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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Turkey (Türkiye)

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 groups in NCT05836116
Study groupRoleWhat they receive
Individuals with ScoliosisHumans 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.

  1. Muscle activation

    Latissimus dorsi muscle activation during izometric exercises

    The measurement unit is mV (millivolt)

    Measured: 30 minutes

Secondary outcomes (2)
  1. Cobb angle

    Cobb angle of affected part of the columba vertebralis

    The measurement unit is degree.

    Measured: 10 minutes

  2. 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.

  1. First posted1 May 2023
  2. Study start1 Apr 2022
  3. Primary completion15 Apr 2022
  4. Study completion15 Oct 2022

Resources

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)
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 19092622
  • Negrini 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 29435499
  • Slattery 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 30179943
  • Trobisch 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 21191550
  • Liang 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 35162203
  • Castelein 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 32697856
  • Zhang 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

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.

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