NCT05771753

Brief Summary

A randomize control study will be conducted, in which data will be collected from young girls having primary dysmenorrhea with the calculated sample size of 17 in each group, questionnaire will be provided to collect the data and then according to sample size number the participants will be randomly assign to the group A and B. group A will perform stretching exercises for eight weeks and group B will perform core stabilizing exercises for 8 weeks, pre and post readings before starting exercises and after eight weeks will be taken. Four different types of tools will be used, for primary dysmenorrhea WALIDD scale will be used, to measure the pain intensity, frequency, duration and severity the PFSD scale will be used and for measuring the strength the side bridge test will be used and to check the effects of primary dysmenorrhea on quality of life, McGill quality of life questionnaire will be used. This study will provide the information that which exercises i-e stretching or strengthening are more effective in reducing the intensity, frequency, duration and severity of pain in primary dysmenorrhea.

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
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 16, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 25, 2023

Completed
Last Updated

March 16, 2023

Status Verified

March 1, 2023

Enrollment Period

8 months

First QC Date

February 28, 2023

Last Update Submit

March 15, 2023

Conditions

Primary Dysmenorrhea

Outcome Measures

Primary Outcomes (4)

  • WaLIDD (working ability, Location, Intensity, Days of pain, Dysmenorrhea) score

    A scale type survey incorporating features of primary dysmenorrhea Score: 0 without dysmenorrhea, I-4 mild dysmenorrhea, 5-7 moderate dysmenorrhea, 8-12 severe dysmenorrhea.

    8 weeks

  • side bridge test

    side bridge test is use to check the strength of individuals

    8 weeks

  • McGill Quality of life

    A questionnaire used to check the effects of diseases on the quality of life

    8 weeks

  • PFSD (pain, frequency, severity, duration) scale

    A self reported pain questionnaire that captures the multidimensionality of pain A composite score was derived by multiplying the number of days of pain, the level of usual pain, and the level of worst pain and then dividing the product by 10.

    8 weeks

Study Arms (2)

Stretching Exercises

EXPERIMENTAL

6 stretching exercise for 8 weeks

Other: Stretching Exercises

Dynamic core stabilizing exercises

EXPERIMENTAL

6 strengthening exercises for 8 weeks

Other: Dynamic core stabilizing exercises

Interventions

Stretching ExercisesOTHER

6 stretching exercises 2 repetitions x1 set, 3 days/week and targeted muscles stretching (Lower Back, Lower limb)

Stretching Exercises
Dynamic core stabilizing exercisesOTHER

This group received core stabilizing exercises 2 repetitions x1 set, 3 days/week and the targeted muscles were abdominals, lower back, and lower limb.

Dynamic core stabilizing exercises

Eligibility Criteria

Age18 Years - 25 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Unmarried young girls of age 18-25.
  • Nulliparous women
  • Voluntarily wants to participate

You may not qualify if:

  • Female with History of any specific disease
  • Having symptoms such as tingling sensation
  • Any history of regular physical activity 3days/week \[daily average 30-45 minutes\] were ruled out of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Sialkot

Sialkot, Punjab Province, 51310, Pakistan

RECRUITING

Related Publications (7)

  • Iacovides S, Avidon I, Baker FC. What we know about primary dysmenorrhea today: a critical review. Hum Reprod Update. 2015 Nov-Dec;21(6):762-78. doi: 10.1093/humupd/dmv039. Epub 2015 Sep 7.

    PMID: 26346058BACKGROUND

  • Karout S, Soubra L, Rahme D, Karout L, Khojah HMJ, Itani R. Prevalence, risk factors, and management practices of primary dysmenorrhea among young females. BMC Womens Health. 2021 Nov 8;21(1):392. doi: 10.1186/s12905-021-01532-w.

    PMID: 34749716BACKGROUND

  • Bernardi M, Lazzeri L, Perelli F, Reis FM, Petraglia F. Dysmenorrhea and related disorders. F1000Res. 2017 Sep 5;6:1645. doi: 10.12688/f1000research.11682.1. eCollection 2017.

    PMID: 28944048BACKGROUND

  • De Sanctis V, Soliman A, Bernasconi S, Bianchin L, Bona G, Bozzola M, Buzi F, De Sanctis C, Tonini G, Rigon F, Perissinotto E. Primary Dysmenorrhea in Adolescents: Prevalence, Impact and Recent Knowledge. Pediatr Endocrinol Rev. 2015 Dec;13(2):512-20.

    PMID: 26841639BACKGROUND

  • Brawn J, Morotti M, Zondervan KT, Becker CM, Vincent K. Central changes associated with chronic pelvic pain and endometriosis. Hum Reprod Update. 2014 Sep-Oct;20(5):737-47. doi: 10.1093/humupd/dmu025. Epub 2014 Jun 11.

    PMID: 24920437BACKGROUND

  • Lindh I, Ellstrom AA, Milsom I. The effect of combined oral contraceptives and age on dysmenorrhoea: an epidemiological study. Hum Reprod. 2012 Mar;27(3):676-82. doi: 10.1093/humrep/der417. Epub 2012 Jan 17.

    PMID: 22252090BACKGROUND

  • Guimaraes I, Povoa AM. Primary Dysmenorrhea: Assessment and Treatment. Rev Bras Ginecol Obstet. 2020 Aug;42(8):501-507. doi: 10.1055/s-0040-1712131. Epub 2020 Jun 19.

    PMID: 32559803BACKGROUND

MeSH Terms

Interventions

Muscle Stretching Exercises

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Iqra Abdul Ghafoor, ppdpt

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Imran Amjad, Phd

CONTACT

03324390125imran.amjad@riphah.edu.pk

Study Design

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

Study Record Dates

First Submitted

February 28, 2023

First Posted

March 16, 2023

Study Start

September 1, 2022

Primary Completion

April 25, 2023

Study Completion

April 25, 2023

Last Updated

March 16, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)