Scoliosis IdiopathicNCT07418983
Exercise Effects on Fascia, Low Back Pain, and Function in Scoliosis
A study testing Scientific Exercise Approach to Scoliosis (SEAS) Exercises and Functional Individual Therapy of Scoliosis Exercises in people with Scoliosis Idiopathic and Fascia, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 24 years
- Conditions the study is for
- Scoliosis Idiopathic, Fascia, Low Back Pain
- What is being tested?
- Scientific Exercise Approach to Scoliosis (SEAS) Exercises and Functional Individual Therapy of Scoliosis Exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Feb 2026to 26 May 2026
- Phase
- Interventional
- 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 11 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University, Faculty of Physical Therapy and Rehabilitation
Ankara, Samanpazarı, 06100
About this study
Official title: 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.
Read the 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.
- Conditions
- Scoliosis Idiopathic, Fascia, Low Back Pain
- Being tested
- Scientific Exercise Approach to Scoliosis (SEAS) Exercises, Functional Individual Therapy of Scoliosis Exercises
- Keywords
- Scoliosis, Low Back Pain, Fascia, Exercise Therapy
- Medical subject headings
- Low Back Pain, Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scientific Exercise Approach to Scoliosis (SEAS) ExercisesBehavioural
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.
Functional Individual Therapy of Scoliosis ExercisesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Functional Individual Therapy of Scoliosis Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: Baseline and 8 weeks after intervention
Secondary outcomes (2)
Functional Disability
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.
Measured: Baseline and 8 weeks after the intervention
Health-Related Quality of Life
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.
Measured: Baseline and 8 weeks after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start20 Feb 2026
- Primary completion12 May 2026
- Study completion26 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scoliosis IdiopathicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alev Dogan Ozbudak, Hacettepe University
- Investigators
- Alev Doğan Özbudak, PT, MSc (PhD Candidate), Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07418983
- Sponsor's protocol ID
- HU-FTR-ADO-01
- Status last verified
- Jun 2026
- First submitted
- 6 Feb 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07418983
- Acronym / sponsor ID
- HU-FTR-ADO-01
- Conditions
- Scoliosis Idiopathic, Fascia, Low Back Pain
- Keywords
- Scoliosis, Low Back Pain, Fascia, Exercise Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 20 Feb 2026 (actual)
- Primary completion
- 12 May 2026 (actual)
- Study completion
- 26 May 2026 (actual)
- First posted
- 18 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Scientific Exercise Approach to Scoliosis (SEAS) Group | Active comparator | Behavioral: Scientific Exercise Approach to Scoliosis (SEAS) ExercisesParticipants receive the Scientific Exercise Approach to Scoliosis (SEAS) program focusing on active self-correction and functional stabilization. |
| Functional Individual Therapy of Scoliosis (FITS) Group | Active comparator | Behavioral: Functional Individual Therapy of Scoliosis ExercisesParticipants receive the Functional Individual Therapy of Scoliosis (FITS) program, designed to improve symmetry, muscular balance, and spinal alignment. |
Who may qualify
- Ages
- 11 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Scientific Exercise Approach to Scoliosis (SEAS) ExercisesParticipants 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. | Behavioural | Scientific Exercise Approach to Scoliosis (SEAS) Group |
| Functional Individual Therapy of Scoliosis ExercisesParticipants 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. | Behavioural | Functional Individual Therapy of Scoliosis (FITS) Group |
Primary outcome
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.
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).
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.
2 secondary outcomes
Functional Disability
Time frame: Baseline and 8 weeks after the intervention
Health-Related Quality of Life
Time frame: Baseline and 8 weeks after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alev Doğan Özbudak, PT, MSc (PhD Candidate) principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scientific Exercise Approach to Scoliosis (SEAS) Exercises and Functional Individual Therapy of Scoliosis Exercises in people with Scoliosis Idiopathic and Fascia, run by Hacettepe 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 5 inclusion and 5 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 16 Jun 2026. 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?
Thoracolumbar Fascia Thickness (time frame: Baseline and 8 weeks after the intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jun 2026.