NCT06713759

Brief Summary

this study will be conducted to determine the impact of postural balance changes on low back pain during pregnancy

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
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2024

Shorter than P25 for all trials

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 28, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 3, 2024

Completed
2 days until next milestone

Study Start

First participant enrolled

December 5, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2025

Completed
Last Updated

December 3, 2024

Status Verified

November 1, 2024

Enrollment Period

2 months

First QC Date

November 28, 2024

Last Update Submit

November 28, 2024

Conditions

Keywords

postural balancelow back painpregnacy

Outcome Measures

Primary Outcomes (2)

  • balance

    The Biodex Balance System SD will be used to assess balance.higher values indicate more deviations and poor balance control.

    up to thirty four weeks

  • pressure pain threshold

    digital pressure algometer from Wagner Instruments will be used to assess pressure pain threshol.The algometer was set to measure at a rate of 100 readings per second and always displayed the highest pressure measured. The round attachment surface had a diameter of 1.12 cm. Newton (N) was set as the unit of measurement on the device. Later, it was converted to kilopascals (kPa) to enable comparability with other studies

    up to thirty four weeks

Secondary Outcomes (1)

  • pain intensity

    up to thirty four weeks

Study Arms (2)

primigravida women

This group will include 20 primigravida pregnant woman with low back pain. They will undergo balance and low back pain assessment (at 2 different time points: one at their second trimester (22-24) weeks and the other one in their third trimester (34th) week

Multigravida women

This group will include 20 pregnant women with low back pain. They will undergo balance and low back pain assessment (at 2 different time points: one at their second trimester (22-24) weeks and the other one in their third trimester (34th) week

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnant women
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

This study will be conducted on forty pregnant women (in second and third trimesters) suffering from low back pain

You may qualify if:

  • Pregnant women in 2nd and 3rd trimesters.
  • Pregnant women suffering from low back pain
  • Their Age will range from 20-35 years.
  • Their Body mass index (BMI) will be less than 35 kg/m2

You may not qualify if:

  • Non pregnant women.
  • Women who have any history of diseases associated with balance disorder
  • Women who have any Neurological disorders.
  • Women who have Lower limbs deformities
  • Women who have Optical problems and disorders
  • Women who have Cerebrovascular disease

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

nada Ali, master

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator: nada fawzy ali

Study Record Dates

First Submitted

November 28, 2024

First Posted

December 3, 2024

Study Start

December 5, 2024

Primary Completion

February 5, 2025

Study Completion

February 5, 2025

Last Updated

December 3, 2024

Record last verified: 2024-11