Immediate Repercussions of High Heels on Spine Posture

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05593991
• Other study ID #: H&S01
• Status: Completed
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: November 28, 2022

Study information

• Verified date: November 2022
• Source: Manusapiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 28, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Elevated heels
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.

Locations

Country	Name	City	State
Italy	Spine Center	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Manusapiens

Country where clinical trial is conducted

Italy, 

References & Publications (11)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)