Immediate Repercussions of High Heels on Spine Posture

November 29, 2022 updated by: Manusapiens

Immediate Repercussions on the Spine Posture From Passive Elevation of the Heels in Healthy Subjects: a Cross-sectional Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The data collected by the rasterstereography device will be:

  1. pelvic tilt angle (PI), the angle determined by the vertical and the tangent to lumbosacral junction (ILS);
  2. ITL-ILS lordotic angle, measured between the tangents of the thoracolumbar junction (ITL) and the lumbosacral junction (ILS);
  3. ICT-ITL kyphotic angle, measured between the tangents of the cervicothoracic junction (ICT) and the thoracolumbar junction (ITL); see fig. 1;
  4. lumbar arrow (FL) horizontal distance in millimeters from the vertical line that passes through the kyphotic apex in the lumbar spine;
  5. cervical arrow (FC) (horizontal distance in millimeters from the virtual vertical plumb line that passes through the kyphotic apex in the cervical spine);
  6. antero-posterior flexion of the trunk (Trunk Inclination-TI) measured as the angle between the vertical line and the line passing through the prominent cervical vertebra (VP) to the line connecting the two dimples (DM); see fig. 2.

Participants will provide information on age, height and weight. A questionnaire will be administered to standardize the types of high-heeled shoes used and to verify their frequency of use.

Evaluation Protocol

  1. sample 1: barefoot neutral position;
  2. sample 2: barefoot neutral position;
  3. sample 3: 3 cm rise under both heels;
  4. sample 4: 7 cm rise under both heels.

The positioning with respect to the measurement system will be carried out according to the indications provided by the supplier.

To standardize the position subjects will be prepared for analysis as follows:

  1. standing, back to the detection system, in a relaxed posture with the knees fully extended with bare feet on the floor (neutral position);
  2. bare trunk with pants and briefs lowered to half of the glutei
  3. in the case of long hair, it will be required to tie it with suitable means (cap, hair clips, hair bands, etc.) so that the neck is visible up to the hairline;
  4. rings, watches and necklaces will be removed to avoid any interference with light lines (necklaces in particular increase this probability).

In the third survey, the heel will be raised by inserting a plastic bar symmetrically under both heels, as proposed in previous studies in which wood was used, by 3 cm; for the fourth evaluation it will be 7 cm.

After the first evaluation in the neutral position, before the evaluation with the heel lift, a second evaluation will be performed under the same conditions to evaluate the reproducibility of the data. The time between the two assessments will be less than 1 minute and the subject will not change position.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Bologna, Italy, 40128
        • Spine Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

All healthy subjects.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Healthy adults
Subjects with elevated heels

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pelvic tilt angle
Time Frame: 5 seconds for each measured condition (barefoot, 3 cm heels elevation, 7 cm heels elevation)
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
Time Frame: 5 seconds for each measured condition (barefoot, 3 cm heels elevation, 7 cm heels elevation)
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
Time Frame: 5 seconds for each measured condition (barefoot, 3 cm heels elevation, 7 cm heels elevation)
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
Time Frame: 5 seconds for each measured condition (barefoot, 3 cm heels elevation, 7 cm heels elevation)
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
Time Frame: 5 seconds for each measured condition (barefoot, 3 cm heels elevation, 7 cm heels elevation)
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
Time Frame: 5 seconds for each measured condition (barefoot, 3 cm heels elevation, 7 cm heels elevation)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Saverio Colonna, MD, Spine Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2022

Primary Completion (Actual)

October 31, 2022

Study Completion (Actual)

November 28, 2022

Study Registration Dates

First Submitted

October 13, 2022

First Submitted That Met QC Criteria

October 20, 2022

First Posted (Actual)

October 26, 2022

Study Record Updates

Last Update Posted (Actual)

November 30, 2022

Last Update Submitted That Met QC Criteria

November 29, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • H&S01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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