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

Primary Purpose

Back Pain

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
high heeled shoes
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Back Pain focused on measuring sagittal balance, posture, lumbar lordosis, high heeled shoes

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Klinik für Unfallchirurgie, University Hospital Zurich

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

high heeled shoes

Arm Description

see detailed description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

meatus plumb line
plumb line from the meatus acusticus in relation to the calcaneal tuberosity on the lateral radiograph of the whole body

Full Information

First Posted
September 18, 2014
Last Updated
May 27, 2015
Sponsor
University of Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT02254694
Brief Title
The Influence of High Heeled Shoes on the Sagittal Balance of the Spine and Whole Body
Official Title
The Influence of High Heeled Shoes on the Sagittal Balance of the Spine and Whole Body
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich

4. Oversight

Data Monitoring Committee
No

5. Study Description

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) .
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Pain
Keywords
sagittal balance, posture, lumbar lordosis, high heeled shoes

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
high heeled shoes
Arm Type
Experimental
Arm Description
see detailed description
Intervention Type
Other
Intervention Name(s)
high heeled shoes
Intervention Description
see detailed study description
Primary Outcome Measure Information:
Title
spino-sacral angle
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.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
meatus plumb line
Description
plumb line from the meatus acusticus in relation to the calcaneal tuberosity on the lateral radiograph of the whole body
Time Frame
1 day

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clément ML Werner, MD, Prof
Organizational Affiliation
University of Zurich, Klinik für Unfallchirurgie
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinik für Unfallchirurgie, University Hospital Zurich
City
Zurich
State/Province
ZH
ZIP/Postal Code
8091
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
3187700
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.
Results Reference
result

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

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