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

• Sponsor: University of Zurich (Other)
• Overall Status: Completed
• CT.gov ID: NCT02254694
• Collaborator: (none)
• Enrollment: 23
• Location: 1
• Arm: 1
• Duration (Months): 8
• Patients Per Site Per Month: 2.9

Study Details

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) .

Condition or Disease	Intervention/Treatment	Phase
Back Pain	Other: high heeled shoes	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 23 participants
• Allocation: N/A
• 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: Sep 1, 2014
• Actual Primary Completion Date: Apr 1, 2015
• Actual Study Completion Date: May 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. spino-sacral angle [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 [1 day]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Zurich
• ClinicalTrials.gov Identifier: NCT02254694
• Other Study ID Numbers: SNCTP000000049
• First Posted: Oct 2, 2014
• Last Update Posted: May 28, 2015
• Last Verified: May 1, 2015

• Keywords provided by University of Zurich: sagittal balance; posture; lumbar lordosis; high heeled shoes
• Additional relevant MeSH terms: Back Pain

Study Results

No Results Posted as of May 28, 2015