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Long Covid19NCT06633666

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

A study testing Acupuncture in people with Long Covid19 and Neuropsychiatric Symptom, run by Hong Kong Baptist University at 1 site in Hong Kong.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Acupuncture
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
1 siteHong Kong
Study dates
30 Jul 2023to 30 Apr 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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;
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Linda Zhong, MD., Ph.D contact

85234116523

ldzhong0305@gmail.com

Hong Kong1 site, 1 recruiting

  • Linda Zhong

    Kowloon Tong, Kowloon

    Linda Zhong, MD,PhD, 34116523, ldzhong0305@gmail.com

    Recruiting

Other trials in Hong Kong

About this study

Official title: Acupuncture for Long COVID Neuropsychiatric Symptoms: a Pragmatic,Randomized Clinical 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.

Read the 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.

Being tested
Acupuncture
Medical subject headings
Post-Acute COVID-19 Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AcupunctureDevice

    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)
Study groups in NCT06633666
Study groupRoleWhat they receive
AcupunctureExperimentalThe 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.
Receives: Device: Acupuncture
Conventional treatmentNo interventionThe control group will not receive acupuncture therapy. This study does not require the use of a placebo.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: At baseline (before intervention), at 6, 12 weeks (the end of intervention), at 18 weeks (follow-up)

Secondary outcomes (6)

  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.

    Measured: 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.

    Measured: 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).

    Measured: 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.

    Measured: At baseline (before intervention), at 6, 12 weeks (the end of intervention), at 18 weeks (follow-up)

  5. 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.

    Measured: At baseline (before intervention), at 6, 12 weeks (the end of intervention), at 18 weeks (follow-up)

  6. 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.

    Measured: At baseline (before intervention), at 6, 12 weeks (the end of intervention), at 18 weeks (follow-up)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Oct 2024
  2. Study start30 Jul 2023
  3. Primary completion31 Jan 2026 (estimated)
  4. Study completion30 Apr 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Care provider, Outcomes assessor
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06633666
Sponsor's protocol ID
2023Cmdevfund
Status last verified
Nov 2024
First submitted
5 Oct 2024
Last updated
13 Nov 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 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.

    PubMed 34582441

  • 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.

    PubMed 19502460

  • 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 29705474

  • 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.

    PubMed 22210103

  • 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.

    PubMed 23159157

  • 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.

    PubMed 18374841

  • 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.

    PubMed 19001484

  • 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.

    PubMed 25956159

  • Hertzog MA. Considerations in determining sample size for pilot studies. Res Nurs Health. 2008 Apr;31(2):180-91. doi: 10.1002/nur.20247.

    PubMed 18183564

  • 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.

    PubMed 20532100

Questions about this trial

What is this clinical trial studying?

A study testing Acupuncture in people with Long Covid19 and Neuropsychiatric Symptom, run by Hong Kong Baptist University at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Linda Zhong, MD., Ph.D (85234116523, ldzhong0305@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cognitive score on the Chinese version of the Mini-Mental State Examination (MMSE) scale (time frame: At baseline (before intervention), at 6, 12 weeks (the end of intervention), at 18 weeks (follow-up)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06633666, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2024.

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