Ignite Creation Date:
2025-12-24 @ 1:14 PM
Ignite Modification Date:
2026-02-08 @ 9:40 AM
Study NCT ID:
NCT04411095
Status:
COMPLETED
Last Update Posted:
2020-06-02
First Post:
2020-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of the Release of the Intrathoracic Fascia on Thoracic Rotation Mobility
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005208', 'term': 'Fasciitis'}], 'ancestors': [{'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-27', 'studyFirstSubmitDate': '2020-04-22', 'studyFirstSubmitQcDate': '2020-05-27', 'lastUpdatePostDateStruct': {'date': '2020-06-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in thoracic rotation mobility', 'timeFrame': 'Before and immediately after the test', 'description': 'Change from baseline rotation, left and right, to rotation immediately after the test'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fascia; Inflammation', 'Thoracic', 'Rotation']}, 'descriptionModule': {'briefSummary': 'Testing the effect of a specific stretch technique versus sham treatment, to objectify the influence of that specific technique on thoracic rotation mobility.', 'detailedDescription': 'Subjects in the experimental group will undergo a technique for stretching the intrathoracic fascia. Before and after, a measurement will be performed with a goniometer, to see if there is a difference in thoracic rotation mobility.\n\nSubjects in the placebo group get a different technique, where the hands of the therapists are simply placed on the thorax, but no manoeuvre will be performed. Before and after, there is a measurement in thoracic rotation mobility.\n\nData will be compared and statistical analyse will be done to see of there is a difference in rotation. So the hypothesis that stretching intrathoracic fascia has an effect on thoracic rotation mobility, will be accepted or rejected.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects between the age of 18 and 65\n* Both men and women\n\nExclusion Criteria:\n\n* Structural disease of cervical or/and thoracic spine and/or head and/or thorax\n* Acute mobility restriction of cervical and/or thoracic spine\n* Acute and/or intense pain\n* A history of trauma and/or operation on cervical and/or thoracic spine\n* Treatment for cancer like chemo or radiation\n* Baby's and children\n* Elderly people"}, 'identificationModule': {'nctId': 'NCT04411095', 'briefTitle': 'The Effect of the Release of the Intrathoracic Fascia on Thoracic Rotation Mobility', 'organization': {'class': 'OTHER', 'fullName': 'International Academy of Osteopathy'}, 'officialTitle': 'The Effect of the Release of the Intrathoracic Fascia on Thoracic Rotation Mobility', 'orgStudyIdInfo': {'id': 'InternationalIAO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stretching of intrathoracic fascia', 'description': 'A technique will be used to stretch the intrathoracic fascia. The subject lies in his/her back, and a flexion of the upper cervical spine is combined with a retraction movement of the lower cervical and upper thoracic spine, this in combination with inspiration.', 'interventionNames': ['Other: Measuring thoracic rotation mobility']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Test without stretching', 'description': 'A placebo technique is performed by positioning the hands of the therapist on the thorax without pressure or performing a technique. Similar as the stretching technique, a deep inspiration is performed by the patient, for each of the intrathoracic cilinders. This without performing a retraction of the lower cervical and upper thoracic spine.', 'interventionNames': ['Other: Measuring thoracic rotation mobility']}], 'interventions': [{'name': 'Measuring thoracic rotation mobility', 'type': 'OTHER', 'description': 'Measuring the thoracic rotation mobility with a goniometer, from a standardized position', 'armGroupLabels': ['Stretching of intrathoracic fascia', 'Test without stretching']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3270', 'city': 'Scherpenheuvel', 'state': 'Vlaams-brabant', 'country': 'Belgium', 'facility': 'Practice for fysiotherapy and osteopathy', 'geoPoint': {'lat': 50.98075, 'lon': 4.97552}}], 'overallOfficials': [{'name': 'IAO Administration', 'role': 'STUDY_DIRECTOR', 'affiliation': 'The International Academy of Osteopathy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'International Academy of Osteopathy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}