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The Influence of High Heeled Shoes on the Sagittal Balance of the Spine and Whole Body

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ClinicalTrials.gov Identifier: NCT02254694
Recruitment Status : Completed
First Posted : October 2, 2014
Last Update Posted : May 28, 2015
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Brief Summary:

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.

The 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.

In 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) .


Condition or disease Intervention/treatment Phase
Back Pain Other: high heeled shoes Not Applicable

Detailed Description:

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.

After 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.

A clinical examination of the spine and pelvis will be performed as well as a pregnancy urine test.

Standing 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).

All data acquisition is going to be performed during a single session, participants will not be followed up.

The 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.

For 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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Influence of High Heeled Shoes on the Sagittal Balance of the Spine and Whole Body
Study Start Date : September 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Experimental: high heeled shoes
see detailed description
Other: high heeled shoes
see detailed study description




Primary Outcome Measures :
  1. spino-sacral angle [ Time Frame: 1 day ]
    "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.


Secondary Outcome Measures :
  1. meatus plumb line [ Time Frame: 1 day ]
    plumb line from the meatus acusticus in relation to the calcaneal tuberosity on the lateral radiograph of the whole body



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • not frequent user of high heeled shoes (i.e. not longer than 6 hours/month with heels > 3 cm)

Exclusion Criteria:

  • osseous metastases
  • missing written informed consent
  • cognitive inability to consent on their own
  • pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02254694


Locations
Switzerland
Klinik für Unfallchirurgie, University Hospital Zurich
Zurich, ZH, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Clément ML Werner, MD, Prof University of Zurich, Klinik für Unfallchirurgie

Publications of Results:
Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT02254694     History of Changes
Other Study ID Numbers: SNCTP000000049
First Posted: October 2, 2014    Key Record Dates
Last Update Posted: May 28, 2015
Last Verified: May 2015

Keywords provided by University of Zurich:
sagittal balance
posture
lumbar lordosis
high heeled shoes

Additional relevant MeSH terms:
Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms