Effect of Clamshell Exercise on Lumbopelvic Stability and Low Back Pain in Post Partum Women

This study will be conducted on 44 females with postpartum LBP & pelvic instability, selected from Dar of women hospital in port said to investigate effect of clamshell exercise on lumbo-pelvic stability and low back pain in postpartum women.

Study Overview

• Status: Not yet recruiting
• Conditions: Lumbosacral Instability; Low Back Pain Post Partum
• Intervention / Treatment: Other: Abdominal bracing; Other: clamshell exercise

• Study Type: Interventional
• Enrollment (Anticipated): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eman M Mahmoud; Phone Number: + 2 1091403074; Email: amira.mahmoud2021@outlook.com
• Study Contact Backup: Name: mahitab Y Ibrahim; Phone Number: + 2 1222606996; Email: mahitab.yosri@pt.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Post-partum females complaining of LBP and lumber instability
2. Their age will be ranged from 25-35 years.
3. Their BMI will be ranged from 25-30 kg/m2

Exclusion Criteria:

1. Spinal deformity.
2. Lower limb deformity.
3. Osteosarcoma
4. Mental disorders. 5-25>BMI>30

6-Performing any physical exercise at the time of the study. 7-Bad general Health

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: control group; Abdominal bracing	Other: Abdominal bracing; they will perform 3 times/week of static abdominal contraction for six weeks.
Active Comparator: study group; Abdominal bracing and clamshell exercise	Other: Abdominal bracing; they will perform 3 times/week of static abdominal contraction for six weeks.; Other: clamshell exercise; Each women will be positioned in side lying on the floor, with the pelvis and the spine in neutral position, the hips will bent at 45° and the knees flexed to 90°. She will abduct the top knee as far as possible, while keeping the heels together, then return to the starting position , the position will be maintained for 5 seconds in an abduction state, and repeated 10 times, with rest for 1 minute to minimize muscle fatigue,they will perform 3 times/week fo 6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the degree of lumbopelvic instability	Change in the degree of lumbopelvic instability will be measured by specific tests(The dip test, the runner pose test and the single leg squat test) and the pateint performance will be graded as poor or good	change in the lumbopelvic instability degree will be measured at baseline and after 6 weeks of the interventions
lumbopelvic range of motion	Degree of lumbopelvic range of motion will be measured by goniometer	change in the lumbopelvic instability degree will be measured at baseline and after 6 weeks of the interventions

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
severity of pain intensity	change in low back pain intensity will be measured using visual analogue scale(VAS) low back pain intensity	change in the lumbopelvic instability will be measured at baseline and after 6 weeks of the interventions
the degree of function disability	the change in the degree of function disability will be measured by Oswestry disability index (ODI)	change in the lumbopelvic instability will be measured at baseline and after 6 weeks of the interventions

Collaborators and Investigators

• Sponsor: Eman Mahmoud Mahmoud El-sayed Ellily

Study record dates

Study Major Dates

• Study Start (Anticipated): May 26, 2023
• Primary Completion (Anticipated): July 26, 2023
• Study Completion (Anticipated): July 26, 2023

Study Registration Dates

• First Submitted: April 6, 2023
• First Submitted That Met QC Criteria: April 27, 2023
• First Posted (Actual): May 8, 2023

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: May 7, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: low back pain; post partum; clamshell exercise; lumbopelvic instability
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: P.T.REC/012/004341

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No