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临床试验/NCT06287281
NCT06287281招募中不适用

Repercussions on Spinal Posture Before and After Wearing High-heeled Shoes in a Sample of Young Women: Cross-sectional Pilot Study

Manusapiens1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2023年12月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
34
试验地点
1
主要终点
effect of high-heeled shoes on cervical arrow

研究概览

简要总结

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.

详细描述

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:

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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;

结局指标

主要结局

effect of high-heeled shoes on cervical arrow

时间窗: 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.

effect of high-heeled shoes on trunk inclination

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

  • different response on trunk inclination between the subgroups (suffering from back pain and asymptomatic)(2 hours after wearing high heels)
  • different response on lumbar arrow between the subgroups (suffering from back pain and asymptomatic)(2 hours after wearing high heels)
  • different response on pelvic inclination between the subgroups (suffering from back pain and asymptomatic)(2 hours after wearing high heels)
  • different response on kyphotic angle between the subgroups (suffering from back pain and asymptomatic)(2 hours after wearing high heels)
  • different response on cervical arrow between the subgroups (suffering from back pain and asymptomatic)(2 hours after wearing high heels)
  • different response on lordotic angle between the subgroups (suffering from back pain and asymptomatic)(2 hours after wearing high heels)

研究者

发起方
Manusapiens
申办方类型
Other
责任方
Sponsor

研究点 (1)

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