Comparison of Schroth Therapy and Kinesiotaping in Lower Back and Back Pain in Young Adults With Idiopathic Scoliosis: A Double-Blind Placebo-Controlled Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Change in Pain Intensity (NRS)
研究概览
简要总结
In this study, the effects of Kinesio Taping methods applied in combination with Schroth therapy on pain and functional capacity in young adults diagnosed with idiopathic scoliosis will be evaluated.
This study is designed as a randomized controlled trial. Participants will be randomly assigned to one of three groups:
Group 1: Schroth therapy combined with Kinesio Taping
Group 2: Schroth therapy alone
Group 3: Schroth therapy combined with sham Kinesio Taping
Kinesio Taping will be applied for 4 weeks. The tape will remain in place for 5 consecutive days, followed by a 2-day rest period for the skin, and this cycle will be repeated throughout the intervention period.
Schroth therapy will be administered 3 times per week for 4 weeks.
Assessments will be conducted at baseline (Week 0), during treatment (Week 2), at the end of treatment (Week 4), and at follow-up (Week 8).
The primary outcome measures will be pain intensity assessed by the Numeric Rating Scale (NRS) and functional disability assessed by the Oswestry Disability Index (ODI). Secondary outcome measures will include the Scoliosis Research Society-22 (SRS-22) questionnaire and the Patient Global Impression of Change (PGIC) scale.
详细描述
The aim of this study is to evaluate the effects of Schroth therapy and the addition of Kinesio Taping on pain, functional capacity, and quality of life in young adults with idiopathic scoliosis who were diagnosed during adolescence and currently experience back pain.
Adolescent idiopathic scoliosis (AIS) is a spinal deformity of unknown origin that develops during adolescence, with a worldwide prevalence of 1-3%. The current clinical gold standard for diagnosing scoliosis is the measurement of the Cobb angle on standing posteroanterior radiographs. The Cobb angle determines the severity classification of AIS; a Cobb angle of ≥40° indicates a severe deformity that may require surgical intervention, whereas lower angles are typically managed with non-surgical treatment approaches. (1)
Individuals aged 18-30 years are often described as having "young adult idiopathic scoliosis" (YAIS). Even if they received successful conservative treatment during adolescence, these individuals may present in adulthood with pain, progression of deformity, and cosmetic concerns. The development of symptoms in this age group increases the need for treatment, and evaluating the effectiveness of interventions applied during this period is clinically meaningful. (2)
The original Schroth exercises were developed in the early 20th century by Katharina Schroth. This exercise-based approach focuses on corrective breathing techniques and postural adjustments to address three-dimensional spinal deformities. (3)
Kinesio Taping (KT) is a conservative treatment method that has gained popularity in recent years for managing musculoskeletal conditions and controlling pain. This technique was first described by Kenzo Kase. (4)
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Both the researcher/evaluator and the participant are blind.
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals aged between 18 and 30 years.
- •Radiologically confirmed diagnosis of idiopathic scoliosis.
- •Cobb angle between 10° and 30° and considered candidates for conservative treatment.
- •Risser stage
- •History of low back or back pain within the last 3 months (defined as NRS ≥ 4).
- •No acute orthopedic or neurological condition that would prevent participation in physical exercise interventions.
- •Willingness to participate voluntarily and provide written informed consent.
- •Ability to attend treatment sessions regularly throughout the study period.
排除标准
- •Diagnosis of non-structural (functional) scoliosis, congenital scoliosis, or neuromuscular scoliosis.
- •History of previous spinal surgery.
- •Participation in scoliosis-specific exercise therapy within the last 6 months.
- •Presence of open wounds, dermatological conditions, or allergy to taping materials.
- •History of psychiatric disorders or neurological diseases.
研究组 & 干预措施
Schroth Therapy + Kinesio Taping
Participants in this group will receive Schroth therapy three times per week for 4 weeks combined with Kinesio Taping. The tape will be applied for 5 consecutive days followed by a 2-day rest period, and this cycle will be repeated for 4 weeks.
干预措施: Schroth Terapisi + Kinesio Bantlama (Other)
Schroth Therapy Alone
Participants in this group will receive Schroth therapy three times per week for 4 weeks without any taping intervention.
干预措施: Schroth Therapy Alone (Other)
Schroth Therapy + Sham Kinesio Taping
Participants in this group will receive Schroth therapy three times per week for 4 weeks combined with sham Kinesio Taping. The sham tape will be applied without therapeutic tension and following a non-corrective technique. The application schedule will be identical to the experimental taping group (5 days on, 2 days off for 4 weeks).
干预措施: Schroth Therapy + Sham Kinesio Taping (Other)
结局指标
主要结局
Change in Pain Intensity (NRS)
时间窗: Baseline (Week 0), Week 2, Week 4, and Week 8
Pain intensity will be assessed using the Numeric Rating Scale (NRS), scale ranging from 0 (no pain) to 10 (worst imaginable pain). Changes in pain intensity will be evaluated across all assessment time points during the study
Change in Functional Disability (ODI)
时间窗: Baseline (Week 0), Week 4, and Week 8
Functional disability will be assessed using the Oswestry Disability Index (ODI), a validated questionnaire designed to measure disability related to low back pain. The ODI consists of 10 items evaluating daily living activities, with higher scores indicating greater disability. Changes in functional disability will be evaluated across the specified assessment time points.
次要结局
- Change in Scoliosis-Specific Quality of Life (SRS-22)(Baseline (Week 0), Week 4, and Week 8)
- Patient Global Impression of Change (PGIC)(Week 2, Week 4, and Week 8)
研究者
Şevval Çakmakcı Alkayış
Medical Doctor
Fatih Sultan Mehmet Training and Research Hospital