Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04620993
Other study ID # 166
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Not yet recruiting NCT03541343 - GreenBRIC Clinical Trial N/A
Completed NCT04873778 - Comparing Effects of Kinesio and Dynamic Tapings in Postpartum Women With Pelvic Girdle Pain N/A
Completed NCT04981418 - Evaluating the Management of Chronic Pelvic Girdle Pain N/A
Terminated NCT02044991 - Ultrasound Guided Posterior Sacroiliac Ligament Corticosteroid Injection in Pregnancy-Related Pelvic Girdle Pain Phase 2
Recruiting NCT06284278 - Telehealth: Diaphragmatic vs. Pelvic Exercise in Postpartum Pregnancy-related Pelvic Girdle Pain N/A
Withdrawn NCT04377516 - Effects of Specific Pelvic Stabilization Exercise in Postpartum Pregnancy-related Pelvic Girdle Pain Women N/A
Completed NCT05181384 - Pelvic Floor Muscles and Stabilization Integrated Training Improved Pregnancy-related Pelvic Girdle Pain N/A
Not yet recruiting NCT05507853 - Exploring Central Sensitization in Pregnant Women
Completed NCT03518840 - Predictive Value of the Active Straight Leg Raise on the Efficacy of a SJB in Posterior PGP During Pregnancy N/A
Recruiting NCT05879575 - Effects and Pathophysiology of Weight Training on Pregnancy-related Pelvic Girdle Pain (PPGP) N/A
Completed NCT03261687 - The Effects of a Water Based Exercise Programme and a Land Based Exercise Programme on Women Experiencing Pregnancy Related Pelvic Girdle Pain N/A
Active, not recruiting NCT05382845 - Screening for Pregnancy Related Pelvic Girdle Pain N/A
Active, not recruiting NCT03606720 - Effect of Low Level Laser Therapy and Pelvic Stabilisation Exercises on Postpartum Pelvic Girdle Pain N/A
Recruiting NCT02789735 - Low Level Laser Therapy in Persistent Pelvic Girdle Pain N/A
Completed NCT02543515 - Psychosocial and Clinical Characteristics Predicting Women's Acceptance of Office Hysteroscopy N/A
Completed NCT01098136 - Pelvic Girdle Pain in a Pregnant Population in Western Norway. N/A
Completed NCT03436888 - Cross-cultural Adaptation and Validation of the Pelvic Girdle Questionnaire in French Language
Recruiting NCT04266184 - Effects of Pelvic Belt and Kinesio Tape on Pain and Functional Mobility in Pregnancy-Related Pelvic Girdle Pain N/A
Not yet recruiting NCT05403437 - Pelvic Girdle Pain Symptom Severity in Pregnant Women With Gestational Diabetes Mellitus
Not yet recruiting NCT05403424 - Biomechanical and Viscoelastic Properties of Thoracolumbar Fascia in Pregnancy Pelvic Girdle Pain