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CompletedNCT06466954Updated Jun 21, 2024

Correlation Between Spinopelvic Alignment and Uterine Dimensions in Primary Dysmenorrhea

An observational study in Primary Dysmenorrhea, sponsored by Cairo University. Completed at 1 site in Egypt. Open to female participants aged 17 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-21.

Sponsored by Cairo University · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
40
Ages
17 Years to 25 Years
Sex
Female
01

Study summary

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.

02

Conditions studied

  • Primary Dysmenorrhea

Keywords

  • Spinal alignment
  • Pelvic alignment
  • Uterine dimensions
  • Primary Dysmenorrhea
03

In context

Lead sponsor

Cairo University is the lead sponsor of 4,909 studies on the registry; 1,445 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

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

04

Who can participate

Ages eligible
17 Years to 25 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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).

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
40 participants (actual)
Patient registry
No

Groups and cohorts

  • Group of Primary Dysmenorrhea

    Females with Primary Dysmenorrhea

    Other: Evaluating spinopelvic alignment parameters · Other: Measuring uterine dimensions

  • Group Without Primary Dysmenorrhea

    Females without Primary Dysmenorrhea

    Other: Evaluating spinopelvic alignment parameters · Other: Measuring uterine dimensions

Interventions

  • OtherEvaluating spinopelvic alignment parameters

    Evaluation of thoracic kyphosis, lumbar lordosis, pelvic tilt, and pelvic torsion

  • OtherMeasuring uterine dimensions

    Measurement of corpus length, corpus width, cervix length, and cervix width

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: It was measured during the 2nd or 3rd days of menstruation for each participant in both groups.

  2. 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.

    Time frame: It was measured during the 2nd or 3rd days of menstruation for each participant in both groups.

  3. 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.

    Time frame: It was measured during the 2nd or 3rd days of menstruation for each participant in both groups.

  4. 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.

    Time frame: It was measured during the 2nd or 3rd days of menstruation for each participant in both groups.

  5. 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.

    Time frame: It was measured during the 2nd or 3rd days of menstruation for each participant in both groups.

  6. 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.

    Time frame: It was measured during the 2nd or 3rd days of menstruation for each participant in both groups.

  7. cervix length

    It was measured by ultrasonography. t was measured as the distance between the internal cervical os and the external os.

    Time frame: It was measured during the 2nd or 3rd days of menstruation for each participant in both groups.

  8. 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.

    Time frame: It was measured during the 2nd or 3rd days of menstruation for each participant in both groups.

07

Study locations

1 site
  • Cairo University
    Giza, Egypt
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2022 to primary completion in Feb 2023, 11 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 14, 2024
First posted
Jun 20, 2024
StartActual
Mar 1, 2022
Primary completionActual
Feb 28, 2023
CompletionActual
Feb 28, 2023
Last update
Jun 21, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 21, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06466954
Lead sponsor
Cairo University
Responsible party
Randa Gomaa (Assistant Lecturer, Cairo University) — Principal investigator
First posted
Jun 20, 2024
Start date
Mar 1, 2022
Primary completion
Feb 28, 2023
Completion
Feb 28, 2023
Last update
Jun 21, 2024

Study contacts

Amel M. Yousef, Prof.
study chair · Faculty of physical therapy, Cairo University, Giza, Egypt.

Oversight

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

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This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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