NCT07418983

Brief Summary

The use of various muscle energy techniques to address fascial restrictions, in addition to three-dimensional correction within scoliosis-specific exercise approaches, suggests that these exercises may have different effects on thoracolumbar fascia thickness. This may, in turn, lead to varying impacts on low back pain and functional improvement. Therefore, the aim of this study is to investigate the effects of different scoliosis-specific exercise approaches on thoracolumbar fascia thickness, low back pain, and function in individuals with idiopathic lumbar scoliosis and chronic low back pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2026

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 18, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

February 20, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 12, 2026

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 26, 2026

Completed
Last Updated

June 16, 2026

Status Verified

June 1, 2026

Enrollment Period

3 months

First QC Date

February 6, 2026

Last Update Submit

June 14, 2026

Conditions

Keywords

ScoliosisLow Back PainFasciaExercise Therapy

Outcome Measures

Primary Outcomes (3)

  • Thoracolumbar Fascia Thickness

    Thoracolumbar fascia thickness will be measured using ultrasound at two bilateral points, located 2-3 cm lateral to the L3 spinous processes. Thoracolumbar fascia thickness will be measured in millimeters using ultrasound imaging. Fascia organization will be classified using a Likert scale as follows: very disorganized, somewhat disorganized, somewhat organized, and very organized, according to the method described in the study protocol.

    Baseline and 8 weeks after the intervention

  • Pain intensity

    Pain intensity will be assessed using a 100-mm Visual Analog Scale (0 = no pain, 100 = worst imaginable pain).

    Baseline and 8 weeks after the intervention

  • Pain quality

    Pain quality will be measured using the Short-Form McGill Pain Questionnaire (SF-MPQ) sensory and affective subscale scores. Higher scores indicate worse pain quality.

    Baseline and 8 weeks after intervention

Secondary Outcomes (2)

  • Functional Disability

    Baseline and 8 weeks after the intervention

  • Health-Related Quality of Life

    Baseline and 8 weeks after the intervention

Study Arms (2)

Scientific Exercise Approach to Scoliosis (SEAS) Group

ACTIVE COMPARATOR

Participants receive the Scientific Exercise Approach to Scoliosis (SEAS) program focusing on active self-correction and functional stabilization.

Behavioral: Scientific Exercise Approach to Scoliosis (SEAS) Exercises

Functional Individual Therapy of Scoliosis (FITS) Group

ACTIVE COMPARATOR

Participants receive the Functional Individual Therapy of Scoliosis (FITS) program, designed to improve symmetry, muscular balance, and spinal alignment.

Behavioral: Functional Individual Therapy of Scoliosis Exercises

Interventions

Participants in the SEAS group will receive one supervised 60-minute clinical session per week for 8 weeks, combined with a 40-minute home exercise program performed 6 days per week according to the SEAS protocol.

Scientific Exercise Approach to Scoliosis (SEAS) Group

Participants in the FITS group will receive one supervised 60-minute clinical session per week for 8 weeks, along with a 40-minute home exercise program performed 6 days per week following the FITS method.

Functional Individual Therapy of Scoliosis (FITS) Group

Eligibility Criteria

Age11 Years - 24 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Aged 11-24 years
  • Diagnosed with idiopathic scoliosis
  • Presenting a single lumbar curve pattern
  • Experiencing low back pain for more than 3 months
  • Pain intensity ≥3 on the Visual Analog Scale (VAS)

You may not qualify if:

  • History of spinal surgery
  • Received any scoliosis treatment within the last year
  • Current use of a spinal brace
  • Regularly used pain medication
  • Presence of neurological, congenital, rheumatological or psychological disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University, Faculty of Physical Therapy and Rehabilitation

Ankara, Samanpazarı, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Low Back PainScoliosis

Interventions

Oceans and SeasExercise

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSpinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Geological PhenomenaPhysical PhenomenaSeawaterSaline WatersEnvironmentEcological and Environmental PhenomenaBiological PhenomenaMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Alev Doğan Özbudak, PT, MSc (PhD Candidate)

    Hacettepe University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
In this study, both the participants and the assessor measuring thoracolumbar fascia thickness are blinded to group allocation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be allocated into two parallel groups to compare the effects of different scoliosis-specific exercise approaches on thoracolumbar fascia thickness, pain, and quality of life.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

February 6, 2026

First Posted

February 18, 2026

Study Start

February 20, 2026

Primary Completion

May 12, 2026

Study Completion

May 26, 2026

Last Updated

June 16, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Individual Participant Data (IPD) will not be shared due to ethical considerations and participant privacy. The study involves sensitive health information of participants with chronic low back pain and idiopathic lumbar scoliosis. Sharing individual-level data could risk identifiability, despite anonymization efforts. Data will be used solely for the current research purposes, including thesis work and related publications.

Locations