NCT07405112

Brief Summary

Adolescent idiopathic scoliosis (AIS) is a three-dimensional spinal deformity characterized by lateral curvature and rotation of the spine. The Cobb angle is the most widely used measurement to quantify the magnitude of spinal deformities. According to the Cobb method, curvatures less than 10 degrees are considered normal spinal asymmetry, whereas curvatures greater than 10 degrees are defined as scoliosis. Based on the coronal Cobb angle, scoliosis is classified as mild (\<20°), moderate (21-35°), moderate-to-severe (36-40°), severe (41-50°), severe-to-very severe (51-55°), and very severe (\>65°). AIS occurs in adolescents aged 10-18 years. Although back and low back pain are frequently reported in individuals with AIS, the relationship between curve severity, pain, and body image perception has not been fully elucidated. Furthermore, it remains unclear whether AIS leads to disability or functional limitations, and whether spinal curve severity influences pain intensity. Therefore, further research is required to clarify these issues. Accordingly, a cross-sectional observational study was designed involving individuals diagnosed with AIS. Participants aged 10-18 years who were diagnosed with AIS and presented to the Scoliosis Clinic of the Physical Medicine and Rehabilitation Department at the University of Health Sciences Antalya Training and Research Hospital will be included. Participants must have no additional comorbid diseases and must voluntarily agree to participate in the study. Participants will be divided into three groups according to curve severity measured by Cobb angle: Group I (mild, \<20°), Group II (moderate, 21-35°), and Group III (moderate-to-severe, 36-40°). Medical history, neurological and physical examinations, and radiological measurements will be performed. Pain will be assessed using the pain-related domain of the Scoliosis Research Society-22 (SRS-22) questionnaire based on participant responses. Body image perception will be evaluated using the Turkish version of the Spinal Appearance Questionnaire (TR-SAQ), completed independently by both participants and evaluators. Intergroup comparisons will be conducted to evaluate the effects of curve severity on pain and body image perception, and to determine the statistical significance of these associations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
78

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2024

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

September 23, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 27, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 27, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 29, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 12, 2026

Completed
Last Updated

February 12, 2026

Status Verified

February 1, 2026

Enrollment Period

1.2 years

First QC Date

January 29, 2026

Last Update Submit

February 8, 2026

Conditions

Keywords

Adolescent idiopathic scoliosisBack painlower back painPain severityCobb angleCurve severityTrunk asymmetryRadiographic parametersbody image

Outcome Measures

Primary Outcomes (2)

  • Pain severity assessed by Scoliosis Research Society-22 (SRS-22) Pain Domain

    Pain severity was assessed using the pain-related domain of the Scoliosis Research Society-22 (SRS-22) questionnaire. The SRS-22 Pain Domain consists of multiple items evaluating pain frequency, pain intensity, and pain-related functional limitations associated with scoliosis. Each item is scored on a 5-point Likert scale, with possible scores ranging from 1 to 5. The domain score is calculated as the mean of the item scores. Minimum score: 1; Maximum score: 5. Higher scores indicate less pain and better pain-related quality of life, whereas lower scores indicate more severe pain.

    At baseline (single assessment at study enrollment)

  • Pain severity assessed by Numerical Rating Scale (NRS)

    Pain intensity was assessed using the Numerical Rating Scale (NRS). The Numerical Rating Scale is a unidimensional patient-reported measure of pain intensity. Participants are asked to rate their current back and/or low back pain on an 11-point scale. Minimum score: 0 ("no pain"); Maximum score: 10 ("worst pain imaginable"). Higher scores indicate greater pain intensity, whereas lower scores indicate less pain.

    Baseline (cross-sectional assessment)

Secondary Outcomes (1)

  • Body Image perception assessed by Turkish version of the Spinal Appearance Questionnaire (TR-SAQ)

    At baseline (single assessment at study enrollment)

Study Arms (3)

Low AIS

In this group participants will be patients diagnosed with adolescent idiopathic scoliosis who have a coronal plane Cobb angle of less than 20°, measured on standing posteroanterior spinal radiographs using the Cobb method. This group represents individuals with mild scoliosis.

Moderate AIS

Participants in this group will be patients diagnosed with adolescent idiopathic scoliosis who have a coronal plane Cobb angle between 21° and 35°, measured on standing posteroanterior spinal radiographs using the Cobb method. This group represents individuals with moderate scoliosis.

Moderate-to-Severe AIS

Participants in this group will be patients diagnosed with adolescent idiopathic scoliosis who have a coronal plane Cobb angle between 36° and 40°, measured on standing posteroanterior spinal radiographs using the Cobb method. This group represents individuals with moderate-to-severe scoliosis.

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The study will include adolescents aged 10-18 years diagnosed with adolescent idiopathic scoliosis (AIS) who present to the Scoliosis Outpatient Clinic of the Physical Medicine and Rehabilitation Department at Antalya Training and Research Hospital, are able to provide reliable responses, and volunteer to participate.

You may qualify if:

  • Voluntary participation
  • Presence of adolescent idiopathic scoliosis (AIS)
  • Age between 10 and 18 years
  • Cobb angle ≥ 10°

You may not qualify if:

  • History of spinal or other joint/bone surgery
  • Age ≥19 years or ≤9 years
  • Presence of spinal or costal deformities other than adolescent idiopathic scoliosis (AIS)
  • History of spinal trauma within the past 1 year
  • Intellectual disability
  • Presence of systemic diseases (rheumatologic, inflammatory, oncologic, - cardiac, respiratory, or neurological disorders)
  • Cobb angle \> 40°

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Antalya Training and Research Hospital

Antalya, Antalya, 07050, Turkey (Türkiye)

Location

Related Publications (3)

  • Teles AR, St-Georges M, Abduljabbar F, Simoes L, Jiang F, Saran N, Ouellet JA, Ferland CE. Back pain in adolescents with idiopathic scoliosis: the contribution of morphological and psychological factors. Eur Spine J. 2020 Aug;29(8):1959-1971. doi: 10.1007/s00586-020-06489-2. Epub 2020 Jun 9.

    PMID: 32519028BACKGROUND
  • Balague F, Pellise F. Adolescent idiopathic scoliosis and back pain. Scoliosis Spinal Disord. 2016 Sep 9;11(1):27. doi: 10.1186/s13013-016-0086-7. eCollection 2016.

    PMID: 27648474BACKGROUND
  • Wong AYL, Samartzis D, Cheung PWH, Cheung JPY. How Common Is Back Pain and What Biopsychosocial Factors Are Associated With Back Pain in Patients With Adolescent Idiopathic Scoliosis? Clin Orthop Relat Res. 2019 Apr;477(4):676-686. doi: 10.1097/CORR.0000000000000569.

    PMID: 30516661BACKGROUND

MeSH Terms

Conditions

Back PainLow Back PainPainScoliosis

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSpinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • NACİYE F TORAMAN, MD

    Antalya Training and Research Hospital, Physical Medicine and Rehabilitation Department

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 29, 2026

First Posted

February 12, 2026

Study Start

September 23, 2024

Primary Completion

November 27, 2025

Study Completion

November 27, 2025

Last Updated

February 12, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

There is not a plan to make individual participant data available outside the study team.

Locations