Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06287281
Status:
RECRUITING
Last Update Posted:
2024-03-01
First Post:
2024-02-11
Brief Title:
High-heeled Shoes in a Sample of Young Women
Sponsor:
Manusapiens
Organization:
Manusapiens
Study Overview
Official Title:
Repercussions on Spinal Posture Before and After Wearing High-heeled Shoes in a Sample of Young Women Cross-sectional Pilot Study
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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
1 The first group group A ASYMPTOMATIC includes subjects who during daily life do not report spinal pain after wearing high-heeled shoes
2 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 87 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
1 first evaluation in neutral position with bare feet T0
2 second evaluation in neutral position wearing shoes T1
3 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 005 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 005 ANOVA will be used to simultaneously compare the pre and post of both groups
If the data does not have a normal distribution p 005 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
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
1 The first group group A ASYMPTOMATIC includes subjects who during daily life do not report spinal pain after wearing high-heeled shoes
2 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 87 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
1 first evaluation in neutral position with bare feet T0
2 second evaluation in neutral position wearing shoes T1
3 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 005 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 005 ANOVA will be used to simultaneously compare the pre and post of both groups
If the data does not have a normal distribution p 005 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None