NCT05593991

Brief Summary

The goal of this cross-sectional study is to evaluate the immediate effect of heels elevation on the spine posture in a group of 100 healthy subjects (50 males, 50 females). The main question it aims to answer is weather high heels immediately affects spinal posture and pelvic position in the sagittal plane. Participants will undergo an elevation of 3cm and then 7cm of both heels, while their spine posture will be examined by means of a rasterstereography device.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Jul 2022

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 13, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 26, 2022

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2022

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 28, 2022

Completed
Last Updated

November 30, 2022

Status Verified

November 1, 2022

Enrollment Period

4 months

First QC Date

October 13, 2022

Last Update Submit

November 29, 2022

Conditions

Healthy

Outcome Measures

Primary Outcomes (6)

  • pelvic tilt angle

    the angle between the vertical and the tangent to the lumbosacral junction

    5 seconds for each measured condition (barefoot, 3 cm heels elevation, 7 cm heels elevation)

  • lordotic angle

    measured between the tangents of the thoracolumbar junction and the lumbosacral junction;

    5 seconds for each measured condition (barefoot, 3 cm heels elevation, 7 cm heels elevation)

  • kyphotic angle

    measured between the tangents of the cervicothoracic junction and the thoracolumbar junction;

    5 seconds for each measured condition (barefoot, 3 cm heels elevation, 7 cm heels elevation)

  • lumbar arrow

    horizontal distance in millimeters of the lumbar spine from the virtual vertical line that passes through the kyphotic apex;

    5 seconds for each measured condition (barefoot, 3 cm heels elevation, 7 cm heels elevation)

  • cervical arrow

    horizontal distance in millimeters of the cervical spine from the virtual vertical line that passes through the kyphotic apex;

    5 seconds for each measured condition (barefoot, 3 cm heels elevation, 7 cm heels elevation)

  • anteroposterior trunk flexion

    measured as the angle between the vertical and the line that passes through the prominent cervical vertebra and the line connecting the two dimples.

    5 seconds for each measured condition (barefoot, 3 cm heels elevation, 7 cm heels elevation)

Study Arms (1)

Healthy adults

EXPERIMENTAL

Subjects with elevated heels

Other: Elevated heels

Interventions

Elevated heelsOTHER

Each subject will undergo the following evaluations: 1. neutral barefoot position; 2. neutral barefoot position (re-test); 3. 3 cm rise of both heels, made with plastic spacer; 4. 7 cm rise of both heels, made with plastic spacer.

Healthy adults

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All healthy subjects.

You may not qualify if:

  • structural or neurological abnormalities that would prevent standing for 5 seconds with their heels on a 7 cm high plinth;
  • regular users of shoes with 7 cm high heels (or more), with a frequency of more than twice a week and / or more than 3 hours / week;
  • low back pain in the past 30 days.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Spine Center

Bologna, 40128, Italy

Location

Related Publications (11)

  • Bird AR, Bendrups AP, Payne CB. The effect of foot wedging on electromyographic activity in the erector spinae and gluteus medius muscles during walking. Gait Posture. 2003 Oct;18(2):81-91. doi: 10.1016/s0966-6362(02)00199-6.

    PMID: 14654211BACKGROUND

  • Snow RE, Williams KR. High heeled shoes: their effect on center of mass position, posture, three-dimensional kinematics, rearfoot motion, and ground reaction forces. Arch Phys Med Rehabil. 1994 May;75(5):568-76.

    PMID: 8185452BACKGROUND

  • Cowley EE, Chevalier TL, Chockalingam N. The effect of heel height on gait and posture: a review of the literature. J Am Podiatr Med Assoc. 2009 Nov-Dec;99(6):512-8. doi: 10.7547/0990512.

    PMID: 19917737BACKGROUND

  • de Oliveira Pezzan PA, Joao SM, Ribeiro AP, Manfio EF. Postural assessment of lumbar lordosis and pelvic alignment angles in adolescent users and nonusers of high-heeled shoes. J Manipulative Physiol Ther. 2011 Nov;34(9):614-21. doi: 10.1016/j.jmpt.2011.09.006.

    PMID: 22078999BACKGROUND

  • Dai M, Li X, Zhou X, Hu Y, Luo Q, Zhou S. High-heeled-related alterations in the static sagittal profile of the spino-pelvic structure in young women. Eur Spine J. 2015 Jun;24(6):1274-81. doi: 10.1007/s00586-015-3857-6. Epub 2015 Mar 10.

    PMID: 25753007BACKGROUND

  • de Lateur BJ, Giaconi RM, Questad K, Ko M, Lehmann JF. Footwear and posture. Compensatory strategies for heel height. Am J Phys Med Rehabil. 1991 Oct;70(5):246-54.

    PMID: 1910649BACKGROUND

  • Franklin ME, Chenier TC, Brauninger L, Cook H, Harris S. Effect of positive heel inclination on posture. J Orthop Sports Phys Ther. 1995 Feb;21(2):94-9. doi: 10.2519/jospt.1995.21.2.94.

    PMID: 7711763BACKGROUND

  • Bendix T, Sorensen SS, Klausen K. Lumbar curve, trunk muscles, and line of gravity with different heel heights. Spine (Phila Pa 1976). 1984 Mar;9(2):223-7. doi: 10.1097/00007632-198403000-00016.

    PMID: 6729584BACKGROUND

  • Chodick G, Ronckers CM, Shalev V, Ron E. Excess lifetime cancer mortality risk attributable to radiation exposure from computed tomography examinations in children. Isr Med Assoc J. 2007 Aug;9(8):584-7.

    PMID: 17877063BACKGROUND

  • Drerup B, Ellger B, Meyer zu Bentrup FM, Hierholzer E. [Functional rasterstereographic images. A new method for biomechanical analysis of skeletal geometry]. Orthopade. 2001 Apr;30(4):242-50. doi: 10.1007/s001320050603. German.

    PMID: 11357446BACKGROUND

  • 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: 3187700BACKGROUND

Study Officials

  • Saverio Colonna, MD

    Spine Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2022

First Posted

October 26, 2022

Study Start

July 1, 2022

Primary Completion

October 31, 2022

Study Completion

November 28, 2022

Last Updated

November 30, 2022

Record last verified: 2022-11

Locations

IT(1)