- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05185050
Prevalence of Myofascial Pain Syndrome in Adolescent Idiopathic Scoliosis
Prevalence of Myofascial Pain Syndrome in Adolescent Idiopathic Scoliosis and the Relationship Between Myofascial Pain Syndrome and Spinal Coronal and Sagittal Alignment in Adolescent Idiopathic Scoliosis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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;
- Regional pain complaint
- 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;
- Complaint of clinical pain and/or sensory change on pressurized palpation of the trigger point
- 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Kucukcekmece
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Istanbul, Kucukcekmece, Turkey, 34303
- Kanuni Sultan Suleyman Training and Research Hospital
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
AIS with MPS
the participants who has Cobb angle above 10 degrees and diagnosed with myofascial pain syndrome
|
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 no pain
the participants who has Cobb angle above 10 degrees and without pain
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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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cobb angle
Time Frame: 1 day
|
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
Time Frame: 1 day
|
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
Time Frame: 1 day
|
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
Time Frame: 1 day
|
Lumbar lordosis is the inward curve of the lumbar, or lower, spine in the lower back
|
1 day
|
|
Sagittal vertical axis
Time Frame: 1 day
|
he C7 plumb line is a radiographic reference to determine the sagittal vertical axis
|
1 day
|
|
pelvic incidence
Time Frame: 1 day
|
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
Time Frame: 1 day
|
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
Time Frame: 1 day
|
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
Time Frame: 1day
|
Visual analog scale (The grade of pain)
|
1day
|
|
Myfascial pain syndrome
Time Frame: 1 day
|
Using by Myfascial pain syndrome diagnostic criteria
|
1 day
|
Collaborators and Investigators
Investigators
- Principal Investigator: Merve Damla Korkmaz, 1, Kanuni Sultan Suleyman Training and Research Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KAEK/2020.07.128
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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