Primary DysmenorrheaNCT05771753
Comparison of Core Stabilization and Dynamic Stretching Exercises in Primary Dysmenorrhea
A study testing Stretching Exercises and Dynamic core stabilizing exercises in people with Primary Dysmenorrhea, run by Riphah International University at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 25 years, women only
- Conditions the study is for
- Primary Dysmenorrhea
- What is being tested?
- Stretching Exercises and Dynamic core stabilizing exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Sep 2022to 25 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Unmarried young girls of age 18-25.
- Nulliparous women
- Voluntarily wants to participate
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
University of Sialkot
Sialkot, Punjab Province, 51310
Iqra Abdul Ghafoor, ppdpt, 03216414266, iqra.ghafoor@riphah.edu.pk
Sarah Sabir, Whpt
About this study
Official title: Comparison of Core Stabilization and Dynamic Stretching Exercises on Symptoms Severity and Quality of Life in Primary Dysmenorrhea
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.
Read the 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.
- Conditions
- Primary Dysmenorrhea
- Being tested
- Stretching Exercises, Dynamic core stabilizing exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stretching ExercisesOther
6 stretching exercises 2 repetitions x1 set, 3 days/week and targeted muscles stretching (Lower Back, Lower limb)
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.
| Study group | Role | What they receive |
|---|---|---|
| Stretching Exercises | Experimental | 6 stretching exercise for 8 weeks Receives: Other: Stretching Exercises |
| Dynamic core stabilizing exercises | Experimental | 6 strengthening exercises for 8 weeks Receives: Other: Dynamic core stabilizing exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
side bridge test
side bridge test is use to check the strength of individuals
Measured: 8 weeks
McGill Quality of life
A questionnaire used to check the effects of diseases on the quality of life
Measured: 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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2023
- Study start1 Sep 2022
- Primary completion25 Apr 2023 (estimated)
- Study completion25 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Primary DysmenorrheaStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Iqra Abdul Ghafoor, ppdpt, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05771753
- Sponsor's protocol ID
- REC/RCR&AHS/22/0548
- Status last verified
- Mar 2023
- First submitted
- 28 Feb 2023
- Last updated
- 16 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26346058Karout 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.
PubMed 34749716Bernardi 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.
PubMed 28944048De 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.
PubMed 26841639Brawn 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.
PubMed 24920437Lindh 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.
PubMed 22252090Guimaraes 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.
PubMed 32559803
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Core Stabilization and Dynamic Stretching Exercises on Symptoms Severity and Quality of Life in Primary Dysmenorrhea
- ClinicalTrials.gov ID
- NCT05771753
- Acronym / sponsor ID
- REC/RCR&AHS/22/0548
- Conditions
- Primary Dysmenorrhea
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 25 Apr 2023 (estimated)
- Study completion
- 25 Apr 2023 (estimated)
- First posted
- 16 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stretching Exercises | Experimental | Other: Stretching Exercises6 stretching exercise for 8 weeks |
| Dynamic core stabilizing exercises | Experimental | Other: Dynamic core stabilizing exercises6 strengthening exercises for 8 weeks |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Unmarried young girls of age 18-25.
- Nulliparous women
- Voluntarily wants to participate
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stretching Exercises6 stretching exercises 2 repetitions x1 set, 3 days/week and targeted muscles stretching (Lower Back, Lower limb) | Other | Stretching Exercises |
| Dynamic core stabilizing exercisesThis group received core stabilizing exercises 2 repetitions x1 set, 3 days/week and the targeted muscles were abdominals, lower back, and lower limb. | Other | Dynamic core stabilizing exercises |
Primary outcome
WaLIDD (working ability, Location, Intensity, Days of pain, Dysmenorrhea) score
Time frame: 8 weeks
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
Time frame: 8 weeks
side bridge test is use to check the strength of individuals
McGill Quality of life
Time frame: 8 weeks
A questionnaire used to check the effects of diseases on the quality of life
PFSD (pain, frequency, severity, duration) scale
Time frame: 8 weeks
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
- Background: PubMed 26346058Iacovides 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.
- Background: PubMed 34749716Karout 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.
- Background: PubMed 28944048Bernardi 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.
- Background: PubMed 26841639De 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.
- Background: PubMed 24920437Brawn 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.
- Background: PubMed 22252090Lindh 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.
- Background: PubMed 32559803Guimaraes 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Iqra Abdul Ghafoor, ppdpt principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stretching Exercises and Dynamic core stabilizing exercises in people with Primary Dysmenorrhea, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Imran Amjad, Phd (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WaLIDD (working ability, Location, Intensity, Days of pain, Dysmenorrhea) score (time frame: 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05771753, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2023.