CClinicalTrials.gg
Not yet recruitingNCT06713759LBPUpdated Dec 3, 2024

Impact of Postural Balance Changes on Low Back Pain During Pregnancy

An observational study in Pregnancy and Low Back Pain, sponsored by October 6 University. Not yet recruiting. Open to female participants aged 20 Years to 35 Years. Per ClinicalTrials.gov, last updated 2024-12-03.

Sponsored by October 6 University · Observational

From the registry’s dates

  • Primary completion was expected by Feb 2025, 1 year 8 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
40
Ages
20 Years to 35 Years
Sex
Female
01

Study summary

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

Read the 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

02

Conditions studied

  • Pregnancy
  • Low Back Pain

Keywords

  • postural balance
  • low back pain
  • pregnacy
03

In context

Back Pain

2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.

This study's planned enrollment of 40 is below the median of 100 across 357 observational studies indexed under Back Pain.

Browse Back Pain studies →

Lead sponsor

October 6 University is the lead sponsor of 135 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 35 Years
Sexes eligible
Female
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

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

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
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
40 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. balance

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

    Time frame: up to thirty four weeks

  2. 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

    Time frame: up to thirty four weeks

Secondary outcomes

  1. pain intensity

    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.

    Time frame: up to thirty four weeks

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06713759
Lead sponsor
October 6 University
Responsible party
Nada Fawzy Ali (principle investigator: nada fawzy ali, October 6 University) — Principal investigator
First posted
Dec 3, 2024
Start date
Dec 5, 2024 (estimated)
Primary completion
Feb 5, 2025 (estimated)
Completion
Feb 5, 2025 (estimated)
Last update
Dec 3, 2024

Study contacts

nada Ali, master
Contact
nodadoda24@gmail.com
01140767665

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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