The Influence of High Heeled Shoes on the Sagittal Balance of the Spine and Whole Body
1 other identifier
interventional
23
1 country
1
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) .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2014
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
September 18, 2014
CompletedFirst Posted
Study publicly available on registry
October 2, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedMay 28, 2015
May 1, 2015
7 months
September 18, 2014
May 27, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
spino-sacral angle
"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.
1 day
Secondary Outcomes (1)
meatus plumb line
1 day
Study Arms (1)
high heeled shoes
EXPERIMENTALsee detailed description
Interventions
Eligibility Criteria
You may qualify if:
- not frequent user of high heeled shoes (i.e. not longer than 6 hours/month with heels \> 3 cm)
You may not qualify if:
- osseous metastases
- missing written informed consent
- cognitive inability to consent on their own
- pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Klinik für Unfallchirurgie, University Hospital Zurich
Zurich, Canton of Zurich, 8091, Switzerland
Related Publications (1)
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.
PMID: 3187700RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Clément ML Werner, MD, Prof
University of Zurich, Klinik für Unfallchirurgie
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 18, 2014
First Posted
October 2, 2014
Study Start
September 1, 2014
Primary Completion
April 1, 2015
Study Completion
May 1, 2015
Last Updated
May 28, 2015
Record last verified: 2015-05