Impact of Postural Balance Changes on Low Back Pain During Pregnancy (LBP)

November 28, 2024 updated by: Nada Fawzy Ali, October 6 University
this study will be conducted to determine the impact of postural balance changes on low back pain during pregnancy

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Back pain is a major problem in the general population, and it is thought to be even more common in pregnant women who have given birth. It has been hypothesized that this type of pregnancy-related low back pain (LBP) may be related to changes in lumbar posture, perhaps accompanied by stretching abdominal muscles or specific hormonal effects of pregnancy .During pregnancy, many hormonal, anatomical, and musculoskeletal changes occur. These changes alter the postural balance and increase the risk of falls. Falls during pregnancy can cause maternal and foetal injuries. Moreover, the incidence of falls during pregnancy is higher compared to non-pregnant women of the same age. The risk of falls increases with the gestational age, and most falls are experienced in the third trimester. so, this study will be designed to conduct new information about the relation between postural changes and low back pain during pregnancy

Study Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
balance
Time Frame: up to thirty four weeks
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
Time Frame: up to thirty four weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain intensity
Time Frame: up to thirty four weeks
visual analogue scale will be used to assess pain intensity. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
up to thirty four weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

October 6 University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 5, 2024

Primary Completion (Estimated)

February 5, 2025

Study Completion (Estimated)

February 5, 2025

Study Registration Dates

First Submitted

November 28, 2024

First Submitted That Met QC Criteria

November 28, 2024

First Posted (Actual)

December 3, 2024

Study Record Updates

Last Update Posted (Actual)

December 3, 2024

Last Update Submitted That Met QC Criteria

November 28, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P.T.REC/012/005384

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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