Biomechanical and Viscoelastic Properties of Plantar Fascia in Pregnant Women

Pelvic Girdle Pain Clinical Trial

Official title:

Investigation of the Effect of Biomechanical and Viscoelastic Properties of Plantar Fascia on Pelvic Girdle Pain in Pregnant Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04620993
• Other study ID #: 166
• Status: Completed
• Start date: January 2, 2021
• Est. completion date: May 23, 2021

Study information

• Verified date: November 2020
• Source: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Pelvic girdle pain is frequently experienced in pregnant women and the mechanism of pelvic girdle pain is not known exactly. The aim of this study is to investigate the effect of biomechanical and viscoelastic properties of plantar fascia on pelvic girdle pain in pregnant women.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: May 23, 2021
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• Pregnant women in the 2nd or 3rd trimester of pregnancy with pelvic girdle pain
• Pregnant women in the 2nd or 3rd trimester of pregnancy without pelvic girdle pain
• First pregnancy
• 20-40 years old
• Healthy woman without pregnancy

Exclusion Criteria:

• Participant having any kind of connective tissue disease
• Presence of orthopedic or neurological problems in the lower extremities that may cause musculoskeletal disorder and biomechanical alignment deviations
• Presence of foot pain that started before pregnancy and lasts for more than 3 months
• Presence of lumbar-pelvic pain that started before pregnancy and lasts for more than 3 months
• Have had 2 or more births
• Presence of multiple pregnancy (twins, triplets etc)
• Presence of ankle-ankle fracture and operation history in the last 6 months

Related Conditions & MeSH terms

• Biomechanical and Viscoelastic Properties of Plantar Fascia
• Pelvic Girdle Pain
• Pregnant Woman

Intervention

Other:
• Evaluation of biomechanics and viscoelastic properties of plantar fascia
The biomechanical and viscoelastic properties of the plantar fascia will be measured in the side lying position. Measurements will be made with the ankle in neutral position and maximum dorsi flexion position.
• Evaluation of navicular drop
The amount of navicular drop of both feet will be measured
• Evaluation of plantar pressure distrubution
The distribution of foot plantar pressure and the amount of change in the center of gravity will be measured in the free standing position.

Locations

Country	Name	City	State
Turkey	Istanbul Saglik Bilimleri University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Country where clinical trial is conducted

Turkey, 

References & Publications (9)

Aldabe D, Milosavljevic S, Bussey MD. Is pregnancy related pelvic girdle pain associated with altered kinematic, kinetic and motor control of the pelvis? A systematic review. Eur Spine J. 2012 Sep;21(9):1777-87. Epub 2012 Jun 21. Review. — View Citation

Aldabe D, Ribeiro DC, Milosavljevic S, Dawn Bussey M. Pregnancy-related pelvic girdle pain and its relationship with relaxin levels during pregnancy: a systematic review. Eur Spine J. 2012 Sep;21(9):1769-76. Epub 2012 Feb 4. Review. — View Citation

Bertuit J, Van Lint CE, Rooze M, Feipel V. Pregnancy and pelvic girdle pain: Analysis of pelvic belt on pain. J Clin Nurs. 2018 Jan;27(1-2):e129-e137. doi: 10.1111/jocn.13888. Epub 2017 Nov 3. — View Citation

Ceprnja D, Chipchase L, Gupta A. Prevalence of pregnancy-related pelvic girdle pain and associated factors in Australia: a cross-sectional study protocol. BMJ Open. 2017 Nov 15;7(11):e018334. doi: 10.1136/bmjopen-2017-018334. — View Citation

Elden H, Gutke A, Kjellby-Wendt G, Fagevik-Olsen M, Ostgaard HC. Predictors and consequences of long-term pregnancy-related pelvic girdle pain: a longitudinal follow-up study. BMC Musculoskelet Disord. 2016 Jul 12;17:276. doi: 10.1186/s12891-016-1154-0. — View Citation

Kerbourc'h F, Bertuit J, Feipel V, Rooze M. Pregnancy and Pelvic Girdle Pain(Analysis of Center of Pressure During Gait). J Am Podiatr Med Assoc. 2017 Jul;107(4):299-306. doi: 10.7547/15-087. — View Citation

Khamis S, Yizhar Z. Effect of feet hyperpronation on pelvic alignment in a standing position. Gait Posture. 2007 Jan;25(1):127-34. Epub 2006 Apr 18. — View Citation

Park SY, Park DJ. Comparison of Foot Structure, Function, Plantar Pressure and Balance Ability According to the Body Mass Index of Young Adults. Osong Public Health Res Perspect. 2019 Apr;10(2):102-107. doi: 10.24171/j.phrp.2019.10.2.09. — View Citation

Wuytack F, Daly D, Curtis E, Begley C. Prognostic factors for pregnancy-related pelvic girdle pain, a systematic review. Midwifery. 2018 Nov;66:70-78. doi: 10.1016/j.midw.2018.07.012. Epub 2018 Aug 8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of biomechanical and viscoelastic properties of plantar fascia	Measuring of the biomechanical and viscoelastic properties of the plantar fascia (with MyotonPro, Myoton AS, Tallin, Estonia) in the side lying position.	Baseline Measurements
Primary	Evaluation of plantar pressure distrubution	Measuring of plantar pressure distrubution (with Tekscan, Boston, MA, USA) in free standing position	Baseline Measurements
Secondary	Evaluation of navicular drop	Measuring of the amount of the navicular drop	Baseline Measurements