NCT06808529

Brief Summary

This study was done to determine the effect of Pilates exercises and TENS acupuncture in primary dysmenorrhea among female students at King Abdulaziz University (KAU).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Jan 2024

Shorter than P25 for early_phase_1

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

Study Start

First participant enrolled

January 30, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 5, 2025

Completed
Last Updated

February 5, 2025

Status Verified

January 1, 2025

Enrollment Period

4 months

First QC Date

January 30, 2025

Last Update Submit

January 30, 2025

Conditions

Dysmenorrhea Primary

Outcome Measures

Primary Outcomes (1)

  • Visual Analogue scale

    Visual Analogue scale for assessing pain level, a score ranging from 0 to 100 mm.

    2 months

Secondary Outcomes (1)

  • Verbal multidimensional scoring system of dysmenorrhea

    2 months

Study Arms (2)

Study group

EXPERIMENTAL

Pilates exercises and TENS Acupuncture

Device: Pilates exercises and TENS Acupuncture

Control group

EXPERIMENTAL

Conservative treatment

Drug: ibuprofen 400 mg

Interventions

Pilates exercises and TENS AcupunctureDEVICE

All performed Pilates exercises for 24 session, 3 sessions per week for (2 consecutive menstrual cycle), each session lasted for 30 minutes in addition to application of TENS acupuncture therapy for 30 minutes, 3 sessions in the first 3 days for (2 consecutive menstrual cycle).

Study group
ibuprofen 400 mgDRUG

All took capsules of ibuprofen(400-milligram) and instructed to take them once every eight hours for three days, one day before the start of their menstrual cycle and on the first two days of menstruation for (2 consecutive menstrual cycle).

Control group

Eligibility Criteria

Age18 Years - 24 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPrimary dysmenorrhea.
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Participants suffering from primary dysmenorrhea.
  • Their age ranged between 18-24 years
  • Their BMI less than 30 kg/m2.

You may not qualify if:

  • Gynecological disorders (secondary dysmenorrhea)
  • Married females,
  • Low back pain due to any other pathology
  • Chronic diseases (diabetes, high blood pressure)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

king Abdulaziz university

Jeddah, 21589, Saudi Arabia

Location

Related Links

MeSH Terms

Interventions

Ibuprofen

Intervention Hierarchy (Ancestors)

PhenylpropionatesAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 30, 2025

First Posted

February 5, 2025

Study Start

January 30, 2024

Primary Completion

May 30, 2024

Study Completion

September 30, 2024

Last Updated

February 5, 2025

Record last verified: 2025-01

Locations

SA(1)