- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07418983
Exercise Effects on Fascia, Low Back Pain, and Function in Scoliosis
Investigation of the Effects of Different 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
Conditions
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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Alev Doğan Özbudak, PT, MSc (PhD Candidate)
- Phone Number: +905549263892
- Email: fztalevdogan@gmail.com
Study Locations
-
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Samanpazarı
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Ankara, Samanpazarı, Turkey (Türkiye), 06100
- Recruiting
- Hacettepe University, Faculty of Physical Therapy and Rehabilitation
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Contact:
- Alev Doğan Özbudak, PT, MSc (PhD Candidate)
- Phone Number: +905549263892
- Email: fztalevdogan@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged 10-50 years
- Diagnosed with idiopathic scoliosis
- Presenting a lumbar scoliosis pattern
- Cobb angle greater than 15°
- Experiencing low back pain for more than 3 months
- Pain intensity ≥3 on the Visual Analog Scale (VAS)
- Able to read and write
Exclusion Criteria:
- History of spinal surgery
- Received any scoliosis treatment within the last year
- Current use of a spinal brace
- Use of pain medication
- Scoliosis due to non-idiopathic causes (e.g., neurological, congenital)
- Presence of neurological, psychological, congenital, or rheumatologic disorders
- Any musculoskeletal pathology affecting the spine or trunk
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
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.
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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.
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Baseline and 8 weeks after intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional Disability
Time Frame: Baseline and 8 weeks after the intervention
|
Functional disability will be assessed using the Oswestry Disability Index (ODI), a 10-item questionnaire evaluating the impact of low back pain on daily activities using a 5-point Likert scale.
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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 will be measured using the Scoliosis Research Society-30 (SRS-30) questionnaire, a 30-item tool widely used in scoliosis populations.
The first 22 items assess general health-related quality of life, while the last 8 items are completed only by patients with scoliosis who underwent surgery.
The questionnaire includes a body diagram to mark painful areas.
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Baseline and 8 weeks after the intervention
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Alev Doğan Özbudak, PT, MSc (PhD Candidate), Hacettepe University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Bone Diseases
- Musculoskeletal Diseases
- Spinal Diseases
- Back Pain
- Spinal Curvatures
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Low Back Pain
- Scoliosis
- Motor Activity
- Movement
- Musculoskeletal Physiological Phenomena
- Musculoskeletal and Neural Physiological Phenomena
- Physical Phenomena
- Environment
- Ecological and Environmental Phenomena
- Biological Phenomena
- Geological Phenomena
- Seawater
- Saline Waters
- Exercise
- Oceans and Seas
Other Study ID Numbers
- HU-FTR-ADO-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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