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

Sponsor

Eman Mahmoud Mahmoud El-sayed Ellily (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05848479

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Lumbosacral Instability Low Back Pain Post Partum	Other: Abdominal bracing Other: clamshell exercise	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

44 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

May 26, 2023

Anticipated Primary Completion Date :

Jul 26, 2023

Anticipated Study Completion Date :

Jul 26, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change in the degree of lumbopelvic instability [change in the lumbopelvic instability degree will be measured at baseline and after 6 weeks of the interventions]
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
lumbopelvic range of motion [change in the lumbopelvic instability degree will be measured at baseline and after 6 weeks of the interventions]
Degree of lumbopelvic range of motion will be measured by goniometer

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 35 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Spinal deformity.
Lower limb deformity.
Osteosarcoma
Mental disorders. 5-25>BMI>30

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Eman Mahmoud Mahmoud El-sayed Ellily

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Eman Mahmoud Mahmoud El-sayed Ellily, post graduate researcher, Cairo University

ClinicalTrials.gov Identifier:

NCT05848479

Other Study ID Numbers:

P.T.REC/012/004341

First Posted:

May 8, 2023

Last Update Posted:

May 9, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Eman Mahmoud Mahmoud El-sayed Ellily, post graduate researcher, Cairo University

clamshell exercise

lumbopelvic instability

low back pain

post partum

Additional relevant MeSH terms:

Back Pain

Low Back Pain

Study Results

No Results Posted as of May 9, 2023