Low Back Pain and Core MuscleNCT05493891

Low Back Pain Intensity and Core Muscle Strength After Different Delivery Modes

An observational study of Low Back Pain and Core Muscle, run by South Valley University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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… Read more about this study

Who is it for?: Ages 18 to 35 years, women only
Conditions the study is for: Low Back Pain and Core Muscle
What is being tested?: Visual analogue scale (VAS) and Pressure Biofeedback Unit (PBU)
Type of treatment: Medical device
How many people: 36 participants
Where: 1 siteEgypt
Study dates: 28 Jun 2021to 5 Aug 2023
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 18 to 35 years
Women only
Adult

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.

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Faculty of physical therapy, South Valley University
Qina, Qena Governorate, 83523

Other trials in Egypt

About this study

Official title: Testing the Association Between Low Back Pain Intensity and Core Muscle Strength in Women Who Underwent Cesarean or Vaginal Deliveries

Read the detailed description

Cesarean delivery (CD) is one of the most common surgical procedures in obstetrics, and it is also one of the oldest medical procedures. The rise in the rate of cesarean sections is one of the most striking hallmarks of modern obstetrics.

In Egypt, the prevalence of CD has increased dramatically over the last decade, with the most recent Egypt Demographic and Health Survey (EDHS) reporting a rate of 52 percent, implying that cesarean sections may be overused or utilized for improper reasons.

The two deep local core muscles are the transversus abdominis and the lumbar multifidus muscles. The definition of Core muscle strength is the active ability of these muscles to not only produce but also, maintain stresses to provide stability for the spine through management of the intra-abdominal pressure.

LBP prevalence in mothers undergoing cesarean delivery was higher compared to its counterpart in mothers undergoing vaginal delivery. The related mechanisms for LBP during the postpartum period following cesarean or vaginal deliveries may be overweight and obesity, postural adaptations, and stressful positions that mothers assume during either delivery or lactation.

Conditions: Low Back Pain and Core Muscle
Being tested: Visual analogue scale (VAS), Pressure Biofeedback Unit (PBU)
Medical subject headings: Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Visual analogue scale (VAS)Other
VAS is a reliable and valid method for assessing the intensity of low back pain (LBP)
Pressure Biofeedback Unit (PBU)Device
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)

Study groups in NCT05493891
Study group	Role	What they receive
Group A		18 participants have been exposed to cesarean delivery Receives: Other: Visual analogue scale (VAS); Device: Pressure Biofeedback Unit (PBU)
Group B		18 participants have been exposed to vaginal delivery Receives: Other: Visual analogue scale (VAS); Device: Pressure Biofeedback Unit (PBU)

What is being measured

The primary outcome is the main question the study is designed to answer.

The intensity of LBP
The intensity of low back pain is a standardized method to quantify the severity of low back pain
Measured: 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
Measured: 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
Measured: 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
Measured: Assessment will be done 6-12 weeks after Cesarean or Vaginal Deliveries

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Jun 20215 Aug 2023

First posted9 Aug 2022
Study start28 Jun 2021
Primary completion29 Jan 2022
Study completion5 Aug 2023

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 Low Back Pain and Core MuscleStudies 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: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05493891
Sponsor's protocol ID: Core muscle strength
Status last verified: Sep 2024
First submitted: 6 Aug 2022
Last updated: 2 Oct 2025
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

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.
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.
PubMed 30985305
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.
PubMed 33642943
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.
PubMed 27088993
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.
PubMed 23636767
Faries MD, Greenwood M. Core training: stabilizing the confusion. Strength and conditioning journal. 2007 Apr 1;29(2):10.
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.
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.
PubMed 2143425
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.
PubMed 21646928

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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RecruitingObservational study
The Relationship Between Transversus Abdominis Muscle Architecture and Upper Extremity Function in Patients With Chronic Low Back Pain
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Enrolling by invitation
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All Low Back Pain and Core Muscle trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Testing the Association Between Low Back Pain Intensity and Core Muscle Strength in Women Who Underwent Cesarean or Vaginal Deliveries
ClinicalTrials.gov ID: NCT05493891
Acronym / sponsor ID: Core muscle strength
Conditions: Low Back Pain and Core Muscle
Study type: Observational
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: South Valley UniversityUniversity, hospital or other
Study start: 28 Jun 2021 (actual)
Primary completion: 29 Jan 2022 (actual)
Study completion: 5 Aug 2023 (actual)
First posted: 9 Aug 2022 (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.

Detailed description

Study design

Observational model: Other
Time perspective: Cross-sectional
Number of arms: 2

Arm	Type	Receives
Group A	–	Other: Visual analogue scale (VAS), Device: Pressure Biofeedback Unit (PBU)18 participants have been exposed to cesarean delivery
Group B	–	Other: Visual analogue scale (VAS), Device: Pressure Biofeedback Unit (PBU)18 participants have been exposed to vaginal delivery

Who may qualify

Ages: 18 to 35 years
Sex: Female only
Age groups: Adult
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.

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (4 listed)

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.

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
Visual analogue scale (VAS)VAS is a reliable and valid method for assessing the intensity of low back pain (LBP)	Other	Group A, Group B
Pressure Biofeedback Unit (PBU)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)	Device	Group A, Group B

Primary outcome

The intensity of LBP
Time frame: Assessment will be done 6-12 weeks after Cesarean OR Vaginal deliveries
The intensity of low back pain is a standardized method to quantify the severity of low back pain
The maximal voluntary isometric contraction of the transversus abdominis muscle
Time frame: Assessment will be done 6-12 weeks after Cesarean or Vaginal Deliveries
The maximum voluntary isometric contraction (MVIC) is an objective standardized method with high reliability used to evaluate and quantify muscle strength
The maximal voluntary isometric contraction of the lumbar multifidus muscle
Time frame: Assessment will be done 6-12 weeks after Cesarean or Vaginal Deliveries
The maximum voluntary isometric contraction (MVIC) is an objective standardized method with high reliability used to evaluate and quantify muscle strength
The correlation coefficient between low back pain intensity and core muscle strength
Time frame: Assessment will be done 6-12 weeks after Cesarean or Vaginal Deliveries
The correlation coefficient between two variables of outcome is a valid statistical method to the association between them

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 2 Oct 2025.
BackgroundAbdel-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: PubMed 30985305Mhyre 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.
Background: PubMed 33642943Ring 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.
Background: PubMed 27088993Traynor 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.
Background: PubMed 23636767Malatova 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.
BackgroundFaries MD, Greenwood M. Core training: stabilizing the confusion. Strength and conditioning journal. 2007 Apr 1;29(2):10.
BackgroundParikh 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: PubMed 2143425MacArthur 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.
Results publication: PubMed 21646928Barber 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.
Individual participant dataSharing planned: Undecided

Related trials for Low Back Pain and Core Muscle

Not yet recruiting
Radiofrequency and Pelvic Floor-Core Exercise for Chronic Low Back Pain in Women With Pelvic Floor Dysfunction
Chronic Low Back Pain, Urinary Incontinence
Not yet recruiting
Gamified Home-Based Core Neuromuscular Training for Chronic Low Back Pain
Low Back Pain, Core Muscles
Recruiting
Pelvic Control Training Using Pressure Biofeedback Versus Core Stability Training in Non-Specific Low Back Pain
Non Specific Low Back Pain, Core Stability
RecruitingObservational study
The Relationship Between Transversus Abdominis Muscle Architecture and Upper Extremity Function in Patients With Chronic Low Back Pain
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Enrolling by invitation
Pelvic Floor Exercises Versus Swiss Ball Exercises in Patients With Non-Specific Chronic Low Back Pain
Non-specific Chronic Low Back Pain

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 Low Back Pain and Core Muscle, run by South Valley University at 1 site in Egypt.

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 6 inclusion and 4 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 2 Oct 2025. 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 Egypt. 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?

The intensity of LBP (time frame: Assessment will be done 6-12 weeks after Cesarean OR Vaginal deliveries). The study lists 4 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 NCT05493891, 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 2 Oct 2025.