Acupuncture for Post COVID-19 Fatigue

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Status: Not yet enrolling

Conditions: Post COVID-19 Condition; Acupuncture; Fatigue

Treatments: Device: Sham Acupuncture; Device: Acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT05749757

2023-013-KY-01

Details and patient eligibility

About

The aim of the study is to access the efficacy and safety of acupuncture for post COVID-19 fatigue.

Enrollment: 84 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged between 18 and 75.
• Confirmed COVID-19 infection in the past four weeks to six months, and a negative RT PCR and/or Antigen-Based Rapid Test at present.
• A main complaint of fatigue emerged newly following COVID-19 infection.
• A score of ≥15 on Chalder Fatigue Scale (CFS, score range 0-33).
• Participating the trial volunteerly and providing written informed consent.

Exclusion criteria

• Severe anxiety and depression: a score of ≥25 on 17-item Hamilton Rating Scale for Depression (HAMD-17) and/or a score scores >29 on 14-item Hamilton Rating Scale for Anxiety (HAMA-14).
• Significant cognitive dysfunction or suicidal tendency.
• Usage of anti-anxiety and/or anti-depression treatments over the last three months.
• Previously diagnosed hypothyroidism or chronic fatigue syndrome.
• A complication of serious and poorly controlled underlying diseases.
• Having symptoms indicating emergency or severe conditions.
• Concurrent use of other anti-fatigue agents or treatments at present.
• Impaired walking ability.
• Pregnant and/or lactating or planning to get pregnant in the next 4 months.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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84 participants in 2 patient groups

Acupuncture

Experimental group

Description:

Hwato brand disposable acupuncture needles (size 0.30 × 40 mm) and adhesive pads will be used. Acupoints of Guanyuan, Zhongwan, Tianshu, Zusanli, Taixi, Shangyintang, Taiyang, Hegu, Taichong and Shenmen will be selected. Participants will receive a total of 10-session acupuncture treatment during four weeks, three times a week in the first two weeks and twice a week in the last two weeks.

Treatment:

Device: Acupuncture

Sham Acupuncture

Sham Comparator group

Description:

Hwato brand disposable placebo needles (with the handle identical to the needles in the acupuncture group and the body at a size 0.30 × 25 mm) and adhesive pads will be used. Acupoints of Guanyuan, Zhongwan, Tianshu, Zusanli, Taixi, Shangyintang, Taiyang, Hegu, Taichong and Shenmen will be selected. Participants will receive a total of 10-session sham acupuncture treatment during four weeks, three times a week in the first two weeks and twice a week in the last two weeks.

Treatment:

Device: Sham Acupuncture