Adolescent Idiopathic Scoliosis (AIS)NCT07448688
Effects of Lumbar Traction Combined With 3D Exercise Therapy on Adolescent Idiopathic Scoliosis
A study testing Lumbar Mechanical Traction in people with Adolescent Idiopathic Scoliosis (AIS) and Exercise (EX), run by Şahide Eda ARTUÇ at 1 site in Turkey (Türkiye).
Trial summary
Adolescent Idiopathic Scoliosis (AIS) is a three-dimensional spinal deformity that appears during adolescence without an identifiable underlying cause. A variety of low-risk physical therapy modalities, such as TENS, acupuncture, kinesio taping, spinal manipulation, and mobilization, have been explored in the… Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Adolescent Idiopathic Scoliosis (AIS), Exercise (EX)
- What is being tested?
- Lumbar Mechanical Traction
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Mar 2026to 5 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosed with AIS
- Having a Cobb angle between 10° and 25°
- With a Risser stage < 4
- Willing to participate in the study
- Patients whose informed consent forms are signed by both the parents and the child
Who cannot join
- History of previous exercise therapy, manual therapy, or other physical therapy interventions
- Current use of brace treatment
- Presence of contraindications for exercise or lumbar spinal traction (e.g., diagnoses such as rickets, osteomalacia)
- Non-idiopathic scoliosis caused by neuromuscular disorders, vertebral malformations, trauma, tumors, or other diseases
- History of previous surgery involving the spine or lower extremities
- Comorbid psychiatric problems, or neuromuscular, cardiovascular, pulmonary, or rheumatic diseases
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Gaziler Physical Therapy and Rehabilitation Training and Research Hospital
Ankara, Çankaya, 06800
ŞAHİDE EDA ARTUÇ, MD, +905534488730, edartuc@gmail.com
TUĞBA ATAN, Associate Professor
About this study
Official title: Impact of Combined Lumbar Spinal Traction and Three-Dimensional Exercise Therapy on Spinal Curve Parameters and Clinical Outcomes in Patients With Adolescent Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis (AIS) is a three-dimensional spinal deformity that appears during adolescence without an identifiable underlying cause.
A variety of low-risk physical therapy modalities, such as TENS, acupuncture, kinesio taping, spinal manipulation, and mobilization, have been explored in the management of scoliosis. Among these approaches, lumbar mechanical spinal traction is a commonly used non-invasive and painless intervention in physical medicine and rehabilitation settings. However, existing research on traction in AIS remains limited and generally of low methodological quality. Preliminary and observational studies have reported mixed outcomes, and the clinical effectiveness of traction appears to depend on factors such as curve characteristics, treatment dose, and integration with active rehabilitation. To date, high-quality randomized controlled evidence evaluating lumbar mechanical spinal traction as an adjunct to scoliosis-specific exercises in AIS is lacking.
This study aims to investigate the combined effects of lumbar mechanical spinal traction and scoliosis-specific exercises in adolescents diagnosed with AIS. A prospective randomized controlled design will be used to assess changes in Cobb angle, posture, pain, and functional status. The findings may help clarify whether adding mechanical traction provides additional benefit beyond exercise alone in the conservative treatment of AIS.
Read the detailed description
Adolescent Idiopathic Scoliosis (AIS) is a structural, three-dimensional deformity of the spine that develops during adolescence without a known underlying cause. Conservative management remains the primary approach for individuals with mild to moderate curvature, with scoliosis-specific exercise programs commonly used to improve postural correction, neuromuscular control, and muscle balance.
Lumbar mechanical spinal traction is a non-invasive physical therapy modality frequently used in clinical practice, with theoretical benefits including reduction of axial loading, elongation of shortened soft tissues, and facilitation of improved spinal alignment.
This study is designed to evaluate whether the addition of lumbar mechanical spinal traction to a standardized scoliosis-specific exercise program provides greater improvement in clinical outcomes than exercise therapy alone. Participants diagnosed with AIS will be recruited from outpatient scoliosis clinics and will undergo baseline clinical and radiological assessment, including Cobb angle measurement, postural evaluation, pain intensity scoring, and functional status assessment.
Lumbar mechanical spinal traction will be administered using a traction table with adjustable force parameters. Treatment sessions will be conducted under the supervision of a physical therapist, and traction force, session duration, and treatment frequency will be standardized across participants. The scoliosis-specific exercise program will consist of individualized, corrective exercises tailored to curve pattern and severity, focusing on spinal elongation, rotational breathing, postural symmetry training, and neuromuscular re-education.
Both groups will receive treatment over a defined intervention period. Follow-up evaluations will be performed at baseline and post-intervention. Outcome measures will include Cobb angle (primary radiographic outcome), posture assessment, pain intensity, and functional status scores. Any adverse events, including transient increases in back pain or discomfort during treatment, will be monitored and recorded.
This study aims to provide clinically relevant evidence regarding the potential benefit of adding lumbar mechanical spinal traction to established conservative management strategies for AIS. The findings may contribute to improving non-surgical treatment protocols and guiding clinical decision-making in the management of adolescents with scoliosis.
- Being tested
- Lumbar Mechanical Traction, Lumbar Mechanical Sham Traction
- Keywords
- mechanical traction
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbar Mechanical TractionDevice
Also called Motorized Traction Therapy System (TM-300; ITO Co., Tokyo, Japan)
Mechanical traction will be applied intermittently with 15-second pull / 15-second relaxation periods while the patient lies in the supine position with the hips and knees flexed at 90 degrees. The treatment will begin with a traction force of 5-10 kg for 5 minutes, and then continue for an additional 15 minutes by increasing the force until the patient reports reaching their traction tolerance or up to a maximum of 30-50% of body weight.
Lumbar Mechanical Sham TractionDevice
Also called Motorized Traction Therapy System (TM-300; ITO Co., Tokyo, Japan)
Sham traction will be applied intermittently for 20 minutes with 15-second pull / 15-second relaxation periods, using a traction force of 5 kg, while the patient lies in the supine position with the hips and knees flexed at 90 degrees.
| Study group | Role | What they receive |
|---|---|---|
| Traction Group | Experimental | In addition to scoliosis-specific exercise training, lumbar mechanical traction will be applied using a standard motorized traction therapy system. Receives: Device: Lumbar Mechanical Traction |
| Sham Group | Sham comparator | In addition to scoliosis-specific exercise training, lumbar mechanical sham traction will be administered. Receives: Device: Lumbar Mechanical Sham Traction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cobb Angle
Measurement of the Cobb angle is the gold standard for diagnosing, monitoring, and planning the treatment of scoliosis. The Cobb angle is defined as the angle formed by the intersection of two lines: one drawn parallel to the superior endplate of the upper end vertebra and the other drawn parallel to the inferior endplate of the lower end vertebra. The angle will be measured digitally using a standard standing full-spine anteroposterior radiograph.
Measured: Baseline (Week 0) and Week 6
Secondary outcomes (6)
Transverse Plane Measurement: Apical Vertebral Rotation (Nash-Moe Classification)
In the Nash-Moe method, the hemivertebra on the convex side of the curve is divided into three parts, and the degree of rotation is graded based on pedicle position within these segments. In neutral vertebrae, pedicle shadows appear symmetric on the convex and concave sides. In Grade 1, there is slight pedicle displacement; in Grade 4, the pedicle shadow on one side disappears completely. Minimum value: Grade 0 (no rotation) Maximum value: Grade 4 (severe rotation) Higher grades indicate greater vertebral rotation.
Measured: Baseline (Week 0) and Week 6
Angular Sagittal Alignment Parameters
Thoracic kyphosis, lumbar lordosis, pelvic tilt, pelvic incidence, and sacral slope will be measured on standing lateral radiographs. All angular measurements will be reported in degrees. The change from baseline to Week 6 will be analyzed.
Measured: Baseline (Week 0) and Week 6
Sagittal Vertical Axis (SVA)
Sagittal Vertical Axis will be measured as the horizontal distance between the C7 plumb line and the posterior superior corner of S1 on standing lateral radiographs.
Measured: Baseline (Week 0)and Week 6
Pain Assessment: Visual Analog Scale (VAS-Pain)
Pain intensity will be assessed using the Visual Analog Scale for Pain (VAS). The VAS consists of a 10-centimeter horizontal line anchored at 0 and 10.
Minimum value: 0 (no pain) Maximum value: 10 (worst imaginable pain) Higher scores indicate greater pain severity. The change from baseline (Week 0) to Week 6 will be analyzed.
Measured: Baseline (Week 0) and Week 6
Trunk Cosmetic Appearance: TRACE (Trunk Aesthetic Clinical Evaluation) Score
Trunk cosmetic appearance will be assessed using the Trunk Aesthetic Clinical Evaluation (TRACE) score, a validated clinical scale used to evaluate visible trunk asymmetry in patients with scoliosis.
The TRACE score ranges from 0 to 12. Minimum value: 0 (no visible asymmetry) Maximum value: 12 (severe trunk asymmetry) Higher scores indicate worse cosmetic deformity.
The change from baseline (Week 0) to Week 6 will be analyzed.
Measured: Baseline (Week 0) and Week 6
Scoliosis Research Society-22 Questionnaire (SRS-22)
Quality of life will be assessed using the Scoliosis Research Society-22 (SRS-22) Questionnaire, a disease-specific instrument for patients with spinal deformities. The questionnaire consists of 22 items across five domains: pain, self-image, function/activity, mental health, and satisfaction with management.
Each item is scored from 1 to 5. The overall score is calculated as the mean of all 22 items.
Minimum value: 1 Maximum value: 5 Higher scores indicate better health-related quality of life.
The change from baseline (Week 0) to Week 6 will be analyzed.
Measured: Baseline (Week 0) and Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start5 Mar 2026 (estimated)
- Primary completion5 Sep 2026 (estimated)
- Study completion5 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent Idiopathic Scoliosis (AIS)Studies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Şahide Eda ARTUÇ
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Şahide Eda ARTUÇ, Turkish League Against Rheumatism
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07448688
- Sponsor's protocol ID
- E2-25-11855
- Status last verified
- Jan 2026
- First submitted
- 18 Jan 2026
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD), including baseline characteristics and outcome measures, will be shared with qualified researchers upon reasonable request. Data will be available after publication of the main results.
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Combined Lumbar Spinal Traction and Three-Dimensional Exercise Therapy on Spinal Curve Parameters and Clinical Outcomes in Patients With Adolescent Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT07448688
- Acronym / sponsor ID
- E2-25-11855
- Keywords
- mechanical traction
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Şahide Eda ARTUÇUniversity, hospital or other
- Study start
- 5 Mar 2026 (estimated)
- Primary completion
- 5 Sep 2026 (estimated)
- Study completion
- 5 Dec 2026 (estimated)
- First posted
- 4 Mar 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.
Adolescent Idiopathic Scoliosis (AIS) is a three-dimensional spinal deformity that appears during adolescence without an identifiable underlying cause.
A variety of low-risk physical therapy modalities, such as TENS, acupuncture, kinesio taping, spinal manipulation, and mobilization, have been explored in the management of scoliosis. Among these approaches, lumbar mechanical spinal traction is a commonly used non-invasive and painless intervention in physical medicine and rehabilitation settings. However, existing research on traction in AIS remains limited and generally of low methodological quality. Preliminary and observational studies have reported mixed outcomes, and the clinical effectiveness of traction appears to depend on factors such as curve characteristics, treatment dose, and integration with active rehabilitation. To date, high-quality randomized controlled evidence evaluating lumbar mechanical spinal traction as an adjunct to scoliosis-specific exercises in AIS is lacking.
This study aims to investigate the combined effects of lumbar mechanical spinal traction and scoliosis-specific exercises in adolescents diagnosed with AIS. A prospective randomized controlled design will be used to assess changes in Cobb angle, posture, pain, and functional status. The findings may help clarify whether adding mechanical traction provides additional benefit beyond exercise alone in the conservative treatment of AIS.
Detailed description
Adolescent Idiopathic Scoliosis (AIS) is a structural, three-dimensional deformity of the spine that develops during adolescence without a known underlying cause. Conservative management remains the primary approach for individuals with mild to moderate curvature, with scoliosis-specific exercise programs commonly used to improve postural correction, neuromuscular control, and muscle balance.
Lumbar mechanical spinal traction is a non-invasive physical therapy modality frequently used in clinical practice, with theoretical benefits including reduction of axial loading, elongation of shortened soft tissues, and facilitation of improved spinal alignment.
This study is designed to evaluate whether the addition of lumbar mechanical spinal traction to a standardized scoliosis-specific exercise program provides greater improvement in clinical outcomes than exercise therapy alone. Participants diagnosed with AIS will be recruited from outpatient scoliosis clinics and will undergo baseline clinical and radiological assessment, including Cobb angle measurement, postural evaluation, pain intensity scoring, and functional status assessment.
Lumbar mechanical spinal traction will be administered using a traction table with adjustable force parameters. Treatment sessions will be conducted under the supervision of a physical therapist, and traction force, session duration, and treatment frequency will be standardized across participants. The scoliosis-specific exercise program will consist of individualized, corrective exercises tailored to curve pattern and severity, focusing on spinal elongation, rotational breathing, postural symmetry training, and neuromuscular re-education.
Both groups will receive treatment over a defined intervention period. Follow-up evaluations will be performed at baseline and post-intervention. Outcome measures will include Cobb angle (primary radiographic outcome), posture assessment, pain intensity, and functional status scores. Any adverse events, including transient increases in back pain or discomfort during treatment, will be monitored and recorded.
This study aims to provide clinically relevant evidence regarding the potential benefit of adding lumbar mechanical spinal traction to established conservative management strategies for AIS. The findings may contribute to improving non-surgical treatment protocols and guiding clinical decision-making in the management of adolescents with scoliosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traction Group | Experimental | Device: Lumbar Mechanical TractionIn addition to scoliosis-specific exercise training, lumbar mechanical traction will be applied using a standard motorized traction therapy system. |
| Sham Group | Sham comparator | Device: Lumbar Mechanical Sham TractionIn addition to scoliosis-specific exercise training, lumbar mechanical sham traction will be administered. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Diagnosed with AIS
- Having a Cobb angle between 10° and 25°
- With a Risser stage < 4
- Willing to participate in the study
- Patients whose informed consent forms are signed by both the parents and the child
Key exclusion criteria (6 listed)
- History of previous exercise therapy, manual therapy, or other physical therapy interventions
- Current use of brace treatment
- Presence of contraindications for exercise or lumbar spinal traction (e.g., diagnoses such as rickets, osteomalacia)
- Non-idiopathic scoliosis caused by neuromuscular disorders, vertebral malformations, trauma, tumors, or other diseases
- History of previous surgery involving the spine or lower extremities
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 |
|---|---|---|
| Lumbar Mechanical TractionAlso: Motorized Traction Therapy System (TM-300; ITO Co., Tokyo, Japan)Mechanical traction will be applied intermittently with 15-second pull / 15-second relaxation periods while the patient lies in the supine position with the hips and knees flexed at 90 degrees. The treatment will begin with a traction force of 5-10 kg for 5 minutes, and then continue for an additional 15 minutes by increasing the force until the patient reports reaching their traction tolerance or up to a maximum of 30-50% of body weight. | Device | Traction Group |
| Lumbar Mechanical Sham TractionAlso: Motorized Traction Therapy System (TM-300; ITO Co., Tokyo, Japan)Sham traction will be applied intermittently for 20 minutes with 15-second pull / 15-second relaxation periods, using a traction force of 5 kg, while the patient lies in the supine position with the hips and knees flexed at 90 degrees. | Device | Sham Group |
Primary outcome
Cobb Angle
Time frame: Baseline (Week 0) and Week 6
Measurement of the Cobb angle is the gold standard for diagnosing, monitoring, and planning the treatment of scoliosis. The Cobb angle is defined as the angle formed by the intersection of two lines: one drawn parallel to the superior endplate of the upper end vertebra and the other drawn parallel to the inferior endplate of the lower end vertebra. The angle will be measured digitally using a standard standing full-spine anteroposterior radiograph.
6 secondary outcomes
Transverse Plane Measurement: Apical Vertebral Rotation (Nash-Moe Classification)
Time frame: Baseline (Week 0) and Week 6
Angular Sagittal Alignment Parameters
Time frame: Baseline (Week 0) and Week 6
Sagittal Vertical Axis (SVA)
Time frame: Baseline (Week 0)and Week 6
Pain Assessment: Visual Analog Scale (VAS-Pain)
Time frame: Baseline (Week 0) and Week 6
Trunk Cosmetic Appearance: TRACE (Trunk Aesthetic Clinical Evaluation) Score
Time frame: Baseline (Week 0) and Week 6
Scoliosis Research Society-22 Questionnaire (SRS-22)
Time frame: Baseline (Week 0) and Week 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD), including baseline characteristics and outcome measures, will be shared with qualified researchers upon reasonable request. Data will be available after publication of the main results.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lumbar Mechanical Traction in people with Adolescent Idiopathic Scoliosis (AIS) and Exercise (EX), run by Şahide Eda ARTUÇ 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 6 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: opening soon, as of the sponsor's last update on 4 Mar 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ŞAHİDE EDA ARTUÇ, MD (+903122911416, edartuc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cobb Angle (time frame: Baseline (Week 0) and Week 6). 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 4 Mar 2026.