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

ConditionsAdolescent Idiopathic Scoliosis (AIS)Exercise (EX)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-18
SponsorŞahide Eda ARTUÇ

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosed with AIS

Having a Cobb angle between 10° and 25°

With a Risser stage < 4

Willing to participate in the study

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Traction GroupExperimental treatment 1 intervention
Group B: Sham GroupSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline (Week 0) and Week 6

Secondary outcomes

1

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.

Time frame
Baseline (Week 0) and Week 6
2

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.

Time frame
Baseline (Week 0) and Week 6
3

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.

Time frame
Baseline (Week 0)and Week 6
4

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.

Time frame
Baseline (Week 0) and Week 6

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Şahide Eda ARTUÇ

Lead sponsor

Turkish League Against Rheumatism

Sponsor institution

Source ClinicalTrials.gov

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