The Orthopaedic Manipulation Techniques of the Lin School of Lingnan Region in the Treatment of Adolescent Idiopathic Scoliosis - A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Change of Scoliosis Research Society-22 (SRS-22)
研究概览
简要总结
To examine the clinical efficacy of the Orthopaedic Manipulation Techniques of the Lin School of Lingnan Region in the treatment of Adolescent Idiopathic Scoliosis
详细描述
After being informed about the study and potential risk, all patients giving written informed consent will undergo a 0-week screening period to determine eligibility for study entry. At week 0, patients who meet the eligibility requirements will be randomized in a single-blind manner(participant) in a 1:1 ratio to Manipulation Techniques Group or Control Group.
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
- Single (Participant)
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adolescents aged between 10 and 18 who can speak and read Chinese
- •Fulfil the diagnostic criteria of scoliosis, i.e. Cobb's angle ≥ 10 degree
- •Risser grade ranging from 0 to 4
- •Informed consent agreement signed by both subject and their parents/guardians
- •Able to participate in follow-up assessments
排除标准
- •History of spine surgery;
- •Cobb's angle >30 degrees
- •Known to have severe respiratory or cardiovascular comorbidities; vertebral tumours and spinal canal abnormalities; Leukaemia, thrombocytopenia and other bleeding disorders
- •Known to have cognitive impairment.
- •Documented pregnancy
- •Wearing brace within 1 month.
- •Involved in other interventional clinical studies at the same time.
- •Uncooperative during treatments
- •Being assessed by investigators as unsuitable to participate.
结局指标
主要结局
Change of Scoliosis Research Society-22 (SRS-22)
时间窗: Baseline, Week 8,16,24
Scoliosis Research Society-22 (SRS-22) questionnaire includes 5 dimensions : 1)function/activity,2) pain,3) self-perceived image, 4)mental health, satisfaction with treatment and 5)other health-related quality of life(HRQL) parameters with a total of 22 items, and is scored by the Likert 5-level scoring method. Possible score range from 0 (no pain)to 5(worst possible pain).A higher score indicates a better quality of life for the patient.
次要结局
- Change of muscle volume by Ultrasonography(Before and after every manipulation with the treatment duration of 16 weeks)
- Change of Cobb's angle measured by Ultrasonography(Before and after the manipulation with the duration of 16 weeks)
- Change of Traditional Chinese version of Spinal Appearance Questionnaire score (TC-SAQ)(Baseline, Week 8,16,24)
- Change of Cobb's angle measured by Xray(Baseline, Week 16)
- Change of spinal rotation by Ultrasonography(Before and after the manipulation with the duration of 16 weeks)
研究者
Kiu Lam Chung
Associate Professor of Practice in Chinese Medicine
Chinese University of Hong Kong