Ignite Creation Date:
2025-12-24 @ 12:43 PM
Ignite Modification Date:
2025-12-29 @ 5:44 AM
Study NCT ID:
NCT05392361
Status:
COMPLETED
Last Update Posted:
2023-03-30
First Post:
2022-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Baclofen Treatment on Nocturnal Muscle Cramps in Patients With Lumbar Spinal Stenosis: a Randomized Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013130', 'term': 'Spinal Stenosis'}], 'ancestors': [{'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077206', 'term': 'Gabapentin'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D001418', 'term': 'Baclofen'}], 'ancestors': [{'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'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': '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'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-03-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-29', 'studyFirstSubmitDate': '2022-05-18', 'studyFirstSubmitQcDate': '2022-05-24', 'lastUpdatePostDateStruct': {'date': '2023-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain score', 'timeFrame': 'follow up 4 weeks', 'description': 'A comparison of pain score between control (conservative management for spinal stenosis) and baclofen group (conservative management for spinal stenosis plus baclofen treatment).\n\nThe pain score will be measured using NRS (Numeric Rating Scale) on a scale from 0-10, with 0 representing "no pain" and 10 "worst possible pain".'}], 'secondaryOutcomes': [{'measure': 'Frequency and severity of nocturnal calf cramps', 'timeFrame': 'follow up 4 weeks, 12 weeks', 'description': 'The frequency(number) and the severity of nocturnal calf cramps that occurred in a week before each time frame will be investigated. The severity of nocturnal calf cramps will be measured by 0-4 point scale (0, no pain; 1, mild pain that disappeared immediately and tolerable; 2, moderate pain accompanied by pain enough to wake up from sleep; 3, severe pain accompanied by pain enough to wake up from sleep for a long time; 4, severe pain that lasted for a long time and affected a daily life of the next day)'}, {'measure': 'Insomnia severity index', 'timeFrame': 'follow up 4 weeks, 12 weeks'}, {'measure': 'Oswestry Disability Index', 'timeFrame': 'follow up 4 weeks, 12 weeks'}, {'measure': 'Patient satisfaction (PGIC)', 'timeFrame': 'follow up 4 weeks, 12 weeks', 'description': 'Patient satisfaction with treatment at 12 weeks after treatment will be measured by 7-point Patient Global Impression of Change (PGIC; 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; 7, very much worse)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['baclofen', 'spinal stenosis', 'nocturnal calf cramps'], 'conditions': ['Lumbar Spinal Stenosis With Nocturnal Calf Cramps']}, 'referencesModule': {'references': [{'pmid': '38063320', 'type': 'DERIVED', 'citation': 'Kim HJ, Yoon KB, Kang M, Lee HW, Kim SH. Use of Baclofen as a Treatment for Nocturnal Calf Cramps in Individuals With Lumbar Spinal Stenosis: A Prospective Randomized Study. Am J Phys Med Rehabil. 2024 May 1;103(5):384-389. doi: 10.1097/PHM.0000000000002364. Epub 2023 Nov 22.'}]}, 'descriptionModule': {'briefSummary': 'Nocturnal calf cramps is a common complaint in patients with lumbar spinal stenosis. The purpose of this study is to evaluate the effect of baclofen in lumbar spinal stenosis patients receiving conservative therapy. We will compare pain score, insomnia severity, functional ability and patient satisfaction between control (conservative management for spinal stenosis) and baclofen group (conservative management for spinal stenosis plus baclofen treatment).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. diagnosed lumbar spinal stenosis with MRI finding\n2. nocturnal calf cramps symptoms at least once per week\n\nExclusion Criteria:\n\n1. electrolyte disorder\n2. congenital muscle disease\n3. muscle cramps related medication (statins, diuretics, calcium channel blockers, anticonvulsants etc.)\n4. cognitive impairments'}, 'identificationModule': {'nctId': 'NCT05392361', 'briefTitle': 'Effect of Baclofen Treatment on Nocturnal Muscle Cramps in Patients With Lumbar Spinal Stenosis: a Randomized Clinical Trial', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': 'Effect of Baclofen Treatment on Nocturnal Muscle Cramps in Patients With Lumbar Spinal Stenosis: a Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '4-2022-0360'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'control group', 'description': 'conservative management for spinal stenosis', 'interventionNames': ['Drug: gabapentin (neurontin® capsule 300mg) treatment']}, {'type': 'EXPERIMENTAL', 'label': 'baclofen group', 'description': 'conservative management for spinal stenosis plus baclofen treatment', 'interventionNames': ['Drug: baclofen (baclofen Tab. 10mg) treatment']}], 'interventions': [{'name': 'gabapentin (neurontin® capsule 300mg) treatment', 'type': 'DRUG', 'description': 'Taking gabapentin (neurontin® capsule 300mg, Pfizer) medication at night as a conservative treatment', 'armGroupLabels': ['control group']}, {'name': 'baclofen (baclofen Tab. 10mg) treatment', 'type': 'DRUG', 'description': 'Taking baclofen (baclofen Tab. 10mg, Handok co, Seoul, Korea) medication at night.', 'armGroupLabels': ['baclofen group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Yonsei University Health System, Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Shin Hyung Kim', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Anesthesiology and Pain Medicine, Yonsei University College of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}