NCT05493891

Brief Summary

Cesarean delivery (CD) may trigger an increase in low back pain (LBP) intensity and induce core muscle weakness. This study will assess the correlation between low back pain intensity and core muscle strength of transverse abdominis and Lumbar multifidus among women who underwent CD and compare it with those who experienced vaginal delivery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

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
6 months until next milestone

First Submitted

Initial submission to the registry

August 6, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 9, 2022

Completed
12 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

August 6, 2022

Last Update Submit

September 28, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • The intensity of LBP

    The intensity of low back pain is a standardized method to quantify the severity of low back pain

    Assessment will be done 6-12 weeks after Cesarean OR Vaginal deliveries

  • The maximal voluntary isometric contraction of the transversus abdominis muscle

    The maximum voluntary isometric contraction (MVIC) is an objective standardized method with high reliability used to evaluate and quantify muscle strength

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

  • The maximal voluntary isometric contraction of the lumbar multifidus muscle

    The maximum voluntary isometric contraction (MVIC) is an objective standardized method with high reliability used to evaluate and quantify muscle strength

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

  • The correlation coefficient between low back pain intensity and core muscle strength

    The correlation coefficient between two variables of outcome is a valid statistical method to the association between them

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

Study Arms (2)

Group A

18 participants have been exposed to cesarean delivery

Other: Visual analogue scale (VAS)Device: Pressure Biofeedback Unit (PBU)

Group B

18 participants have been exposed to vaginal delivery

Other: Visual analogue scale (VAS)Device: Pressure Biofeedback Unit (PBU)

Interventions

VAS is a reliable and valid method for assessing the intensity of low back pain (LBP)

Group AGroup B

PBU is a valid and reliable instrument for measuring the maximal voluntary isometric contraction of both lumbar multifidus and transversus abdominis muscles (core muscle strength)

Group AGroup B

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsBecause this study is specific to women's health physical therapy specialty
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

36 participants participated in our study, and were classified into 2 groups; (group A) represents 18 mothers undergoing cesarean birth, and (group B) represents 18 mothers undergoing normal vaginal birth.

You may qualify if:

  • All women are either primiparous or multiparous.
  • Their ages ranged from 18 to 35 years.
  • All participants had a body mass index (BMI) of not more than 29.5, and a waist-to-hip ratio of not more than 1.
  • Participants were assessed between the 6th week to the 12th week postnatal.
  • All participants were able to continue all assessment procedures.
  • They were medically stable.

You may not qualify if:

  • Women who were below 18 years old or above 35 years old.
  • Women who had a (BMI) above 29.5 or a waist-to-hip ratio above 1.
  • Women who did not continue all assessment procedures.
  • Women who had a past history of specific LBP as those who were diagnosed with spondylolisthesis, lumbar disc prolapse, or structural scoliosis.

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 (9)

  • Barber EL, Lundsberg LS, Belanger K, Pettker CM, Funai EF, Illuzzi JL. Indications contributing to the increasing cesarean delivery rate. Obstet Gynecol. 2011 Jul;118(1):29-38. doi: 10.1097/AOG.0b013e31821e5f65.

    PMID: 21646928BACKGROUND
  • Abdel-Tawab N, Oraby D, Hassanein N, and El-Nakib S. Cesarean Section Deliveries in EGYPT: Trends, Practices, Perceptions and Cost, Cairo: Population Council. 2018.

    BACKGROUND
  • Mhyre JM, Sultan P. General Anesthesia for Cesarean Delivery: Occasionally Essential but Best Avoided. Anesthesiology. 2019 Jun;130(6):864-866. doi: 10.1097/ALN.0000000000002708. No abstract available.

    PMID: 30985305BACKGROUND
  • Ring L, Landau R, Delgado C. The Current Role of General Anesthesia for Cesarean Delivery. Curr Anesthesiol Rep. 2021;11(1):18-27. doi: 10.1007/s40140-021-00437-6. Epub 2021 Feb 24.

    PMID: 33642943BACKGROUND
  • Traynor AJ, Aragon M, Ghosh D, Choi RS, Dingmann C, Vu Tran Z, Bucklin BA. Obstetric Anesthesia Workforce Survey: A 30-Year Update. Anesth Analg. 2016 Jun;122(6):1939-46. doi: 10.1213/ANE.0000000000001204.

    PMID: 27088993BACKGROUND
  • Malatova R, Rokytova J, Stumbauer J. The use of muscle dynamometer for correction of muscle imbalances in the area of deep stabilising spine system. Proc Inst Mech Eng H. 2013 Aug;227(8):896-903. doi: 10.1177/0954411913486078. Epub 2013 May 1.

    PMID: 23636767BACKGROUND
  • Faries MD, Greenwood M. Core training: stabilizing the confusion. Strength and conditioning journal. 2007 Apr 1;29(2):10.

    BACKGROUND
  • Parikh S, Suchi J. Prevalence of low back pain and its impact on quality of life in post-partum women. International Journal of Scientific Research. 2016; 7:14342-8.

    BACKGROUND
  • MacArthur C, Lewis M, Knox EG, Crawford JS. Epidural anaesthesia and long term backache after childbirth. BMJ. 1990 Jul 7;301(6742):9-12. doi: 10.1136/bmj.301.6742.9.

    PMID: 2143425BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

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

August 6, 2022

First Posted

August 9, 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