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NCT Number: NCT07448688

Effects of Lumbar Traction Combined With 3D Exercise Therapy on 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.

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Key information

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gaziler Physical Therapy and Rehabilitation Training and Research Hospital

Ankara, Çankaya, 06800, Turkey (Türkiye)

Location contact

SİBEL MANDIROĞLU, Associate Professor

SUB_INVESTIGATOR

TUĞBA ATAN, Associate Professor

SUB_INVESTIGATOR

İREM ERTORAN İNAN, MD

SUB_INVESTIGATOR

ŞAHİDE EDA ARTUÇ, MD

CONTACT

[email protected]

+905534488730

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Lumbar Mechanical Traction

Device

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.

Other names: Motorized Traction Therapy System (TM-300; ITO Co., Tokyo, Japan)

Lumbar Mechanical Sham Traction

Device

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.

Other names: Motorized Traction Therapy System (TM-300; ITO Co., Tokyo, Japan)

Primary outcomes

  1. 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.

Secondary outcomes

  1. Transverse Plane Measurement: Apical Vertebral Rotation (Nash-Moe Classification)

    Time frame: Baseline (Week 0) and Week 6

    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.

  2. Angular Sagittal Alignment Parameters

    Time frame: Baseline (Week 0) and Week 6

    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.

  3. Sagittal Vertical Axis (SVA)

    Time frame: Baseline (Week 0)and Week 6

    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.

  4. Pain Assessment: Visual Analog Scale (VAS-Pain)

    Time frame: Baseline (Week 0) and Week 6

    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.

  5. Trunk Cosmetic Appearance: TRACE (Trunk Aesthetic Clinical Evaluation) Score

    Time frame: Baseline (Week 0) and Week 6

    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.

  6. Scoliosis Research Society-22 Questionnaire (SRS-22)

    Time frame: Baseline (Week 0) and Week 6

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

ŞAHİDE EDA ARTUÇ, MD

CONTACT

[email protected]

+903122911416

Sponsors and collaborators

Lead sponsor

Şahide Eda Artuç

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 4, 2026
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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