Clinical trial NCT04620993: Biomechanical and Viscoelastic Properties of Plantar Fascia in Pregnant Women
Official title: Investigation of the Effect of Biomechanical and Viscoelastic Properties of Plantar Fascia on Pelvic Girdle Pain in Pregnant Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Girdle Pain
Biomechanical and Viscoelastic Properties of Plantar Fascia
Pregnant Woman
Keywords: pelvic girdle pain, pregnant women, plantar fascia
Lead sponsor: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Sponsor class: OTHER
First posted: 2020-11-09
Enrollment: 73
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Pegnant women with pelvic girdle pain Pegnant women without pelvic girdle pain Non pregnant healthy women

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of biomechanical and viscoelastic properties of plantar fascia
timeFrame: Baseline Measurements
measure: Evaluation of plantar pressure distrubution
timeFrame: Baseline Measurements
Secondary outcomes:
measure: Evaluation of navicular drop
timeFrame: Baseline Measurements
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Saglık Bilimleri University
Study officials:
References:
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.
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.
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.
citation: Kerbourc'h F, Bertuit J, Feipel V, Rooze M. Pregnancy and Pelvic Girdle PainAnalysis of Center of Pressure During Gait. J Am Podiatr Med Assoc. 2017 Jul;107(4):299-306. doi: 10.7547/15-087.
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. doi: 10.1007/s00586-012-2162-x. Epub 2012 Feb 4.
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.
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.
citation: 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. doi: 10.1007/s00586-012-2401-1. Epub 2012 Jun 21.
citation: Khamis S, Yizhar Z. Effect of feet hyperpronation on pelvic alignment in a standing position. Gait Posture. 2007 Jan;25(1):127-34. doi: 10.1016/j.gaitpost.2006.02.005. Epub 2006 Apr 18.