Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-26 @ 3:13 AM
Study NCT ID:
NCT07116720
Status:
RECRUITING
Last Update Posted:
2025-08-12
First Post:
2025-08-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Unloading Maneuvers During Spinal Flexion Exposure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Cross-sectional study with intervention'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-25', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-10-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-06', 'studyFirstSubmitDate': '2025-08-06', 'studyFirstSubmitQcDate': '2025-08-06', 'lastUpdatePostDateStruct': {'date': '2025-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in muscle stiffness', 'timeFrame': '90 minutes', 'description': 'Muscle stiffness will be measured using ultrasound-based shear wave elastography during prone lying and forward stooping. Erector spinae and multifidus muscle stiffness will be expressed as the shear modulus value in kilopascals.'}], 'secondaryOutcomes': [{'measure': 'Change in range of motion', 'timeFrame': '90 minutes', 'description': 'Trunk flexion range of motion will be evaluated using Spinal Mouse in maximal trunk flexion while standing.'}, {'measure': 'Change in seated spinal height', 'timeFrame': '90 minutes', 'description': 'Seated spinal height will be measured on a custom-developed stadiometer, with the participants in a seated position.'}, {'measure': 'Change in lumbar lordosis angle', 'timeFrame': '90 minutes', 'description': 'The lumbar lordosis angle will be evaluated using Spinal Mouse during upright standing.'}, {'measure': 'Change in trunk extension maximal strength', 'timeFrame': '90 minutes', 'description': 'Isometric trunk extension peak torque will be assessed on a trunk dynamometer.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Occupational Exposure']}, 'descriptionModule': {'briefSummary': 'An experimental study, which will aim to investigate the acute effects of unloading maneuvers during an intermittent spinal flexion protocol on changes in trunk mechanical and neuromuscular properties.', 'detailedDescription': 'Our experimental study will include 30 participants. All participants will complete a 60-min intermittent spinal flexion protocol. During rest periods within the protocol, the participants from the intervention group will perform unloading maneuvers for the lumbar spine. Measurements of trunk mechanical and neuromuscular properties. will be performed prior to and following the 60-min protocol.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '30 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Occupational workers with a predominantly non static job (e.g. combination of sitting and standing)\n\nExclusion Criteria:\n\n* History of chronic low back pain\n* Episode of acute low back pain\n* Hip injury in the past six months\n* Previous spine, pelvis or hip surgery\n* Hypermobility, diagnosed with the Beighton score\n* High intensity resistance training (\\> 75 % of 1 repetition maximum) more than two times a week\n* Sporting or recreational activities, that include repetitive spinal flexion or maintenance of a flexed posture (for example cycling or rowing).'}, 'identificationModule': {'nctId': 'NCT07116720', 'briefTitle': 'Unloading Maneuvers During Spinal Flexion Exposure', 'organization': {'class': 'OTHER', 'fullName': 'University of Primorska'}, 'officialTitle': 'The Effect of Unloading Maneuvers During Spinal Flexion Exposure', 'orgStudyIdInfo': {'id': 'SWE_Flexion3_Intervention'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Adult participants completing only the spinal flexion protocol'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'Adult participants performing unloading maneuvers in between the spinal flexion protocol', 'interventionNames': ['Other: Unloading maneuvers']}], 'interventions': [{'name': 'Unloading maneuvers', 'type': 'OTHER', 'description': 'Participants will perform unloading maneuvers four times with 15 min of spinal flexion protocol in between. The intervention will include self traction on a box (5 s) and sustained standing trunk extension (8 s). Both maneuvers will be repeated twice at each timepoint.', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6310', 'city': 'Izola', 'state': 'Primorska', 'status': 'RECRUITING', 'country': 'Slovenia', 'contacts': [{'name': 'Matej Voglar, PhD', 'role': 'CONTACT', 'email': 'matej.voglar@fvz.upr.si', 'phone': '0038656635803'}], 'facility': 'Faculty of Health Sciences, University of Primorska', 'geoPoint': {'lat': 45.53661, 'lon': 13.66015}}], 'centralContacts': [{'name': 'Matej Voglar, PhD', 'role': 'CONTACT', 'email': 'matej.voglar@fvz.upr.si', 'phone': '0038656635803'}, {'name': 'Rok Vatovec, PhD', 'role': 'CONTACT', 'email': 'rok.vatovec@fvz.upr.si', 'phone': '0038656635802'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'ipdSharing': 'YES', 'description': 'Coded individual data will be uploaded on public scientific data repository.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Primorska', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Matej Voglar', 'investigatorAffiliation': 'University of Primorska'}}}}