Exercise Effects on Fascia, Low Back Pain, and Function in Scoliosis

June 14, 2026 updated by: Alev Dogan Ozbudak, Hacettepe University

Comparative Effects of Two Exercise Approaches on Thoracolumbar Fascia and Clinical Outcomes in Idiopathic Lumbar Scoliosis With Chronic Low Back Pain: A Randomized Controlled Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Low back pain is the most common complaint among individuals with lumbar scoliosis. In a study conducted in Japan, the prevalence of low back pain was reported as 34.7%, which was nearly three times higher than that observed in students without scoliosis. Pain resulting from scoliosis leads to a high level of functional disability, which consequently reduces quality of life.

The thoracolumbar fascia consists of dense connective tissue layers separated by loose connective tissue that allows the tight layers to glide over one another during trunk movement. It provides a mechanical connection between the lumbar spine and several muscles, including the transversus abdominis, portions of the latissimus dorsi, and the internal oblique muscles. In individuals with idiopathic scoliosis, thickening of this fascia has been observed, and it has been reported that this thickening is further increased in the presence of chronic low back pain. Fascial thickening in individuals with scoliosis has been proposed as a potential factor contributing to both pain and movement restrictions.

In the treatment of scoliosis, scoliosis-specific exercise approaches are widely used. These approaches typically include various active self-correction strategies (based on the location, shape, and magnitude of the curve) and individually tailored exercises. Some scoliosis-specific exercise approaches incorporate techniques such as contract-relax, myofascial release, trigger point therapy, and joint mobilization to eliminate muscular and fascial restrictions that impede movement, thereby preparing individuals with scoliosis for three-dimensional correction. In addition, these exercises have been reported to exert positive therapeutic effects on pain and quality of life in individuals with idiopathic scoliosis.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
34

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Alev Doğan Özbudak, PT, MSc (PhD Candidate)
  • Phone Number: +905549263892
  • Email: fztalevdogan@gmail.com

Study Locations

  • Turkey (Türkiye)
    • Samanpazarı
      • Ankara, Samanpazarı, Turkey (Türkiye), 06100
        • Hacettepe University, Faculty of Physical Therapy and Rehabilitation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Scientific Exercise Approach to Scoliosis (SEAS) Group
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
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.
Active Comparator: Functional Individual Therapy of Scoliosis (FITS) Group
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Thoracolumbar Fascia Thickness
Time Frame: Baseline and 8 weeks after the intervention
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
Time Frame: Baseline and 8 weeks after the intervention
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
Time Frame: Baseline and 8 weeks after intervention
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Functional Disability
Time Frame: Baseline and 8 weeks after the intervention
Functional disability will be assessed using thethe Revised Oswestry Disability Questionnaire (RODQ), a 10-item questionnaire evaluating the impact of low back pain on daily activities using a 5-point Likert scale.
Baseline and 8 weeks after the intervention
Health-Related Quality of Life
Time Frame: Baseline and 8 weeks after the intervention
Health-related quality of life was evaluated using the Scoliosis Research Society-22 (SRS-22) questionnaire, which is specifically designed and validated for individuals with scoliosis. This instrument consists of 22 items covering five domains: function/activity, pain, self-image, mental health, and satisfaction with management. Higher scores obtained from the questionnaire indicate a better health status and improved quality of life across the evaluated domains.
Baseline and 8 weeks after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hacettepe University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Alev Doğan Özbudak, PT, MSc (PhD Candidate), Hacettepe University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 20, 2026

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 12, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 26, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 6, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 18, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HU-FTR-ADO-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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