Low Back PainNCT06530173
Relationship Between Striae Gravidarum and Low-Back Pain Among Pregnant Women: a Cross-Sectional Study
An observational study of Low Back Pain, run by Assiut University.
Trial summary
To improve the quality of pregnant women's lives and provide better control for pregnancy-associated symptoms. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Low Back Pain
- How many people
- 234 participants
- Where
- No sites listed yet
- Study dates
- Aug 2024to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 45 years
- Women only
- Adult
Study population: All healthy pregnant women presenting to the Antenatal care clinic for routine antenatal care visits will be subjected to enrollment.
Who may be able to join
- • Adult (>18 years) primigravida at 36-37 weeks of gestation. Uncomplicated singleton pregnancy.
Who cannot join
- • Women with multiple pregnancies.
- Women having any signs of labor; including detected uterine contractions, rupture of membranes, or cervical dilatation.
- Women with any systemic disease, such as gestational diabetes or preeclampsia.
- Women using any medications during pregnancy, except for iron and vitamins supplements.
- Women using preventive topical treatment for striaegravidarum.
Trial locations and contacts
No sites are listed yet.
About this study
- To improve the quality of pregnant women's lives and provide better control for pregnancy-associated symptoms.
Read the detailed description
Women commonly experience low back pain (LBP) during pregnancy, and its severity tends to increase as the pregnancy advances. The reported prevalence of LBP among pregnant women varies widely within the literature, ranging from 20% up to 90%(Katonis et al., 2011; Liddle \& Pennick, 2015). This is mostly owing to the different definitions and diagnostic criteria of LBP and thus, its real prevalence is still undetermined. In Africa, LBP was found to affect around 50% of pregnant women(Jimoh et al., 2013; Oyeyemi et al., 2013); however and to our knowledge, the prevalence of this condition in Egypt has not been previously described.
Although the occurrence of LBP in pregnancy is typical and would spontaneously resolve after delivery; yet, LBP can be severe enough to negatively impact the quality of pregnant women's lives and increase the health cost burden on them and on the community as well(Kokanali \& Caglar, 2019). Furthermore,such a condition can affect women's ability to effectively fulfill their work duties and increase the work loss due to them taking sick leaves or even quitting their jobs(Sencan et al., 2018). Therefore, it is very essential to make every effort not only to reduce such pain, but also to identify itsetiology in order to prevent its occurrence. Although smoking, high body mass index (BMI) and increased workload have been found to be associated with LBP; however, the exact cause of LBP remains unclear(Katonis et al., 2011; Liddle \& Pennick, 2015; Sabino \& Grauer, 2008).
On the other hand, striaegravidarum (SG) is another common condition found in pregnancy, affecting 55-90% of pregnant women. SG is typically found after the 24th week of gestation as atrophic linear scars on the breasts, abdomen, buttocks, hips, and thighs (Chang et al., 2004; Farahnik et al., 2017). These lesions can cause serious cosmetic problems and pose a psychological burden on pregnant women (Korgavkar \& Wang, 2015). Similarly to LBP, the underlying etiology of such a condition is stillunknown. Yet, some have identified several factors that increase its risk, such as young age, large fetus, increased weight gain and high BMI (Farahnik et al., 2017; Korgavkar \& Wang, 2015; Picard et al., 2015).
Interestingly, some have suggested thatan interaction between hormonal and mechanical factors as the underlying mechanismof SG formation. At first, the hormonal changes associated with pregnancy may weaken the connective tissue in the skin. Then, as the pregnancy progresses, the resulting mechanical stretching may add to this weakening and result inSG(Farahnik et al., 2017; Korgavkar \& Wang, 2015). In a similar manner, the weakening of the connective tissue can affect the spine stability and thus, back pain starts to develop as the mechanical load related to pregnancy increases on the spine (Casagrande et al., 2015).
With that being said, an association between SG and LBP in pregnancy has been recently suggested in a Turkish study byKokanali \& Caglar (2019). They found that the presence of SG was more common and its severity was greater among pregnant women with LBP than among those without LBP. They also reported a positive correlation between SG and LBP severity.However, such an association has not been previously investigated among Egyptian women, and therefore, we will conduct this study in order to assessthe association between SG and LBP among pregnant women living in assuit, Egypt
- Conditions
- Low Back Pain
- Keywords
- low back pain in pregnancy, stria gravidraum
- Medical subject headings
- Low Back Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationship Between Striae Gravidarum and Low-Back Pain Among Pregnant Women
- To assess the association between the presence and severity of striaegravidarum and low back pain among pregnant women
Measured: Baseline
Secondary outcomes (1)
• To determine the prevalence of low back pain among pregnant women.
- To evaluate the effect of women's socio-demographic characteristics on the presence of striae gravidarum or low back pain.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study startAug 2024 (estimated)
- Primary completionAug 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 234 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ereen Samir Roshdy poules, Assiut University
- Investigators
- Sayed Mostafa, Prof, Study chairAhmed Abbas, Associate Prof, Study directorMohamed Shahat, Lecturer, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06530173
- Sponsor's protocol ID
- Striae and Low-Back pain
- Status last verified
- Jul 2024
- First submitted
- 27 Jul 2024
- Last updated
- 31 Jul 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 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Striae Gravidarum and Low-Back Pain Among Pregnant Women: a Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT06530173
- Acronym / sponsor ID
- Striae and Low-Back pain
- Conditions
- Low Back Pain
- Keywords
- low back pain in pregnancy, stria gravidraum
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 234 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Aug 2024 (estimated)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 31 Jul 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.
- To improve the quality of pregnant women's lives and provide better control for pregnancy-associated symptoms.
Detailed description
Women commonly experience low back pain (LBP) during pregnancy, and its severity tends to increase as the pregnancy advances. The reported prevalence of LBP among pregnant women varies widely within the literature, ranging from 20% up to 90%(Katonis et al., 2011; Liddle \& Pennick, 2015). This is mostly owing to the different definitions and diagnostic criteria of LBP and thus, its real prevalence is still undetermined. In Africa, LBP was found to affect around 50% of pregnant women(Jimoh et al., 2013; Oyeyemi et al., 2013); however and to our knowledge, the prevalence of this condition in Egypt has not been previously described.
Although the occurrence of LBP in pregnancy is typical and would spontaneously resolve after delivery; yet, LBP can be severe enough to negatively impact the quality of pregnant women's lives and increase the health cost burden on them and on the community as well(Kokanali \& Caglar, 2019). Furthermore,such a condition can affect women's ability to effectively fulfill their work duties and increase the work loss due to them taking sick leaves or even quitting their jobs(Sencan et al., 2018). Therefore, it is very essential to make every effort not only to reduce such pain, but also to identify itsetiology in order to prevent its occurrence. Although smoking, high body mass index (BMI) and increased workload have been found to be associated with LBP; however, the exact cause of LBP remains unclear(Katonis et al., 2011; Liddle \& Pennick, 2015; Sabino \& Grauer, 2008).
On the other hand, striaegravidarum (SG) is another common condition found in pregnancy, affecting 55-90% of pregnant women. SG is typically found after the 24th week of gestation as atrophic linear scars on the breasts, abdomen, buttocks, hips, and thighs (Chang et al., 2004; Farahnik et al., 2017). These lesions can cause serious cosmetic problems and pose a psychological burden on pregnant women (Korgavkar \& Wang, 2015). Similarly to LBP, the underlying etiology of such a condition is stillunknown. Yet, some have identified several factors that increase its risk, such as young age, large fetus, increased weight gain and high BMI (Farahnik et al., 2017; Korgavkar \& Wang, 2015; Picard et al., 2015).
Interestingly, some have suggested thatan interaction between hormonal and mechanical factors as the underlying mechanismof SG formation. At first, the hormonal changes associated with pregnancy may weaken the connective tissue in the skin. Then, as the pregnancy progresses, the resulting mechanical stretching may add to this weakening and result inSG(Farahnik et al., 2017; Korgavkar \& Wang, 2015). In a similar manner, the weakening of the connective tissue can affect the spine stability and thus, back pain starts to develop as the mechanical load related to pregnancy increases on the spine (Casagrande et al., 2015).
With that being said, an association between SG and LBP in pregnancy has been recently suggested in a Turkish study byKokanali \& Caglar (2019). They found that the presence of SG was more common and its severity was greater among pregnant women with LBP than among those without LBP. They also reported a positive correlation between SG and LBP severity.However, such an association has not been previously investigated among Egyptian women, and therefore, we will conduct this study in order to assessthe association between SG and LBP among pregnant women living in assuit, Egypt
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- All healthy pregnant women presenting to the Antenatal care clinic for routine antenatal care visits will be subjected to enrollment.
Key inclusion criteria (1 listed)
- • Adult (>18 years) primigravida at 36-37 weeks of gestation. Uncomplicated singleton pregnancy.
Key exclusion criteria (5 listed)
- • Women with multiple pregnancies.
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
Relationship Between Striae Gravidarum and Low-Back Pain Among Pregnant Women
Time frame: Baseline
• To assess the association between the presence and severity of striaegravidarum and low back pain among pregnant women
1 secondary outcome
• To determine the prevalence of low back pain among pregnant women.
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 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. This study is not recruiting at the moment.
Sayed Mostafa, Prof study chair
Ahmed Abbas, Associate Prof study director
Mohamed Shahat, Lecturer study director
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain, run by Assiut 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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 31 Jul 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ereen Samir, Resident (01283115083, ereensamir530@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relationship Between Striae Gravidarum and Low-Back Pain Among Pregnant Women (time frame: Baseline). 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 31 Jul 2024.