NCT05185050

Brief Summary

this is an observational and cross-sectional prevalence study. 10-18 years aged participants with adolescent idiopathic scoliosis were recruited in the study. Myofascial pain syndrome will be questioned to the participants. additionally, all participants will be evaluated using their findings for scoliosis and myofascial pain syndrome diagnostic criteria. Cobb angle, coronal balance, shoulder and pelvis asymmetry, sagittal spino-pelvic parameters of the spine (cervical lordosis, thoracic kyphosis, lumbar lordosis angles and sagittal vertical axis, sacral slop angle and pelvic incidence) will be measured.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
168

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2021

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

October 10, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 23, 2021

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 11, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 25, 2022

Completed
Last Updated

June 27, 2022

Status Verified

June 1, 2022

Enrollment Period

3 months

First QC Date

December 23, 2021

Last Update Submit

June 22, 2022

Conditions

Keywords

scoliosissagittal alignmentcobb anglemyofascial pain

Outcome Measures

Primary Outcomes (10)

  • Cobb angle

    The Cobb angle is the most widely used measurement to quantify the magnitude of spinal deformities, especially in the case of scoliosis, on plain radiographs. Scoliosis is defined as a lateral spinal curvature with a Cobb angle of \>10°

    1 day

  • The angle of cervical lordosis

    Cervical Lordosis refers to the natural curve of the spine in the neck, known as the cervical spine

    1 day

  • The angle of thoracic kyphosis

    thoracic Kyphosis is an abnormally excessive convex curvature of the spine as it occurs in the thoracic regions

    1 day

  • The angle of lumbar lordosis

    Lumbar lordosis is the inward curve of the lumbar, or lower, spine in the lower back

    1 day

  • Sagittal vertical axis

    he C7 plumb line is a radiographic reference to determine the sagittal vertical axis

    1 day

  • pelvic incidence

    Pelvic incidence is defined as the angle between a line perpendicular to the sacral plate at its midpoint and a line connecting this point to the femoral head axis.

    1 day

  • sacral slope

    Sacral slope isdefined as the angle between a sacral plate and the horizontal line. A vertical sacrum is described by a low sacral slope value and a horizontal sacrum by a high value sacral slope

    1 day

  • pelvic tilt

    Pelvic tilt is defined by a line through midpoint of the sacral plate and midpoint of the femoral head axes and the vertical line through the midpoint of the femoral head axis.

    1 day

  • VAS

    Visual analog scale (The grade of pain)

    1day

  • Myfascial pain syndrome

    Using by Myfascial pain syndrome diagnostic criteria

    1 day

Study Arms (2)

AIS with MPS

the participants who has Cobb angle above 10 degrees and diagnosed with myofascial pain syndrome

Diagnostic Test: physical examination and measurement of spinal alignment

AIS with no pain

the participants who has Cobb angle above 10 degrees and without pain

Diagnostic Test: physical examination and measurement of spinal alignment

Interventions

physical examination for scoliosis and myofascial pain syndrome, measurement of spinal coronal and sagittal alignment in X-ray, and pain intensity (with Visual analog scale) if necessary (for MPS group)

AIS with MPSAIS with no pain

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Aged between 10-18 years with adolescent idiopathic scoliosis

You may qualify if:

  • aged between 10-18 years
  • diagnosed as adolescent idiopathic scoliosis
  • agreed to participate in the study

You may not qualify if:

  • neuromuscular or any other type of scoliosis
  • any surgical treatment for scoliosis or spine.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kanuni Sultan Süleyman Training and Research Hospital

Istanbul, Kucukcekmece, 34303, Turkey (Türkiye)

Location

MeSH Terms

Conditions

ScoliosisMyofascial Pain Syndromes

Interventions

Physical Examination

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal DiseasesMuscular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Merve Damla Korkmaz, 1

    Kanuni Sultan Suleyman Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist Doctor

Study Record Dates

First Submitted

December 23, 2021

First Posted

January 11, 2022

Study Start

October 10, 2021

Primary Completion

January 10, 2022

Study Completion

April 25, 2022

Last Updated

June 27, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will share

Study Results will be shared after publication.

Time Frame
1 day

Locations