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Completed

NCT Number: NCT06466954

Correlation Between Spinopelvic Alignment and Uterine Dimensions in Primary Dysmenorrhea

This study was conducted to investigate the correlation between spinopelvic alignment and uterine dimensions in primary dysmenorrhea.

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Key information

Conditions

Primary Dysmenorrhea

Age range

17 year–25 year

Sex eligibility

Female

Study type

Observational

Primary location

Cairo University

Giza, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Evaluating spinopelvic alignment parameters

Other

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

Measuring uterine dimensions

Other

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 20, 2024
Registry last updated
Jun 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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