NCT05538325

Brief Summary

Pregnancy may impact the musculoskeletal apparatus of females through pregnancy-associated biomechanical, vascular, and hormonal changes. Pregnant females may complain of lumbopelvic pain, especially during their last trimester. This lumbopelvic pain can be the result of an enlarged uterus and unstable lumbopelvic joints.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2021

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 28, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 29, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 13, 2022

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 5, 2023

Completed
Last Updated

October 2, 2025

Status Verified

September 1, 2024

Enrollment Period

7 months

First QC Date

September 8, 2022

Last Update Submit

September 28, 2025

Conditions

Outcome Measures

Primary Outcomes (6)

  • Lumbar Spine Extension Active Range of Motion

    It represent the non-painful full range of motion from standing upright to leaning backward in the sagittal plane

    Assessment will be done 6-12 weeks after Cesarean or Vaginal birth

  • Lumbar Spine Flexion Active Range of Motion

    It represent the non-painful full range of motion from standing upright to leaning forward in the sagittal plane

    Assessment will be done 6-12 weeks after Cesarean or Vaginal birth

  • Lumbar Spine Right Side Bending Active Range of Motion

    It represent the non-painful full range of motion from standing upright to leaning sideway to the right in the frontal plane

    Assessment will be done 6-12 weeks after Cesarean or Vaginal birth

  • Lumbar Spine Left Side Bending Active Range of Motion

    It represent the non-painful full range of motion from standing upright to leaning sideway to the left in the frontal plane

    Assessment will be done 6-12 weeks after Cesarean or Vaginal birth

  • Lumbar Spine Right Axial Rotation Active Range of Motion

    It represents the non-painful full range of motion from standing with trunk forward bended 90 degree then head, neck, shoulders, and trunk rotation to the right side

    Assessment will be done 6-12 weeks after Cesarean or Vaginal birth

  • Lumbar Spine Left Axial Rotation Active Range of Motion

    It represents the non-painful full range of motion from standing with trunk forward bended 90 degree then head, neck, shoulders, and trunk rotation to the left side

    Assessment will be done 6-12 weeks after Cesarean or Vaginal birth

Study Arms (3)

Group A

25 females who experienced cesarean birth

Device: Bubble Inclinometer and Digital Pelvic Inclinometer

Group B

16 females who experienced vaginal birth

Device: Bubble Inclinometer and Digital Pelvic Inclinometer

Group C

25 females who were the controls, did not experience any pregnancy

Device: Bubble Inclinometer and Digital Pelvic Inclinometer

Interventions

They are valid and reliable devices to measure the range of motion of the lumbar spine

Group AGroup BGroup C

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsIt is a study for investigation of cesarean or vaginal birth complications on the lumbar spine movements after the end of puerperium
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

66 women participated in this study. They were recruited from the Woman and Child Hospital of South Valley University, located in Qena governorate, Egypt.

You may qualify if:

  • All women either primiparous or multiparous have not had anaesthesia (epidural, spinal, or general) for at least one year prior to the last obstetric anaesthesia.
  • Their ages ranged from 18 to 35 years.
  • Participants were assessed between the 6th week to the 12th week postnatal.
  • All participants were able to continue all assessment procedures.
  • They might have a mild or moderate myofascial LBP

You may not qualify if:

  • Women who were below 18 years old or above 35 years.
  • Women who did not continue all assessment procedures.
  • Women who had a severe myofascial LBP or any specific low back conditions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of physical therapy, South Valley University

Qina, Qena Governorate, 83523, Egypt

Location

Related Publications (8)

  • Thabah M, Ravindran V. Musculoskeletal problems in pregnancy. Rheumatol Int. 2015 Apr;35(4):581-7. doi: 10.1007/s00296-014-3135-7. Epub 2014 Sep 25.

    PMID: 25253297BACKGROUND
  • Kesikburun S, Guzelkucuk U, Fidan U, Demir Y, Ergun A, Tan AK. Musculoskeletal pain and symptoms in pregnancy: a descriptive study. Ther Adv Musculoskelet Dis. 2018 Nov 19;10(12):229-234. doi: 10.1177/1759720X18812449. eCollection 2018 Dec.

    PMID: 30515249BACKGROUND
  • Ritchie JR. Orthopedic considerations during pregnancy. Clin Obstet Gynecol. 2003 Jun;46(2):456-66. doi: 10.1097/00003081-200306000-00024. No abstract available.

    PMID: 12808395BACKGROUND
  • Franklin ME, Conner-Kerr T. An analysis of posture and back pain in the first and third trimesters of pregnancy. J Orthop Sports Phys Ther. 1998 Sep;28(3):133-8. doi: 10.2519/jospt.1998.28.3.133.

    PMID: 9742469BACKGROUND
  • Sung S, Mahdy H. Cesarean section. InStatPearls [Internet] 2021 Apr 25. StatPearls Publishing.

    BACKGROUND
  • Sanya AO, Olajitan A. Comparison of abdominal muscle strength in post-parous and nil parous subjects. Afr J Med Med Sci. 1999 Mar-Jun;28(1-2):49-53.

    PMID: 12953987BACKGROUND
  • Fan C, Guidolin D, Ragazzo S, Fede C, Pirri C, Gaudreault N, Porzionato A, Macchi V, De Caro R, Stecco C. Effects of Cesarean Section and Vaginal Delivery on Abdominal Muscles and Fasciae. Medicina (Kaunas). 2020 May 27;56(6):260. doi: 10.3390/medicina56060260.

    PMID: 32471194BACKGROUND
  • Ghodke PS, Shete D, Anap D. Prevalence of sacroiliac joint dysfunction in postpartum women-a cross sectional study. Physiother Rehabil. 2017;2(3):149.

    BACKGROUND

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Physical Therapy for Women's Health

Study Record Dates

First Submitted

September 8, 2022

First Posted

September 13, 2022

Study Start

June 28, 2021

Primary Completion

January 29, 2022

Study Completion

August 5, 2023

Last Updated

October 2, 2025

Record last verified: 2024-09

Locations