Acupuncture for Post COVID-19 Fatigue

NCT05749757 | Unknown

• 1 other identifier: 2023-013-KY-01
• Study Type: interventional
• Target: 84
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Acupuncture; Post COVID-19 Condition; Fatigue

Outcome Measures

Primary Outcomes (1)

• The change from baseline in the Chalder Fatigue Scale (CFS) score

  CFS evaluates physical and mental fatigue with two subscales and 11 items. Total fatigue score is obtained by summing 11 items, which were rated on a four-point Likert scale (0=better than usual, 1=no worse than usual, 2=worse than usual, and 3=much worse than usual). Higher scores indicate more severe fatigue.

  Week 4

Secondary Outcomes (11)

• The change from baseline in the Chalder Fatigue Scale (CFS) score

  Weeks 8, 12, and 16

• Proportion of participants with a score of less than 15 on CFS

  Weeks 4, 8, 12, and 16

• The change from baseline in the distance of Six-Minute Walk Test (6MWT).

  Weeks 4, 8 and 16

• The proportion of participants rated as "very much improved" or "much improved" based on the Patient Global Impression-Change (PGI-C).

  Weeks 4, 8, 12, and 16

• The change from baseline in the score of physical function dimension of Medical Outcomes Study 36-item Short-Form General Health Survey (SF-36).

  Weeks 4, 8, 12, and 16

Other Outcomes (2)

• Expectance assessment

  Baseline

• Blinding assessment

  Within 5 minutes after the either treatment in week 4

Study Arms (2)

Acupuncture

EXPERIMENTAL

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.

Device: Acupuncture

Sham Acupuncture

SHAM COMPARATOR

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.

Device: Sham Acupuncture

Interventions

Acupuncture 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.

Acupuncture

Sham Acupuncture 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.

Sham Acupuncture

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guang'anmen Hospital of China Academy of Chinese Medical Sciences: lead

MeSH Terms

Conditions

Fatigue

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Central Study Contacts

Yuanjie Sun

CONTACT

86 18810337542; puzhisun@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 28, 2023
• First Posted: March 1, 2023
• Study Start: March 1, 2023
• Primary Completion: July 31, 2023
• Study Completion: December 31, 2023
• Last Updated: March 2, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will be available with publication until until six months after publication.
• Access Criteria: Formal request should be sent to puzhisun@163.com with a methodologically sound proposal. Researchers whose proposal has been approved. Researchers whose proposal has been approved will sign a data access agreement.