Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
100 participants
INTERVENTIONAL
2022-07-01
2022-11-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
High-heeled Shoes in a Sample of Young Women
NCT06287281
The Effect of Somatic Dysfunction of the Pelvis, Sacrum and Lower Lumbar Spine on Weight Bearing
NCT01097109
Impact of Postural Balance Changes on Low Back Pain During Pregnancy
NCT06713759
Standing Trunk Extension and Spinal Height in Low Back Pain
NCT03785457
Effect of the Diaphragm Stretching Technique on Nonspecific Low Back Pain
NCT06375018
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
1. pelvic tilt angle (PI), the angle determined by the vertical and the tangent to lumbosacral junction (ILS);
2. ITL-ILS lordotic angle, measured between the tangents of the thoracolumbar junction (ITL) and the lumbosacral junction (ILS);
3. ICT-ITL kyphotic angle, measured between the tangents of the cervicothoracic junction (ICT) and the thoracolumbar junction (ITL); see fig. 1;
4. lumbar arrow (FL) horizontal distance in millimeters from the vertical line that passes through the kyphotic apex in the lumbar spine;
5. cervical arrow (FC) (horizontal distance in millimeters from the virtual vertical plumb line that passes through the kyphotic apex in the cervical spine);
6. 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
1. sample 1: barefoot neutral position;
2. sample 2: barefoot neutral position;
3. sample 3: 3 cm rise under both heels;
4. 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:
1. standing, back to the detection system, in a relaxed posture with the knees fully extended with bare feet on the floor (neutral position);
2. bare trunk with pants and briefs lowered to half of the glutei
3. 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;
4. 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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Healthy adults
Subjects with elevated heels
Elevated heels
Each 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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Elevated heels
Each 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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
65 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Manusapiens
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Saverio Colonna, MD
Role: PRINCIPAL_INVESTIGATOR
Spine Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Spine Center
Bologna, , Italy
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
H&S01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.