Scoliosis; AdolescenceNCT05185050
Prevalence of Myofascial Pain Syndrome in Adolescent Idiopathic Scoliosis
An observational study of Scoliosis; Adolescence and Myofascial Pain Syndrome, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Scoliosis; Adolescence, Myofascial Pain Syndrome, Trigger Point Pain, Myofascial
- What is being tested?
- physical examination and measurement of spinal alignment
- How many people
- 168 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Oct 2021to 25 Apr 2022
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- Child, Adult
Study population: Aged between 10-18 years with adolescent idiopathic scoliosis
Who may be able to join
- aged between 10-18 years
- diagnosed as adolescent idiopathic scoliosis
- agreed to participate in the study
Who cannot join
- neuromuscular or any other type of scoliosis
- any surgical treatment for scoliosis or spine.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kanuni Sultan Süleyman Training and Research Hospital
Istanbul, Kucukcekmece, 34303
About this study
Official title: 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
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.
Read the 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
- 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.
- Conditions
- Scoliosis; Adolescence, Myofascial Pain Syndrome, Trigger Point Pain, Myofascial, Physical Medicine and Rehabilitation
- Being tested
- physical examination and measurement of spinal alignment
- Keywords
- scoliosis, sagittal alignment, cobb angle, myofascial pain
- Medical subject headings
- Scoliosis, Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical examination and measurement of spinal alignmentDiagnostic test
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)
| Study group | Role | What they receive |
|---|---|---|
| AIS with MPS | the participants who has Cobb angle above 10 degrees and diagnosed with myofascial pain syndrome Receives: 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 Receives: Diagnostic Test: physical examination and measurement of spinal alignment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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°
Measured: 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
Measured: 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
Measured: 1 day
The angle of lumbar lordosis
Lumbar lordosis is the inward curve of the lumbar, or lower, spine in the lower back
Measured: 1 day
Sagittal vertical axis
he C7 plumb line is a radiographic reference to determine the sagittal vertical axis
Measured: 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.
Measured: 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
Measured: 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.
Measured: 1 day
VAS
Visual analog scale (The grade of pain)
Measured: 1day
Myfascial pain syndrome
Using by Myfascial pain syndrome diagnostic criteria
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start10 Oct 2021
- Primary completion10 Jan 2022
- Study completion25 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scoliosis; AdolescenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 168 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Damla Korkmaz, Kanuni Sultan Suleyman Training and Research Hospital
- Investigators
- Merve Damla Korkmaz, 1, Principal investigator, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05185050
- Sponsor's protocol ID
- KAEK/2020.07.128
- Status last verified
- Jun 2022
- First submitted
- 23 Dec 2021
- Last updated
- 27 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Results will be shared after publication.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05185050
- Acronym / sponsor ID
- KAEK/2020.07.128
- Conditions
- Scoliosis; Adolescence, Myofascial Pain Syndrome, Trigger Point Pain, Myofascial, Physical Medicine and Rehabilitation
- Keywords
- scoliosis, sagittal alignment, cobb angle, myofascial pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 10 Oct 2021 (actual)
- Primary completion
- 10 Jan 2022 (actual)
- Study completion
- 25 Apr 2022 (actual)
- First posted
- 11 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- 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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AIS with MPS | – | Diagnostic Test: physical examination and measurement of spinal alignmentthe participants who has Cobb angle above 10 degrees and diagnosed with myofascial pain syndrome |
| AIS with no pain | – | Diagnostic Test: physical examination and measurement of spinal alignmentthe participants who has Cobb angle above 10 degrees and without pain |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Aged between 10-18 years with adolescent idiopathic scoliosis
Key inclusion criteria (3 listed)
- aged between 10-18 years
- diagnosed as adolescent idiopathic scoliosis
- agreed to participate in the study
Key exclusion criteria (2 listed)
- neuromuscular or any other type of scoliosis
- any surgical treatment for scoliosis or spine.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| physical examination and measurement of spinal alignmentphysical 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) | Diagnostic test | AIS with MPS, AIS with no pain |
Primary outcome
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°
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
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
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
Sagittal vertical axis
Time frame: 1 day
he C7 plumb line is a radiographic reference to determine the sagittal vertical axis
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.
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
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.
VAS
Time frame: 1day
Visual analog scale (The grade of pain)
Myfascial pain syndrome
Time frame: 1 day
Using by Myfascial pain syndrome diagnostic criteria
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2022.
- Individual participant dataSharing planned: Yes. Study Results will be shared after publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Merve Damla Korkmaz, 1 principal investigator
Kanuni Sultan Suleyman Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Scoliosis; Adolescence and Myofascial Pain Syndrome, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cobb angle (time frame: 1 day). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2022.