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

Hong Kong Baptist University

Status

Enrolling

Conditions

Neuropsychiatric Symptom

Long Covid19

Acupuncture

Treatments

Device: Acupuncture

Study type

Interventional

Funder types

Other

Identifiers

NCT06633666

2023Cmdevfund

Details and patient eligibility

About

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.

Full 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.

Enrollment

160 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

160 participants in 2 patient groups

Acupuncture

Experimental group

Description:

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.

Treatment:

Device: Acupuncture

Conventional treatment

No Intervention group

Description:

The control group will not receive acupuncture therapy. This study does not require the use of a placebo.