'}, {'id': 'D000077206', 'term': 'Gabapentin'}], 'ancestors': [{'id': 'D005680', 'term': 'gamma-Aminobutyric Acid'}, {'id': 'D000613', 'term': 'Aminobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D003509', 'term': 'Cyclohexanecarboxylic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-28', 'studyFirstSubmitDate': '2022-03-20', 'studyFirstSubmitQcDate': '2022-04-11', 'lastUpdatePostDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy in Neuropathic pain management', 'timeFrame': 'outcome will be assessed one month after the initiation of medication', 'description': 'Visual analogue scale pain, minimum score is 0, maximum is 10, the higher ther score the more severe pain'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pregabalin', 'Gabapentin', 'neuropathic pain', 'spine surgery'], 'conditions': ['Failed Back Surgery Syndrome']}, 'descriptionModule': {'briefSummary': 'Neuropathic pain is a common complication following different types of spine surgery making negative impact on health, along with life style changes and management, many neurologist prescribed either Pregabalin or Gabapentin to manage this condition with overall good results.\n\nour study aims to evaluate the efficacy of Pregabalin and Gabapentin in the management of this condition and to compare between them'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with Previous spine surgery and subsequent chronic back pain\n\nExclusion Criteria:\n\n* Patients with connective tissue diseases\n* Patients with psychiatric illnesses'}, 'identificationModule': {'nctId': 'NCT05324761', 'briefTitle': 'Management of Pain Associated With Failed Back Surgery Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Al-Kindy College of Medicine'}, 'officialTitle': 'Pregabalin Versus Gabapentin Efficacy in the Management of Neuropathic Pain Associated With Failed Back Surgery Syndrome', 'orgStudyIdInfo': {'id': '13 Al-KindyCM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Pregabalin', 'description': 'A dose of 75 mg of Pregabalin twice daily for one month will be prescribed to each patient enrolled this study arm', 'interventionNames': ['Drug: Pregabalin 75mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Gabapentin', 'description': 'A dose of 300 mg of Gabapentin twice daily for one month will be prescribed to each patient enrolled this study arm', 'interventionNames': ['Drug: Gabapentin 300mg']}], 'interventions': [{'name': 'Pregabalin 75mg', 'type': 'DRUG', 'description': 'Each patient complaining of pain associated with spine surgery who is randomly enrolled this arm of the study and start the specific medication of the arm with the recommended dose and duration for a period of one month, patient will be followed regularly regarding compliance to doses and to register any side effect.', 'armGroupLabels': ['Pregabalin']}, {'name': 'Gabapentin 300mg', 'type': 'DRUG', 'description': 'Each patient complaining of pain associated with spine surgery who is randomly enrolled this arm of the study and start the specific medication of the arm with the recommended dose and duration for a period of one month, patient will be followed regularly regarding compliance to doses and to register any side effect.', 'armGroupLabels': ['Gabapentin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Baghdad', 'country': 'Iraq', 'facility': 'Laith Thamer Al-Ameri', 'geoPoint': {'lat': 33.34058, 'lon': 44.40088}}], 'overallOfficials': [{'name': 'Laith Al-Ameri', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Baghdad - Al-Kindy College of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Al-Kindy College of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant Professor', 'investigatorFullName': 'Laith Thamer Al-Ameri', 'investigatorAffiliation': 'Al-Kindy College of Medicine'}}}}