NCT05848479

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 6, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 8, 2023

Completed
18 days until next milestone

Study Start

First participant enrolled

May 26, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 26, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 26, 2023

Completed
Last Updated

May 9, 2023

Status Verified

May 1, 2023

Enrollment Period

2 months

First QC Date

April 6, 2023

Last Update Submit

May 7, 2023

Conditions

Keywords

clamshell exerciselumbopelvic instabilitylow back painpost partum

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • severity of pain intensity

    change in the lumbopelvic instability will be measured at baseline and after 6 weeks of the interventions

  • the degree of function disability

    change in the lumbopelvic instability will be measured at baseline and after 6 weeks of the interventions

Study Arms (2)

control group

ACTIVE COMPARATOR

Abdominal bracing

Other: Abdominal bracing

study group

ACTIVE COMPARATOR

Abdominal bracing and clamshell exercise

Other: Abdominal bracingOther: clamshell exercise

Interventions

they will perform 3 times/week of static abdominal contraction for six weeks.

control groupstudy group

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

study group

Eligibility Criteria

Age25 Years - 35 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Spinal deformity.
  • Lower limb deformity.
  • Osteosarcoma
  • Mental disorders. 5-25\>BMI\>30
  • Performing any physical exercise at the time of the study. 7-Bad general Health

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
post graduate researcher

Study Record Dates

First Submitted

April 6, 2023

First Posted

May 8, 2023

Study Start

May 26, 2023

Primary Completion

July 26, 2023

Study Completion

July 26, 2023

Last Updated

May 9, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share