Acupuncture, Long Covid19, Neuropsychiatric Symptom
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEAcupuncture
1. 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)
Sponsors
Hong Kong Baptist University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cognitive score on the Chinese version of the Mini-Mental State Examination (MMSE) scale | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Score of Insomnia Severity Index (ISI) | At baseline (before intervention), at 6, 12 weeks (the end of intervention), at 18 weeks (follow-up) | 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. |
| 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) | 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). |
| 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) | 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. |
| Hamilton Anxiety Rating Scale (HAMA) | At baseline (before intervention), at 6, 12 weeks (the end of intervention), at 18 weeks (follow-up) | A 14-item scale for assessing anxiety symptoms across somatic and psychological domains. Scoring ranges are: 0-7 (normal), 8-14 (mild anxiety), 15-28 (moderate anxiety), and ≥29 (severe anxiety), with higher scores indicating greater anxiety severity. |
| Traditional Chinese Medicine Symptom Scale | At baseline (before intervention), at 6, 12 weeks (the end of intervention), at 18 weeks (follow-up) | A TCM-specific symptom scale following Guidelines for Clinical Research on New Chinese Medicine, assessing syndrome severity based on TCM diagnostics. Scores quantify symptom burden with defined thresholds for mild, moderate, and severe syndrome levels, enabling standardized assessment of TCM syndrome differentiation. |
| Hamilton Depression Scale (HAMD) | At baseline (before intervention), at 6, 12 weeks (the end of intervention), at 18 weeks (follow-up) | 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. |
Countries
Hong Kong
Contacts
Primary ContactLinda Zhong, MD., Ph.D
Outcome results
None listed