NCT07095725

Brief Summary

This study aims to investigate the effect of primary dysmenorrhea on the activity of the abdominal and back muscles in young adult females.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Start

First participant enrolled

July 1, 2025

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

July 23, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 31, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2025

Completed
Last Updated

August 5, 2025

Status Verified

July 1, 2025

Enrollment Period

4 months

First QC Date

July 23, 2025

Last Update Submit

July 31, 2025

Conditions

Keywords

Muscle ActivityMaximum Voluntary ContractionEMGPrimary Dysmenorrhea

Outcome Measures

Primary Outcomes (2)

  • Activity of rectus abdominis muscle

    Maximum voluntary contraction in (μV) of rectus abdominis using electromyography device (EMG)

    3 months

  • Activity of erector spinae muscle at L3 vertebrae Level

    Maximum voluntary contraction in (μV) of erector spinae at L3 Level using electromyography device (EMG)

    3 Month

Study Arms (3)

Group A: Mild dysmenorrhea

Females with mild PD, scoring (1-4) on the WaLLID scale.

Diagnostic Test: Record EMG maximum amplitude from rectus abdominis, erector spinae L3 level

Group B: Moderate dysmenorrhea

Females with moderate PD, scoring (5-7) on the WaLLID scale.

Diagnostic Test: Record EMG maximum amplitude from rectus abdominis, erector spinae L3 level

Group C: Severe dysmenorhhea

Females with severe PD, scoring (8-12) on the WaLLID scale.

Diagnostic Test: Record EMG maximum amplitude from rectus abdominis, erector spinae L3 level

Interventions

EMG Electrode Placement and Muscle Assessment: Electrodes for the rectus abdominis were placed longitudinally at the umbilical level. For the erector spinae, L3 was located using a line between the posterior superior iliac crests, and electrodes were placed \~3 cm lateral to the L3 spinous process. Assessment: Rectus Abdominis: In the crook-lying position, participants performed a slow curl-up (\~35-40°), holding for 10 seconds. Erector Spinae: In the prone position with a 10-cm pad under the abdomen, participants lifted the upper body with neutral cervical alignment for 10 seconds. Each test was repeated three times with 2-minute rest intervals.

Group A: Mild dysmenorrheaGroup B: Moderate dysmenorrheaGroup C: Severe dysmenorhhea

Eligibility Criteria

Age18 Years - 25 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsYoung females with primary dysmenorrhea
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Young adult females with primary dysmenorrhea

You may qualify if:

  • All females clinically diagnosed with PD, as confirmed and referred by a gynecologist.
  • Age ranges from 18 to 25 years.
  • BMI ranges from 20 to 25 kg/m2 .
  • Onset of menstrual pain 6-24 months after menarche.
  • Having a regular menstrual cycle (28 ± 7 days with no intermittent bleeding).
  • Their PD symptoms will be determined according to the WaLLID questionnaire and will be classified into mild PD (1-4), moderate PD (5-7), severe PD (8-12).
  • All participants are virgins.

You may not qualify if:

  • Menstrual irregularity.
  • Use of antidepressant or steroid drugs.
  • Secondary dysmenorrhea.
  • Musculoskeletal problems in the abdominal region, pelvic region, or spine.
  • Surgical history involving the abdominal region, pelvic region, or spine in the last year.
  • Any psychiatric or gynecological problems.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Misr University for Science and Technology

Giza, Egypt

RECRUITING

Study Officials

  • Mahenour Esmail Shendy, Bachelor of Physical Therapy

    Teaching Assistant of Physical Therapy For Women's Health- Misr University for Science and Technology

    PRINCIPAL INVESTIGATOR
  • Doaa Ahmed Osman, Assistant Professor

    Physical Therapy for Women's Health - Faculty of Physical Therapy- Cairo University

    STUDY CHAIR
  • Manal Ahmed Elshafei, Lecturer

    Physical Therapy for Women's Health - Faculty of Physical Therapy- Cairo University

    STUDY DIRECTOR
  • Ihab Kamal Younis, lecturer

    Obstetrics and Gynecology department - Faculty of Medicine Misr university for science and technology

    STUDY DIRECTOR

Central Study Contacts

Mahenour Esmail Shendy, Bachelor of Physical Therapy

CONTACT

Abdelrahman Salah Sawan, Bachelor of Physical Therapy

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Teaching Assistant

Study Record Dates

First Submitted

July 23, 2025

First Posted

July 31, 2025

Study Start

July 1, 2025

Primary Completion

October 20, 2025

Study Completion

November 20, 2025

Last Updated

August 5, 2025

Record last verified: 2025-07

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