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临床试验/NCT07448688
NCT07448688尚未招募不适用

Impact of Combined Lumbar Spinal Traction and Three-Dimensional Exercise Therapy on Spinal Curve Parameters and Clinical Outcomes in Patients With Adolescent Idiopathic Scoliosis

Şahide Eda ARTUÇ1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年3月5日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
Cobb Angle

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
12 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Traction Group

Experimental

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

干预措施: Lumbar Mechanical Traction (Device)

Sham Group

Sham Comparator

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

干预措施: Lumbar Mechanical Sham Traction (Device)

结局指标

主要结局

Cobb Angle

时间窗: Baseline (Week 0) and Week 6

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.

次要结局

  • 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)
  • Scoliosis Research Society-22 Questionnaire (SRS-22)(Baseline (Week 0) and Week 6)

研究者

发起方
Şahide Eda ARTUÇ
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Şahide Eda ARTUÇ

Principal Investigator, MD, Physical Medicine and Rehabilitation Specialist

Turkish League Against Rheumatism

研究点 (1)

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