Acupuncture for Post COVID-19 Condition (Long COVID) Neuropsychiatric Symptoms
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorHong Kong Baptist University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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);
Trial design
Design model
Parallel
Treatments tested in this trial
Acupuncture
Device1. Fatigue Principal points: Pishu (BL 20), Ganshu (BL 18), Shenshu (BL 23), Baihui (GV 20), Guanyuan (RN 4), Zusanli (ST 36), Sanyinjiao (SP 6) 2. Anxiety/ depression Principal points: Yintang (EX-HN3), Baihui (GV 20), Taichong (LR 3), Neiguan (PC 6), Danzhong (RN 7) 3. Cognitive impairment/ memory loss Principal points: Baihui (GV 20), Sishencong (EX-HN1), Fengfu (GV 16), Taixi (K 13), Xuanzhong (GB 39), Zusanli (ST 36) 4. Insomnia Principal points: Zhaohai (K 16), Shenmai (BL 62), Shenmen (HT 7), Sanyinjiao (SP 6), Anmian (EX-HN22), Sishencong (EX-HN1)
Treatment groups
160 Participants
are divided into 2 treatment groupsGroup A: AcupunctureExperimental treatment 1 intervention
Group B: Conventional treatmentNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Cognitive 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 6, 12 weeks (the end of intervention), at 18 weeks (follow-up)Secondary outcomes
1
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 6, 12 weeks (the end of intervention), at 18 weeks (follow-up)2
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 6, 12 weeks (the end of intervention), at 18 weeks (follow-up)3
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 6, 12 weeks (the end of intervention), at 18 weeks (follow-up)4
Hamilton Depression Scale (HAMD)
A validated 24-item scale used to assess depressive severity across emotional, cognitive, and somatic domains. Scores range as follows: 0-7 (normal), 8-17 (mild depression), 18-24 (moderate depression), and ≥25 (severe depression), with higher scores indicating more severe depressive symptoms.
Time frame
At baseline (before intervention), at 6, 12 weeks (the end of intervention), at 18 weeks (follow-up)Sponsors and contacts
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Source ClinicalTrials.gov