Pelvic Girdle PainNCT04620993
Biomechanical and Viscoelastic Properties of Plantar Fascia in Pregnant Women
An observational study of Pelvic Girdle Pain and Biomechanical and Viscoelastic Properties of Plantar Fascia, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Girdle Pain, Biomechanical and Viscoelastic Properties of Plantar Fascia, Pregnant Woman
- What is being tested?
- Evaluation of biomechanics and viscoelastic properties of plantar fascia, Evaluation of navıcular drop and Evaluation of plantar pressure distrubution
- How many people
- 73 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2021to 23 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pegnant women with pelvic girdle pain Pegnant women without pelvic girdle pain Non pregnant healthy women
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effect of Biomechanical and Viscoelastic Properties of Plantar Fascia on Pelvic Girdle Pain in Pregnant Women
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.
- Conditions
- Pelvic Girdle Pain, Biomechanical and Viscoelastic Properties of Plantar Fascia, Pregnant Woman
- Being tested
- Evaluation of biomechanics and viscoelastic properties of plantar fascia, Evaluation of navıcular drop, Evaluation of plantar pressure distrubution
- Keywords
- pelvic girdle pain, pregnant women, plantar fascia
- Medical subject headings
- Pelvic Girdle Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of biomechanics and viscoelastic properties of plantar fasciaOther
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 navıcular dropOther
The amount of navicular drop of both feet will be measured
Evaluation of plantar pressure distrubutionOther
The distribution of foot plantar pressure and the amount of change in the center of gravity will be measured in the free standing position.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Evaluation of biomechanics and viscoelastic properties of plantar fascia; Other: Evaluation of navıcular drop; Other: 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. Receives: Other: Evaluation of biomechanics and viscoelastic properties of plantar fascia; Other: Evaluation of navıcular drop; Other: Evaluation of plantar pressure distrubution | |
| Group 3: healthy women | This group will consist of healthy women who have not been pregnant. Receives: Other: Evaluation of biomechanics and viscoelastic properties of plantar fascia; Other: Evaluation of navıcular drop; Other: Evaluation of plantar pressure distrubution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline Measurements
Evaluation of plantar pressure distrubution
Measuring of plantar pressure distrubution (with Tekscan, Boston, MA, USA) in free standing position
Measured: Baseline Measurements
Secondary outcomes (1)
Evaluation of navicular drop
Measuring of the amount of the navicular drop
Measured: Baseline Measurements
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2020
- Study start2 Jan 2021
- Primary completion1 May 2021
- Study completion23 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Pelvic Girdle PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04620993
- Sponsor's protocol ID
- 166
- Status last verified
- Nov 2020
- First submitted
- 3 Nov 2020
- Last updated
- 20 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 31065537Elden 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.
PubMed 27406174Bertuit 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.
PubMed 28544276Kerbourc'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.
PubMed 28880594Aldabe 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.
PubMed 22310881Ceprnja 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.
PubMed 29146651Wuytack 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.
PubMed 30142609Aldabe 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.
PubMed 22718046Khamis 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.
PubMed 16621569
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Biomechanical and Viscoelastic Properties of Plantar Fascia on Pelvic Girdle Pain in Pregnant Women
- ClinicalTrials.gov ID
- NCT04620993
- Acronym / sponsor ID
- 166
- Conditions
- Pelvic Girdle Pain, Biomechanical and Viscoelastic Properties of Plantar Fascia, Pregnant Woman
- Keywords
- pelvic girdle pain, pregnant women, plantar fascia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, TurkeyUniversity, hospital or other
- Study start
- 2 Jan 2021 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 23 May 2021 (actual)
- First posted
- 9 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: pregnant women with pelvic girdle pain | – | Other: Evaluation of biomechanics and viscoelastic properties of plantar fascia, Other: Evaluation of navıcular drop, Other: Evaluation of plantar pressure distrubutionThis group will consist of pregnant women who are in the 2nd or 3rd trimester of pregnancy and have pelvic girdle pain. |
| Group 2:pregnant women without pelvic girdle pain | – | Other: Evaluation of biomechanics and viscoelastic properties of plantar fascia, Other: Evaluation of navıcular drop, Other: Evaluation of plantar pressure distrubutionThis group will consist of pregnant women who are in the 2nd or 3rd trimester of pregnancy but have not pelvic girdle pain. |
| Group 3: healthy women | – | Other: Evaluation of biomechanics and viscoelastic properties of plantar fascia, Other: Evaluation of navıcular drop, Other: Evaluation of plantar pressure distrubutionThis group will consist of healthy women who have not been pregnant. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pegnant women with pelvic girdle pain Pegnant women without pelvic girdle pain Non pregnant healthy women
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluation of biomechanics and viscoelastic properties of plantar fasciaThe 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. | Other | Group 1: pregnant women with pelvic girdle pain, Group 2:pregnant women without pelvic girdle pain, Group 3: healthy women |
| Evaluation of navıcular dropThe amount of navicular drop of both feet will be measured | Other | Group 1: pregnant women with pelvic girdle pain, Group 2:pregnant women without pelvic girdle pain, Group 3: healthy women |
| Evaluation of plantar pressure distrubutionThe distribution of foot plantar pressure and the amount of change in the center of gravity will be measured in the free standing position. | Other | Group 1: pregnant women with pelvic girdle pain, Group 2:pregnant women without pelvic girdle pain, Group 3: healthy women |
Primary outcome
Evaluation of biomechanical and viscoelastic properties of plantar fascia
Time frame: Baseline Measurements
Measuring of the biomechanical and viscoelastic properties of the plantar fascia (with MyotonPro, Myoton AS, Tallin, Estonia) in the side lying position.
Evaluation of plantar pressure distrubution
Time frame: Baseline Measurements
Measuring of plantar pressure distrubution (with Tekscan, Boston, MA, USA) in free standing position
1 secondary outcome
Evaluation of navicular drop
Time frame: Baseline Measurements
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2022.
- Background: PubMed 31065537Park 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.
- Results publication: PubMed 27406174Elden 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.
- Results publication: PubMed 28544276Bertuit 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.
- Results publication: PubMed 28880594Kerbourc'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.
- Results publication: PubMed 22310881Aldabe 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.
- Results publication: PubMed 29146651Ceprnja 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.
- Results publication: PubMed 30142609Wuytack 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.
- Results publication: PubMed 22718046Aldabe 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.
- Results publication: PubMed 16621569Khamis 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Girdle Pain and Biomechanical and Viscoelastic Properties of Plantar Fascia, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of biomechanical and viscoelastic properties of plantar fascia (time frame: Baseline Measurements). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04620993, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2022.