NCT05836116

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2022

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 1, 2023

Completed
Last Updated

May 1, 2023

Status Verified

April 1, 2023

Enrollment Period

14 days

First QC Date

April 18, 2023

Last Update Submit

April 18, 2023

Conditions

Keywords

ScoliosisLatissimus Dorsi MuscleEMGIzometric exercises

Outcome Measures

Primary Outcomes (1)

  • Muscle activation

    Latissimus dorsi muscle activation during izometric exercises The measurement unit is mV (millivolt)

    30 minutes

Secondary Outcomes (2)

  • Cobb angle

    10 minutes

  • Gibbosity angle

    5 minutes

Study Arms (2)

Individuals with Scoliosis

Humans with scoliosis, between age 18-35

Other: Evaluation of Muscle Activation

Healthy Group (Control group)

Healthy human subjects between age 18-35

Other: Evaluation of Muscle Activation

Interventions

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.

Also known as: Evaluation of Cobb Angle, Evaluation of Gibbosity
Healthy Group (Control group)Individuals with Scoliosis

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
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.

You may qualify if:

  • Scoliosis group
  • aged 18-35,
  • Risser stage \>4,
  • Cobb angle of 10-35°,
  • range of 18 \<BMI \<25,
  • volunteered to participate
  • Healthy group
  • aged 18-35,
  • range of 18 \<BMI \<25,
  • volunteered to participate

You may not qualify if:

  • with a history of neuromuscular, cardiovascular, pulmonary, vestibular, or rheumatological diseases,
  • had previously received any surgical or conservative treatment of the spine,
  • exercised regularly

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kirikkale University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation

Kırıkkale, Turkey (Türkiye)

Location

Related Publications (7)

  • 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.

    PMID: 19092622BACKGROUND
  • 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.

    PMID: 29435499BACKGROUND
  • 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.

    PMID: 30179943BACKGROUND
  • 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.

    PMID: 21191550BACKGROUND
  • 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.

    PMID: 35162203BACKGROUND
  • 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.

    PMID: 32697856BACKGROUND
  • 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.

    PMID: 25424687BACKGROUND

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • MUHAMMET AYHAN ORAL, PhD

    Kırıkkale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 18, 2023

First Posted

May 1, 2023

Study Start

April 1, 2022

Primary Completion

April 15, 2022

Study Completion

October 15, 2022

Last Updated

May 1, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations