NCT04620993

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 3, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 9, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

January 2, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 23, 2021

Completed
Last Updated

January 20, 2022

Status Verified

November 1, 2020

Enrollment Period

4 months

First QC Date

November 3, 2020

Last Update Submit

January 19, 2022

Conditions

Keywords

pelvic girdle pain, pregnant women, plantar fascia

Outcome Measures

Primary Outcomes (2)

  • 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

  • Evaluation of plantar pressure distrubution

    Measuring of plantar pressure distrubution (with Tekscan, Boston, MA, USA) in free standing position

    Baseline Measurements

Secondary Outcomes (1)

  • Evaluation of navicular drop

    Baseline Measurements

Study Arms (3)

Group 1: pregnant women with pelvic girdle pain

This group will consist of pregnant women who are in the 2nd or 3rd trimester of pregnancy and have pelvic girdle pain.

Other: Evaluation of biomechanics and viscoelastic properties of plantar fasciaOther: Evaluation of navıcular dropOther: Evaluation of plantar pressure distrubution

Group 2:pregnant women without pelvic girdle pain

This group will consist of pregnant women who are in the 2nd or 3rd trimester of pregnancy but have not pelvic girdle pain.

Other: Evaluation of biomechanics and viscoelastic properties of plantar fasciaOther: Evaluation of navıcular dropOther: Evaluation of plantar pressure distrubution

Group 3: healthy women

This group will consist of healthy women who have not been pregnant.

Other: Evaluation of biomechanics and viscoelastic properties of plantar fasciaOther: Evaluation of navıcular dropOther: Evaluation of plantar pressure distrubution

Interventions

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.

Group 1: pregnant women with pelvic girdle painGroup 2:pregnant women without pelvic girdle painGroup 3: healthy women

The amount of navicular drop of both feet will be measured

Group 1: pregnant women with pelvic girdle painGroup 2:pregnant women without pelvic girdle painGroup 3: healthy women

The distribution of foot plantar pressure and the amount of change in the center of gravity will be measured in the free standing position.

Group 1: pregnant women with pelvic girdle painGroup 2:pregnant women without pelvic girdle painGroup 3: healthy women

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPegnant women with pelvic girdle pain Pegnant women without pelvic girdle pain Non pregnant healthy women
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Pegnant women with pelvic girdle pain Pegnant women without pelvic girdle pain Non pregnant healthy women

You may qualify if:

  • 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
  • years old
  • Healthy woman without pregnancy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Saglık Bilimleri University

Istanbul, Turkey (Türkiye)

Location

Related Publications (9)

  • 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.

    PMID: 31065537BACKGROUND
  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Pelvic Girdle Pain

Condition Hierarchy (Ancestors)

Musculoskeletal PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPelvic Pain

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2020

First Posted

November 9, 2020

Study Start

January 2, 2021

Primary Completion

May 1, 2021

Study Completion

May 23, 2021

Last Updated

January 20, 2022

Record last verified: 2020-11

Locations