NCT06287281

Brief Summary

At a postural level, many doctors, physiotherapists and chiropractors are convinced that lower back pain induced by heels is due to an increase in lumbar lordosis associated with an anterior pelvic tilt; this thought is even shared by the American Chiropractic Association and the American Physical Therapy Association. Furthermore, in most of the websites consulted, even by non-experts, the reason for the onset of spinal pain is attributed to hyperlordosis and pelvic anteversion. However, this thought is not entirely in agreement with other scientific publications. Therefore it is necessary to pay attention to online searches which often answer these questions without taking EBM into account. None of the studies reported above take into consideration the time factor. In fact, all the studies have evaluated the immediate changes brought about by heel raising. Women who complain of lower back pain when wearing high-heeled shoes rarely experience pain as soon as they start wearing them. The objective of the research arises from these considerations. The aim of this study (primary outcome) is to investigate whether wearing high-heeled shoes for at least 2 hours modifies the spinopelvic parameters compared to the barefoot condition and as soon as the shoes are worn. The secondary outcome will be to verify in the sample analyzed whether there are different behaviors between the subgroups of those who have complained in their anamnesis and those who have never complained of lower back pain when using high-heeled shoes for a few hours.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

December 15, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 11, 2024

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2024

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 1, 2024

Completed
Last Updated

March 1, 2024

Status Verified

February 1, 2024

Enrollment Period

2 months

First QC Date

February 11, 2024

Last Update Submit

February 22, 2024

Conditions

Outcome Measures

Primary Outcomes (6)

  • effect of high-heeled shoes on trunk inclination

    The aim of this study is to investigate whether wearing high-heeled shoes for at least 2 hours modifies the flexion of the antero-posterior trunk (measured as the angle between the vertical and the line that passes through the prominent cervical vertebra and the line that connects the two dimples) compared to the barefoot condition and as soon as the shoes are worn.

    2 hours after wearing high heels

  • effect of high-heeled shoes on pelvic inclination

    The aim of this study is to investigate whether wearing high-heeled shoes for at least 2 hours modifies the pelvic inclination angle (the angle between the vertical and the tangent to the lumbosacral junction) compared to the barefoot condition and as soon as the shoes are worn.

    2 hours after wearing high heels

  • effect of high-heeled shoes on lordotic angle

    The aim of this study is to investigate whether wearing high-heeled shoes for at least 2 hours modifies the lordotic angle (angle measured between the tangents of the thoracolumbar junction and the lumbosacral junction) compared to the barefoot condition and as soon as the shoes are worn.

    2 hours after wearing high heels

  • effect of high-heeled shoes on kyphotic angle

    The aim of this study is to investigate whether wearing high-heeled shoes for at least 2 hours modifies the kyphotic angle (angle measured between the tangents of the cervicothoracic junction and the thoracolumbar junction) compared to the barefoot condition and as soon as the shoes are worn.

    2 hours after wearing high heels

  • effect of high-heeled shoes on lumbar arrow

    The aim of this study is to investigate whether wearing high-heeled shoes for at least 2 hours modifies the lumbar arrow (horizontal distance in millimeters of the lumbar spine from the virtual vertical line that passes through the kyphotic apex) compared to the barefoot condition and as soon as the shoes are worn.

    2 hours after wearing high heels

  • effect of high-heeled shoes on cervical arrow

    The aim of this study is to investigate whether wearing high-heeled shoes for at least 2 hours modifies the cervical arrow (horizontal distance in millimeters of the cervical spine from the virtual vertical line that passes through the kyphotic apex) compared to the barefoot condition and as soon as the shoes are worn.

    2 hours after wearing high heels

Secondary Outcomes (6)

  • different response on trunk inclination between the subgroups (suffering from back pain and asymptomatic)

    2 hours after wearing high heels

  • different response on pelvic inclination between the subgroups (suffering from back pain and asymptomatic)

    2 hours after wearing high heels

  • different response on lordotic angle between the subgroups (suffering from back pain and asymptomatic)

    2 hours after wearing high heels

  • different response on kyphotic angle between the subgroups (suffering from back pain and asymptomatic)

    2 hours after wearing high heels

  • different response on lumbar arrow between the subgroups (suffering from back pain and asymptomatic)

    2 hours after wearing high heels

  • +1 more secondary outcomes

Interventions

stand upright for 2 hours wearing your own shoes with heels at least 7 cm high

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Usual female users of shoes with heels at least 7 cm high, with a frequency of at least twice a week and/or less than 3 hours/week

You may qualify if:

  • female subjects aged between 20 and 40 years
  • Usual users of shoes with heels at least 7 cm high, with a frequency of at least twice a week and/or less than 3 hours/week

You may not qualify if:

  • structural or neurological anomalies that may prevent you from remaining weight-bearing, for approximately 2 hours, with shoes having a heel (difference between the heel and the plateau) of at least 7 cm high;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Spine Center

Bologna, 40128, Italy

RECRUITING

Related Publications (10)

  • Lee CM, Jeong EH, Freivalds A (2001) Biomechanical effects of wearing high-heeled shoes. Int J Indust Ergonom 28:321-326

    BACKGROUND
  • 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
  • Schroder G, Kundt G, Otte M, Wendig D, Schober HC. Impact of pregnancy on back pain and body posture in women. J Phys Ther Sci. 2016 Apr;28(4):1199-207. doi: 10.1589/jpts.28.1199. Epub 2016 Apr 28.

    PMID: 27190453BACKGROUND
  • Gerber SB, Costa RV, Grecco LA, Pasini H, Marconi NF, Oliveira CS. Interference of high-heeled shoes in static balance among young women. Hum Mov Sci. 2012 Oct;31(5):1247-52. doi: 10.1016/j.humov.2012.02.005. Epub 2012 Jun 27.

    PMID: 22742722BACKGROUND
  • Han D. Muscle activation of paraspinal muscles in different types of high heels during standing. J Phys Ther Sci. 2015 Jan;27(1):67-9. doi: 10.1589/jpts.27.67. Epub 2015 Jan 9.

    PMID: 25642040BACKGROUND
  • Russell BS. The effect of high-heeled shoes on lumbar lordosis: a narrative review and discussion of the disconnect between Internet content and peer-reviewed literature. J Chiropr Med. 2010 Dec;9(4):166-73. doi: 10.1016/j.jcm.2010.07.003. Epub 2010 Oct 14.

    PMID: 22027108BACKGROUND
  • Kwon YJ, Song M, Baek IH, Lee T. The effect of simulating a leg-length discrepancy on pelvic position and spinal posture. J Phys Ther Sci. 2015 Mar;27(3):689-91. doi: 10.1589/jpts.27.689. Epub 2015 Mar 31.

    PMID: 25931709BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Saverio Colonna, MD

    Spine Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
2 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2024

First Posted

March 1, 2024

Study Start

December 15, 2023

Primary Completion

February 15, 2024

Study Completion

February 28, 2024

Last Updated

March 1, 2024

Record last verified: 2024-02

Locations