Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2026-01-05 @ 1:40 PM
Study NCT ID:
NCT02444351
Status:
COMPLETED
Last Update Posted:
2019-01-11
First Post:
2015-04-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Botulinum Toxin Type A Injection Into the Gastrocnemius Muscle for Treatment of Nocturnal Calf Cramps in Patients With Lumbar Spinal Stenosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019274', 'term': 'Botulinum Toxins, Type A'}], 'ancestors': [{'id': 'D001905', 'term': 'Botulinum Toxins'}, {'id': 'D008666', 'term': 'Metalloendopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D045726', 'term': 'Metalloproteases'}, {'id': 'D001426', 'term': 'Bacterial Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001427', 'term': 'Bacterial Toxins'}, {'id': 'D014118', 'term': 'Toxins, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2016-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-09', 'studyFirstSubmitDate': '2015-04-28', 'studyFirstSubmitQcDate': '2015-05-11', 'lastUpdatePostDateStruct': {'date': '2019-01-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-05-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain score', 'timeFrame': 'follow up 2 weeks (14 days) after injection', 'description': 'A comparison of pain score between control (conservative management for spinal stenosis) and botox group (conservative management for spinal stenosis plus botox injection into the gastrocnemius muscle).'}], 'secondaryOutcomes': [{'measure': 'patient satisfaction questionnaire using 0 to 4 scale', 'timeFrame': 'follow up 3 months after injection', 'description': 'assessment of patient satisfaction using 0 to 4 scale (0; very dissatisfied, 1; dissatisfied, 2; fair, 3; satisfied, 4; very satisfied)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Spinal Stenosis With Nocturnal Calf Cramps']}, 'referencesModule': {'references': [{'pmid': '28209505', 'type': 'DERIVED', 'citation': 'Park SJ, Yoon KB, Yoon DM, Kim SH. Botulinum Toxin Treatment for Nocturnal Calf Cramps in Patients With Lumbar Spinal Stenosis: A Randomized Clinical Trial. Arch Phys Med Rehabil. 2017 May;98(5):957-963. doi: 10.1016/j.apmr.2017.01.017. Epub 2017 Feb 14.'}]}, '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 botulinum toxin A injection into the gastrocnemius muscle in lumbar spinal stenosis patients receiving conservative therapy. We will compare pain score, insomnia severity, functional ability, patient satisfaction, and neurophysiological variables change using electrical stimulator between control (conservative management for spinal stenosis) and botox group (conservative management for spinal stenosis plus botox injection into the gastrocnemius muscle).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 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': 'NCT02444351', 'briefTitle': 'Botulinum Toxin Type A Injection Into the Gastrocnemius Muscle for Treatment of Nocturnal Calf Cramps in Patients With Lumbar Spinal Stenosis', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'orgStudyIdInfo': {'id': '4-2015-0169'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'control group', 'interventionNames': ['Other: no intervention']}, {'type': 'EXPERIMENTAL', 'label': 'botox group', 'interventionNames': ['Drug: botulinum toxin type A (Nabota®) injection into the gastrocnemius muscle']}], 'interventions': [{'name': 'botulinum toxin type A (Nabota®) injection into the gastrocnemius muscle', 'type': 'DRUG', 'description': 'ultrasound-guided botulinum toxin type A (Nabota®, Daewoong co. Seoul, Korea) injection into the gastrocnemius muscle (maximum 200unit per each calf).', 'armGroupLabels': ['botox group']}, {'name': 'no intervention', 'type': 'OTHER', 'description': 'Patients in the control group will not receive any injection on the gastrocnemius muscle.', 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '120-752', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}