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
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|
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)|
|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|
Experimental: high heeled shoes
see detailed description
Other: high heeled shoes
see detailed study description
- 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.
- 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
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
|Klinik für Unfallchirurgie, University Hospital Zurich|
|Zurich, ZH, Switzerland, 8091|
|Principal Investigator:||Clément ML Werner, MD, Prof||University of Zurich, Klinik für Unfallchirurgie|