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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acupuncture | Experimental | The acupuncture intervention will be conducted for 2 sessions per week during a 12-week treatment duration and will be followed up at week 18. This research is based on the TCM theory of individualized acupuncture. Qualified participants will first conduct TCM syndrome differentiation according to the five main manifestations of Long COVID neuropsychiatric symptoms including fatigue, anxiety/depression, cognitive impairment, memory loss, and insomnia. They will be divided into four treatment groups according to their main clinical symptoms, and the participants in the treatment group will be treated with the selected acupoints according to their disease category. The selection of the acupoints for each syndrome type are formulated with reference to the 13th Five-Year Plan Textbook "Acupuncture and Moxibustion Therapy" published by the China Press of Traditional Chinese Medicine Co.,Ltd. |
|
| Conventional treatment | No Intervention | The control group will not receive acupuncture therapy. This study does not require the use of a placebo. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At baseline (before intervention), at 6, 12 weeks (the end of intervention), at 18 weeks (follow-up) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At baseline (before intervention), at 6, 12 weeks (the end of intervention), at 18 weeks (follow-up) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Linda Zhong, MD., Ph.D | Contact | 85234116523 | ldzhong0305@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Dong Jue Wei, MD. | Hong Kong Baptist University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Linda Zhong | Recruiting | Kowloon Tong | Kowloon | Hong Kong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33692530 | Background | Sudre CH, Murray B, Varsavsky T, Graham MS, Penfold RS, Bowyer RC, Pujol JC, Klaser K, Antonelli M, Canas LS, Molteni E, Modat M, Jorge Cardoso M, May A, Ganesh S, Davies R, Nguyen LH, Drew DA, Astley CM, Joshi AD, Merino J, Tsereteli N, Fall T, Gomez MF, Duncan EL, Menni C, Williams FMK, Franks PW, Chan AT, Wolf J, Ourselin S, Spector T, Steves CJ. Attributes and predictors of long COVID. Nat Med. 2021 Apr;27(4):626-631. doi: 10.1038/s41591-021-01292-y. Epub 2021 Mar 10. | |
| 34582441 |
| Label | URL |
|---|---|
| A clinical case definition of post COVID-19 condition | View source |
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Not provided
| ID | Term |
|---|---|
| D000094024 | Post-Acute COVID-19 Syndrome |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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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.
|
| 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. |
| 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 | 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). | At baseline (before intervention), at 6, 12 weeks (the end of intervention), at 18 weeks (follow-up) |
| 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. | At baseline (before intervention), at 6, 12 weeks (the end of intervention), at 18 weeks (follow-up) |
| Hamilton Anxiety Rating Scale (HAMA) | 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. | At baseline (before intervention), at 6, 12 weeks (the end of intervention), at 18 weeks (follow-up) |
| Traditional Chinese Medicine Symptom Scale | 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. | At baseline (before intervention), at 6, 12 weeks (the end of intervention), at 18 weeks (follow-up) |
| Background |
| Taquet M, Dercon Q, Luciano S, Geddes JR, Husain M, Harrison PJ. Incidence, co-occurrence, and evolution of long-COVID features: A 6-month retrospective cohort study of 273,618 survivors of COVID-19. PLoS Med. 2021 Sep 28;18(9):e1003773. doi: 10.1371/journal.pmed.1003773. eCollection 2021 Sep. |
| 19502460 | Background | Suzuki M, Yokoyama Y, Yamazaki H. Research into acupuncture for respiratory disease in Japan: a systematic review. Acupunct Med. 2009 Jun;27(2):54-60. doi: 10.1136/aim.2009.000471. |
| 31539602 | Background | von Trott P, Oei SL, Ramsenthaler C. Acupuncture for Breathlessness in Advanced Diseases: A Systematic Review and Meta-analysis. J Pain Symptom Manage. 2020 Feb;59(2):327-338.e3. doi: 10.1016/j.jpainsymman.2019.09.007. Epub 2019 Sep 18. |
| 24349293 | Background | Cheong KB, Zhang JP, Huang Y, Zhang ZJ. The effectiveness of acupuncture in prevention and treatment of postoperative nausea and vomiting--a systematic review and meta-analysis. PLoS One. 2013 Dec 13;8(12):e82474. doi: 10.1371/journal.pone.0082474. eCollection 2013. |
| 29128952 | Background | Zhang Y, Lin L, Li H, Hu Y, Tian L. Effects of acupuncture on cancer-related fatigue: a meta-analysis. Support Care Cancer. 2018 Feb;26(2):415-425. doi: 10.1007/s00520-017-3955-6. Epub 2017 Nov 11. |
| 27430619 | Background | Lee SH, Lim SM. Acupuncture for insomnia after stroke: a systematic review and meta-analysis. BMC Complement Altern Med. 2016 Jul 19;16:228. doi: 10.1186/s12906-016-1220-z. |
| 29705474 | Background | Amorim D, Amado J, Brito I, Fiuza SM, Amorim N, Costeira C, Machado J. Acupuncture and electroacupuncture for anxiety disorders: A systematic review of the clinical research. Complement Ther Clin Pract. 2018 May;31:31-37. doi: 10.1016/j.ctcp.2018.01.008. Epub 2018 Jan 31. |
| 22210103 | Background | Flower A, Witt C, Liu JP, Ulrich-Merzenich G, Yu H, Lewith G. Guidelines for randomised controlled trials investigating Chinese herbal medicine. J Ethnopharmacol. 2012 Apr 10;140(3):550-4. doi: 10.1016/j.jep.2011.12.017. Epub 2011 Dec 23. |
| 23159157 | Background | Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M. Developing and evaluating complex interventions: the new Medical Research Council guidance. Int J Nurs Stud. 2013 May;50(5):587-92. doi: 10.1016/j.ijnurstu.2012.09.010. Epub 2012 Nov 15. No abstract available. |
| 18374841 | Background | Kahn RS, Fleischhacker WW, Boter H, Davidson M, Vergouwe Y, Keet IP, Gheorghe MD, Rybakowski JK, Galderisi S, Libiger J, Hummer M, Dollfus S, Lopez-Ibor JJ, Hranov LG, Gaebel W, Peuskens J, Lindefors N, Riecher-Rossler A, Grobbee DE; EUFEST study group. Effectiveness of antipsychotic drugs in first-episode schizophrenia and schizophreniform disorder: an open randomised clinical trial. Lancet. 2008 Mar 29;371(9618):1085-97. doi: 10.1016/S0140-6736(08)60486-9. |
| 19001484 | Background | Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, Oxman AD, Moher D; CONSORT group; Pragmatic Trials in Healthcare (Practihc) group. Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ. 2008 Nov 11;337:a2390. doi: 10.1136/bmj.a2390. |
| 25956159 | Background | Loudon K, Treweek S, Sullivan F, Donnan P, Thorpe KE, Zwarenstein M. The PRECIS-2 tool: designing trials that are fit for purpose. BMJ. 2015 May 8;350:h2147. doi: 10.1136/bmj.h2147. No abstract available. |
| 18183564 | Background | Hertzog MA. Considerations in determining sample size for pilot studies. Res Nurs Health. 2008 Apr;31(2):180-91. doi: 10.1002/nur.20247. |
| 20532100 | Background | Kadam P, Bhalerao S. Sample size calculation. Int J Ayurveda Res. 2010 Jan;1(1):55-7. doi: 10.4103/0974-7788.59946. No abstract available. |
| D007239 |
| Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |