NCT05709951

Brief Summary

To compare the effects of Functional and Core stability exercises on pain and sleep quality in Patients with Primary Dysmenorrhea and to check the results of exercises may be effective in pain during Menstrual and before cramping in menses.

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
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2022

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 1, 2022

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2023

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 2, 2023

Completed
Last Updated

February 2, 2023

Status Verified

January 1, 2023

Enrollment Period

1 year

First QC Date

January 4, 2023

Last Update Submit

January 24, 2023

Conditions

Primary Dysmenorrhea

Keywords

Core stability,Exercises,Primary dysmenorrhea,sleep quality

Outcome Measures

Primary Outcomes (3)

  • Visual analogue scale for lower abdominal pain

    The subjective and verified visual analogue scale is used to quantify both acute and chronic pain (1). On the 10 cm line, scores are recorded by making a mark. Pain intensity is measured along a 10-cm line with 0 denoting "no pain" and 10 denoting "worst pain."

    8 week

  • Menstrual Symptom Questionnaire

    Menstrual Symptom Questionnaire (MSQ) to assess dysmenorrhea symptoms. The MSQ is a 24 item self-report measure which assesses menstrual pain and symptoms (e.g. 'I have cramps that begin on the first day of my period'; 'I feel depressed for several days before my period'). The score on each item ranges from 1 (never) to 5 (always) with a higher composite score indicating more symptoms.

    8 weeks

  • Pittsburgh Sleep Quality Index

    Pittsburgh Sleep Quality Index (PSQI) evaluates sleep disruptions and quality over a 1-month period. In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty).

    8 week

Study Arms (2)

Functional exercises

ACTIVE COMPARATOR

Piriformis stretching Cobra pose Sit up Bridging exercise

Other: Functional Exercises

Core Stability Exercises

ACTIVE COMPARATOR

Pelvic bridging Plank Cat and camel Curl up

Other: Core Stability Exercises

Interventions

Functional ExercisesOTHER

The patients were requested to perform these functional exercises for 4 days per week three times for 20 min (8 weeks).

Also known as: Exercises
Functional exercises
Core Stability ExercisesOTHER

The patients were requested to perform 4 core strengthening exercises for 4 days per week three times for 20 min (8 weeks)

Also known as: Exercises
Core Stability Exercises

Eligibility Criteria

Age15 Years - 30 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale with primary dysmenorrhea
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Having used medication for menstrual pain and not having used oral contraceptives during the three months prior to admission to the study.
  • Pain must be periodic (at least following 3 menstrual cycles).
  • Lower abdominal cramps pain ends after periods and gradually diminish over 12 to 72 hrs.
  • No history of blood disorders including thalassemia and folate or iron-deficiency anemia

You may not qualify if:

  • Pelvic inflammatory disease
  • Ovarian cysts
  • Chronic abdominal pain
  • Fibroids, obstructive endometrial polyps,
  • Irritable bowel syndrome
  • Major abdominal or pelvic surgery
  • Intrauterine devices.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jinnah Hospital

Lahore, Punjab Province, Pakistan

RECRUITING

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Fatima Tariq, PhD

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fatima Tariq, Phd

CONTACT

03344255033fatima.tariq@riphah.edu.pk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Blinding
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2023

First Posted

February 2, 2023

Study Start

February 1, 2022

Primary Completion

February 1, 2023

Study Completion

February 1, 2023

Last Updated

February 2, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)