Primary DysmenorrheaNCT06466954
Correlation Between Spinopelvic Alignment and Uterine Dimensions in Primary Dysmenorrhea
An observational study of Primary Dysmenorrhea, run by Cairo University at 1 site in Egypt.
Trial summary
This study was conducted to investigate the correlation between spinopelvic alignment and uterine dimensions in primary dysmenorrhea. Read more about this study
- Who is it for?
- Ages 17 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Primary Dysmenorrhea
- What is being tested?
- Evaluating spinopelvic alignment parameters and Measuring uterine dimensions
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2022to 28 Feb 2023
- 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 17 to 25 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: A sample of 40 girls was recruited from undergraduate students at Faculty of Physical Therapy, Cairo University and actively participated in this research.
Who may be able to join
- Virginal and non-smokers.
- They should have regular menstrual cycles, verified through a three-month calendar record, with cycle durations averaging between 28 to 35 days.
- The body mass index (BMI) varied between 18.5 to 25 kg/m2.
- Additionally, girls in the study group should have moderate to severe PD (WaLIDD score ≥ 5).
Who cannot join
- Pelvic or gynecological disorders.
- Musculoskeletal disorders as low back pain.
- Spinal deformities as kyphosis and scoliosis.
- History of lower limb injuries.
- Diabetes.
- Cardiopulmonary diseases.
- Any physical impairment.
- They didn't use analgesics, non-steroidal anti-inflammatory drugs or oral contraceptives.
Trial locations and contacts
1 site in 1 country.
About this study
This study was conducted to investigate the correlation between spinopelvic alignment and uterine dimensions in primary dysmenorrhea.
Read the detailed description
Primary dysmenorrhea (PD) is a common condition characterized by severe menstrual cramps and lower abdominal pain before or during menstruation, without any underlying pelvic pathology. It is highly prevalent among adolescents and young women, with 16% to 93% of adolescents and 70% to 90% of young women experiencing PD. The severe menstrual discomfort associated with PD often leads to absenteeism from school or work, with approximately one-third to half of individuals missing at least one day per menstrual cycle, and 5% to 14% experiencing more frequent absences.
While the exact etiology of PD is not fully understood, researchers have proposed a potential relationship between PD and musculoskeletal factors. One hypothesis suggests that abnormal pelvic and lumbar spine alignment, coupled with abdominal muscle spasms, may affect the positioning of the uterus, increasing the susceptibility to dysmenorrhea. Additionally, lumbar spine misalignment could potentially impact uterine blood supply through vasoconstriction, contributing to menstrual pain.
Spinal misalignment has been proposed as a possible underlying cause of PD, with some studies suggesting that manual therapy techniques may alleviate PD symptoms. Furthermore, a lack of coordination between the pelvic floor muscles and surrounding soft tissues has also been implicated as a potential causative factor. However, research investigating the relationship between PD and musculoskeletal factors remains limited, and further exploration of the biomechanical factors influencing the pelvic region is needed. Therefore, this study aimed to investigate the correlation between spinopelvic alignment and uterine dimensions in primary dysmenorrhea.
- Conditions
- Primary Dysmenorrhea
- Being tested
- Evaluating spinopelvic alignment parameters, Measuring uterine dimensions
- Keywords
- Spinal alignment, Pelvic alignment, Uterine dimensions, Primary Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluating spinopelvic alignment parametersOther
Evaluation of thoracic kyphosis, lumbar lordosis, pelvic tilt, and pelvic torsion
Measuring uterine dimensionsOther
Measurement of corpus length, corpus width, cervix length, and cervix width
| Study group | Role | What they receive |
|---|---|---|
| Group of Primary Dysmenorrhea | Females with Primary Dysmenorrhea Receives: Other: Evaluating spinopelvic alignment parameters; Other: Measuring uterine dimensions | |
| Group Without Primary Dysmenorrhea | Females without Primary Dysmenorrhea Receives: Other: Evaluating spinopelvic alignment parameters; Other: Measuring uterine dimensions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kyphotic angle
It was measured by a 4D formetric device as the maximum degree of kyphotic curvature, specifically the angle formed between the upper inflection point adjacent to the vertebral prominence and the thoracic-lumbar inflection point.
Measured: It was measured during the 2nd or 3rd days of menstruation for each participant in both groups.
Lordotic angle
It was measured by a 4D formetric device as the maximum lordotic angle, calculated as the angle formed between the surface tangents at the thoracic-lumbar inflection point and the lower lumbar-sacral inflection point.
Measured: It was measured during the 2nd or 3rd days of menstruation for each participant in both groups.
Pelvic tilt
It was determined by a 4D formetric device as the vertical disparity in millimeters (mm) between the two lumbar dimples. A positive value signifies that the right dimple is positioned higher than the left, while a negative value indicates the reverse, all in relation to a horizontal reference line connecting both dimples within the measuring system.
Measured: It was measured during the 2nd or 3rd days of menstruation for each participant in both groups.
Pelvic torsion
It was measured by a 4D formetric device within the frontal plane, this measurement represents the degree of rotation of the right sacral dimple relative to the left sacral dimple.
Measured: It was measured during the 2nd or 3rd days of menstruation for each participant in both groups.
corpus length
It was measured by ultrasonography. The longitudinal axis of the uterine corpus was determined at a longitudinal plane where the internal cervical os and endometrium appeared at their tallest, measured from the projection point of the endometrium on the uterine corpus to the internal cervical os.
Measured: It was measured during the 2nd or 3rd days of menstruation for each participant in both groups.
corpus width
It was measured by ultrasonography. The transverse axis of the uterine corpus was assessed at the same plane, positioned perpendicular to the longitudinal diameter of the uterine corpus where it exhibited its maximum width.
Measured: It was measured during the 2nd or 3rd days of menstruation for each participant in both groups.
cervix length
It was measured by ultrasonography. t was measured as the distance between the internal cervical os and the external os.
Measured: It was measured during the 2nd or 3rd days of menstruation for each participant in both groups.
cervix width
It was measured by ultrasonography. The measurement of the transverse diameter of the uterine cervix was conducted at its thickest section, oriented perpendicular to an imaginary line corresponding to the longitudinal measurement of the cervix.
Measured: It was measured during the 2nd or 3rd days of menstruation for each participant in both groups.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2024
- Study start1 Mar 2022
- Primary completion28 Feb 2023
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary DysmenorrheaStudies of the same condition, open and under way.
- More trials run by Cairo 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Randa Gomaa, Cairo University
- Investigators
- Amel M. Yousef, Prof., Study chair, Faculty of physical therapy, Cairo University, Giza, Egypt.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06466954
- Sponsor's protocol ID
- P.T.REC/012/003235
- Status last verified
- Jun 2024
- First submitted
- 14 Jun 2024
- Last updated
- 21 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Spinopelvic Alignment and Uterine Dimensions in Primary Dysmenorrhea
- ClinicalTrials.gov ID
- NCT06466954
- Acronym / sponsor ID
- P.T.REC/012/003235
- Conditions
- Primary Dysmenorrhea
- Keywords
- Spinal alignment, Pelvic alignment, Uterine dimensions, Primary Dysmenorrhea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 20 Jun 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 was conducted to investigate the correlation between spinopelvic alignment and uterine dimensions in primary dysmenorrhea.
Detailed description
Primary dysmenorrhea (PD) is a common condition characterized by severe menstrual cramps and lower abdominal pain before or during menstruation, without any underlying pelvic pathology. It is highly prevalent among adolescents and young women, with 16% to 93% of adolescents and 70% to 90% of young women experiencing PD. The severe menstrual discomfort associated with PD often leads to absenteeism from school or work, with approximately one-third to half of individuals missing at least one day per menstrual cycle, and 5% to 14% experiencing more frequent absences.
While the exact etiology of PD is not fully understood, researchers have proposed a potential relationship between PD and musculoskeletal factors. One hypothesis suggests that abnormal pelvic and lumbar spine alignment, coupled with abdominal muscle spasms, may affect the positioning of the uterus, increasing the susceptibility to dysmenorrhea. Additionally, lumbar spine misalignment could potentially impact uterine blood supply through vasoconstriction, contributing to menstrual pain.
Spinal misalignment has been proposed as a possible underlying cause of PD, with some studies suggesting that manual therapy techniques may alleviate PD symptoms. Furthermore, a lack of coordination between the pelvic floor muscles and surrounding soft tissues has also been implicated as a potential causative factor. However, research investigating the relationship between PD and musculoskeletal factors remains limited, and further exploration of the biomechanical factors influencing the pelvic region is needed. Therefore, this study aimed to investigate the correlation between spinopelvic alignment and uterine dimensions in primary dysmenorrhea.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group of Primary Dysmenorrhea | – | Other: Evaluating spinopelvic alignment parameters, Other: Measuring uterine dimensionsFemales with Primary Dysmenorrhea |
| Group Without Primary Dysmenorrhea | – | Other: Evaluating spinopelvic alignment parameters, Other: Measuring uterine dimensionsFemales without Primary Dysmenorrhea |
Who may qualify
- Ages
- 17 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- A sample of 40 girls was recruited from undergraduate students at Faculty of Physical Therapy, Cairo University and actively participated in this research.
Key inclusion criteria (4 listed)
- Virginal and non-smokers.
- They should have regular menstrual cycles, verified through a three-month calendar record, with cycle durations averaging between 28 to 35 days.
- The body mass index (BMI) varied between 18.5 to 25 kg/m2.
- Additionally, girls in the study group should have moderate to severe PD (WaLIDD score ≥ 5).
Key exclusion criteria (8 listed)
- Pelvic or gynecological disorders.
- Musculoskeletal disorders as low back pain.
- Spinal deformities as kyphosis and scoliosis.
- History of lower limb injuries.
- Diabetes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluating spinopelvic alignment parametersEvaluation of thoracic kyphosis, lumbar lordosis, pelvic tilt, and pelvic torsion | Other | Group Without Primary Dysmenorrhea, Group of Primary Dysmenorrhea |
| Measuring uterine dimensionsMeasurement of corpus length, corpus width, cervix length, and cervix width | Other | Group Without Primary Dysmenorrhea, Group of Primary Dysmenorrhea |
Primary outcome
Kyphotic angle
Time frame: It was measured during the 2nd or 3rd days of menstruation for each participant in both groups.
It was measured by a 4D formetric device as the maximum degree of kyphotic curvature, specifically the angle formed between the upper inflection point adjacent to the vertebral prominence and the thoracic-lumbar inflection point.
Lordotic angle
Time frame: It was measured during the 2nd or 3rd days of menstruation for each participant in both groups.
It was measured by a 4D formetric device as the maximum lordotic angle, calculated as the angle formed between the surface tangents at the thoracic-lumbar inflection point and the lower lumbar-sacral inflection point.
Pelvic tilt
Time frame: It was measured during the 2nd or 3rd days of menstruation for each participant in both groups.
It was determined by a 4D formetric device as the vertical disparity in millimeters (mm) between the two lumbar dimples. A positive value signifies that the right dimple is positioned higher than the left, while a negative value indicates the reverse, all in relation to a horizontal reference line connecting both dimples within the measuring system.
Pelvic torsion
Time frame: It was measured during the 2nd or 3rd days of menstruation for each participant in both groups.
It was measured by a 4D formetric device within the frontal plane, this measurement represents the degree of rotation of the right sacral dimple relative to the left sacral dimple.
corpus length
Time frame: It was measured during the 2nd or 3rd days of menstruation for each participant in both groups.
It was measured by ultrasonography. The longitudinal axis of the uterine corpus was determined at a longitudinal plane where the internal cervical os and endometrium appeared at their tallest, measured from the projection point of the endometrium on the uterine corpus to the internal cervical os.
corpus width
Time frame: It was measured during the 2nd or 3rd days of menstruation for each participant in both groups.
It was measured by ultrasonography. The transverse axis of the uterine corpus was assessed at the same plane, positioned perpendicular to the longitudinal diameter of the uterine corpus where it exhibited its maximum width.
cervix length
Time frame: It was measured during the 2nd or 3rd days of menstruation for each participant in both groups.
It was measured by ultrasonography. t was measured as the distance between the internal cervical os and the external os.
cervix width
Time frame: It was measured during the 2nd or 3rd days of menstruation for each participant in both groups.
It was measured by ultrasonography. The measurement of the transverse diameter of the uterine cervix was conducted at its thickest section, oriented perpendicular to an imaginary line corresponding to the longitudinal measurement of the cervix.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 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.
Amel M. Yousef, Prof. study chair
Faculty of physical therapy, Cairo University, Giza, Egypt.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Dysmenorrhea, run by Cairo University at 1 site in Egypt.
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 8 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: finished, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kyphotic angle (time frame: It was measured during the 2nd or 3rd days of menstruation for each participant in both groups.). The study lists 8 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 21 Jun 2024; AzTrials last refreshed its copy on 26 Oct 2026.