Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2025-12-25 @ 8:57 PM
Study NCT ID:
NCT05743556
Status:
UNKNOWN
Last Update Posted:
2023-03-02
First Post:
2023-02-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Comparison of Effectivity Therapy by HILT and TRT in Muscle Hypertonus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013035', 'term': 'Spasm'}], 'ancestors': [{'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-03-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-01', 'studyFirstSubmitDate': '2023-02-15', 'studyFirstSubmitQcDate': '2023-02-15', 'lastUpdatePostDateStruct': {'date': '2023-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'determine whether HILT causes a change in neck muscle tone after 6 applications', 'timeFrame': '15 minutes', 'description': 'High- intensive laser therapy will be applied to m. scaleni, m. levator scapulae and m. trapezius. Before and after application, the degree of tenderness of the muscle will be determined using an algometer. This will be recorded in an Excel MS spreadsheet.'}, {'measure': 'determine whether TRT causes a change in neck muscle tone after 6 applications', 'timeFrame': '15 minutes', 'description': 'Radiofrekvention therapy will be applied to m. scaleni, m. levator scapulae and m. trapezius. Before and after application, the degree of tenderness of the muscle will be determined using an algometer. This will be recorded in an Excel MS spreadsheet.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['muscle tone', 'HILT', 'TRT', 'scalene muscle', 'levator scapulae', 'trapezius muscle'], 'conditions': ['Muscle Tone Abnormalities', 'Muscle Spasm']}, 'descriptionModule': {'briefSummary': 'Comparing the effect of high-intensity laser therapy (HILT) and targeted radiofrequency therapy (TRT) on muscle tone in the cervical and thoracic regions. The research aims to determine the effectiveness of the effect of novel physical therapy on the change of muscle tone in the cervical and thoracic region. This is an intervention experiment applied to a group of 60 probands.', 'detailedDescription': "Approximately 60 probands, aged 18-60 years, with no gender preference, will be recruited from patients of an unnamed healthcare facility based on their voluntary participation while receiving a current indication for physiotherapy with a diagnosis of CB syndrome.\n\nSubjects will be randomized into three groups. The first probands (n'20) will have HILT applied bilaterally to the mm. scalene, m.levator scapulae and m.trapezius pars descendens. The second group (n'20) will have TRT applied bilaterally to mm. scalene, m.levator scapulae and m.trapezius pars descendens. No physical therapy or physiotherapy will be used for the third group (n'20) for the duration of the study. Subjects will be examined and treated three times a week for a total of 6 times. The effect of each type of therapy will be demonstrated palpationally and subjectively using an analogue pain scale and an algometer. The obtained results will be further statistically processed."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* the presence of hypertonus in the mm.scalene, m.levator scapulae and m.trapezius pars descendens bilaterally\n* tension demonstrated by palpation and subjective assessment of the patient on an analogue pain scale\n\nExclusion Criteria:\n\n* Individuals with acute or infectious disease\n* probands psychiatric diagnoses\n* patients with cancers\n* problems with skin integrity disorders\n* other contraindications to the use of HILT and TRT'}, 'identificationModule': {'nctId': 'NCT05743556', 'briefTitle': 'The Comparison of Effectivity Therapy by HILT and TRT in Muscle Hypertonus', 'organization': {'class': 'OTHER', 'fullName': 'Charles University, Czech Republic'}, 'officialTitle': 'Comparison of the Effect of HILT and TRT on Muscle Tone in Cervicobrachial Syndrome', 'orgStudyIdInfo': {'id': 'Cemusova, HILT, TRT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HILT group', 'description': 'Therapy of muscle hypertonus by Hight intensive laser applied on cervical muscles.', 'interventionNames': ['Device: HILT laserotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TRT group', 'description': 'Muscle hypertonus of the cervical area treated by Target radio frequency current.', 'interventionNames': ['Device: TRT therapy']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Group of patients with muscle cervical hyper tone without any therapy.'}], 'interventions': [{'name': 'HILT laserotherapy', 'type': 'DEVICE', 'description': 'application of high intensive laser therapy on cervical muscles', 'armGroupLabels': ['HILT group']}, {'name': 'TRT therapy', 'type': 'DEVICE', 'description': 'application of radiofrekvention therapy on cervical muscles', 'armGroupLabels': ['TRT group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Prague', 'country': 'Czechia', 'facility': 'Charles University, Faculty of physical education and sport', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}], 'overallOfficials': [{'name': 'Jitka Malá, PhDr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Charles University Prague'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charles University, Czech Republic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}