HealthyNCT05593991
Immediate Repercussions of High Heels on Spine Posture
A study testing Elevated heels in people with Healthy, run by Manusapiens at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Elevated heels
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2022to 28 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All healthy subjects.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Elevated heels
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elevated heelsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy adults | Experimental | Subjects with elevated heels Receives: Other: Elevated heels |
What is being measured
The primary outcome is the main question the study is designed to answer.
pelvic tilt angle
the angle between the vertical and the tangent to the lumbosacral junction
Measured: 5 seconds for each measured condition (barefoot, 3 cm heels elevation, 7 cm heels elevation)
lordotic angle
measured between the tangents of the thoracolumbar junction and the lumbosacral junction;
Measured: 5 seconds for each measured condition (barefoot, 3 cm heels elevation, 7 cm heels elevation)
kyphotic angle
measured between the tangents of the cervicothoracic junction and the thoracolumbar junction;
Measured: 5 seconds for each measured condition (barefoot, 3 cm heels elevation, 7 cm heels elevation)
lumbar arrow
horizontal distance in millimeters of the lumbar spine from the virtual vertical line that passes through the kyphotic apex;
Measured: 5 seconds for each measured condition (barefoot, 3 cm heels elevation, 7 cm heels elevation)
cervical arrow
horizontal distance in millimeters of the cervical spine from the virtual vertical line that passes through the kyphotic apex;
Measured: 5 seconds for each measured condition (barefoot, 3 cm heels elevation, 7 cm heels elevation)
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.
Measured: 5 seconds for each measured condition (barefoot, 3 cm heels elevation, 7 cm heels elevation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2022
- Study start1 Jul 2022
- Primary completion31 Oct 2022
- Study completion28 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manusapiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Saverio Colonna, MD, Principal investigator, Spine Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05593991
- Sponsor's protocol ID
- H&S01
- Status last verified
- Nov 2022
- First submitted
- 13 Oct 2022
- Last updated
- 30 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 14654211Snow 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.
PubMed 8185452Cowley 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.
PubMed 19917737de 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.
PubMed 22078999Dai 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.
PubMed 25753007de 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.
PubMed 1910649Franklin 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.
PubMed 7711763Bendix 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.
PubMed 6729584Chodick 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.
PubMed 17877063Drerup 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.
PubMed 11357446Opila 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.
PubMed 3187700
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Repercussions on the Spine Posture From Passive Elevation of the Heels in Healthy Subjects: a Cross-sectional Study
- ClinicalTrials.gov ID
- NCT05593991
- Acronym / sponsor ID
- H&S01
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- ManusapiensUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 28 Nov 2022 (actual)
- First posted
- 26 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy adults | Experimental | Other: Elevated heelsSubjects with elevated heels |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All healthy subjects.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elevated heelsEach 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. | Other | Healthy adults |
Primary outcome
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
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;
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;
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;
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;
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2022.
- Background: PubMed 14654211Bird 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.
- Background: PubMed 8185452Snow 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.
- Background: PubMed 19917737Cowley 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.
- Background: PubMed 22078999de 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.
- Background: PubMed 25753007Dai 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.
- Background: PubMed 1910649de 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.
- Background: PubMed 7711763Franklin 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.
- Background: PubMed 6729584Bendix 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.
- Background: PubMed 17877063Chodick 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.
- Background: PubMed 11357446Drerup 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.
- Background: PubMed 3187700Opila 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saverio Colonna, MD principal investigator
Spine Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Elevated heels in people with Healthy, run by Manusapiens at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pelvic tilt angle (time frame: 5 seconds for each measured condition (barefoot, 3 cm heels elevation, 7 cm heels elevation)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05593991, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2022.