Biomechanical and Viscoelastic Properties of Thoracolumbar Fascia in Pregnancy Pelvic Girdle Pain

Sponsor
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05403424
Collaborator
(none)
60
1
18.5
3.2

Study Details

Study Description

Brief Summary

It has not been objectively clarified how the thoracolumbar fascia (TLF) changes the biomechanical adaptations that occur in the lumbopelvic region during pregnancy and whether it is associated with pelvic girdle pain (PGP). Therefore, the aim of this study is to determine the biomechanical and viscoelastic properties of TLF, which adapts to the changes in the lumbopelvic region in pregnant women with pelvic girdle pain, and to investigate its relationship with PGP.

Condition or Disease Intervention/Treatment Phase
  • Other: Evaluation of pain
  • Diagnostic Test: Application of pelvic girdle diagnostic tests
  • Other: Evaluation of biomechanics and viscoelastic properties of thoracolumbar fascia
  • Other: Evaluation of activity limitation

Study Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Other
Time Perspective:
Cross-Sectional
Official Title:
Investigation of Biomechanical and Viscoelastic Properties of Thoracolumbar Fascia in Pregnant Women With Pelvic Girdle Pain
Anticipated Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Jun 15, 2023
Anticipated Study Completion Date :
Dec 15, 2023

Arms and Interventions

Arm Intervention/Treatment
Group 1: Pregnant women with pelvic girdle pain

This group will consist of pregnant women diagnosed with pelvic girdle pain.

Other: Evaluation of pain
The severity of pelvic girdle pain will be evaluated with the Visual Analog Scale (VAS).

Diagnostic Test: Application of pelvic girdle diagnostic tests
Pelvic girdle pain diagnostic tests will be applied.

Other: Evaluation of biomechanics and viscoelastic properties of thoracolumbar fascia
The biomechanical and viscoelastic properties of the thoracolumbar fascia will be measured in the prone position and measurements will be taken from three different points

Other: Evaluation of activity limitation
Pelvic Girdle Questionnaire will be filled

Group 2: Pregnant women without pelvic girdle pain

This group will consist of pregnant women who do not have pelvic girdle pain.

Other: Evaluation of pain
The severity of pelvic girdle pain will be evaluated with the Visual Analog Scale (VAS).

Diagnostic Test: Application of pelvic girdle diagnostic tests
Pelvic girdle pain diagnostic tests will be applied.

Other: Evaluation of biomechanics and viscoelastic properties of thoracolumbar fascia
The biomechanical and viscoelastic properties of the thoracolumbar fascia will be measured in the prone position and measurements will be taken from three different points

Other: Evaluation of activity limitation
Pelvic Girdle Questionnaire will be filled

Group 3: Non-pregnant women

This group will consist of non-pregnant women.

Other: Evaluation of biomechanics and viscoelastic properties of thoracolumbar fascia
The biomechanical and viscoelastic properties of the thoracolumbar fascia will be measured in the prone position and measurements will be taken from three different points

Outcome Measures

Primary Outcome Measures

  1. Evaluation of biomechanical properties of thoracolumbar fascia [Measurement the change from baseline stiffness values of Thoracolumbar fascia at 12. week and at 22. week]

    Measuring of the stiffness (N/m) of the thoracolumbar fascia (with MyotonPro, Myoton AS, Tallin, Estonia) in the prone position.

  2. Evaluation of biomechanical properties of thoracolumbar fascia [Measurement the change from baseline decrement values of Thoracolumbar fascia at 12. week and at 22. week]

    Measuring of the decrement of the thoracolumbar fascia (with MyotonPro, Myoton AS, Tallin, Estonia) in the prone position.

  3. Evaluation of biomechanical properties of thoracolumbar fascia [Measurement the change from baseline tone values of Thoracolumbar fascia at 12. week and at 22. week]

    Measuring of the tone (Hz) of the thoracolumbar fascia (with MyotonPro, Myoton AS, Tallin, Estonia) in the prone position.

  4. Evaluation of viscoelastic properties of thoracolumbar fascia [Measurement the change from baseline creep values of Thoracolumbar fascia at 12. week and at 22. week]

    Measuring of the creep of the thoracolumbar fascia (with MyotonPro, Myoton AS, Tallin, Estonia) in the prone position.

  5. Evaluation of viscoelastic properties of thoracolumbar fascia [Measurement the change from baseline relaxation time values of Thoracolumbar fascia at 12. week and at 22. week]

    Measuring of thethe relaxation time (ms) of the thoracolumbar fascia (with MyotonPro, Myoton AS, Tallin, Estonia) in the prone position.

Secondary Outcome Measures

  1. Determining of painful areas [Baseline]

    Marking of body chart

  2. Evaluation of pain [Baseline]

    Pain will be evaluated with Visual analog scale (VAS). The VAS is scaled between 0-10 points (0: no pain, 10: most severe pain).

  3. Application of PGP diagnostic tests [Baseline]

    Pelvic Girdle Pain diagnostic tests will be applied.

  4. Pelvic Girdle Questionnaire [Baseline]

    Activity limitation will be evaluated Pelvic Girdle Questionnaire

  5. Evaluation of Body Weight [Measurement the change from baseline body weight (kg) at 12. and 22. weeks.]

    Measuring of the Body Weight

  6. Evaluation of Body Mass Index (BMI) [Measurement the change from baseline BMI values at 12.and 22. weeks]

    BMI (kg/m2) will be calculated as person's weight in kilograms divided by the square of height in meters.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • First-time pregnancy

  • Pregnant women diagnosed with pelvic girdle pain in 1st and 2nd trimesters

  • Pregnant women who do not have pelvic girdle pain in 1st and 2nd trimesters

  • Women not being pregnant

  • Pre-pregnancy Body-Mass-Index (BMI) < 30 kg/m2

Exclusion Criteria:
  • Presence of connective tissue disease

  • Deterioration of skin integrity in measurement areas

  • Presence of orthopedic, neurological, rheumatic problems that may cause musculoskeletal disorders and deviations from normal biomechanical alignment

  • History of spine, pelvis, or lower extremity surgery or fracture in the past 6 months

  • Definition of chronic low back-pelvic region pain (lasting for more than 3 months and pain severity >4 according to VAS) before pregnancy

  • Identification of metabolic disorders such as Type I, II diabetes, gestational diabetes mellitus (GDM), preeclampsia before and/or during pregnancy)

Contacts and Locations

Locations

Site City State Country Postal Code
1 İstanbul Medeniyet University İstanbul Turkey

Sponsors and Collaborators

  • Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
ClinicalTrials.gov Identifier:
NCT05403424
Other Study ID Numbers:
  • 33 09/03/2022
First Posted:
Jun 3, 2022
Last Update Posted:
Jun 3, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 3, 2022