Primary DysmenorrheaNCT06210048
Sacroiliac Joint Dysfunction and Spinal Mobility in Women With Primary Dysmenorrhoea
An observational study of Primary Dysmenorrhea, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
Evaluation of sacroiliac joint dysfunction in young women with primary dysmenorrhoea using joint provocation and mobility tests and spinal mobility using Spinal Mouse and investigation of the relationship between primary dysmenorrhoea, sacroiliac joint dysfunction and spinal mobility. Read more about this study
- Who is it for?
- Ages 18 to 25 years, women only
- Conditions the study is for
- Primary Dysmenorrhea
- How many people
- 63 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2023to 30 Dec 2023
- Phase
- Observational
- 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
Study population: Only women with a regular menstrual cycle and primary dysmenorrhoea
Who may be able to join
- Being a woman between the ages of 18-24
- Being single
- Have a regular menstrual cycle (every 24-32 days)
- Duration of menstruation between 3-7 days
- Severity of primary dysmenorrhoea according to VAS
Who cannot join
- Refusal to participate
- Diagnosis as a patient with secondary dysmenorrhoea
- Presence of chronic disease
- Regular medication
- Polycystic ovary syndrome
- Pelvic inflammatory diseases
- History of uterine, cervical or ovarian cancer
- Previous gynaecological interventions
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Faculty of Health Sciences Bolu Abant İzzet Baysal University
Bolu, 14300
About this study
Official title: Investigation of Sacroiliac Joint Dysfunction and Spinal Mobility in Women With Primary Dysmenorrhoea
Evaluation of sacroiliac joint dysfunction in young women with primary dysmenorrhoea using joint provocation and mobility tests and spinal mobility using Spinal Mouse and investigation of the relationship between primary dysmenorrhoea, sacroiliac joint dysfunction and spinal mobility.
Read the detailed description
Dysmenorrhoea is defined as pathological symptoms associated with menstruation, manifested by abdominal cramps and pain during menstruation and interfering with social life. The pain is of uterine origin and is one of the most common gynaecological disorders in women of childbearing age. It is divided into two types as primary dysmenorrhoea and secondary dysmenorrhoea.
Primary dysmenorrhoea is the most common form and is characterised by cramping pelvic pain that begins shortly before or at the onset of menstruation and lasts for one to three days. It usually begins during puberty and manifests itself with painful menstruation in women with normal pelvic anatomy.
Sacroiliac joint dysfunction is thought to be caused by different causes such as sacroiliac strain, sacroiliac instability and sacroiliac arthritis. One of the distinguishing features is local tenderness in the sacroiliac joint.
There are limited number of studies showing the relationship between sacroiliac joint dysfunction and menstrual cycle. Studies have shown that osteopathic manual therapy techniques applied to the pelvis are effective in alleviating the severity of primary dysmenorrhoea. At the same time, researchers have reported that mobilisation applied to the lumbopelvic regions is good for menstrual pain. Thus, it can be said that mobility is important in primary dysmenorrhoea.
- Conditions
- Primary Dysmenorrhea
- Keywords
- Pain, Sacroiliac Joint Dysfunction, Spinal Mobility
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Mild Primary Dysmenorrhoea | Consists of participants with mild dysmenorrhea according to VAS score | |
| Moderate Primary Dysmenorrhoea | Consists of participants with moderate dysmenorrhea according to VAS score | |
| Severe Primary Dysmenorrhoea | Consists of participants with severe dysmenorrhea according to VAS score |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standing Flexion Test
While the patient leans forward with his knees extended, the physiotherapist places his hands behind the patient, just under the spina iliaca posterior superior (SIPS). If one of the SIPS is superior to the other, the test is considered positive.
Measured: Baseline
Sitting Flexion Test
The physical therapist places his fingers just below the bases of the sacrum and just below the angulus inferior lateralis. If any of the SIPS goes more superior than the other, the test is considered positive.
Measured: Baseline
Springing Test
The patient lies in the prone position. While the physiotherapist applies pressure to the sacrum with the hypothenar region of one hand, he tries to detect the posterior sacrum with the other hand.
Measured: Baseline
Gillet Test
The patient is standing. The physiotherapist palpates the SIPS with the thumb of one hand and the sacrum with the other hand. The test is considered positive if there is no or limited postero-inferior movement of the SIPS when the patient flexes the hip-knee.
Measured: Baseline
Hyperextension Test
The patient is standing. The physiotherapist palpates the SIPS with the thumb of one hand and the sacrum with the other hand. The test is considered positive if there is no or limited antero-superior movement of the SIPS when the patient hyperextends the hip.
Measured: Baseline
Gaenslen Test
While the patient lies in the supine position, the physiotherapist passively hangs one of the patient's legs off the bed. In this way, maximum hip hyperextension is achieved. When the other leg is passively flexed, pain in the Sacroiliac Joint (SIJ) on the side hanging from the bed means that the test is positive.
Measured: Baseline
Sacroiliac Compression Test
The patient is positioned in a side-lying position with the knees flexed at 90 degrees and the hips at 45 degrees of flexion. The physiotherapist applies a compression force from the upper iliac crest to the lower iliac crest, and pain in the SIJ means that the test is positive.
Measured: Baseline
Sacroiliac Distraction Test
The patient is positioned supine. The physiotherapist creates distraction force by applying force from the SIPS in the posterior and lateral directions, with his hands crossed. Pain in SIJ means the test is positive.
Measured: Baseline
Posterior Friction Test
The patient is positioned supine. By flexing the hip to 90 degrees and adducting the femur, axial pressure is applied along the femur. Pain over the ilium means the test is positive
Measured: Baseline
Patrick FABER Test
While the patient is in a supine position, his heel is placed on the opposite knee. Thus, flexion, abduction and external rotation movements occur in the hip. The physiotherapist applies force through the opposite side SIPS. The test is considered positive if SIJ pain occurs.
Measured: Baseline
Secondary outcomes (1)
Spinal Mobility Test
Spinal mobility and inclination angle were evaluated using a Spinal Mouse. Spinal Mouse® is a radiation-free device that can measure the curvatures of the spine in the frontal and sagittal planes and transfer it to a computer program via Bluetooth. It can measure 4 different angles: thoracic angle, lumbar angle, inclination angle and sacrum-hip angle.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start15 May 2023
- Primary completion30 Nov 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary DysmenorrheaStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ömer Osman Pala, Abant Izzet Baysal University
- Investigators
- Ömer Osman PALA, Principal investigator, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06210048
- Sponsor's protocol ID
- AIBU-FTR-OOP-2
- Status last verified
- Feb 2024
- First submitted
- 10 Oct 2023
- Last updated
- 1 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Sacroiliac Joint Dysfunction and Spinal Mobility in Women With Primary Dysmenorrhoea
- ClinicalTrials.gov ID
- NCT06210048
- Acronym / sponsor ID
- AIBU-FTR-OOP-2
- Conditions
- Primary Dysmenorrhea
- Keywords
- Pain, Sacroiliac Joint Dysfunction, Spinal Mobility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 15 May 2023 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 18 Jan 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.
Evaluation of sacroiliac joint dysfunction in young women with primary dysmenorrhoea using joint provocation and mobility tests and spinal mobility using Spinal Mouse and investigation of the relationship between primary dysmenorrhoea, sacroiliac joint dysfunction and spinal mobility.
Detailed description
Dysmenorrhoea is defined as pathological symptoms associated with menstruation, manifested by abdominal cramps and pain during menstruation and interfering with social life. The pain is of uterine origin and is one of the most common gynaecological disorders in women of childbearing age. It is divided into two types as primary dysmenorrhoea and secondary dysmenorrhoea.
Primary dysmenorrhoea is the most common form and is characterised by cramping pelvic pain that begins shortly before or at the onset of menstruation and lasts for one to three days. It usually begins during puberty and manifests itself with painful menstruation in women with normal pelvic anatomy.
Sacroiliac joint dysfunction is thought to be caused by different causes such as sacroiliac strain, sacroiliac instability and sacroiliac arthritis. One of the distinguishing features is local tenderness in the sacroiliac joint.
There are limited number of studies showing the relationship between sacroiliac joint dysfunction and menstrual cycle. Studies have shown that osteopathic manual therapy techniques applied to the pelvis are effective in alleviating the severity of primary dysmenorrhoea. At the same time, researchers have reported that mobilisation applied to the lumbopelvic regions is good for menstrual pain. Thus, it can be said that mobility is important in primary dysmenorrhoea.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mild Primary Dysmenorrhoea | – | –Consists of participants with mild dysmenorrhea according to VAS score |
| Moderate Primary Dysmenorrhoea | – | –Consists of participants with moderate dysmenorrhea according to VAS score |
| Severe Primary Dysmenorrhoea | – | –Consists of participants with severe dysmenorrhea according to VAS score |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Only women with a regular menstrual cycle and primary dysmenorrhoea
Key inclusion criteria (5 listed)
- Being a woman between the ages of 18-24
- Being single
- Have a regular menstrual cycle (every 24-32 days)
- Duration of menstruation between 3-7 days
- Severity of primary dysmenorrhoea according to VAS
Key exclusion criteria (8 listed)
- Refusal to participate
- Diagnosis as a patient with secondary dysmenorrhoea
- Presence of chronic disease
- Regular medication
- Polycystic ovary syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Standing Flexion Test
Time frame: Baseline
While the patient leans forward with his knees extended, the physiotherapist places his hands behind the patient, just under the spina iliaca posterior superior (SIPS). If one of the SIPS is superior to the other, the test is considered positive.
Sitting Flexion Test
Time frame: Baseline
The physical therapist places his fingers just below the bases of the sacrum and just below the angulus inferior lateralis. If any of the SIPS goes more superior than the other, the test is considered positive.
Springing Test
Time frame: Baseline
The patient lies in the prone position. While the physiotherapist applies pressure to the sacrum with the hypothenar region of one hand, he tries to detect the posterior sacrum with the other hand.
Gillet Test
Time frame: Baseline
The patient is standing. The physiotherapist palpates the SIPS with the thumb of one hand and the sacrum with the other hand. The test is considered positive if there is no or limited postero-inferior movement of the SIPS when the patient flexes the hip-knee.
Hyperextension Test
Time frame: Baseline
The patient is standing. The physiotherapist palpates the SIPS with the thumb of one hand and the sacrum with the other hand. The test is considered positive if there is no or limited antero-superior movement of the SIPS when the patient hyperextends the hip.
Gaenslen Test
Time frame: Baseline
While the patient lies in the supine position, the physiotherapist passively hangs one of the patient's legs off the bed. In this way, maximum hip hyperextension is achieved. When the other leg is passively flexed, pain in the Sacroiliac Joint (SIJ) on the side hanging from the bed means that the test is positive.
Sacroiliac Compression Test
Time frame: Baseline
The patient is positioned in a side-lying position with the knees flexed at 90 degrees and the hips at 45 degrees of flexion. The physiotherapist applies a compression force from the upper iliac crest to the lower iliac crest, and pain in the SIJ means that the test is positive.
Sacroiliac Distraction Test
Time frame: Baseline
The patient is positioned supine. The physiotherapist creates distraction force by applying force from the SIPS in the posterior and lateral directions, with his hands crossed. Pain in SIJ means the test is positive.
Posterior Friction Test
Time frame: Baseline
The patient is positioned supine. By flexing the hip to 90 degrees and adducting the femur, axial pressure is applied along the femur. Pain over the ilium means the test is positive
Patrick FABER Test
Time frame: Baseline
While the patient is in a supine position, his heel is placed on the opposite knee. Thus, flexion, abduction and external rotation movements occur in the hip. The physiotherapist applies force through the opposite side SIPS. The test is considered positive if SIJ pain occurs.
1 secondary outcome
Spinal Mobility Test
Time frame: Baseline
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 1 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.
Ömer Osman PALA principal investigator
Abant Izzet Baysal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Dysmenorrhea, run by Abant Izzet Baysal University 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 5 inclusion and 8 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 1 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 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?
Standing Flexion Test (time frame: Baseline). The study lists 10 primary outcomes in all. 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 1 Mar 2024.