- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05493891
Low Back Pain Intensity and Core Muscle Strength After Different Delivery Modes
Testing the Association Between Low Back Pain Intensity and Core Muscle Strength in Women Who Underwent Cesarean or Vaginal Deliveries
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Qena Governorate
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Qina, Qena Governorate, Egypt, 83523
- Faculty of physical therapy, South Valley University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Group A
18 participants have been exposed to cesarean delivery
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VAS is a reliable and valid method for assessing the intensity of low back pain (LBP)
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)
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Group B
18 participants have been exposed to vaginal delivery
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VAS is a reliable and valid method for assessing the intensity of low back pain (LBP)
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)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The intensity of LBP
Time Frame: Assessment will be done 6-12 weeks after Cesarean OR Vaginal deliveries
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The intensity of low back pain is a standardized method to quantify the severity of low back pain
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Assessment will be done 6-12 weeks after Cesarean OR Vaginal deliveries
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The maximal voluntary isometric contraction of the transversus abdominis muscle
Time Frame: Assessment will be done 6-12 weeks after Cesarean or Vaginal Deliveries
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The maximum voluntary isometric contraction (MVIC) is an objective standardized method with high reliability used to evaluate and quantify muscle strength
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Assessment will be done 6-12 weeks after Cesarean or Vaginal Deliveries
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The maximal voluntary isometric contraction of the lumbar multifidus muscle
Time Frame: Assessment will be done 6-12 weeks after Cesarean or Vaginal Deliveries
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The maximum voluntary isometric contraction (MVIC) is an objective standardized method with high reliability used to evaluate and quantify muscle strength
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Assessment will be done 6-12 weeks after Cesarean or Vaginal Deliveries
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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
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The correlation coefficient between two variables of outcome is a valid statistical method to the association between them
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Assessment will be done 6-12 weeks after Cesarean or Vaginal Deliveries
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Collaborators and Investigators
Sponsor
Publications and helpful links
General 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.
- 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.
- 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.
- Faries MD, Greenwood M. Core training: stabilizing the confusion. Strength and conditioning journal. 2007 Apr 1;29(2):10.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Core muscle strength
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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