ScoliosisNCT05836116
Evaluation of Latissimus Dorsi Muscle During Isometric Exercises in Scoliosis
An observational study of Scoliosis, run by Kırıkkale University at 1 site in Turkey (Türkiye).
Trial summary
Scoliosis is a complex three-dimensional deformity of the spine, of uncertain etiology, but multifactorial and mainly involves characteristic changes in the sagittal plane also, changes in the coronal plane, and varying degrees of vertebral rotation in the axial plane. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Scoliosis
- What is being tested?
- Evaluation of Muscle Activation
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2022to 15 Oct 2022
- 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: This study, which was designed to evaluate the lateral and medial part muscular activations of the LD muscle during isometric exercises in 20 healthy individuals (8 females, 12 males) and 20 individuals with scoliosis (14 females and 6 males) participated total of 40 individuals. In the scoliotic group, scoliosis was diagnosed by radiographic imaging by a specialist, referred to receive exercise therapy participated in the study was included.
Who may be able to join
- Scoliosis group
- aged 18-35,
- Risser stage >4,
- Cobb angle of 10-35°,
- range of 18 <BMI <25,
- volunteered to participate
Show all 10Show fewer
- Healthy group
- aged 18-35,
- range of 18 <BMI <25,
- volunteered to participate
Who cannot join
- with a history of neuromuscular, cardiovascular, pulmonary, vestibular, or rheumatological diseases,
- had previously received any surgical or conservative treatment of the spine,
- exercised regularly
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kirikkale University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation
Kirikkale
About this study
Official title: Evaluation of Lateral and Medial Part Activations of Latissimus Dorsi Muscle During Isometric Exercises in Individuals With Scoliosis
Scoliosis is a complex three-dimensional deformity of the spine, of uncertain etiology, but multifactorial and mainly involves characteristic changes in the sagittal plane also, changes in the coronal plane, and varying degrees of vertebral rotation in the axial plane. In recent studies, pre-scoliotic changes are also examined. Some risk factors for the development of scoliosis include gender, age, ethnicity, and family history. Since apical rotation, gibbosity, and costa vertebral angle are considered to be associated with rotation in the literature, these parameters have been defined as risk factors for the progression of the curve.
Cobb angle, Risser sign, and chronological age are taken as the basis to determine the progression of scoliosis.The onset, progression, and treatment of scoliosis include biomechanical changes and parameters. Structural changes, biomechanical changes, and asymmetries develop between the concave and convex sides. Some studies show that paravertebral muscle asymmetry is caused by the curvature of the spine. Trapeze, LD (latissimus dorsi), and erector spine muscles are examples of paravertebral muscles affected.
The LD is a large, smooth muscle lining the lower posterior rib cage and is one of the paravertebral muscles most commonly affected in scoliosis. LD has shoulder, lumbar spine, and sacroiliac joint connections. Scapula, rib cage, and lumbar region deformities seen in scoliosis can be explained by LD. This may make LD a significant cause of scoliosis. In addition, dynamic and static muscle activation rates of LD should be considered in the diagnosis of scoliosis.In the treatment of scoliosis, treatment methods such as physiotherapeutic scoliosis-specific exercise (PSSE), corset, surgery, EMG biofeedback, and neuromuscular training are used.This asymmetry observed in the paraspinal muscles of individuals with scoliosis made us think that we should analyze the LD muscular activations in more detail. The aim of our study is to examine the muscle activation values of the lateral and medial parts of the LD during isometric exercises.
Read the detailed description
Scoliosis is a complex three-dimensional deformity of the spine, of uncertain etiology, but multifactorial and mainly involves characteristic changes in the sagittal plane also, changes in the coronal plane, and varying degrees of vertebral rotation in the axial plane. The prevalence of scoliosis in the general population worldwide is 0.93% to 12%. In the last few decades, different factors affecting the prevalence of scoliosis have been identified, such as gender, age, skeletal maturity, body mass index, family history, and ethnicity. Discussions about the causes of scoliosis are still ongoing, whether it is only genetic or due to factors such as exercise and environment. In recent studies, pre-scoliotic changes are also examined. Some risk factors for the development of scoliosis include gender, age, ethnicity, and family history. Since apical rotation, gibbosity, and costa vertebral angle are considered to be associated with rotation in the literature, these parameters have been defined as risk factors for the progression of the curve.
Cobb angle, Risser sign, and chronological age are taken as the basis to determine the progression of scoliosis. The main diagnostic criterion for scoliosis with varying degrees of vertebral axial rotation is spinal curvature greater than or equal to 10° in the coronal plane on a flat anteroposterior X-ray image. The Adam's Test is universally accepted as the primary means of diagnosing scoliosis. The Adam's test shows the rotational component of scoliosis. The onset, progression, and treatment of scoliosis include biomechanical changes and parameters. Structural changes, biomechanical changes, and asymmetries develop between the concave and convex sides. Some studies show that paravertebral muscle asymmetry is caused by the curvature of the spine. Trapeze, LD (latissimus dorsi), and erector spine muscles are examples of paravertebral muscles affected.
The LD is a large, smooth muscle lining the lower posterior rib cage and is one of the paravertebral muscles most commonly affected in scoliosis. LD has shoulder, lumbar spine, and sacroiliac joint connections. Scapula, rib cage, and lumbar region deformities seen in scoliosis can be explained by LD. This may make LD a significant cause of scoliosis. In addition, dynamic and static muscle activation rates of LD should be considered in the diagnosis of scoliosis.
Although guidelines have been established for treatments in the direction of spinal curvature, the choice of treatment type is often subjective and based on clinicians' experience. In the treatment of scoliosis, treatment methods such as physiotherapeutic scoliosis-specific exercise (PSSE), corset, surgery, EMG biofeedback, and neuromuscular training are used. Asymmetry observed in the paraspinal muscles of individuals with scoliosis made us think that we should analyze the LD muscular activations in more detail. The aim of our study is to examine the muscle activation values of the lateral and medial parts of the LD during isometric exercises.
- Conditions
- Scoliosis
- Being tested
- Evaluation of Muscle Activation
- Keywords
- Scoliosis, Latissimus Dorsi Muscle, EMG, Izometric exercises
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of Muscle ActivationOther
Also called Evaluation of Cobb Angle, Evaluation of Gibbosity
Evaluation of Muscle Activation The sEMG device, which is a surface EMG system (Myomonitor, Delsys Inc, Boston, MA), was used to measure the lateral and medial muscle activation levels of the latissimus dorsi.
Electrode placement was determined according to SENIAM (Surface Electromyography for Non-Invasive Evaluation of Muscles) criteria.
Evaluation of the Gibbosity Trunk rotation (gibbosity) assessments were performed using Adam's test and using a scoliometer . The bending test (Adam's test) is performed in both standing and forward bending positions. The standing version was used in our study.Each measurement equal to 0° on the scoliometer was defined as symmetry at the measured level of the trunk. All other scoliometer values were defined as asymmetry.
Evaluation of the Cobb Angle Cobb angles of the curves of the individuals participating in the study were measured with the MicroDicom application.
| Study group | Role | What they receive |
|---|---|---|
| Individuals with Scoliosis | Humans with scoliosis, between age 18-35 Receives: Other: Evaluation of Muscle Activation | |
| Healthy Group (Control group) | Healthy human subjects between age 18-35 Receives: Other: Evaluation of Muscle Activation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle activation
Latissimus dorsi muscle activation during izometric exercises
The measurement unit is mV (millivolt)
Measured: 30 minutes
Secondary outcomes (2)
Cobb angle
Cobb angle of affected part of the columba vertebralis
The measurement unit is degree.
Measured: 10 minutes
Gibbosity angle
Gibosity angle of affected part of the columba vertebralis
The measurement unit is degree.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start1 Apr 2022
- Primary completion15 Apr 2022
- Study completion15 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for ScoliosisStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kırıkkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammet Ayhan ORAL, Kırıkkale University
- Investigators
- MUHAMMET AYHAN ORAL, PhD, Principal investigator, Kırıkkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05836116
- Sponsor's protocol ID
- LD activation in Scoliosis
- Status last verified
- Apr 2023
- First submitted
- 18 Apr 2023
- Last updated
- 1 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kouwenhoven JW, Castelein RM. The pathogenesis of adolescent idiopathic scoliosis: review of the literature. Spine (Phila Pa 1976). 2008 Dec 15;33(26):2898-908. doi: 10.1097/BRS.0b013e3181891751.
PubMed 19092622Negrini S, Donzelli S, Aulisa AG, Czaprowski D, Schreiber S, de Mauroy JC, Diers H, Grivas TB, Knott P, Kotwicki T, Lebel A, Marti C, Maruyama T, O'Brien J, Price N, Parent E, Rigo M, Romano M, Stikeleather L, Wynne J, Zaina F. 2016 SOSORT guidelines: orthopaedic and rehabilitation treatment of idiopathic scoliosis during growth. Scoliosis Spinal Disord. 2018 Jan 10;13:3. doi: 10.1186/s13013-017-0145-8. eCollection 2018.
PubMed 29435499Slattery C, Verma K. Classifications in Brief: The Lenke Classification for Adolescent Idiopathic Scoliosis. Clin Orthop Relat Res. 2018 Nov;476(11):2271-2276. doi: 10.1097/CORR.0000000000000405. No abstract available.
PubMed 30179943Trobisch P, Suess O, Schwab F. Idiopathic scoliosis. Dtsch Arztebl Int. 2010 Dec;107(49):875-83; quiz 884. doi: 10.3238/arztebl.2010.0875. Epub 2010 Dec 10.
PubMed 21191550Liang R, Yip J, Fan Y, Cheung JPY, To KM. Electromyographic Analysis of Paraspinal Muscles of Scoliosis Patients Using Machine Learning Approaches. Int J Environ Res Public Health. 2022 Jan 21;19(3):1177. doi: 10.3390/ijerph19031177.
PubMed 35162203Castelein RM, Pasha S, Cheng JC, Dubousset J. Idiopathic Scoliosis as a Rotatory Decompensation of the Spine. J Bone Miner Res. 2020 Oct;35(10):1850-1857. doi: 10.1002/jbmr.4137. Epub 2020 Sep 9.
PubMed 32697856Zhang Y, Yang Y, Dang X, Zhao L, Ren J, Zhang L, Sun J. Factors relating to curve progression in female patients with adolescent idiopathic scoliosis treated with a brace. Eur Spine J. 2015 Feb;24(2):244-8. doi: 10.1007/s00586-014-3674-3. Epub 2014 Nov 26.
PubMed 25424687
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Lateral and Medial Part Activations of Latissimus Dorsi Muscle During Isometric Exercises in Individuals With Scoliosis
- ClinicalTrials.gov ID
- NCT05836116
- Acronym / sponsor ID
- LD activation in Scoliosis
- Conditions
- Scoliosis
- Keywords
- Scoliosis, Latissimus Dorsi Muscle, EMG, Izometric exercises
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Kırıkkale UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 15 Apr 2022 (actual)
- Study completion
- 15 Oct 2022 (actual)
- First posted
- 1 May 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.
Scoliosis is a complex three-dimensional deformity of the spine, of uncertain etiology, but multifactorial and mainly involves characteristic changes in the sagittal plane also, changes in the coronal plane, and varying degrees of vertebral rotation in the axial plane. In recent studies, pre-scoliotic changes are also examined. Some risk factors for the development of scoliosis include gender, age, ethnicity, and family history. Since apical rotation, gibbosity, and costa vertebral angle are considered to be associated with rotation in the literature, these parameters have been defined as risk factors for the progression of the curve.
Cobb angle, Risser sign, and chronological age are taken as the basis to determine the progression of scoliosis.The onset, progression, and treatment of scoliosis include biomechanical changes and parameters. Structural changes, biomechanical changes, and asymmetries develop between the concave and convex sides. Some studies show that paravertebral muscle asymmetry is caused by the curvature of the spine. Trapeze, LD (latissimus dorsi), and erector spine muscles are examples of paravertebral muscles affected.
The LD is a large, smooth muscle lining the lower posterior rib cage and is one of the paravertebral muscles most commonly affected in scoliosis. LD has shoulder, lumbar spine, and sacroiliac joint connections. Scapula, rib cage, and lumbar region deformities seen in scoliosis can be explained by LD. This may make LD a significant cause of scoliosis. In addition, dynamic and static muscle activation rates of LD should be considered in the diagnosis of scoliosis.In the treatment of scoliosis, treatment methods such as physiotherapeutic scoliosis-specific exercise (PSSE), corset, surgery, EMG biofeedback, and neuromuscular training are used.This asymmetry observed in the paraspinal muscles of individuals with scoliosis made us think that we should analyze the LD muscular activations in more detail. The aim of our study is to examine the muscle activation values of the lateral and medial parts of the LD during isometric exercises.
Detailed description
Scoliosis is a complex three-dimensional deformity of the spine, of uncertain etiology, but multifactorial and mainly involves characteristic changes in the sagittal plane also, changes in the coronal plane, and varying degrees of vertebral rotation in the axial plane. The prevalence of scoliosis in the general population worldwide is 0.93% to 12%. In the last few decades, different factors affecting the prevalence of scoliosis have been identified, such as gender, age, skeletal maturity, body mass index, family history, and ethnicity. Discussions about the causes of scoliosis are still ongoing, whether it is only genetic or due to factors such as exercise and environment. In recent studies, pre-scoliotic changes are also examined. Some risk factors for the development of scoliosis include gender, age, ethnicity, and family history. Since apical rotation, gibbosity, and costa vertebral angle are considered to be associated with rotation in the literature, these parameters have been defined as risk factors for the progression of the curve.
Cobb angle, Risser sign, and chronological age are taken as the basis to determine the progression of scoliosis. The main diagnostic criterion for scoliosis with varying degrees of vertebral axial rotation is spinal curvature greater than or equal to 10° in the coronal plane on a flat anteroposterior X-ray image. The Adam's Test is universally accepted as the primary means of diagnosing scoliosis. The Adam's test shows the rotational component of scoliosis. The onset, progression, and treatment of scoliosis include biomechanical changes and parameters. Structural changes, biomechanical changes, and asymmetries develop between the concave and convex sides. Some studies show that paravertebral muscle asymmetry is caused by the curvature of the spine. Trapeze, LD (latissimus dorsi), and erector spine muscles are examples of paravertebral muscles affected.
The LD is a large, smooth muscle lining the lower posterior rib cage and is one of the paravertebral muscles most commonly affected in scoliosis. LD has shoulder, lumbar spine, and sacroiliac joint connections. Scapula, rib cage, and lumbar region deformities seen in scoliosis can be explained by LD. This may make LD a significant cause of scoliosis. In addition, dynamic and static muscle activation rates of LD should be considered in the diagnosis of scoliosis.
Although guidelines have been established for treatments in the direction of spinal curvature, the choice of treatment type is often subjective and based on clinicians' experience. In the treatment of scoliosis, treatment methods such as physiotherapeutic scoliosis-specific exercise (PSSE), corset, surgery, EMG biofeedback, and neuromuscular training are used. Asymmetry observed in the paraspinal muscles of individuals with scoliosis made us think that we should analyze the LD muscular activations in more detail. The aim of our study is to examine the muscle activation values of the lateral and medial parts of the LD during isometric exercises.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individuals with Scoliosis | – | Other: Evaluation of Muscle ActivationHumans with scoliosis, between age 18-35 |
| Healthy Group (Control group) | – | Other: Evaluation of Muscle ActivationHealthy human subjects between age 18-35 |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- This study, which was designed to evaluate the lateral and medial part muscular activations of the LD muscle during isometric exercises in 20 healthy individuals (8 females, 12 males) and 20 individuals with scoliosis (14 females and 6 males) participated total of 40 individuals. In the scoliotic group, scoliosis was diagnosed by radiographic imaging by a specialist, referred to receive exercise therapy participated in the study was included.
Key inclusion criteria (10 listed)
- Scoliosis group
- aged 18-35,
- Risser stage >4,
- Cobb angle of 10-35°,
- range of 18 <BMI <25,
Key exclusion criteria (3 listed)
- with a history of neuromuscular, cardiovascular, pulmonary, vestibular, or rheumatological diseases,
- had previously received any surgical or conservative treatment of the spine,
- exercised regularly
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 |
|---|---|---|
| Evaluation of Muscle ActivationAlso: Evaluation of Cobb Angle, Evaluation of GibbosityEvaluation of Muscle Activation The sEMG device, which is a surface EMG system (Myomonitor, Delsys Inc, Boston, MA), was used to measure the lateral and medial muscle activation levels of the latissimus dorsi. Electrode placement was determined according to SENIAM (Surface Electromyography for Non-Invasive Evaluation of Muscles) criteria. Evaluation of the Gibbosity Trunk rotation (gibbosity) assessments were performed using Adam's test and using a scoliometer . The bending test (Adam's test) is performed in both standing and forward bending positions. The standing version was used in our study.Each measurement equal to 0° on the scoliometer was defined as symmetry at the measured level of the trunk. All other scoliometer values were defined as asymmetry. Evaluation of the Cobb Angle Cobb angles of the curves of the individuals participating in the study were measured with the MicroDicom application. | Other | Healthy Group (Control group), Individuals with Scoliosis |
Primary outcome
Muscle activation
Time frame: 30 minutes
Latissimus dorsi muscle activation during izometric exercises The measurement unit is mV (millivolt)
2 secondary outcomes
Cobb angle
Time frame: 10 minutes
Gibbosity angle
Time frame: 5 minutes
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 1 May 2023.
- Background: PubMed 19092622Kouwenhoven JW, Castelein RM. The pathogenesis of adolescent idiopathic scoliosis: review of the literature. Spine (Phila Pa 1976). 2008 Dec 15;33(26):2898-908. doi: 10.1097/BRS.0b013e3181891751.
- Background: PubMed 29435499Negrini S, Donzelli S, Aulisa AG, Czaprowski D, Schreiber S, de Mauroy JC, Diers H, Grivas TB, Knott P, Kotwicki T, Lebel A, Marti C, Maruyama T, O'Brien J, Price N, Parent E, Rigo M, Romano M, Stikeleather L, Wynne J, Zaina F. 2016 SOSORT guidelines: orthopaedic and rehabilitation treatment of idiopathic scoliosis during growth. Scoliosis Spinal Disord. 2018 Jan 10;13:3. doi: 10.1186/s13013-017-0145-8. eCollection 2018.
- Background: PubMed 30179943Slattery C, Verma K. Classifications in Brief: The Lenke Classification for Adolescent Idiopathic Scoliosis. Clin Orthop Relat Res. 2018 Nov;476(11):2271-2276. doi: 10.1097/CORR.0000000000000405. No abstract available.
- Background: PubMed 21191550Trobisch P, Suess O, Schwab F. Idiopathic scoliosis. Dtsch Arztebl Int. 2010 Dec;107(49):875-83; quiz 884. doi: 10.3238/arztebl.2010.0875. Epub 2010 Dec 10.
- Background: PubMed 35162203Liang R, Yip J, Fan Y, Cheung JPY, To KM. Electromyographic Analysis of Paraspinal Muscles of Scoliosis Patients Using Machine Learning Approaches. Int J Environ Res Public Health. 2022 Jan 21;19(3):1177. doi: 10.3390/ijerph19031177.
- Background: PubMed 32697856Castelein RM, Pasha S, Cheng JC, Dubousset J. Idiopathic Scoliosis as a Rotatory Decompensation of the Spine. J Bone Miner Res. 2020 Oct;35(10):1850-1857. doi: 10.1002/jbmr.4137. Epub 2020 Sep 9.
- Background: PubMed 25424687Zhang Y, Yang Y, Dang X, Zhao L, Ren J, Zhang L, Sun J. Factors relating to curve progression in female patients with adolescent idiopathic scoliosis treated with a brace. Eur Spine J. 2015 Feb;24(2):244-8. doi: 10.1007/s00586-014-3674-3. Epub 2014 Nov 26.
- Individual participant dataSharing planned: No
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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.
MUHAMMET AYHAN ORAL, PhD principal investigator
Kırıkkale 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 Scoliosis, run by Kırıkkale 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 10 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: finished, as of the sponsor's last update on 1 May 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?
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?
Muscle activation (time frame: 30 minutes). 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 NCT05836116, which also lists 7 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 1 May 2023.