Trials / Not Yet Recruiting
Not Yet RecruitingNCT07448688
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
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- Sponsor
- Şahide Eda ARTUÇ · Academic / Other
- Sex
- All
- Age
- 12 Years – 18 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2026-03-05
- Primary completion
- 2026-09-05
- Completion
- 2026-12-05
- First posted
- 2026-03-04
- Last updated
- 2026-03-04
Locations
1 site across 1 country: Turkey (Türkiye)
Source: ClinicalTrials.gov record NCT07448688. Inclusion in this directory is not an endorsement.