Ignite Creation Date:
2025-12-24 @ 7:03 PM
Ignite Modification Date:
2025-12-30 @ 5:41 PM
Study NCT ID:
NCT01041157
Status:
UNKNOWN
Last Update Posted:
2009-12-31
First Post:
2009-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Botulinum Toxin Injection Efficiency
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014103', 'term': 'Torticollis'}, {'id': 'D009128', 'term': 'Muscle Spasticity'}], 'ancestors': [{'id': 'D004421', 'term': 'Dystonia'}, {'id': 'D020820', 'term': 'Dyskinesias'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009122', 'term': 'Muscle Hypertonia'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D055070', 'term': 'Resistance Training'}], 'ancestors': [{'id': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D064797', 'term': 'Physical Conditioning, Human'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 22}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-12', 'completionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-12-30', 'studyFirstSubmitDate': '2009-12-08', 'studyFirstSubmitQcDate': '2009-12-30', 'lastUpdatePostDateStruct': {'date': '2009-12-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Muscle tone in splenius capitis muscle', 'timeFrame': 'five months'}], 'secondaryOutcomes': [{'measure': 'Pain in the neck', 'timeFrame': 'five months'}, {'measure': 'Mobility in the neck', 'timeFrame': 'five months'}, {'measure': 'Neck muscle strength', 'timeFrame': 'five months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Torticollis', 'Botulinum Toxins'], 'conditions': ['Torticollis', 'Muscle Spasticity']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to examine the effect of the botulinum toxin injection into muscle tone, strength and mobility with and without muscle exercise effect.', 'detailedDescription': 'The purpose is also to find out patients subjective symptoms between injections. Hypothesis: Efficiency of the botulinum toxin is more powerful with the muscle exercise before injection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Clinical diagnosis of cervical dystonia\n* Spasticity in splenius capitis muscle\n* Regular treatment with botulinum toxin injection\n\nExclusion Criteria:\n\n* Don't want to take part the Trial\n* Very long distance from home to Jyväskylä Central Hospital"}, 'identificationModule': {'nctId': 'NCT01041157', 'briefTitle': 'Botulinum Toxin Injection Efficiency', 'organization': {'class': 'OTHER', 'fullName': 'Jyväskylä Central Hospital'}, 'officialTitle': 'Effectiveness of Botulinum Toxin Injection After Exercising Splenius Capitis Muscle in Patients With Cervical Dystonia', 'orgStudyIdInfo': {'id': 'KSKS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'resistance training', 'interventionNames': ['Other: Resistance training']}], 'interventions': [{'name': 'Resistance training', 'type': 'OTHER', 'description': 'Neck muscle trainings effect on botulinum toxin efficiency', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jyväskylä', 'country': 'Finland', 'facility': 'Central Finland Helth Care District', 'geoPoint': {'lat': 62.24147, 'lon': 25.72088}}], 'overallOfficials': [{'name': 'Jari Ylinen, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Senior physician'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jyväskylä Central Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eurostars', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Ylinen Jari', 'oldOrganization': 'Jyvaskylä Central Hospital'}}}}