Acupuncture for Long COVID Neuropsychiatric Symptoms: a Pragmatic,Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Cognitive score on the Chinese version of the Mini-Mental State Examination (MMSE) scale
研究概览
简要总结
In this study, a 12-week pragmatic, randomized, double-blinded clinical trial will be conducted to evaluate the efficacy of acupuncture for the treatment of long Covid neuropsychiatric symptoms and provide reference for clinical non-drug treatment.
详细描述
This is a pragmatic, randomized, double-blinded clinical trial on acupuncture for treating neuropsychiatric symptoms in long Covid patients. A total of 160 participants will be diagnosed by a registered Chinese medicine practitioner and randomly assigned to the acupuncture and the control group with a 1:1 ratio. The acupuncture group will receive 24 sessions of interventions during a 12-week treatment duration (2 sessions per week) and will be followed up at week 18. The control group will only receive conventional therapy.
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 (Care Provider, Outcomes Assessor)
盲法说明
The participants will be assigned to the treatment group or the control group according to the ratio of 1:1. This process is carried out by an independent researcher (Research Assistant), and the evaluators and outcome assessor will not know the grouping of the participants until the end of the study.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •meet the clinical diagnosis of Long COVID by the World Health Organization (WHO), with no neuropsychiatric symptoms 1 year before infection with Covid-19, and continue to have at least one neuropsychiatric symptom for 2 months after SARS-CoV-2 turned negative 3 months above;
- •aged 12 to 80 years;
- •willing and able to consent, and complete all assessment and study procedures
排除标准
- •patients with a history of chronic neuropsychiatric symptoms;
- •cardiovascular diseases pre-existing to the Covid-19 episode such as arrhythmia, heart failure, myocardial infarction, and patients with cardiac pacemakers;
- •documented pre-existing history of psychiatric illness, including substance abuse;
- •suicidal tendencies (attempted suicide in the 12 months before the study);
- •any chronic or remote neurological disorder (i.e. stroke, head trauma, epilepsy, tumor);
- •those who participated in other clinical trials within one month;
- •pregnant or lactating female patients;
- •have surgery within two months before the study or will have a scheduled surgery during the study;
- •acute brain injury or acute encephalopathy from another etiology than Covid-19 (e.g., sepsis, liver or renal failure, alcohol or drug withdrawal, drug toxicity);
- •open-heart cardiac surgery or cardiac arrest during the last 6 months;
- •patients who received acupuncture treatment 1 month before the start of the study;
- •patients who were unable to complete the assessment during screening due to severe mental, cognitive, or emotional impairment
结局指标
主要结局
Cognitive score on the Chinese version of the Mini-Mental State Examination (MMSE) scale
时间窗: At baseline (before intervention), at 6, 12 weeks (the end of intervention), at 18 weeks (follow-up)
The MMSE can evaluate of five different domains of cognitive functions: (1) Orientation, with a maximum of 10 points, (2) Memory, with a maximum of 6 points, (3) Attention and calculation, with a maximum of 5 points, (4) Language, with a maximum of 8 points, and (5) Design copying, with a maximum of 1 point. It has a maximum score of 30, with MMSE score denotes severity of cognitive impairment as follows; mild: MMSE 21 to 24, moderate: MMSE 10 to 20, severe: MMSE less than 10.
次要结局
- Depression on the Chinese Beck Depression Inventory (CBDI)(At baseline (before intervention), at 6, 12 weeks (the end of intervention), at 18 weeks (follow-up))
- Score of Insomnia Severity Index (ISI)(At baseline (before intervention), at 6, 12 weeks (the end of intervention), at 18 weeks (follow-up))
- Score of Brief Fatigue Inventory-Taiwanese (BFI-T) Form(At baseline (before intervention), at 6, 12 weeks (the end of intervention), at 18 weeks (follow-up))
- Hamilton Depression Scale (HAMD)(At baseline (before intervention), at 6, 12 weeks (the end of intervention), at 18 weeks (follow-up))
- Hamilton Anxiety Rating Scale (HAMA)(At baseline (before intervention), at 6, 12 weeks (the end of intervention), at 18 weeks (follow-up))
- Traditional Chinese Medicine Symptom Scale(At baseline (before intervention), at 6, 12 weeks (the end of intervention), at 18 weeks (follow-up))
研究者
Zhong Lidan
Visiting Associate Professor
Hong Kong Baptist University