Ignite Creation Date:
2025-12-25 @ 1:44 AM
Ignite Modification Date:
2026-02-27 @ 12:48 AM
Study NCT ID:
NCT02254694
Status:
COMPLETED
Last Update Posted:
2015-05-28
First Post:
2014-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Influence of High Heeled Shoes on the Sagittal Balance of the Spine and Whole Body
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D008141', 'term': 'Lordosis'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D013121', 'term': 'Spinal Curvatures'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-27', 'studyFirstSubmitDate': '2014-09-18', 'studyFirstSubmitQcDate': '2014-09-29', 'lastUpdatePostDateStruct': {'date': '2015-05-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'spino-sacral angle', 'timeFrame': '1 day', 'description': '"spino-sacral angle" measured on the lateral EOS-radiograph of the whole body as described in: "Classification of the normal variation in the sagittal alignment of the human lumbar spine and pelvis in the standing position." Roussouly P, Gollogly S, Berthonnaud E, Dimnet J. Spine (Phila Pa 1976). 2005 Feb 1;30(3):346-53.'}], 'secondaryOutcomes': [{'measure': 'meatus plumb line', 'timeFrame': '1 day', 'description': 'plumb line from the meatus acusticus in relation to the calcaneal tuberosity on the lateral radiograph of the whole body'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['sagittal balance', 'posture', 'lumbar lordosis', 'high heeled shoes'], 'conditions': ['Back Pain']}, 'referencesModule': {'references': [{'pmid': '3187700', 'type': 'RESULT', 'citation': 'Opila KA, Wagner SS, Schiowitz S, Chen J. Postural alignment in barefoot and high-heeled stance. Spine (Phila Pa 1976). 1988 May;13(5):542-7. doi: 10.1097/00007632-198805000-00018.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to investigate the influence of high heeled shoes on the sagittal balance of the spine and the whole body.\n\nThe investigators hypothesize that wearing high heeled shoes leads to a hyperlordosis of the cervical spine, a decrease of thoracic kyphosis, hyperlordosis of the lumbar spine and a posterior tilt of the pelvis resulting in a posterior shift of the body's center of gravity. This would be an explanation for the increased prevalence of back pain in individuals frequently wearing high heels.\n\nIn order to assess these changes, differences in the two following outcome parameters will be measured on a standing lateral EOS-radiograph of the whole body - barefoot and with high heeled shoes: spino-sacral angle (primary) and meatus plumb line (secondary) .", 'detailedDescription': "Female volunteers (age ≥ 21 years) that are not frequent user of high heeled shoes (i.e. not longer than 6 hours/month with heels \\> 3 cm) will be included. Exclusion criteria are osseous metastases, missing written informed consent, cognitive inability to consent on their own, and pregnancy. Based on own preliminary studies, a sample size of 19 (+3 to anticipate drop outs) patients is aimed for.\n\nAfter obtaining informed consent, the participants will be interviewed with special regard to their age, gender, height, weight, shoe size, past medical history, occupational and recreational activities, and duration and frequency of wearing high heeled shoes.\n\nA clinical examination of the spine and pelvis will be performed as well as a pregnancy urine test.\n\nStanding lateral EOS-radiographs (http://www.eos-imaging.com/) of the whole body will be taken - once barefoot and once with high heeled shoes (heel height 9 cm).\n\nAll data acquisition is going to be performed during a single session, participants will not be followed up.\n\nThe following parameters will be assessed on the radiographs: presence and number of (healed) fractures, osseous metastases, sagittal C7 plumb line, meatus plumb line, cervical lordosis, thoracic kyphosis, lumbar lordosis, spino- sacral angle as described by Roussouly et al. (2006), pelvic incidence, pelvic tilt.\n\nFor statistical analysis, all data will be collected in a statistic software file (SPSS. 21.0, SPSS Inc, Chicago, Illinois). After testing for normal distribution, these differences in means of the primary and secondary outcome parameters between the barefoot and the high heeled radiograph will be assessed using a paired Student's T-test or non-parametric tests. The level of significance is p \\< 0.05."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* not frequent user of high heeled shoes (i.e. not longer than 6 hours/month with heels \\> 3 cm)\n\nExclusion Criteria:\n\n* osseous metastases\n* missing written informed consent\n* cognitive inability to consent on their own\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT02254694', 'briefTitle': 'The Influence of High Heeled Shoes on the Sagittal Balance of the Spine and Whole Body', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'The Influence of High Heeled Shoes on the Sagittal Balance of the Spine and Whole Body', 'orgStudyIdInfo': {'id': 'SNCTP000000049'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'high heeled shoes', 'description': 'see detailed description', 'interventionNames': ['Other: high heeled shoes']}], 'interventions': [{'name': 'high heeled shoes', 'type': 'OTHER', 'description': 'see detailed study description', 'armGroupLabels': ['high heeled shoes']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8091', 'city': 'Zurich', 'state': 'Canton of Zurich', 'country': 'Switzerland', 'facility': 'Klinik für Unfallchirurgie, University Hospital Zurich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Clément ML Werner, MD, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Zurich, Klinik für Unfallchirurgie'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}