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Completed

NCT Number: NCT05593991

Immediate Repercussions of High Heels on Spine Posture

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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Spine Center

Bologna, 40128, Italy

About this study

The data collected by the rasterstereography device will be:

  • pelvic tilt angle (PI), the angle determined by the vertical and the tangent to lumbosacral junction (ILS);
  • ITL-ILS lordotic angle, measured between the tangents of the thoracolumbar junction (ITL) and the lumbosacral junction (ILS);
  • ICT-ITL kyphotic angle, measured between the tangents of the cervicothoracic junction (ICT) and the thoracolumbar junction (ITL); see fig. 1;
  • lumbar arrow (FL) horizontal distance in millimeters from the vertical line that passes through the kyphotic apex in the lumbar spine;
  • cervical arrow (FC) (horizontal distance in millimeters from the virtual vertical plumb line that passes through the kyphotic apex in the cervical spine);
  • 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

  • sample 1: barefoot neutral position;
  • sample 2: barefoot neutral position;
  • sample 3: 3 cm rise under both heels;
  • 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:

  • standing, back to the detection system, in a relaxed posture with the knees fully extended with bare feet on the floor (neutral position);
  • bare trunk with pants and briefs lowered to half of the glutei
  • 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;
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Elevated heels

Other

Each subject will undergo the following evaluations:

  • neutral barefoot position;
  • neutral barefoot position (re-test);
  • 3 cm rise of both heels, made with plastic spacer;
  • 7 cm rise of both heels, made with plastic spacer.

Primary outcomes

  1. 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

  2. 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;

  3. 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;

  4. 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. 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;

  6. 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.

Sponsors and collaborators

Lead sponsor

Manusapiens

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Oct 26, 2022
Registry last updated
Nov 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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