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

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

Overview

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.

Interventions

• 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.
• 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.

Primary outcome measures

• Cobb Angle [Time frame: Baseline (Week 0) and Week 6]

Secondary outcome measures (6)

• 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 1 center

• Gaziler Physical Therapy and Rehabilitation Training and Research Hospital — Ankara

Identifiers

NCT: NCT07448688 · E2-25-11855

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗