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

Efficacy of acupuncture compared to a waiting control condition in patients with post-COVID fatigue - a randomised controlled pilot study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN15106165
Enrollment
50
Registered
2024-03-28
Start date
2024-04-02
Completion date
Unknown
Last updated
2024-04-15

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

Conditions

Post-COVID fatigue Not Applicable

Interventions

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 day

Sponsors

University Hospital Heidelberg
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 1. Acute diseases requiring treatment 2. Severe neurological diseases (severe persistent headache or cognitive impairment) 3. High-dose corticosteroid therapy 4. Immunosuppressive therapy 5. Pregnancy 6. Needle phobia 7. Insufficient understanding of the German or English language.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Germany

Contacts

Public ContactBeate Wild
beate.wild@med.uni-heidelberg.de+49 6221 568663

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026