A Randomized Controlled Trial on the Treatment of Chronic Tic Disorder With Nourishing the Vital Energy and Regulating the Spirit Needle Technique
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- The Yale Global Tic Severity Scale
研究概览
简要总结
This study was conducted to observe the efficacy of Nourishing the vital energy and Regulating the spirit needle technique in the treatment of chronic tic disorder through the Yale Global Tic Severity Scale (YGTSS) and the Chinese Medicine Symptom Rating Scale in order to provide a new, safe and feasible treatment option and idea for the treatment of chronic Tic Disorder.
详细描述
In this study, 76 children who met the diagnostic criteria for chronic tic disorder were collected and randomly divided into the therapy group(n-38)and control group(n=38) according to a random number table. The patients were treated 3 times a week for 7 weeks, a total of 20 times. YGTSS scores and the Chinese Medicine Symptom Rating Scale were performed before and after 2 courses of treatment, and clinical efficacy and adverse events were observed in both groups, and YGTSS scores were recorded at follow-up 4 week safter the end of treatment and 12 weeks after the end of treatment, respectively. All data were statistically processed and analysed using SPSS 25.0 software, and relevant differences were compared after processing and analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with tic disorders per the Diagnostic and Statistical Manual of Mental Disorders, version 5 (DSM-5) criteria Presence of either motor tics or vocal tics with symptoms present for at least 3 months Aged 5-18 years (all genders) No tic-related medications or therapies for 8 weeks before treatment Willing to complete 8-week acupuncture treatment
排除标准
- •Secondary tics from structural neurological lesions (e.g., epilepsy), pharmacologically induced tics, or neurodevelopmental comorbidities Severe communication barriers or cognitive impairments affecting trial participation Severe organ dysfunction meeting clinical diagnostic thresholds Concurrent participation in interventional clinical trials History of acupuncture-related syncope or presyncope episodes Absolute contraindications to acupuncture (e.g., severe needle phobia, skin infections at acupoints)
结局指标
主要结局
The Yale Global Tic Severity Scale
时间窗: at baseline (pre-treatment), after 8-week treatment, after 4-week follow-up
The Yale Global Tic Severity Scale (YGTSS) Score is designed to assess the severity of symptoms in children with Tourette's Syndrome by scoring the type of tics, frequency of tics, intensity of tics, complexity of tics, degree of interference with normal behavior, and degree of impairment of social functioning in the child, with a total score ranging from 0-75, with higher scores indicating greater severity of the child's condition.
次要结局
未报告次要终点
研究者
Hong Gao
Deputy dean
The Third Affiliated hospital of Zhejiang Chinese Medical University