Low Back PainNCT06287281
High-heeled Shoes in a Sample of Young Women
An observational study of Low Back Pain and Healthy, run by Manusapiens at 1 site in Italy.
Trial summary
At a postural level, many doctors, physiotherapists and chiropractors are convinced that lower back pain induced by heels is due to an increase in lumbar lordosis associated with an anterior pelvic tilt; this thought is even shared by the American Chiropractic Association and the American Physical Therapy Association. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain, Healthy
- What is being tested?
- heel hight shoes
- How many people
- 34 participants
- Where
- 1 siteItaly
- Study dates
- 15 Dec 2023to 28 Feb 2024
- How long will I take part?
- 2 Months
- Phase
- Observational
- 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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Usual female users of shoes with heels at least 7 cm high, with a frequency of at least twice a week and/or less than 3 hours/week
Who may be able to join
- female subjects aged between 20 and 40 years
- Usual users of shoes with heels at least 7 cm high, with a frequency of at least twice a week and/or less than 3 hours/week
Who cannot join
- structural or neurological anomalies that may prevent you from remaining weight-bearing, for approximately 2 hours, with shoes having a heel (difference between the heel and the plateau) of at least 7 cm high;
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Spine Center
Bologna, 40128
Saverio Colonna, MD, +39 051 095 2375, direzione@spine-center.it
About this study
Official title: Repercussions on Spinal Posture Before and After Wearing High-heeled Shoes in a Sample of Young Women: Cross-sectional Pilot Study
At a postural level, many doctors, physiotherapists and chiropractors are convinced that lower back pain induced by heels is due to an increase in lumbar lordosis associated with an anterior pelvic tilt; this thought is even shared by the American Chiropractic Association and the American Physical Therapy Association.
Furthermore, in most of the websites consulted, even by non-experts, the reason for the onset of spinal pain is attributed to hyperlordosis and pelvic anteversion. However, this thought is not entirely in agreement with other scientific publications. Therefore it is necessary to pay attention to online searches which often answer these questions without taking EBM into account.
Read more
None of the studies reported above take into consideration the time factor. In fact, all the studies have evaluated the immediate changes brought about by heel raising. Women who complain of lower back pain when wearing high-heeled shoes rarely experience pain as soon as they start wearing them.
The objective of the research arises from these considerations. The aim of this study (primary outcome) is to investigate whether wearing high-heeled shoes for at least 2 hours modifies the spinopelvic parameters compared to the barefoot condition and as soon as the shoes are worn.
The secondary outcome will be to verify in the sample analyzed whether there are different behaviors between the subgroups of those who have complained in their anamnesis and those who have never complained of lower back pain when using high-heeled shoes for a few hours.
Read the detailed description
A three-dimensional analysis of the posterior surface will be performed with the Formetric 4D® rasterstereographic device (Diers International GmbH, Schlangenbad, Germany).
Participants will be given a questionnaire which investigates:
- Age, weight, height of the participants;
- Any pain in the spine (measured by NPS) usually reported by subjects after using high-heeled shoes;
- Type of profession;
- Frequency with which the subjects wear the heeled shoe (how many hours per week);
- Heel height of the shoe with which they participate in the clinical study;
- Any spinal pain (measured by NPS) after wearing heeled footwear for the study period.
This last data will be filled in at the end of the evaluation.
For the evaluation of the secondary outcome, on the basis of the data from the medical history sheet, the sample will be divided into two groups:
- The first group (group A, ASYMPTOMATIC) includes subjects who during daily life do not report spinal pain after wearing high-heeled shoes;
- The second group (group S, SYMPTOMATIC) is made up of participants who usually complain of more or less intense pain after using the shoe.
The subjects will be asked to bring their own pair of shoes with a heel that is at least 8.7 cm, the average height reported by the work of Schroeder and Hollander, where average height means the difference between the height of the heel and the height of the raised part at the forefoot level (plateau). A particular heel width will not be required, because it seems that the height of the heel influences muscle activation, in particular the paravertebral muscles, while the width of the heel has no significant effects on them.
Conversely, amplitude has a greater influence on balance when standing and while walking.
Three evaluation will be performed:
- first evaluation in neutral position with bare feet (T0)
- second evaluation in neutral position wearing shoes (T1);
- third evaluation like the previous one but at least 2 hours apart, in which it will be required to remain standing still or walk (T2).
Statistic analysis
A descriptive analysis of the population will be performed to determine the mean values and standard deviations (SD) of both the combined group and the subgroups A and S. T-tests for independent data will be used to verify whether there are any significant differences between the two subgroups .
The distribution of the data will be verified using graphical representation. If the distribution is normal (p <0.05) for the comparison between T1 vs T2 the t-test for paired data will be used and between the subgroups (T1S vs T1A and T2S vs T2A) t-test for independent data with statistical significance accepted for p values <0.05. ANOVA will be used to simultaneously compare the pre and post of both groups.
If the data does not have a normal distribution (p >0.05) the Wilcoxon test will be used for the comparison between the T1 vs T2 data of the total group and the Mann-Whitney U test for the comparison between subgroups (T1S vs T1A and T2S vs T2A). The Friedman test will be used to simultaneously compare the pre and post of both groups.
- Conditions
- Low Back Pain, Healthy
- Being tested
- heel hight shoes
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
heel hight shoesOther
stand upright for 2 hours wearing your own shoes with heels at least 7 cm high
What is being measured
The primary outcome is the main question the study is designed to answer.
effect of high-heeled shoes on trunk inclination
The aim of this study is to investigate whether wearing high-heeled shoes for at least 2 hours modifies the flexion of the antero-posterior trunk (measured as the angle between the vertical and the line that passes through the prominent cervical vertebra and the line that connects the two dimples) compared to the barefoot condition and as soon as the shoes are worn.
Measured: 2 hours after wearing high heels
effect of high-heeled shoes on pelvic inclination
The aim of this study is to investigate whether wearing high-heeled shoes for at least 2 hours modifies the pelvic inclination angle (the angle between the vertical and the tangent to the lumbosacral junction) compared to the barefoot condition and as soon as the shoes are worn.
Measured: 2 hours after wearing high heels
effect of high-heeled shoes on lordotic angle
The aim of this study is to investigate whether wearing high-heeled shoes for at least 2 hours modifies the lordotic angle (angle measured between the tangents of the thoracolumbar junction and the lumbosacral junction) compared to the barefoot condition and as soon as the shoes are worn.
Measured: 2 hours after wearing high heels
effect of high-heeled shoes on kyphotic angle
The aim of this study is to investigate whether wearing high-heeled shoes for at least 2 hours modifies the kyphotic angle (angle measured between the tangents of the cervicothoracic junction and the thoracolumbar junction) compared to the barefoot condition and as soon as the shoes are worn.
Measured: 2 hours after wearing high heels
effect of high-heeled shoes on lumbar arrow
The aim of this study is to investigate whether wearing high-heeled shoes for at least 2 hours modifies the lumbar arrow (horizontal distance in millimeters of the lumbar spine from the virtual vertical line that passes through the kyphotic apex) compared to the barefoot condition and as soon as the shoes are worn.
Measured: 2 hours after wearing high heels
effect of high-heeled shoes on cervical arrow
The aim of this study is to investigate whether wearing high-heeled shoes for at least 2 hours modifies the cervical arrow (horizontal distance in millimeters of the cervical spine from the virtual vertical line that passes through the kyphotic apex) compared to the barefoot condition and as soon as the shoes are worn.
Measured: 2 hours after wearing high heels
Secondary outcomes (6)
different response on trunk inclination between the subgroups (suffering from back pain and asymptomatic)
The secondary outcome will be to verify in the sample analyzed whether there are different behaviors of the flexion of the antero-posterior trunk (measured as the angle between the vertical and the line that passes through the prominent cervical vertebra and the line that connects the two dimples) between the subgroups of those who suffer from low-back pain and those who have never complained of low-back pain when using high-heeled shoes for a few hours.
Measured: 2 hours after wearing high heels
different response on pelvic inclination between the subgroups (suffering from back pain and asymptomatic)
The secondary outcome will be to verify in the sample analyzed whether there are different behaviors of the pelvic inclination angle (the angle between the vertical and the tangent to the lumbosacral junction) between the subgroups of those who suffer from low-back pain and those who have never complained of low-back pain when using high-heeled shoes for a few hours.
Measured: 2 hours after wearing high heels
different response on lordotic angle between the subgroups (suffering from back pain and asymptomatic)
The secondary outcome will be to verify in the sample analyzed whether there are different behaviors of the lordotic angle (angle measured between the tangents of the thoracolumbar junction and the lumbosacral junction) between the subgroups of those who suffer from low-back pain and those who have never complained of low-back pain when using high-heeled shoes for a few hours.
Measured: 2 hours after wearing high heels
different response on kyphotic angle between the subgroups (suffering from back pain and asymptomatic)
The secondary outcome will be to verify in the sample analyzed whether there are different behaviors of the kyphotic angle (angle measured between the tangents of the cervicothoracic junction and the thoracolumbar junction) between the subgroups of those who suffer from low-back pain and those who have never complained of low-back pain when using high-heeled shoes for a few hours.
Measured: 2 hours after wearing high heels
different response on lumbar arrow between the subgroups (suffering from back pain and asymptomatic)
The secondary outcome will be to verify in the sample analyzed whether there are different behaviors of the lumbar arrow (horizontal distance in millimeters of the lumbar spine from the virtual vertical line that passes through the kyphotic apex) between the subgroups of those who suffer from low-back pain and those who have never complained of low-back pain when using high-heeled shoes for a few hours.
Measured: 2 hours after wearing high heels
different response on cervical arrow between the subgroups (suffering from back pain and asymptomatic)
The secondary outcome will be to verify in the sample analyzed whether there are different behaviors of the cervical arrow (horizontal distance in millimeters of the cervical spine from the virtual vertical line that passes through the kyphotic apex) between the subgroups of those who suffer from low-back pain and those who have never complained of low-back pain when using high-heeled shoes for a few hours.
Measured: 2 hours after wearing high heels
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study start15 Dec 2023
- Primary completion15 Feb 2024
- Study completion28 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 34 participants (estimated)
- Target duration
- 2 Months
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
- NCT06287281
- Sponsor's protocol ID
- Heel01
- Status last verified
- Feb 2024
- First submitted
- 11 Feb 2024
- Last updated
- 1 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lee CM, Jeong EH, Freivalds A (2001) Biomechanical effects of wearing high-heeled shoes. Int J Indust Ergonom 28:321-326
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.
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 7711763Schroder G, Kundt G, Otte M, Wendig D, Schober HC. Impact of pregnancy on back pain and body posture in women. J Phys Ther Sci. 2016 Apr;28(4):1199-207. doi: 10.1589/jpts.28.1199. Epub 2016 Apr 28.
PubMed 27190453Gerber SB, Costa RV, Grecco LA, Pasini H, Marconi NF, Oliveira CS. Interference of high-heeled shoes in static balance among young women. Hum Mov Sci. 2012 Oct;31(5):1247-52. doi: 10.1016/j.humov.2012.02.005. Epub 2012 Jun 27.
PubMed 22742722Han D. Muscle activation of paraspinal muscles in different types of high heels during standing. J Phys Ther Sci. 2015 Jan;27(1):67-9. doi: 10.1589/jpts.27.67. Epub 2015 Jan 9.
PubMed 25642040Russell BS. The effect of high-heeled shoes on lumbar lordosis: a narrative review and discussion of the disconnect between Internet content and peer-reviewed literature. J Chiropr Med. 2010 Dec;9(4):166-73. doi: 10.1016/j.jcm.2010.07.003. Epub 2010 Oct 14.
PubMed 22027108Kwon YJ, Song M, Baek IH, Lee T. The effect of simulating a leg-length discrepancy on pelvic position and spinal posture. J Phys Ther Sci. 2015 Mar;27(3):689-91. doi: 10.1589/jpts.27.689. Epub 2015 Mar 31.
PubMed 25931709
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repercussions on Spinal Posture Before and After Wearing High-heeled Shoes in a Sample of Young Women: Cross-sectional Pilot Study
- ClinicalTrials.gov ID
- NCT06287281
- Acronym / sponsor ID
- Heel01
- Conditions
- Low Back Pain, Healthy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- ManusapiensUniversity, hospital or other
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- 15 Feb 2024 (actual)
- Study completion
- 28 Feb 2024 (estimated)
- First posted
- 1 Mar 2024 (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.
At a postural level, many doctors, physiotherapists and chiropractors are convinced that lower back pain induced by heels is due to an increase in lumbar lordosis associated with an anterior pelvic tilt; this thought is even shared by the American Chiropractic Association and the American Physical Therapy Association.
Furthermore, in most of the websites consulted, even by non-experts, the reason for the onset of spinal pain is attributed to hyperlordosis and pelvic anteversion. However, this thought is not entirely in agreement with other scientific publications. Therefore it is necessary to pay attention to online searches which often answer these questions without taking EBM into account.
None of the studies reported above take into consideration the time factor. In fact, all the studies have evaluated the immediate changes brought about by heel raising. Women who complain of lower back pain when wearing high-heeled shoes rarely experience pain as soon as they start wearing them.
The objective of the research arises from these considerations. The aim of this study (primary outcome) is to investigate whether wearing high-heeled shoes for at least 2 hours modifies the spinopelvic parameters compared to the barefoot condition and as soon as the shoes are worn.
The secondary outcome will be to verify in the sample analyzed whether there are different behaviors between the subgroups of those who have complained in their anamnesis and those who have never complained of lower back pain when using high-heeled shoes for a few hours.
Detailed description
A three-dimensional analysis of the posterior surface will be performed with the Formetric 4D® rasterstereographic device (Diers International GmbH, Schlangenbad, Germany).
Participants will be given a questionnaire which investigates:
- Age, weight, height of the participants;
- Any pain in the spine (measured by NPS) usually reported by subjects after using high-heeled shoes;
- Type of profession;
- Frequency with which the subjects wear the heeled shoe (how many hours per week);
- Heel height of the shoe with which they participate in the clinical study;
- Any spinal pain (measured by NPS) after wearing heeled footwear for the study period.
This last data will be filled in at the end of the evaluation.
For the evaluation of the secondary outcome, on the basis of the data from the medical history sheet, the sample will be divided into two groups:
- The first group (group A, ASYMPTOMATIC) includes subjects who during daily life do not report spinal pain after wearing high-heeled shoes;
- The second group (group S, SYMPTOMATIC) is made up of participants who usually complain of more or less intense pain after using the shoe.
The subjects will be asked to bring their own pair of shoes with a heel that is at least 8.7 cm, the average height reported by the work of Schroeder and Hollander, where average height means the difference between the height of the heel and the height of the raised part at the forefoot level (plateau). A particular heel width will not be required, because it seems that the height of the heel influences muscle activation, in particular the paravertebral muscles, while the width of the heel has no significant effects on them.
Conversely, amplitude has a greater influence on balance when standing and while walking.
Three evaluation will be performed:
- first evaluation in neutral position with bare feet (T0)
- second evaluation in neutral position wearing shoes (T1);
- third evaluation like the previous one but at least 2 hours apart, in which it will be required to remain standing still or walk (T2).
Statistic analysis
A descriptive analysis of the population will be performed to determine the mean values and standard deviations (SD) of both the combined group and the subgroups A and S. T-tests for independent data will be used to verify whether there are any significant differences between the two subgroups .
The distribution of the data will be verified using graphical representation. If the distribution is normal (p <0.05) for the comparison between T1 vs T2 the t-test for paired data will be used and between the subgroups (T1S vs T1A and T2S vs T2A) t-test for independent data with statistical significance accepted for p values <0.05. ANOVA will be used to simultaneously compare the pre and post of both groups.
If the data does not have a normal distribution (p >0.05) the Wilcoxon test will be used for the comparison between the T1 vs T2 data of the total group and the Mann-Whitney U test for the comparison between subgroups (T1S vs T1A and T2S vs T2A). The Friedman test will be used to simultaneously compare the pre and post of both groups.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Months
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Usual female users of shoes with heels at least 7 cm high, with a frequency of at least twice a week and/or less than 3 hours/week
Key inclusion criteria (2 listed)
- female subjects aged between 20 and 40 years
- Usual users of shoes with heels at least 7 cm high, with a frequency of at least twice a week and/or less than 3 hours/week
Key exclusion criteria (1 listed)
- structural or neurological anomalies that may prevent you from remaining weight-bearing, for approximately 2 hours, with shoes having a heel (difference between the heel and the plateau) of at least 7 cm high;
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 |
|---|---|---|
| heel hight shoesstand upright for 2 hours wearing your own shoes with heels at least 7 cm high | Other | – |
Primary outcome
effect of high-heeled shoes on trunk inclination
Time frame: 2 hours after wearing high heels
The aim of this study is to investigate whether wearing high-heeled shoes for at least 2 hours modifies the flexion of the antero-posterior trunk (measured as the angle between the vertical and the line that passes through the prominent cervical vertebra and the line that connects the two dimples) compared to the barefoot condition and as soon as the shoes are worn.
effect of high-heeled shoes on pelvic inclination
Time frame: 2 hours after wearing high heels
The aim of this study is to investigate whether wearing high-heeled shoes for at least 2 hours modifies the pelvic inclination angle (the angle between the vertical and the tangent to the lumbosacral junction) compared to the barefoot condition and as soon as the shoes are worn.
effect of high-heeled shoes on lordotic angle
Time frame: 2 hours after wearing high heels
The aim of this study is to investigate whether wearing high-heeled shoes for at least 2 hours modifies the lordotic angle (angle measured between the tangents of the thoracolumbar junction and the lumbosacral junction) compared to the barefoot condition and as soon as the shoes are worn.
effect of high-heeled shoes on kyphotic angle
Time frame: 2 hours after wearing high heels
The aim of this study is to investigate whether wearing high-heeled shoes for at least 2 hours modifies the kyphotic angle (angle measured between the tangents of the cervicothoracic junction and the thoracolumbar junction) compared to the barefoot condition and as soon as the shoes are worn.
effect of high-heeled shoes on lumbar arrow
Time frame: 2 hours after wearing high heels
The aim of this study is to investigate whether wearing high-heeled shoes for at least 2 hours modifies the lumbar arrow (horizontal distance in millimeters of the lumbar spine from the virtual vertical line that passes through the kyphotic apex) compared to the barefoot condition and as soon as the shoes are worn.
effect of high-heeled shoes on cervical arrow
Time frame: 2 hours after wearing high heels
The aim of this study is to investigate whether wearing high-heeled shoes for at least 2 hours modifies the cervical arrow (horizontal distance in millimeters of the cervical spine from the virtual vertical line that passes through the kyphotic apex) compared to the barefoot condition and as soon as the shoes are worn.
6 secondary outcomes
different response on trunk inclination between the subgroups (suffering from back pain and asymptomatic)
Time frame: 2 hours after wearing high heels
different response on pelvic inclination between the subgroups (suffering from back pain and asymptomatic)
Time frame: 2 hours after wearing high heels
different response on lordotic angle between the subgroups (suffering from back pain and asymptomatic)
Time frame: 2 hours after wearing high heels
different response on kyphotic angle between the subgroups (suffering from back pain and asymptomatic)
Time frame: 2 hours after wearing high heels
different response on lumbar arrow between the subgroups (suffering from back pain and asymptomatic)
Time frame: 2 hours after wearing high heels
different response on cervical arrow between the subgroups (suffering from back pain and asymptomatic)
Time frame: 2 hours after wearing high heels
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
- BackgroundLee CM, Jeong EH, Freivalds A (2001) Biomechanical effects of wearing high-heeled shoes. Int J Indust Ergonom 28:321-326
- 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 27190453Schroder G, Kundt G, Otte M, Wendig D, Schober HC. Impact of pregnancy on back pain and body posture in women. J Phys Ther Sci. 2016 Apr;28(4):1199-207. doi: 10.1589/jpts.28.1199. Epub 2016 Apr 28.
- Background: PubMed 22742722Gerber SB, Costa RV, Grecco LA, Pasini H, Marconi NF, Oliveira CS. Interference of high-heeled shoes in static balance among young women. Hum Mov Sci. 2012 Oct;31(5):1247-52. doi: 10.1016/j.humov.2012.02.005. Epub 2012 Jun 27.
- Background: PubMed 25642040Han D. Muscle activation of paraspinal muscles in different types of high heels during standing. J Phys Ther Sci. 2015 Jan;27(1):67-9. doi: 10.1589/jpts.27.67. Epub 2015 Jan 9.
- Background: PubMed 22027108Russell BS. The effect of high-heeled shoes on lumbar lordosis: a narrative review and discussion of the disconnect between Internet content and peer-reviewed literature. J Chiropr Med. 2010 Dec;9(4):166-73. doi: 10.1016/j.jcm.2010.07.003. Epub 2010 Oct 14.
- Background: PubMed 25931709Kwon YJ, Song M, Baek IH, Lee T. The effect of simulating a leg-length discrepancy on pelvic position and spinal posture. J Phys Ther Sci. 2015 Mar;27(3):689-91. doi: 10.1589/jpts.27.689. Epub 2015 Mar 31.
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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?
An observational study of Low Back Pain and 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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 1 Mar 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Saverio Colonna, MD (+393356213419, saverio.colonna@libero.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effect of high-heeled shoes on trunk inclination (time frame: 2 hours after wearing high heels). 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 NCT06287281, which also lists 10 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 1 Mar 2024; AzTrials last refreshed its copy on 8 Nov 2026.