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

NCT07448688 | Not Yet Recruiting

• 1 other identifier: E2-25-11855
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Adolescent Idiopathic Scoliosis (AIS); Exercise (EX)

Keywords

mechanical traction

Outcome Measures

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.

  Baseline (Week 0) and Week 6

Secondary Outcomes (6)

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

  Baseline (Week 0) and Week 6

• Angular Sagittal Alignment Parameters

  Baseline (Week 0) and Week 6

• Sagittal Vertical Axis (SVA)

  Baseline (Week 0)and Week 6

• Pain Assessment: Visual Analog Scale (VAS-Pain)

  Baseline (Week 0) and Week 6

• Trunk Cosmetic Appearance: TRACE (Trunk Aesthetic Clinical Evaluation) Score

  Baseline (Week 0) and Week 6

Study Arms (2)

Traction Group

EXPERIMENTAL

In addition to scoliosis-specific exercise training, lumbar mechanical traction will be applied using a standard motorized traction therapy system.

Device: Lumbar Mechanical Traction

Sham Group

SHAM COMPARATOR

In addition to scoliosis-specific exercise training, lumbar mechanical sham traction will be administered.

Device: Lumbar Mechanical Sham Traction

Interventions

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.

Also known as: Motorized Traction Therapy System (TM-300; ITO Co., Tokyo, Japan)

Traction Group

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.

Also known as: Motorized Traction Therapy System (TM-300; ITO Co., Tokyo, Japan)

Sham Group

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Şahide Eda ARTUÇ: lead

Study Sites (1)

Gaziler Physical Therapy and Rehabilitation Training and Research Hospital

Ankara, Çankaya, 06800, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

ŞAHİDE EDA ARTUÇ, MD

CONTACT

+903122911416; edartuc@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Independent of the individuals who are aware of the treatment allocation, both the patients receiving the treatment and the investigator performing the outcome assessments will be blinded to the treatment group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, MD, Physical Medicine and Rehabilitation Specialist

Study Record Dates

• First Submitted: January 18, 2026
• First Posted: March 4, 2026
• Study Start: March 5, 2026
• Primary Completion (Estimated): September 5, 2026
• Study Completion (Estimated): December 5, 2026
• Last Updated: March 4, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available beginning 6 months after publication of the primary results and will remain available for at least 5 years.
• 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

Locations

TU (1)