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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05185050
Other study ID # KAEK/2020.07.128
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 10, 2021
Est. completion date April 25, 2022

Study information

Verified date June 2022
Source Kanuni Sultan Suleyman Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Description:

This is an observational and cross-sectional prevalence study. Patients diagnosed with adolescent idiopathic scoliosis who applied to the Physical Medicine and Rehabilitation Clinic of Kanuni Sultan Süleyman Training and Research Hospital will be included in our study. These participants will be aged between 10-18 years. These patients 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. Diagnostic criteria of Myofascial Pain Syndrome; As the Major Criteria; 1. Regional pain complaint 2. Pain or sensory change reflected from trigger points to a specific area 3. Palpable taut band in accessible muscles 4. Extreme tenderness at one point along the taut band 5. Decreased range of motion that can be measured As for the Minor Criteria; 1. Complaint of clinical pain and/or sensory change on pressurized palpation of the trigger point 2. Local twitch response of the tender point on the taut band with palpation and needling 3. Reduction of pain by injection of the tender point or stretching of the muscle Five major and at least 1 minor criteria are required for the clinical diagnosis of myofascial pain syndrome. Patients with a previous history of surgery for scoliosis and neuromuscular scoliosis were excluded from the study.


Recruitment information / eligibility

Status Completed
Enrollment 168
Est. completion date April 25, 2022
Est. primary completion date January 10, 2022
Accepts healthy volunteers
Gender All
Age group 10 Years to 18 Years
Eligibility Inclusion Criteria: - aged between 10-18 years - diagnosed as adolescent idiopathic scoliosis - agreed to participate in the study Exclusion Criteria: - neuromuscular or any other type of scoliosis - any surgical treatment for scoliosis or spine.

Study Design


Intervention

Diagnostic Test:
physical examination and measurement of spinal alignment
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)

Locations

Country Name City State
Turkey Kanuni Sultan Süleyman Training and Research Hospital Istanbul Kucukcekmece

Sponsors (1)

Lead Sponsor Collaborator
Kanuni Sultan Suleyman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary The angle of lumbar lordosis Lumbar lordosis is the inward curve of the lumbar, or lower, spine in the lower back 1 day
Primary Sagittal vertical axis he C7 plumb line is a radiographic reference to determine the sagittal vertical axis 1 day
Primary 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
Primary 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
Primary 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
Primary VAS Visual analog scale (The grade of pain) 1day
Primary Myfascial pain syndrome Using by Myfascial pain syndrome diagnostic criteria 1 day
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