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Comparison of Core Stabilization and Dynamic Stretching Exercises in Primary Dysmenorrhea

Primary Purpose

Primary Dysmenorrhea

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Stretching Exercises
Dynamic core stabilizing exercises
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Dysmenorrhea

Eligibility Criteria

18 Years - 25 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Unmarried young girls of age 18-25. Nulliparous women Voluntarily wants to participate Exclusion Criteria: 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.

Sites / Locations

  • University of SialkotRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Stretching Exercises

Dynamic core stabilizing exercises

Arm Description

6 stretching exercise for 8 weeks

6 strengthening exercises for 8 weeks

Outcomes

Primary Outcome Measures

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.
side bridge test
side bridge test is use to check the strength of individuals
McGill Quality of life
A questionnaire used to check the effects of diseases on the quality of life
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.

Secondary Outcome Measures

Full Information

First Posted
February 28, 2023
Last Updated
March 15, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05771753
Brief Title
Comparison of Core Stabilization and Dynamic Stretching Exercises in Primary Dysmenorrhea
Official Title
Comparison of Core Stabilization and Dynamic Stretching Exercises on Symptoms Severity and Quality of Life in Primary Dysmenorrhea
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
April 25, 2023 (Anticipated)
Study Completion Date
April 25, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Primary dysmenorrhea is a Greek term which means difficult flow and the term describe painful periods. The pain is usually felt in the lower abdomen but sometimes it may radiate in thighs and to the back. Primary dysmenorrhea is the most common type of gynecological disorder among females worldwide. Some females may feel some associated symptoms like nausea, vomiting diarrhea, headache, dizziness and in severe conditions syncope. All of these symptoms occur usually in females with normal pelvic anatomy and symptoms occur just before menses. Primary dysmenorrhea occurs 6-12 months after the onset of ovulation cycle. Primary dysmenorrhea can be distinguished from secondary dysmenorrhea on the basis of symptoms and other pelvic or reproductive organ disorders. Endometriosis is the most common cause of secondary dysmenorrhea, in secondary dysmenorrhea pain starts few days before the onset of menstrual cycles and may last longer than the cycle. The chances of secondary dysmenorrhea are more prevalent in females above the age of 20. A complete pelvic examination should be performed in females who are sexually active and have dysmenorrhea and those who are suspected to have endometriosis. In general population the prevalence of Primary dysmenorrhea is about 47-80%. Seventy five to eighty five percent of female have said to report that the symptoms of primary dysmenorrhea are mild. Primary dysmenorrhea is not life threatening and does not cause any disabilities but some researches have said that most young girls are reported to be absent from school/college and not being able to perform any activity due to the severity of pain. Some evidence shows the link between dysmenorrhea and prostaglandin, the level of prostaglandin is said to be increased and leads to uterine contraction and ischemia. The release of prostaglandin leads to excessive uterine contraction and the constriction of small endometrial blood vessels leads to ischemia and thus pain. The level of prostaglandin is said to be increased during premenstrual phase in which progesterone level decreases and the level of prostaglandin increases in endometrial cells by the action of membrane phospholipids. The action of prostaglandin synthesis inhibitors plays an important role in pain relief. Another interesting factor shows the link between physical activity and dysmenorrhea. Females who perform physical activities like exercise for the purpose of developing or maintaining fitness have reported to be going through less pain and behavioral changes. Physical activities and exercises are believed to have reduced the level of stress and stress related symptoms. When we do exercise endorphins hormones are released from brain which increases the pain threshold and have said to improve the mood of the person performing exercise. It has also been observed that performing isometric exercises for 8 weeks has reduced the intensity and duration of pain but has no effects on the amount of bleeding. Performing stretching exercises for 8 weeks has also reduced the severity and length of pain in young girls and they have reported to be taking less medicine. The purpose of this research is to 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Dysmenorrhea

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stretching Exercises
Arm Type
Experimental
Arm Description
6 stretching exercise for 8 weeks
Arm Title
Dynamic core stabilizing exercises
Arm Type
Experimental
Arm Description
6 strengthening exercises for 8 weeks
Intervention Type
Other
Intervention Name(s)
Stretching Exercises
Intervention Description
6 stretching exercises 2 repetitions x1 set, 3 days/week and targeted muscles stretching (Lower Back, Lower limb)
Intervention Type
Other
Intervention Name(s)
Dynamic core stabilizing exercises
Intervention Description
This group received core stabilizing exercises 2 repetitions x1 set, 3 days/week and the targeted muscles were abdominals, lower back, and lower limb.
Primary Outcome Measure Information:
Title
WaLIDD (working ability, Location, Intensity, Days of pain, Dysmenorrhea) score
Description
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.
Time Frame
8 weeks
Title
side bridge test
Description
side bridge test is use to check the strength of individuals
Time Frame
8 weeks
Title
McGill Quality of life
Description
A questionnaire used to check the effects of diseases on the quality of life
Time Frame
8 weeks
Title
PFSD (pain, frequency, severity, duration) scale
Description
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.
Time Frame
8 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Unmarried young girls of age 18-25. Nulliparous women Voluntarily wants to participate Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Imran Amjad, Phd
Phone
03324390125
Email
imran.amjad@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iqra Abdul Ghafoor, ppdpt
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Sialkot
City
Sialkot
State/Province
Punjab
ZIP/Postal Code
51310
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Iqra Abdul Ghafoor, ppdpt
Phone
03216414266
Email
iqra.ghafoor@riphah.edu.pk
First Name & Middle Initial & Last Name & Degree
Sarah Sabir, Whpt
First Name & Middle Initial & Last Name & Degree
Iqra Abdul Ghafoor, ppdpt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26346058
Citation
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.
Results Reference
background
PubMed Identifier
34749716
Citation
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.
Results Reference
background
PubMed Identifier
28944048
Citation
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.
Results Reference
background
PubMed Identifier
26841639
Citation
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.
Results Reference
background
PubMed Identifier
24920437
Citation
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.
Results Reference
background
PubMed Identifier
22252090
Citation
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.
Results Reference
background
PubMed Identifier
32559803
Citation
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.
Results Reference
background

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Comparison of Core Stabilization and Dynamic Stretching Exercises in Primary Dysmenorrhea

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