- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05538325
Assessment of Lumbar Spine Active Range of Motion in Women Who Were Experienced Cesarean or Vaginal Birth
After the End of the Puerperium: Kinematic Assessment of Lumbar Spine Active Range of Motion in Women Who Experienced Cesarean or Vaginal Birth
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Cesarean birth can affect the lumbopelvic biomechanics through its impact on the sacroiliac joints and the abdominal muscles. while vaginal birth can trigger lumbopelvic pain through its impact on the pelvic joints like the symphysis pubis and sacroiliacs.
When puerperium is finished, most of these pregnancy-related changes assume its prepregnant conditions.
Physiotherapists are responsible for providing PT care for women to improve their quality of life during the puerperium and even during the delayed postpartum interval.
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 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Group A
25 females who experienced cesarean birth
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They are valid and reliable devices to measure the range of motion of the lumbar spine
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Group B
16 females who experienced vaginal birth
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They are valid and reliable devices to measure the range of motion of the lumbar spine
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Group C
25 females who were the controls, did not experience any pregnancy
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They are valid and reliable devices to measure the range of motion of the lumbar spine
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lumbar Spine Flexion Active Range of Motion
Time Frame: Assessment will be done 6-12 weeks after Cesarean or Vaginal birth
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It represent the non-painful full range of motion from standing upright to leaning forward in the sagittal plane
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Assessment will be done 6-12 weeks after Cesarean or Vaginal birth
|
|
Lumbar Spine Extension Active Range of Motion
Time Frame: Assessment will be done 6-12 weeks after Cesarean or Vaginal birth
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It represent the non-painful full range of motion from standing upright to leaning backward in the sagittal plane
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Assessment will be done 6-12 weeks after Cesarean or Vaginal birth
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Lumbar Spine Right Side Bending Active Range of Motion
Time Frame: Assessment will be done 6-12 weeks after Cesarean or Vaginal birth
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It represent the non-painful full range of motion from standing upright to leaning sideway to the right in the frontal plane
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Assessment will be done 6-12 weeks after Cesarean or Vaginal birth
|
|
Lumbar Spine Left Side Bending Active Range of Motion
Time Frame: Assessment will be done 6-12 weeks after Cesarean or Vaginal birth
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It represent the non-painful full range of motion from standing upright to leaning sideway to the left in the frontal plane
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Assessment will be done 6-12 weeks after Cesarean or Vaginal birth
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Lumbar Spine Right Axial Rotation Active Range of Motion
Time Frame: Assessment will be done 6-12 weeks after Cesarean or Vaginal birth
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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
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Assessment will be done 6-12 weeks after Cesarean or Vaginal birth
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Lumbar Spine Left Axial Rotation Active Range of Motion
Time Frame: Assessment will be done 6-12 weeks after Cesarean or Vaginal birth
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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
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Assessment will be done 6-12 weeks after Cesarean or Vaginal birth
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- Ritchie JR. Orthopedic considerations during pregnancy. Clin Obstet Gynecol. 2003 Jun;46(2):456-66. doi: 10.1097/00003081-200306000-00024. No abstract available.
- 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.
- 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.
- 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.
- Ghodke PS, Shete D, Anap D. Prevalence of sacroiliac joint dysfunction in postpartum women-a cross sectional study. Physiother Rehabil. 2017;2(3):149.
- Sung S, Mahdy H. Cesarean section. InStatPearls [Internet] 2021 Apr 25. StatPearls Publishing.
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
Other Study ID Numbers
- Lumbar Spine ROM
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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