- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06466954
Correlation Between Spinopelvic Alignment and Uterine Dimensions in Primary Dysmenorrhea
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Giza, Egypt
- Cairo University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Group of Primary Dysmenorrhea
Females with Primary Dysmenorrhea
|
Measurement of corpus length, corpus width, cervix length, and cervix width
Evaluation of thoracic kyphosis, lumbar lordosis, pelvic tilt, and pelvic torsion
|
|
Group Without Primary Dysmenorrhea
Females without Primary Dysmenorrhea
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Measurement of corpus length, corpus width, cervix length, and cervix width
Evaluation of thoracic kyphosis, lumbar lordosis, pelvic tilt, and pelvic torsion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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It was measured during the 2nd or 3rd days of menstruation for each participant in both groups.
|
|
Lordotic angle
Time Frame: It was measured during the 2nd or 3rd days of menstruation for each participant in both groups.
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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.
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It was measured during the 2nd or 3rd days of menstruation for each participant in both groups.
|
|
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.
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It was measured during the 2nd or 3rd days of menstruation for each participant in both groups.
|
|
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.
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It was measured during the 2nd or 3rd days of menstruation for each participant in both groups.
|
|
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.
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It was measured during the 2nd or 3rd days of menstruation for each participant in both groups.
|
|
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.
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It was measured during the 2nd or 3rd days of menstruation for each participant in both groups.
|
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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.
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It was measured during the 2nd or 3rd days of menstruation for each participant in both groups.
|
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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.
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It was measured during the 2nd or 3rd days of menstruation for each participant in both groups.
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Amel M. Yousef, Prof., Faculty of physical therapy, Cairo University, Giza, Egypt.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/003235
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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