Woman; Primary DysmenorrhoeaNCT04254510
The Effect of Myofascial Release Technique on the Treatment of Primary Dysmenorrhea in Psoas Muscle
A study testing Myofascial relaxation technique in people with Woman; Primary Dysmenorrhoea, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
Dysmenorrhea is a series of pathological symptoms associated with menstruation that interfere with daily activities such as abdominal cramps and pain in the menstrual period. General symptoms such as nausea, vomiting, lumbago, diarrhea and headache are also common. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Woman; Primary Dysmenorrhoea
- What is being tested?
- Myofascial relaxation technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Feb 2020to 20 Apr 2020
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- The age range is 18-30,
- Intense pain compared to visual analog scale in the lower region of the abdomen during or just before the menstruation period (> 4),
- No pregnancy history,
- Not using drugs for dysmenorrhea symptoms
Who cannot join
- Not agreeing to participate in the study,
- Endometriosis, ovarian cyst, uterine fibroid, congenital malformation or pelvic inflammation,
- Having a diagnosis of secondary dysmenorrhea
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Myofascial Relaxation Technique on the Treatment of Primary Dysmenorrhea in Psoas Muscle
Dysmenorrhea is a series of pathological symptoms associated with menstruation that interfere with daily activities such as abdominal cramps and pain in the menstrual period. General symptoms such as nausea, vomiting, lumbago, diarrhea and headache are also common. Primary dysmenorrhea refers to menstrual pain that does not depend on the underlying pathology. The kidneys act on the fascia of the psoas muscle. If the psoas muscle does not shorten and grow sufficiently, the kidneys may not move for a certain period of time and may experience ptosis. This causes venous ponding and may cause varicocele in men and primary dysmenorrhea in women. Techniques to be applied directly to the fascia of the psoas muscle can reduce symptoms of dysmenorrhea in women. In the literature review, no studies investigating the effectiveness of a treatment applied directly and only on the psoas muscle on primary dysmenorrhea were not found. This study can set an example for future studies. In our study, myofascial relaxation technique will be applied in women with primary dysmenorrhoea and its effect on pain will be examined.
- Conditions
- Woman; Primary Dysmenorrhoea
- Being tested
- Myofascial relaxation technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myofascial relaxation techniqueOther
- Before the intervention, the number of days of the last menstrual cycle of all participants, the number of painful days throughout the cycle, pain intensity values according to the Visual Analogue Scale will be recorded, and the scores will be recorded in the participants.
- Technique of direct relaxation of fascia of both psoas muscles to the participants in the myofascial relaxation group since the end of the last cycle, 90-120 sec. It will be applied by the physiotherapist twice a week.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Myofascial relaxation technique Receives: Other: Myofascial relaxation technique |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog scale
Pain intensity will be questioned by scale.For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) . To avoid clustering of scores around a preferred numeric value, numbers or verbal descriptors at intermediate points are not recommended
Measured: 5 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start10 Feb 2020
- Primary completion3 Apr 2020
- Study completion20 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Woman; Primary DysmenorrhoeaStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, esra pehlivan, Istanbul Medipol University Hospital
- Investigators
- Tülay Ülkü Sevim, Study chair, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04254510
- Sponsor's protocol ID
- MRT_Dysmenorrhea
- Status last verified
- Feb 2020
- First submitted
- 3 Feb 2020
- Last updated
- 21 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Myofascial Relaxation Technique on the Treatment of Primary Dysmenorrhea in Psoas Muscle
- ClinicalTrials.gov ID
- NCT04254510
- Acronym / sponsor ID
- MRT_Dysmenorrhea
- Conditions
- Woman; Primary Dysmenorrhoea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 10 Feb 2020 (actual)
- Primary completion
- 3 Apr 2020 (actual)
- Study completion
- 20 Apr 2020 (actual)
- First posted
- 5 Feb 2020 (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 series of pathological symptoms associated with menstruation that interfere with daily activities such as abdominal cramps and pain in the menstrual period. General symptoms such as nausea, vomiting, lumbago, diarrhea and headache are also common. Primary dysmenorrhea refers to menstrual pain that does not depend on the underlying pathology. The kidneys act on the fascia of the psoas muscle. If the psoas muscle does not shorten and grow sufficiently, the kidneys may not move for a certain period of time and may experience ptosis. This causes venous ponding and may cause varicocele in men and primary dysmenorrhea in women. Techniques to be applied directly to the fascia of the psoas muscle can reduce symptoms of dysmenorrhea in women. In the literature review, no studies investigating the effectiveness of a treatment applied directly and only on the psoas muscle on primary dysmenorrhea were not found. This study can set an example for future studies. In our study, myofascial relaxation technique will be applied in women with primary dysmenorrhoea and its effect on pain will be examined.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Other: Myofascial relaxation techniqueMyofascial relaxation technique |
| Control group | No intervention | – |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- The age range is 18-30,
- Intense pain compared to visual analog scale in the lower region of the abdomen during or just before the menstruation period (> 4),
- No pregnancy history,
- Not using drugs for dysmenorrhea symptoms
Key exclusion criteria (3 listed)
- Not agreeing to participate in the study,
- Endometriosis, ovarian cyst, uterine fibroid, congenital malformation or pelvic inflammation,
- Having a diagnosis of secondary dysmenorrhea
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 |
|---|---|---|
| Myofascial relaxation technique* Before the intervention, the number of days of the last menstrual cycle of all participants, the number of painful days throughout the cycle, pain intensity values according to the Visual Analogue Scale will be recorded, and the scores will be recorded in the participants. * Technique of direct relaxation of fascia of both psoas muscles to the participants in the myofascial relaxation group since the end of the last cycle, 90-120 sec. It will be applied by the physiotherapist twice a week. | Other | Study Group |
Primary outcome
Visual analog scale
Time frame: 5 seconds
Pain intensity will be questioned by scale.For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) . To avoid clustering of scores around a preferred numeric value, numbers or verbal descriptors at intermediate points are not recommended
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 21 Apr 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Woman; Primary Dysmenorrhoea
Not yet recruiting
Transcutaneous Cervical Vagus Nerve Stimulation for Primary Dysmenorrhea
Primary Dysmenorrhea (PD), Menstrual Pain
Not yet recruiting
The Effect of Hydrogen-Rich Water on Dysmenorrhea and Menstrual Symptom Severity
Dysmenorrhea Primary
Not yet recruiting
Effect of Virtual Reality on Pain and Anxiety in Women With Dysmenorrhea
Primary Dysmenorrhea, Menstrual Pain
Not yet recruiting
Whole-Body Vibration and Aerobic Exercise for Primary Dysmenorrhea in Young Adult Women
Primary Dysmenorrhea
Not yet recruitingObservational study
Heavy Menstrual Bleeding and Dysmenorrhea Among Undergraduate Females in the Faculty of Medicine of Assiut University
Dysmenorrhea, Heavy Menstrual Bleeding
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.
Tülay Ülkü Sevim study chair
Saglik Bilimleri Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Myofascial relaxation technique in people with Woman; Primary Dysmenorrhoea, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
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 4 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: finished, as of the sponsor's last update on 21 Apr 2020. 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 Turkey (Türkiye). 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?
Visual analog scale (time frame: 5 seconds). 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 21 Apr 2020.