NCT06615037

Brief Summary

The goal of this observational study is to investigate the effect of primary dysmenorrhea on strength of hip joint muscles in females.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 24, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 26, 2024

Completed
5 days until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2025

Completed
Last Updated

February 5, 2025

Status Verified

February 1, 2025

Enrollment Period

4 months

First QC Date

September 24, 2024

Last Update Submit

February 4, 2025

Conditions

Keywords

Dysmenorrheaprimary dysmenorrheaHip joint strengthisokinetic strength profile

Outcome Measures

Primary Outcomes (1)

  • 1- Hip flexors isokinetic strength 2- Hip extensors isokinetic strength

    The Biodex isokinetic dynamometer (System 4 pro) will be used to assess the strength of hip flexors and extensors during different phases of menstrual cycle.

    3 months

Study Arms (2)

Group A: Symptomatic dysmenorrhea

According to WaLLID Scale Questionnaire

Other: Assess Hip joint strength by Biodex isokinetic dynamometer (System 4 Pro)

Group B: Asymptomatic dysmenorrhea

According to WaLLID Scale Questionnaire

Other: Assess Hip joint strength by Biodex isokinetic dynamometer (System 4 Pro)

Interventions

Assessment of the strength of hip flexors and extensors muscles: * Participants will be in a supine-lying position, the highest reliability (ICC = 0.90) according to the results of the meta-analysis (Contreras et al., 2021). * Seat orientation 0°. * Dynamometer tilt 0° and orientation 0°. * The axis of the dynamometer on the greater trochanter of the femur. * The test parameters included a 0-90 degree range of motion. * During the isokinetic testing movement, the hip was first flexed from a neutral (starting) position to 90° (for hip flexion) and then the direction of the movement was reversed (for hip extension) * Angular speed at 120°/s which shows excellent reliability (ICC = 95%) with concentric contraction mode (Contreras et al., 2021) .

Group A: Symptomatic dysmenorrheaGroup B: Asymptomatic dysmenorrhea

Eligibility Criteria

Age20 Years - 25 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsAdult females Having a regular menstrual cycle (28 ± 7 days with no intermittent bleeding), No pathology related to the pelvis, Having no injury in the lower limb and Not consuming contraceptives, dietary supplements and steroid drugs.
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

44 adult females , age range: 20-25 years , BMI: 18-25 , 22 participants have symptomatic primary dysmenorrhea and 22 have asymptomatic primary dysmenorrhea according WaLLID Questionnaire

You may qualify if:

  • Age range from 20 to 25 years.
  • BMI ranges from 20 to 25 kg/m2.
  • Having a regular menstrual cycle (28 ± 7 days with no intermittent bleeding).
  • No pathology related to the pelvis.
  • Having no injury in the lower limb.
  • Not consuming contraceptives, dietary supplements and steroid drugs.

You may not qualify if:

  • Menstrual irregularity.
  • Pregnancy or suspicion of pregnancy.
  • Having given birth.
  • Using an intrauterine device.
  • Oral contraceptives or antidepressant use.
  • Having a diagnosis of secondary dysmenorrhea.
  • Surgical history involving the abdominal region, pelvic region, and/or the spine in the last year.
  • Having musculoskeletal problems related to lower extremities.
  • Having any psychiatric or gynecological problems.
  • Suffering from premenstrual syndrome.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Giza, 12511, Egypt

Location

MeSH Terms

Conditions

Dysmenorrhea

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and SymptomsPelvic PainPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Nourhan Mohamed Mitwally Amer

    Bachelor Physical Therapy- MUST

    PRINCIPAL INVESTIGATOR
  • Amal Mohamed Yousef, Professor

    Cairo University

    STUDY CHAIR
  • Mai Mohamed Ali, Lecturer

    Cairo University

    STUDY DIRECTOR
  • Ehab Kamal Mohamed Younis, lecturer

    Lecturer of obstetrics and gynecology - Faculty of Medicine - Misr university for science and technology

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

September 24, 2024

First Posted

September 26, 2024

Study Start

October 1, 2024

Primary Completion

January 15, 2025

Study Completion

January 15, 2025

Last Updated

February 5, 2025

Record last verified: 2025-02

Locations