NCT06031649

Brief Summary

The biomechanical characteristics of lumbar paraspinal muscles may give us insight into different lower back dysfunctions in postpartum mothers after cesarean section.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2021

Shorter than P25 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
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2022

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

August 25, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 11, 2023

Completed
Last Updated

February 7, 2025

Status Verified

January 1, 2025

Enrollment Period

7 months

First QC Date

August 25, 2023

Last Update Submit

February 3, 2025

Conditions

Low Back Pain, Mechanical

Outcome Measures

Primary Outcomes (2)

  • Lumbar Paraspinal Muscles Stiffness, measured by the MyotonPRO device in units of N/m.

    muscular stiffness refers to muscle resistance against forces that deform it.

    6-12 weeks after cesarean section

  • Lumbar Paraspinal Muscles Elasticity, measured by the MyotonPRO device in a relative unit

    Muscular Elasticity refers to the muscular ability to return to its original shape after the removal of tensional forces.

    6-12 weeks after cesarean section

Secondary Outcomes (2)

  • Lumbar Paraspinal Muscles Stress Relaxation Time, measured by the MyotonPRO device in milliseconds

    6-12 weeks after cesarean section

  • Lumbar Paraspinal Muscles Creep, measured by the MyotonPRO device in a relative unit

    6-12 weeks after cesarean section

Study Arms (2)

Group A

30 mother underwent cesarean section

Device: MyotonPRO device

Group B

30 healthy females who were in the control group

Device: MyotonPRO device

Interventions

MyotonPRO deviceDEVICE

It is a valid and reliable device for measuring the muscular mechanical properties

Also known as: Myotonometry
Group AGroup B

Eligibility Criteria

Age20 Years - 34 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsA study in the scope of physiotherapy for women's health
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

60 females participated in this research, aged between 20 and 34 years old. They were free of specific lower back disorders. They were recruited from the outpatient clinics of South Valley Hospitals

You may qualify if:

  • Women who experienced cesarean section at least for one time
  • Women Who are free of specific lower back disorders
  • Women who are below 34 years old and above 20 years old

You may not qualify if:

  • Women who experienced normal vaginal birth
  • Women who complain of a specific lower back disorder
  • Women who are above 34 years old or below 20 years old
  • Women who have a body mass index above 30 Kg/m2

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 (3)

  • Van Deun B, Hobbelen JSM, Cagnie B, Van Eetvelde B, Van Den Noortgate N, Cambier D. Reproducible Measurements of Muscle Characteristics Using the MyotonPRO Device: Comparison Between Individuals With and Without Paratonia. J Geriatr Phys Ther. 2018 Oct/Dec;41(4):194-203. doi: 10.1519/JPT.0000000000000119.

    PMID: 28005829BACKGROUND

  • Struzik A, Karamanidis K, Lorimer A, Keogh JWL, Gajewski J. Application of Leg, Vertical, and Joint Stiffness in Running Performance: A Literature Overview. Appl Bionics Biomech. 2021 Oct 21;2021:9914278. doi: 10.1155/2021/9914278. eCollection 2021.

    PMID: 34721664BACKGROUND

  • 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

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
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Physical Therapy for Women's Health

Study Record Dates

First Submitted

August 25, 2023

First Posted

September 11, 2023

Study Start

June 28, 2021

Primary Completion

January 29, 2022

Study Completion

February 15, 2022

Last Updated

February 7, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)