Correlation Between Spinopelvic Alignment and Uterine Dimensions in Primary Dysmenorrhea

NCT ID: NCT06466954

Last Updated: 2024-06-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-01

Study Completion Date

2023-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Primary Dysmenorrhea

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group of Primary Dysmenorrhea

Females with Primary Dysmenorrhea

Evaluating spinopelvic alignment parameters

Intervention Type OTHER

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

Measuring uterine dimensions

Intervention Type OTHER

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

Group Without Primary Dysmenorrhea

Females without Primary Dysmenorrhea

Evaluating spinopelvic alignment parameters

Intervention Type OTHER

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

Measuring uterine dimensions

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Evaluating spinopelvic alignment parameters

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

Intervention Type OTHER

Measuring uterine dimensions

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

17 Years

Maximum Eligible Age

25 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Cairo University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Randa Gomaa

Assistant Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Amel M. Yousef, Prof.

Role: STUDY_CHAIR

Faculty of physical therapy, Cairo University, Giza, Egypt.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Cairo University

Giza, , Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

P.T.REC/012/003235

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The Use of Doppler to Diagnose Myometrial Masses
NCT01833871 UNKNOWN PHASE2/PHASE3