NCT02254694

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

September 18, 2014

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 2, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

May 28, 2015

Status Verified

May 1, 2015

Enrollment Period

7 months

First QC Date

September 18, 2014

Last Update Submit

May 27, 2015

Conditions

Keywords

sagittal balanceposturelumbar lordosishigh heeled shoes

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

EXPERIMENTAL

see detailed description

Other: high heeled shoes

Interventions

see detailed study description

high heeled shoes

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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.

MeSH Terms

Conditions

Back PainLordosis

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSpinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • Clément ML Werner, MD, Prof

    University of Zurich, Klinik für Unfallchirurgie

    PRINCIPAL INVESTIGATOR

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

Locations