Idiopathic ScoliosisNCT06055140
Evaluation of Thoracolumbar Fascia and Relationship With Low Back Pain in Individuals With Idiopathic Scoliosis
An observational study of Idiopathic Scoliosis and Pain, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
This observational study seeks to explore the potential association between thoracolumbar fascia characteristics and low back pain in individuals diagnosed with idiopathic scoliosis. Read more about this study
- Who is it for?
- Ages 10 years and olderHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Scoliosis, Pain
- How many people
- 57 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2023to Jan 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study population will be selected using snowball sampling from individuals diagnosed with idiopathic scoliosis and aged 10 years or older, who meet the inclusion criteria. Snowball sampling involves initially recruiting participants who meet the inclusion criteria and then asking them to refer other potential participants from their social network who also have idiopathic scoliosis. Exclusion criteria will involve individuals with neurological, psychological, congenital, or rheumatological conditions, those with a history of surgery or trauma involving the lower extremities or spinal region within the last 1 year, and individuals who have received any previous treatment related to scoliosis.
Who may be able to join
- Being 10 years of age or older
- Having a diagnosis of idiopathic scoliosis
- Having a Cobb angle measurement above 15 degrees
- Being 10 years of age or older
- Have no pathological spinal curvature.
- Have no history of low back pain in the last 3 months (Visual Analog Scale score <3/10).
Who cannot join
- Having any neurological, psychological, congenital, or rheumatological condition
- Having a history of surgery or trauma involving the lower extremities or spinal region within the last 1 year
- Having received any previous treatment related to scoliosis
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University, Institute of Health Sciences, Faculty of Physical Therapy and Rehabilitation
Ankara, Altındağ, 06100
About this study
This observational study seeks to explore the potential association between thoracolumbar fascia characteristics and low back pain in individuals diagnosed with idiopathic scoliosis.
Read the detailed description
This observational study aims to investigate the potential link between thoracolumbar fascia characteristics and low back pain in individuals with idiopathic scoliosis. The hypothesis underlying this study posits that alterations in thoracolumbar fascia thickness and properties contribute to changes in trunk flexibility and subsequently influence the occurrence and intensity of low back pain in patients with idiopathic scoliosis. The researchers believe that an increase in thoracolumbar fascia thickness may lead to reduced trunk flexibility, restricting the normal range of motion and potentially causing or exacerbating low back pain.
To explore this hypothesis, the study will include participants diagnosed with idiopathic scoliosis. The researchers will measure thoracolumbar fascia thickness using ultrasound and assess trunk flexibility through various range of motion tests, including trunk flexion, extension, and lateral flexion using a goniometer, as well as the sit-and-reach test. To quantify the severity of the spinal curvature, the Cobb angle will be measured on anteroposterior standing radiographs.
Participants will also be asked to report their pain levels using the Visual Analog Scale, a simple tool where individuals rate their pain on a scale from 0 to 10. By analyzing the collected data, the researchers aim to establish potential correlations between thoracolumbar fascia thickness, trunk flexibility, and low back pain in individuals with idiopathic scoliosis.
- Conditions
- Idiopathic Scoliosis, Pain
- Keywords
- fascia, scoliosis, pain
- Medical subject headings
- Pain, Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Idiopathic scoliosis without pain | In this group, there will be individuals diagnosed with idiopathic scoliosis whose Cobb angle is above 15 degrees and whose pain level, as assessed by the Visual Analog Scale, is below 3. | |
| Idiopathic scoliosis with pain | In this group, there will be individuals diagnosed with idiopathic scoliosis whose Cobb angle is above 15 degrees, and their pain level, as assessed by the Visual Analog Scale, is above 3. | |
| Control | In this group, there will be healthy individuals whose pain level, as assessed by the Visual Analog Scale, is below 3. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thoracolumbar Fascia Thickness
The thoracolumbar fascia thickness (mm) obtained after ultrasonographic assessment.
Measured: Baseline
Secondary outcomes (6)
Visual analog scale
The pain levels of individuals obtained after the Visual Analog Scale assessment.Patients will be asked to mark their perceived pain levels on a 100-millimeter horizontal line.
Measured: Baseline
Trunk Normal Range of Motion
The degrees of trunk flexion, extension, right lateral flexion, and left lateral flexion obtained after goniometric measurements.
Measured: Baseline
Trunk Flexibility
The sit-and-reach test and trunk rotation values will be recorded in centimeters.
Measured: Baseline
McGill Short Form Pain Questionnaire
A questionnaire providing numerical outputs about the sensory qualities, affective qualities, and intensity of pain.
Measured: Baseline
Oswestry Low Back Pain Disability Questionnaire
A questionnaire scored from 0 to 50, assessing the impact of low back pain on daily life activities.
Measured: Baseline
Scoliosis Research Society-30 (SRS-30)
This questionnaire consists of 30 questions and is used to evaluate the health-related quality of life in individuals with scoliosis.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2023
- Study start1 Oct 2023 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Idiopathic ScoliosisStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 57 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gözde Yagci (Gür), Hacettepe University
- Investigators
- Sibel Yerli, MSc, PT, Principal investigator, Hacettepe UniversitySatuk Bugrahan Yinanc, MSc, PT, Principal investigator, Hacettepe UniversityGözde Yağcı, PhD, PT, Study director, Hacettepe UniversityFatih Erbahçeci, PhD, PT, Study director, Hacettepe UniversityLevent Özçakar, Phd, MD, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06055140
- Sponsor's protocol ID
- GO 23/516
- Status last verified
- Sep 2023
- First submitted
- 20 Sep 2023
- Last updated
- 26 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Choudhry MN, Ahmad Z, Verma R. Adolescent Idiopathic Scoliosis. Open Orthop J. 2016 May 30;10:143-54. doi: 10.2174/1874325001610010143. eCollection 2016.
PubMed 27347243Pirri C, Pirri N, Guidolin D, Macchi V, Porzionato A, De Caro R, Stecco C. Ultrasound Imaging of Thoracolumbar Fascia Thickness: Chronic Non-Specific Lower Back Pain versus Healthy Subjects; A Sign of a "Frozen Back"? Diagnostics (Basel). 2023 Apr 16;13(8):1436. doi: 10.3390/diagnostics13081436.
PubMed 37189537
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Thoracolumbar Fascia and Relationship With Low Back Pain in Individuals With Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT06055140
- Acronym / sponsor ID
- GO 23/516
- Conditions
- Idiopathic Scoliosis, Pain
- Keywords
- fascia, scoliosis, pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 57 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 26 Sep 2023 (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 observational study seeks to explore the potential association between thoracolumbar fascia characteristics and low back pain in individuals diagnosed with idiopathic scoliosis.
Detailed description
This observational study aims to investigate the potential link between thoracolumbar fascia characteristics and low back pain in individuals with idiopathic scoliosis. The hypothesis underlying this study posits that alterations in thoracolumbar fascia thickness and properties contribute to changes in trunk flexibility and subsequently influence the occurrence and intensity of low back pain in patients with idiopathic scoliosis. The researchers believe that an increase in thoracolumbar fascia thickness may lead to reduced trunk flexibility, restricting the normal range of motion and potentially causing or exacerbating low back pain.
To explore this hypothesis, the study will include participants diagnosed with idiopathic scoliosis. The researchers will measure thoracolumbar fascia thickness using ultrasound and assess trunk flexibility through various range of motion tests, including trunk flexion, extension, and lateral flexion using a goniometer, as well as the sit-and-reach test. To quantify the severity of the spinal curvature, the Cobb angle will be measured on anteroposterior standing radiographs.
Participants will also be asked to report their pain levels using the Visual Analog Scale, a simple tool where individuals rate their pain on a scale from 0 to 10. By analyzing the collected data, the researchers aim to establish potential correlations between thoracolumbar fascia thickness, trunk flexibility, and low back pain in individuals with idiopathic scoliosis.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Idiopathic scoliosis without pain | – | –In this group, there will be individuals diagnosed with idiopathic scoliosis whose Cobb angle is above 15 degrees and whose pain level, as assessed by the Visual Analog Scale, is below 3. |
| Idiopathic scoliosis with pain | – | –In this group, there will be individuals diagnosed with idiopathic scoliosis whose Cobb angle is above 15 degrees, and their pain level, as assessed by the Visual Analog Scale, is above 3. |
| Control | – | –In this group, there will be healthy individuals whose pain level, as assessed by the Visual Analog Scale, is below 3. |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will be selected using snowball sampling from individuals diagnosed with idiopathic scoliosis and aged 10 years or older, who meet the inclusion criteria. Snowball sampling involves initially recruiting participants who meet the inclusion criteria and then asking them to refer other potential participants from their social network who also have idiopathic scoliosis. Exclusion criteria will involve individuals with neurological, psychological, congenital, or rheumatological conditions, those with a history of surgery or trauma involving the lower extremities or spinal region within the last 1 year, and individuals who have received any previous treatment related to scoliosis.
Key inclusion criteria (6 listed)
- Being 10 years of age or older
- Having a diagnosis of idiopathic scoliosis
- Having a Cobb angle measurement above 15 degrees
- Being 10 years of age or older
- Have no pathological spinal curvature.
Key exclusion criteria (3 listed)
- Having any neurological, psychological, congenital, or rheumatological condition
- Having a history of surgery or trauma involving the lower extremities or spinal region within the last 1 year
- Having received any previous treatment related to scoliosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Thoracolumbar Fascia Thickness
Time frame: Baseline
The thoracolumbar fascia thickness (mm) obtained after ultrasonographic assessment.
6 secondary outcomes
Visual analog scale
Time frame: Baseline
Trunk Normal Range of Motion
Time frame: Baseline
Trunk Flexibility
Time frame: Baseline
McGill Short Form Pain Questionnaire
Time frame: Baseline
Oswestry Low Back Pain Disability Questionnaire
Time frame: Baseline
Scoliosis Research Society-30 (SRS-30)
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
- Background: PubMed 27347243Choudhry MN, Ahmad Z, Verma R. Adolescent Idiopathic Scoliosis. Open Orthop J. 2016 May 30;10:143-54. doi: 10.2174/1874325001610010143. eCollection 2016.
- Background: PubMed 37189537Pirri C, Pirri N, Guidolin D, Macchi V, Porzionato A, De Caro R, Stecco C. Ultrasound Imaging of Thoracolumbar Fascia Thickness: Chronic Non-Specific Lower Back Pain versus Healthy Subjects; A Sign of a "Frozen Back"? Diagnostics (Basel). 2023 Apr 16;13(8):1436. doi: 10.3390/diagnostics13081436.
- Individual participant dataSharing planned: Undecided
Related trials for Idiopathic Scoliosis
Active, not recruiting
Diaphragm Mobilization in Adolescent Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis
Recruiting
Tranexamic Acid in Pediatric Idiopathic Scoliosis Surgery
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Turkish Adaptation and Validation of the Scoliosis Misconception Scale in Adolescents With Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis (AIS)
Not yet recruitingObservational study
Clinical and Biological Parameters in Adolescent Idiopathic Scoliosis
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Recruiting
Studying Melatonin and Recovery in Teens
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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.
Sibel Yerli, MSc, PT principal investigator
Hacettepe University
Satuk Bugrahan Yinanc, MSc, PT principal investigator
Hacettepe University
Gözde Yağcı, PhD, PT study director
Hacettepe University
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 Idiopathic Scoliosis and Pain, run by Hacettepe University 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 6 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 26 Sep 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sibel Yerli, MSc (+905374243742, sibelyerli@hacettepe.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thoracolumbar Fascia Thickness (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06055140, which also lists 2 linked publications.
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 26 Sep 2023.