Efficacy and safety of acupuncture treatment for fatigue after COVID-19 infection: a pilot randomized sham-controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0008656

Enrollment

Registered

2023-07-28

Start date

2023-09-04

Completion date

Unknown

Last updated

2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Others : During acupuncture treatment, the Park Sham Acupuncture Device is attached to the acupoint, and a single-use sterilized disposable needle (Acuprime, UK) will be used with a depth of 5-20 mm,

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Those who have been diagnosed with COVID-19 and quarantined (and cured) at least one month ago 2) Adults between 20 and 65 years of age 3) Those who are experiencing fatigue that has persisted for more than 4 weeks after being cured of COVID-19, and whose symptom intensity of 4 or higher on the 0-10 numeric rating scale 4) Those who voluntarilly agree to participate in the study through a written consent form after being clearly explained of the purpose and characteristics of this clinical study

Exclusion criteria

Exclusion criteria: 1) Those who have a history of diseases(cancer, anemia, hypothyroidism or psychiatric disease such as depression) or surgical operation that can cause sequelae before the infection of COVID-19 2) Those who have a fear of acupuncture treatment 3) Women who are pregnant, may become pregnant or are lactating 4) Those who are judged that it is difficult to comply with this treatment protocol, visiting the hospital, or filing in a questionnaire, etc. 5) Those who are participating in another clinical study 6) Subjects who are judged to be inappropriate for the clinical study by the researchers

Design outcomes

Primary

Measure	Time frame
0-10 numeric rating scale (NRS);Brief fatigue inventory (BFI);Fatigue severity scale(FSS);Adverse event evaluation after acupuncture treatment	—

Secondary

Measure	Time frame
EuroQoL-5Dimension-5L (EQ-5D-5L);Concomitant medications and changes in treatment history;Study design and subject compliance to acupuncture treatment;Was it Worth It (WIWI) questionnaires;Blinding index assessment for randomization	—

Countries

Korea, Republic of

Contacts

Public ContactJi-Su Lee

Kyung Hee University Oriental Medical Center

khkm.dlwlnt0114@gmail.com+82-2-958-9209

Outcome results