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NCT Number: NCT06713759

Impact of Postural Balance Changes on Low Back Pain During Pregnancy

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

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Key information

Age range

20 year–35 year

Sex eligibility

Female

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

nada Ali, master

CONTACT

[email protected]

01140767665

Sponsors and collaborators

Lead sponsor

October 6 University

Other

Registry information

Acronym: LBP

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 3, 2024
Registry last updated
Dec 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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