In this study, a 16-week randomized, sham-controlled, double-blinded clinical trial will be conducted to to investigate the efficacy and safety of electro-acupuncture compared to sham acupuncture for treatment of long covid neuropsychiatric symptoms.
This is a prospective, randomized, sham-controlled, double-blinded and multiple center trial on electro-acupuncture for treating neuropsychiatric symptoms in long covid patients. A total of 150 participants will be randomly assigned to the electro-acupuncture and the sham-control group with 1:1 ratio. Both groups will receive 32 sessions of interventions during 16-week treatment duration (2 session per week), and will be followed up for 8 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
150
Disposable acupuncture needles (0.20 mm in diameter) are are used in the study. The acupoints are GV20(Baihui), EX-HN1(Sishencong), EX-HN3(Yintang), SP6(Sanyinjiao), ST36(Zusanli), ST40(Fenglong), and LR3(Taichong). Electrical stimulation will be delivered with waves at 2-5 Hz from an electroacupuncture device. The needles will be retained in position for 30 minutes.
Streitberger's non-invasive acupuncture needles (Gauge 8 x 1.2"/ 0.30 x 30mm) will be applied to serve as a sham control at the same acupoints with the same stimulation modality and then connecting the needle to the incorrect output socket of the electrical acupuncture stimulation instrument. The sham points are "pseudo stimulation".
Zhong Lidan
Kowloon Tong, Kowloon, Hong Kong
RECRUITINGCognitive score on the Chinese version of the Mini-Mental State Examination (MMSE) scale
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.
Time frame: At baseline (before intervention), at 4, 8, 12, 16 weeks (the end of intervention) and 2 months after intervention (the end of follow-up).
Depression on the Chinese Beck Depression Inventory (CBDI)
The scale has a total of 21 questions, with an overall score of 63, 14-19 being mild depression, 20-28 being moderate depression, and above 29 being severe depression.
Time frame: At baseline (before intervention), at 4, 8, 12, 16 weeks (the end of intervention) and 2 months after intervention (the end of follow-up).
Score of Insomnia Severity Index (ISI)
The Insomnia Severity Index in Chinese includes 5 questions to assess the severity and impact of insomnia, on an 0 to 4 scale, with the higher score reflecting worse insomnia symptoms.
Time frame: At baseline (before intervention), at 4, 8, 12, 16 weeks (the end of intervention) and 2 months after intervention (the end of follow-up).
Score of Brief Fatigue Inventory-Taiwanese (BFI-T) Form
BFI-T form is to assess the severity of fatigue and the impact of fatigue on daily functioning. Scoring Respondents rate each item on a 0-10 numeric scale, with 0 meaning "no fatigue" and 10 meaning "fatigue as bad as you can imagine." Scores are categorized as Mild (1-3), Moderate (4-6), and Severe (7-10).
Time frame: At baseline (before intervention), at 4, 8, 12, 16 weeks (the end of intervention) and 2 months after intervention (the end of follow-up).
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Score of the Short Form 12 (SF12)
The SF-12V2 is a widely used generic HRQoL instrument, and its Chinese version has been validated and normed in the general Chinese population in Hong Kong. It consists of 12 questions measuring eight domains of health, including physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The scores are generated using an algorithm to generate a combined physical and mental health score for comparison with normative data. In the normative data: 1) the mean score was set to 50; 2) a score \> 50 indicated better physical or mental health than the mean; 3) a score \< 50 indicated worse physical or mental health than the mean.
Time frame: At baseline (before intervention), at 4, 8, 12, 16 weeks (the end of intervention) and 2 months after intervention (the end of follow-up).