Acupuncture for Post COVID-19 Condition (Long COVID) Neuropsychiatric Symptoms

Официальное название

Acupuncture for Long COVID Neuropsychiatric Symptoms: a Pragmatic,Randomized Clinical Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Acupuncture
  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

Первичные конечные точки

• Cognitive score on the Chinese version of the Mini-Mental State Examination (MMSE) scale [Срок оценки: At baseline (before intervention), at 6, 12 weeks (the end of intervention), at 18 weeks (follow-up)]

Вторичные конечные точки (6)

• Depression on the Chinese Beck Depression Inventory (CBDI) [Срок оценки: At baseline (before intervention), at 6, 12 weeks (the end of intervention), at 18 weeks (follow-up)]
• Score of Insomnia Severity Index (ISI) [Срок оценки: 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 [Срок оценки: At baseline (before intervention), at 6, 12 weeks (the end of intervention), at 18 weeks (follow-up)]
• Hamilton Depression Scale (HAMD) [Срок оценки: At baseline (before intervention), at 6, 12 weeks (the end of intervention), at 18 weeks (follow-up)]
• Hamilton Anxiety Rating Scale (HAMA) [Срок оценки: At baseline (before intervention), at 6, 12 weeks (the end of intervention), at 18 weeks (follow-up)]
• Traditional Chinese Medicine Symptom Scale [Срок оценки: At baseline (before intervention), at 6, 12 weeks (the end of intervention), at 18 weeks (follow-up)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Гонконг · 1 центр

• Linda Zhong — Kowloon Tong

Публикации

• 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 PMID 33692530
• 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. PMID 34582441
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• 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. PMID 31539602
• 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. PMID 24349293
• 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. PMID 29128952
• 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. PMID 27430619
• 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. PMID 29705474

Идентификаторы

NCT: NCT06633666 · 2023Cmdevfund

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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