NCT06210048

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 10, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 18, 2024

Completed
Last Updated

March 1, 2024

Status Verified

February 1, 2024

Enrollment Period

7 months

First QC Date

October 10, 2023

Last Update Submit

February 29, 2024

Conditions

Keywords

PainSacroiliac Joint DysfunctionSpinal Mobility

Outcome Measures

Primary Outcomes (10)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (1)

  • Spinal Mobility Test

    Baseline

Other Outcomes (3)

  • Menstruation Symptom Scale (MSS)

    Baseline

  • The Visual Analogue Scale (VAS)

    Baseline

  • Functional and Emotional Dysmenorrhoea (Painful Menstruation) Scale (FEDS)

    Baseline

Study Arms (3)

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

Eligibility Criteria

Age18 Years - 25 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsDismonere occurs only in women
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Only women with a regular menstrual cycle and primary dysmenorrhoea

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Health Sciences Bolu Abant İzzet Baysal University

Bolu, 14300, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ömer Osman PALA

    Bolu Abant İzzet Baysal University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 10, 2023

First Posted

January 18, 2024

Study Start

May 15, 2023

Primary Completion

November 30, 2023

Study Completion

December 30, 2023

Last Updated

March 1, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations