Efficacy of acupuncture in post-COVID fatigue – A randomised controlled pilot study

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2024
INTERVENTION: The intervention group will receive acupuncture consisting of 10 treatment sessions. Each session will be between 20‐30 minutes in length. Intervals between treatment sessions can vary from 3 to 7 days. However, according to feasibility and the circumstances of the participants (e.g., holidays or illness) longer intervals between sessions will be allowed. The treatment is semi‐standardized, with 2‐3 predefined and up to 15 other individually selectable acupuncture points. Acupuncture will be carried out by a licensed acupuncturist. Participants in the control group will not receive acupuncture treatment for three months. After three months they will be offered the acupuncture treatment described above. The randomisation will be done using REDcap ( a web application for building and managing online surveys and databases). CONDITION: Post‐COVID fatigue ; Not Applicable PRIMARY OUTCOME: Feasibility and acceptability measures:; The study design is well accepted by those persons meeting the inclusion criteria. This is defined by ; 1.The rate of persons consenting to participation is over 50% measured as the percentage of those who consent to the study out of those who have met the criteria (by using telephone interviews and questionnaires at baseline).; 2.More than 70% of the included persons complete the study (measured as the percentage of persons who completed the study out of those who were included in the study using notes of the participation in treatment sessions at the end of treatment. ; ; Primary outcome measure:; 1. Fatigue measured by the Chalder Fatigue Scale (CFS‐11) (by using the 0‐3 scale for each item) at the end of acupuncture treatment; SECONDARY OUTCOME: 1. Fatigue measured by the FA12 and FAS at the end of treatment and at 3‐months follow‐up; 2. Somatic and psychological outcomes such as pain, concentration, and health anxiety measured by using questionnaires at the end of treatment and at the 3‐months follow‐up; 3. Heart rate variability measured using a portable HRV measurement instrument with high signal quality at the end of treatment and at 3‐months follow‐up; 4. Psycho‐neuro‐immunologic parameters measured using blood sampling at the end of treatment and at 3‐months follow‐up INCLUSION CRITERIA: 1. Post‐COVID fatigue defined according to the WHO criteria: continuation or development of fatigue symptoms 3 months after a SARS‐CoV‐2 infection, with these symptoms lasting for at least 2 months with no other explanation 2. Actual CFS‐11 Score of >= 4 using a binary coding (0/1) in the first 10 items 3. Age = 18 years 4. Informed consent
Epistemonikos ID: a19778ba84d8c1ebc551923750968b20997e37a7
First added on: Mar 29, 2024