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CompletedNCT06210048Updated Mar 1, 2024

Sacroiliac Joint Dysfunction and Spinal Mobility in Women With Primary Dysmenorrhoea

An observational study in Primary Dysmenorrhea, sponsored by Abant Izzet Baysal University. Completed at 1 site in Turkey. Open to female participants aged 18 Years to 25 Years. Per ClinicalTrials.gov, last updated 2024-03-01.

Sponsored by Abant Izzet Baysal University · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
63
Ages
18 Years to 25 Years
Sex
Female
01

Study 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 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.

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Conditions studied

  • Primary Dysmenorrhea

Keywords

  • Pain
  • Sacroiliac Joint Dysfunction
  • Spinal Mobility
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In context

Joint Diseases

712 studies on the registry are indexed under Joint Diseases; 127 are open to participants now.

This study's enrollment of 63 is below the median of 100 across 216 observational studies indexed under Joint Diseases.

Browse Joint Diseases studies →

Lead sponsor

Abant Izzet Baysal University is the lead sponsor of 242 studies on the registry; 64 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 25 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Only women with a regular menstrual cycle and primary dysmenorrhoea

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

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
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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
63 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline

  2. 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.

    Time frame: Baseline

  3. 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.

    Time frame: Baseline

  4. 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.

    Time frame: Baseline

  5. 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.

    Time frame: Baseline

  6. 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.

    Time frame: Baseline

  7. 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.

    Time frame: Baseline

  8. 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.

    Time frame: Baseline

  9. 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

    Time frame: Baseline

  10. 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.

    Time frame: 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.

    Time frame: Baseline

Other outcomes

  1. 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.

    Time frame: Baseline

  2. 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

    Time frame: Baseline

  3. 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.

    Time frame: Baseline

07

Study locations

1 site
  • Faculty of Health Sciences Bolu Abant İzzet Baysal University
    Bolu, 14300, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 1, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06210048
Lead sponsor
Abant Izzet Baysal University
Responsible party
Ömer Osman Pala (Assistant Professor, Abant Izzet Baysal University) — Principal investigator
First posted
Jan 18, 2024
Start date
May 15, 2023
Primary completion
Nov 30, 2023
Completion
Dec 30, 2023
Last update
Mar 1, 2024

Study contacts

Ömer Osman PALA
principal investigator · Bolu Abant İzzet Baysal University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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