- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05593991
Immediate Repercussions of High Heels on Spine Posture
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
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Bologna, Italy, 40128
- Spine Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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:
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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
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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;
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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)
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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)
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lumbar arrow
Time Frame: 5 seconds for each measured condition (barefoot, 3 cm heels elevation, 7 cm heels elevation)
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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)
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cervical arrow
Time Frame: 5 seconds for each measured condition (barefoot, 3 cm heels elevation, 7 cm heels elevation)
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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)
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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
Sponsor
Investigators
- Principal Investigator: Saverio Colonna, MD, Spine Center
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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