NCT06045169

Brief Summary

This study will be a quasi experimental study in which females aged 18 - 30 years with primary dysmenorrhea will be recruited in single group. They will be given a total of 3 sessions of treatment during a period of one menstrual cycle (One Week). Before and after the introduction of intervention pain and quality of life of participants will be assessed.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

February 15, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2023

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2023

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2024

Completed
Last Updated

September 21, 2023

Status Verified

September 1, 2023

Enrollment Period

7 months

First QC Date

September 13, 2023

Last Update Submit

September 13, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pain intensity

    Pain will be measured using numeric pain rating scale which is an 10 point scale scored from zero indicating no pain and 10 indicating worst pain.

    1 week

Secondary Outcomes (2)

  • Quality of life of participant

    1 week

  • WALIDD

    1 week

Study Arms (1)

Single Group

OTHER

Post isometric relaxation with participants using 20% of their maximum voluntary contraction will be given to global muscles of core commonly involved in primary dysmenorrhea glutus maximus, Illiopsoas and pirifirmis. Post isometric contraction will be held for 6 to 10 seconds followed by 15 o 30 seconds stretch, rst time will be 5 seconds in between repetations and number of repetations will be 3-5.

Procedure: Post Isometric Relaxation

Interventions

Post isometric relaxation with participants using 20% of their maximum voluntary contraction will be given to global muscles of core commonly involved in primary dysmenorrhea glutus maximus, Illiopsoas and pirifirmis. Post isometric contraction will be held for 6 to 10 seconds followed by 15 o 30 seconds stretch, rst time will be 5 seconds in between repetations and number of repetations will be 3-5.

Single Group

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale between ages 18-30 years
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Female aged 18 - 30
  • Primary Dysmenorrhea
  • Unmarried

You may not qualify if:

  • Not on any contraceptive medicine for treatment of pelvic pathology
  • Secondary Dysmenorrhea and other issues such as endometriosis, Pelvic inflammatory disease, Ovarian cyst

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University College of Physical Therapy

Rawalpindi, Punjab Province, 46000, Pakistan

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Quasi Experimental Pre-test Post-test design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2023

First Posted

September 21, 2023

Study Start

February 15, 2023

Primary Completion

September 20, 2023

Study Completion

February 10, 2024

Last Updated

September 21, 2023

Record last verified: 2023-09

Locations