Dysmenorrhea PrimaryNCT06320145
Effect of Cryotherapy on Primary Dysmenorrhoea
A study testing Cryotherapy and core stability exercises in people with Dysmenorrhea Primary, run by Cairo University at 1 site in Egypt.
Trial summary
Dysmenorrhea is a menstrual disorder defined by the presence of painful cramps of uterine origin that occur during menstruation. It is one of the most common causes of pelvic pain and short-term absenteeism from school or work, among young and adult women. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women only
- Conditions the study is for
- Dysmenorrhea Primary
- What is being tested?
- Cryotherapy and core stability exercises
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 13 Mar 2023to 1 Oct 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 30 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- All females with moderate to severe primary dysmenorrhea (as determined by V.A.S and WaLIDD Scale).
- All females will be virginal and non-smokers.
- Their BMI will be range from 20-30 kg/m2.
- They have regular menstrual cycle with menstrual cycle length of 28-30 days.
- Exclusion Criteria: (patients will be excluded if they had):
- Any Pelvic pathology
Show all 12Show fewer
- Malignancy.
- Uncontrolled type l Diabetes.
- Epilepsy
- pacemaker
- cancer
- skin disease
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Dysmenorrhea is a menstrual disorder defined by the presence of painful cramps of uterine origin that occur during menstruation. It is one of the most common causes of pelvic pain and short-term absenteeism from school or work, among young and adult women.
Cryotherapy, therapeutic cooling, is one of the modalities widely used in sports medicine for a variety of treatment purposes. Physiological and neurological responses of musculoskeletal tissues to cooling have been extensively examined in the literature.
Read the detailed description
Dysmenorrhea is an existing mainstream gynecologic problem which habitually affects females of reproductive age.
Dysmenorrhea is of two types: Primary dysmenorrhea and secondary dysmenorrhea :.
primary dysmenorrhea is painful menstrual cramps without any evident pathology to account for them, and it occurs in up to 50% of menstruating females and causes significant disruption in quality of life and absenteeism.
The main cause of primary dysmenorrhea is prostaglandin production. This is naturally present substance that is made by uterine cells. It helps in contraction of the muscles, thus assisting in shedding of the uterine lining every month. When the production of prostaglandin is high, it leads to excessive pain and cramps. The prostaglandin is the main cause of other symptoms associated with primary dysmenorrhea, like nausea and vomiting.
Dysmenorrhea has a negative effect on a woman's life. It may be so severe as to confine the woman to bed during adolescence, dysmenorrhea leads to high rates of absence from school and non-participation in activities. Mild to moderate cases can usually be treated by reassurance and paracetamol
Cryotherapy, a physical therapy modality, is widespread in clinical rehabilitation practice for the management of the inflammatory phase of tissue repair. It can decrease tissue temperature and subsequently reduce inflammatory symptoms such as pain and swelling. Generally, the mechanisms underlying the reduction of inflammatory symptoms by cryotherapy are associated with a decrease in tissue temperature and reduction of vasopermiability, blood flow, nerve conduction velocity, and cell metabolism .
Core stability exercise has been known as a beneficial intervention in the management of several medical prob- lems. Core stability exercises strengthen and coordinate the muscles around the abdominal, lumbar, and pelvic regions Because it has been suggested that the core stability exercises mainly affect the lumbosacral muscles and increase blood supply in lumbosacral structures .
the purpose of core strengthening is to combine the concepts of lumber stabilization and how instability can lead to injury and pain specifically during stressful times of the female body and one of these repetitive stressful times is dysmenorrhea.
The lumber portion of spine is sturdy and designed to take the force of the body and it also involved in the origin and insertion of certain musculature and nerve innervations to their correlated areas. If at any time a certain part of the lumbar spine is weak, it is not as its optimal level to handle functional stress, which can result in pain throughout the abdomen, low back, or thighs. These areas just happen to be the same areas that are affected by females suffering from dysmenorrhea
Core strengthening allows the small intrinsic musculature surrounding the lumbar spine to be conditioned for greater performance, this type of training allows for isolation and strengthening of core muscle groups. When these muscles are strong, they are much more prepared to handle daily forces of normal biomechanics, even when the body is under the stress of the menstrual cycle , Core strengthening is a description of the muscular control around the lumbar spine to maintain functional stability.
- Conditions
- Dysmenorrhea Primary
- Being tested
- Cryotherapy, core stability exercises
- Keywords
- Cryotherapy, Primary dysmenorrhoea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryotherapyDevice
This device used at the first, second and third day of period to decrease pain for 20 min at first, second and third day
core stability exercisesOther
core stability exercises
| Study group | Role | What they receive |
|---|---|---|
| Group A (Cryotherapy Group) | Experimental | About 15 Women suffering from primary dysmenorrhoea who will receive cryotherapy sessions (3 days per week for 20 minutes), in addition to core stability exercise. Receives: Device: Cryotherapy; Other: core stability exercises |
| Group B (core stability Group) | Experimental | About 15 Women suffering from primary dysmenorrhoea who will receive core stability exercises only Receives: Other: core stability exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain assessed by VAS
Pain which is assessed by VAS scale ( which is from 0 to 10 the VAS as being 10 cm horizontal line with one end described as (no pain =0), and other end (the worst pain I ever felt = 10). Patients will be asked to mark a point on the line between the extremes that relates to their level of pain
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start13 Mar 2023
- Primary completion13 Sep 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dysmenorrhea PrimaryStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marslino Mohsen Beshrida, Cairo University
- Investigators
- SOHAIR ELKOSAIRY, Professor, Study chair, Chairman of Physical Therapy,Faculty of Physical Therapy,Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06320145
- Sponsor's protocol ID
- P.T.REC/012/004045
- Status last verified
- Mar 2024
- First submitted
- 13 Mar 2023
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cryotherapy on Primary Dysmenorrhoea
- ClinicalTrials.gov ID
- NCT06320145
- Acronym / sponsor ID
- P.T.REC/012/004045
- Conditions
- Dysmenorrhea Primary
- Keywords
- Cryotherapy, Primary dysmenorrhoea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 13 Mar 2023 (actual)
- Primary completion
- 13 Sep 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 20 Mar 2024 (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.
Dysmenorrhea is a menstrual disorder defined by the presence of painful cramps of uterine origin that occur during menstruation. It is one of the most common causes of pelvic pain and short-term absenteeism from school or work, among young and adult women.
Cryotherapy, therapeutic cooling, is one of the modalities widely used in sports medicine for a variety of treatment purposes. Physiological and neurological responses of musculoskeletal tissues to cooling have been extensively examined in the literature.
Detailed description
Dysmenorrhea is an existing mainstream gynecologic problem which habitually affects females of reproductive age.
Dysmenorrhea is of two types: Primary dysmenorrhea and secondary dysmenorrhea :.
primary dysmenorrhea is painful menstrual cramps without any evident pathology to account for them, and it occurs in up to 50% of menstruating females and causes significant disruption in quality of life and absenteeism.
The main cause of primary dysmenorrhea is prostaglandin production. This is naturally present substance that is made by uterine cells. It helps in contraction of the muscles, thus assisting in shedding of the uterine lining every month. When the production of prostaglandin is high, it leads to excessive pain and cramps. The prostaglandin is the main cause of other symptoms associated with primary dysmenorrhea, like nausea and vomiting.
Dysmenorrhea has a negative effect on a woman's life. It may be so severe as to confine the woman to bed during adolescence, dysmenorrhea leads to high rates of absence from school and non-participation in activities. Mild to moderate cases can usually be treated by reassurance and paracetamol
Cryotherapy, a physical therapy modality, is widespread in clinical rehabilitation practice for the management of the inflammatory phase of tissue repair. It can decrease tissue temperature and subsequently reduce inflammatory symptoms such as pain and swelling. Generally, the mechanisms underlying the reduction of inflammatory symptoms by cryotherapy are associated with a decrease in tissue temperature and reduction of vasopermiability, blood flow, nerve conduction velocity, and cell metabolism .
Core stability exercise has been known as a beneficial intervention in the management of several medical prob- lems. Core stability exercises strengthen and coordinate the muscles around the abdominal, lumbar, and pelvic regions Because it has been suggested that the core stability exercises mainly affect the lumbosacral muscles and increase blood supply in lumbosacral structures .
the purpose of core strengthening is to combine the concepts of lumber stabilization and how instability can lead to injury and pain specifically during stressful times of the female body and one of these repetitive stressful times is dysmenorrhea.
The lumber portion of spine is sturdy and designed to take the force of the body and it also involved in the origin and insertion of certain musculature and nerve innervations to their correlated areas. If at any time a certain part of the lumbar spine is weak, it is not as its optimal level to handle functional stress, which can result in pain throughout the abdomen, low back, or thighs. These areas just happen to be the same areas that are affected by females suffering from dysmenorrhea
Core strengthening allows the small intrinsic musculature surrounding the lumbar spine to be conditioned for greater performance, this type of training allows for isolation and strengthening of core muscle groups. When these muscles are strong, they are much more prepared to handle daily forces of normal biomechanics, even when the body is under the stress of the menstrual cycle , Core strengthening is a description of the muscular control around the lumbar spine to maintain functional stability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (Cryotherapy Group) | Experimental | Device: Cryotherapy, Other: core stability exercisesAbout 15 Women suffering from primary dysmenorrhoea who will receive cryotherapy sessions (3 days per week for 20 minutes), in addition to core stability exercise. |
| Group B (core stability Group) | Experimental | Other: core stability exercisesAbout 15 Women suffering from primary dysmenorrhoea who will receive core stability exercises only |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- All females with moderate to severe primary dysmenorrhea (as determined by V.A.S and WaLIDD Scale).
- All females will be virginal and non-smokers.
- Their BMI will be range from 20-30 kg/m2.
- They have regular menstrual cycle with menstrual cycle length of 28-30 days.
- Any Pelvic pathology
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| CryotherapyThis device used at the first, second and third day of period to decrease pain for 20 min at first, second and third day | Device | Group A (Cryotherapy Group) |
| core stability exercisescore stability exercises | Other | Group A (Cryotherapy Group), Group B (core stability Group) |
Primary outcome
Pain assessed by VAS
Time frame: 2 months
Pain which is assessed by VAS scale ( which is from 0 to 10 the VAS as being 10 cm horizontal line with one end described as (no pain =0), and other end (the worst pain I ever felt = 10). Patients will be asked to mark a point on the line between the extremes that relates to their level of pain
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
- 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.
SOHAIR ELKOSAIRY, Professor study chair
Chairman of Physical Therapy,Faculty of Physical Therapy,Cairo 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 Cryotherapy and core stability exercises in people with Dysmenorrhea Primary, run by Cairo University at 1 site in Egypt.
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 12 inclusion and 0 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: finished, as of the sponsor's last update on 20 Mar 2024. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain assessed by VAS (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Mar 2024.