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

INTERVENTION: Others(acupuncture treatment) : 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, depending on the anatomical location of the acupoint. The needle is retained for 20 minutes, and the treatment is administered three times a week for a total of 12 sessions over a period of 4 weeks. For sham acupuncture treatment, the Park Sham Acupuncture Device is attached to the acupoint, and a single‐use sterilized sham needle (Acuprime, UK) is used. The sham needle is a blunt needle that contacts the skin without penetration, being retained for 20 minutes. Sham acupuncture treatment is also administered three times a week for a total of 12 sessions over 4 weeks. ‐ A total of 10 acupuncture points are selected, including CV12, CV4, and bilateral LI4, SP6, ST36 and LI11. ‐ The patient s position during acupuncture is determined based on the acupoint location and the patient s condition, using the supine or sitting position. ‐ During the treatment, a barrier is installed to prevent the patient from observing the treatment process. ‐ Infrared lamp is applied to the CV12 and CV4 areas during the 20‐minute needle retention. CONDITION: Certain infectious and parasitic diseases PRIMARY OUTCOME: 0‐10 numeric rating scale (NRS) Adverse event evaluation after acupuncture treatment Brief fatigue inventory (BFI) Fatigue severity scale(FSS) SECONDARY OUTCOME: Blinding inde Xassessment for randomization Concomitant medications and changes in treatment history EuroQoL‐5Dimension‐5L (EQ‐5D‐5L) Study design and subject compliance to acupuncture treatment Was it Worth It (WIWI) questionnaires 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