Acupuncture for Post COVID-19 Fatigue

NCT ID: NCT05749757

Last Updated: 2023-03-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-01

Study Completion Date

2023-12-31

Brief Summary

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

Detailed Description

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Conditions

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Acupuncture Post COVID-19 Condition Fatigue

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Acupuncture

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.

Group Type EXPERIMENTAL

Acupuncture

Intervention Type DEVICE

For Shangyitang acupoint, the needle will be inserted towards the direction of nasal tip horizontally to a depth of 10-20mm without any manipulation, and a pad will be adhered afterwards. For other acupoints, the needles will be inserted through adhesive pads to 10-20mm. Needles will be lifted, thrust, and twirled for 3 times to achieve deqi sensation, and will be manipulated every ten minutes during 30-minute maintenance.

Sham Acupuncture

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.

Group Type SHAM_COMPARATOR

Sham Acupuncture

Intervention Type DEVICE

For all the points, the needles will be inserted into adhesive pads without skin penetration. Needles will be lifted, thrust and twirled for 3 times to mimic real acupuncture. No manipulation will be conducted during 30-minute maintenance.

Interventions

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Acupuncture

For Shangyitang acupoint, the needle will be inserted towards the direction of nasal tip horizontally to a depth of 10-20mm without any manipulation, and a pad will be adhered afterwards. For other acupoints, the needles will be inserted through adhesive pads to 10-20mm. Needles will be lifted, thrust, and twirled for 3 times to achieve deqi sensation, and will be manipulated every ten minutes during 30-minute maintenance.

Intervention Type DEVICE

Sham Acupuncture

For all the points, the needles will be inserted into adhesive pads without skin penetration. Needles will be lifted, thrust and twirled for 3 times to mimic real acupuncture. No manipulation will be conducted during 30-minute maintenance.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guang'anmen Hospital of China Academy of Chinese Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Yuanjie Sun

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Yuanjie Sun

Role: CONTACT

86 18810337542

Other Identifiers

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2023-013-KY-01

Identifier Type: -

Identifier Source: org_study_id

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