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

November 11, 2024 updated by: Zhong Lidan, Hong Kong Baptist University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Hong Kong
    • Kowloon
      • Kowloon Tong, Kowloon, Hong Kong
        • Recruiting
        • Linda Zhong
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acupuncture

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.
Device: 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 7), Sanyinjiao (SP 6), Anmian (EX-HN22), Sishencong (EX-HN1)
No Intervention: Conventional treatment
The control group will not receive acupuncture therapy. This study does not require the use of a placebo.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depression on the Chinese Beck Depression Inventory (CBDI)
Time Frame: 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.
At baseline (before intervention), at 6, 12 weeks (the end of intervention), at 18 weeks (follow-up)
Score of Insomnia Severity Index (ISI)
Time Frame: 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.
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
Time Frame: 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).
At baseline (before intervention), at 6, 12 weeks (the end of intervention), at 18 weeks (follow-up)
Hamilton Depression Scale (HAMD)
Time Frame: 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.
At baseline (before intervention), at 6, 12 weeks (the end of intervention), at 18 weeks (follow-up)
Hamilton Anxiety Rating Scale (HAMA)
Time Frame: 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.
At baseline (before intervention), at 6, 12 weeks (the end of intervention), at 18 weeks (follow-up)
Traditional Chinese Medicine Symptom Scale
Time Frame: 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.
At baseline (before intervention), at 6, 12 weeks (the end of intervention), at 18 weeks (follow-up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hong Kong Baptist University

Investigators

  • Study Chair: Dong Jue Wei, MD., Hong Kong Baptist University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 30, 2023

Primary Completion (Estimated)

January 31, 2026

Study Completion (Estimated)

April 30, 2026

Study Registration Dates

First Submitted

October 5, 2024

First Submitted That Met QC Criteria

October 8, 2024

First Posted (Actual)

October 9, 2024

Study Record Updates

Last Update Posted (Estimated)

November 13, 2024

Last Update Submitted That Met QC Criteria

November 11, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023Cmdevfund

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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