The Effect and Safety of Plum-blossom Needle for Tourette Syndrome: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- change of YGTSS score from baseline at the 12th week
研究概览
简要总结
To evaluate the effect and safety of plum-blossom needle for Tourette syndrome.
详细描述
This is a randomized, controlled trial with two parallel arms. A total of 60 patients will be randomly allocated into the plum-blossom needle group (n=30) and the habit reversal training (HRT) group (n=30). 12-week treatment will be given to all patients of each group, follow-up will be made at the 12th week after treatment. The primary outcome measure will be the mean change from baseline in the total tic score on the Yale Global Tic Severity Scale (YGTSS) at the 12th week. Secondary outcome measures will include the mean changes in score of YGTSS, TS Clinical Global Impression Scale (CGI) and the Children and Adolescents' Quality of Life Scale from baseline at other time. Safety will also be evaluated.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meeting the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders of the American Psychiatric Association (DSM-IV) for TS.
- •Agree to participate in the trial and sign written informed consent by both guardians and subjects.
排除标准
- •Having severe problem in heart, liver or kidney, or having hyperthyroidism.
- •After evaluated by psychiatrists based on the Kiddie-Sads-Present and Lifetime Version, those who are associated with co-morbid conditions such as mental retardation, pervasive developmental disorder, schizophrenia, mania episode, bipolar disorder, anxiety and depression and specific learning disorder will be excluded.
- •Tics symptoms caused by some drugs.
- •Currently receiving any other form of pharmacological or non-pharmacological treatment for their Tourette syndrome.
- •Patients with a history of psychotropic substance or alcohol use during the 3 months preceding screening.
- •Patients with a history of nonresponsiveness to HRT or participating in another clinical trial.
研究组 & 干预措施
Plum-blossom needle group
Patients randomized into this group will receive plum-blossom needle as treatment. DU 20, DU 16, GB 20, EX-HN5, BL 15, BL 18, BL 23 will be selected as acupoints. Each point will be tapped gently one by one by plum blossom needle until the skin get slightly redness. The treatments will be given two sessions per week, consistently for 12weeks (24 sessions in all).
干预措施: Plum-blossom needle group (Other)
HRT group
Patients randomized into this group will receive habit reversal training (HRT) as treatment. Habit reversal training will consist of the following 4 parts: (1) self-monitoring, (2) competing responses, (3) relaxation training and (4) contingency management. The training will be given weekly in the 12 weeks (totally 12 sessions) by a special rehabilitation therapist, first two sessions 1.5 h, and remaining sessions 1 h for each treatment.
干预措施: HRT group (Behavioral)
结局指标
主要结局
change of YGTSS score from baseline at the 12th week
时间窗: baseline, week 12
the symptom scale used in this trial will be the Yale Global Tic Severity Scale. (YGTSS).
次要结局
- change of YGTSS score from baseline at other point times(baseline, week 4, week 8, week 24.)
- CGI score(week 4, week 8, week 12, week 24.)
- change of quality of life from baseline(baseline, week 12, week 24.)
研究者
Yu Jinna
Attending doctor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences