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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06210048
Other study ID # AIBU-FTR-OOP-2
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 15, 2023
Est. completion date December 30, 2023

Study information

Verified date February 2024
Source Abant Izzet Baysal University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 63
Est. completion date December 30, 2023
Est. primary completion date November 30, 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 25 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Faculty of Health Sciences Bolu Abant Izzet Baysal University Bolu

Sponsors (1)

Lead Sponsor Collaborator
Abant Izzet Baysal University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Other Menstruation Symptom Scale (MSS) It is a five-point Likert-type scale consisting of 24 items. Participants are asked to assign a number between 1 (never) and 5 (always) to the symptoms they experience related to menstruation. The MSS score is calculated by averaging the total score of the items in the scale. An increase in the mean score indicates an increase in the severity of menstrual symptoms. Baseline
Other The Visual Analogue Scale (VAS) The Visual Analogue Scale (VAS) is the most common scale used to assess pain intensity on a horizontal/vertical bar of 10 or 100 mm. The starting point indicates the absence of pain, while the end point indicates that the pain is too much to bear Baseline
Other Functional and Emotional Dysmenorrhoea (Painful Menstruation) Scale (FEDS) It is a 5-point Likert-type scale consisting of 14 items. An increase in the mean score indicates an increase in the functional and emotional severity of dysmenorrhoea.The minimum and maximum scores to be obtained from the overall scale are 14 and 70 respectively. As the score increases, the participant's degree of being affected by menstruation increases as well. Baseline
Primary 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. Baseline
Primary 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. Baseline
Primary 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. Baseline
Primary 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. Baseline
Primary 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. Baseline
Primary 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. Baseline
Primary 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. Baseline
Primary 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. Baseline
Primary 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 Baseline
Primary 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. Baseline
Secondary Spinal Mobility Test Spinal mobility and inclination angle were evaluated using a Spinal Mouse. Spinal MouseĀ® 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. Baseline
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