Effects of Lumbar Traction Combined With 3D Exercise Therapy on Adolescent Idiopathic Scoliosis

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Adolescent Idiopathic Scoliosis (AIS); Exercise (EX)
• Intervention / Treatment: Device: Lumbar Mechanical Traction; Device: Lumbar Mechanical Sham Traction

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: ŞAHİDE EDA ARTUÇ, MD; Phone Number: +903122911416; Email: edartuc@gmail.com

Study Locations

• Turkey (Türkiye)
  • Çankaya
    • Ankara, Çankaya, Turkey (Türkiye), 06800
      • Gaziler Physical Therapy and Rehabilitation Training and Research Hospital
      • Contact: ŞAHİDE EDA ARTUÇ, MD; Phone Number: +905534488730; Email: edartuc@gmail.com
      • Sub-Investigator: TUĞBA ATAN, Associate Professor
      • Sub-Investigator: İREM ERTORAN İNAN, MD
      • Sub-Investigator: SİBEL MANDIROĞLU, Associate Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Traction Group; In addition to scoliosis-specific exercise training, lumbar mechanical traction will be applied using a standard motorized traction therapy system.	Device: Lumbar Mechanical Traction; 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)
Sham Comparator: Sham Group; In addition to scoliosis-specific exercise training, lumbar mechanical sham traction will be administered.	Device: Lumbar Mechanical Sham Traction; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline (Week 0) and Week 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	Baseline (Week 0) and Week 6

Collaborators and Investigators

• Sponsor: Şahide Eda Artuç

Study record dates

Study Major Dates

• Study Start (Estimated): March 5, 2026
• Primary Completion (Estimated): September 5, 2026
• Study Completion (Estimated): December 5, 2026

Study Registration Dates

• First Submitted: January 18, 2026
• First Submitted That Met QC Criteria: February 28, 2026
• First Posted (Actual): March 4, 2026

Study Record Updates

• Last Update Posted (Actual): March 4, 2026
• Last Update Submitted That Met QC Criteria: February 28, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: mechanical traction
• Additional Relevant MeSH Terms: Behavior; Motor Activity
• Other Study ID Numbers: E2-25-11855

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data will be available beginning 6 months after publication of the primary results and will remain available for at least 5 years.
• IPD Sharing Access Criteria: Qualified researchers affiliated with academic or medical institutions may request access by contacting the principal investigator. Access will be granted after approval of a proposal and signing of a data use agreement
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No