PregnancyLBPNCT06713759
Impact of Postural Balance Changes on Low Back Pain During Pregnancy
An observational study of Pregnancy and Low Back Pain, run by October 6 University.
Trial summary
this study will be conducted to determine the impact of postural balance changes on low back pain during pregnancy Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Pregnancy, Low Back Pain
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 5 Dec 2024to 5 Feb 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Study population: This study will be conducted on forty pregnant women (in second and third trimesters) suffering from low back pain
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
- Conditions
- Pregnancy, Low Back Pain
- Keywords
- postural balance, low back pain, pregnacy
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
balance
The Biodex Balance System SD will be used to assess balance.higher values indicate more deviations and poor balance control.
Measured: 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
Measured: 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.
Measured: up to thirty four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2024
- Study start5 Dec 2024 (estimated)
- Primary completion5 Feb 2025 (estimated)
- Study completion5 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nada Fawzy Ali, October 6 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06713759
- Sponsor's protocol ID
- P.T.REC/012/005384
- Acronym
- LBP
- Status last verified
- Nov 2024
- First submitted
- 28 Nov 2024
- Last updated
- 3 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Postural Balance Changes on Low Back Pain During Pregnancy
- ClinicalTrials.gov ID
- NCT06713759
- Acronym / sponsor ID
- LBP / P.T.REC/012/005384
- Conditions
- Pregnancy, Low Back Pain
- Keywords
- postural balance, low back pain, pregnacy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Study start
- 5 Dec 2024 (estimated)
- Primary completion
- 5 Feb 2025 (estimated)
- Study completion
- 5 Feb 2025 (estimated)
- First posted
- 3 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
this study will be conducted to determine the impact of postural balance changes on low back pain during pregnancy
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- This study will be conducted on forty pregnant women (in second and third trimesters) suffering from low back pain
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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
1 secondary outcome
pain intensity
Time frame: up to thirty four weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy and Low Back Pain, run by October 6 University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact nada Ali, master (01140767665, nodadoda24@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
balance (time frame: up to thirty four weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2024.