Status:
COMPLETED
Randomised Study to Investigate the Effectiveness of Acupuncture for the Relief of Long COVID-19 Related Fatigue
Lead Sponsor:
Royal Marsden NHS Foundation Trust
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The Covid pandemic has left us with a significant number of people suffering from Long COVID, which is a clinical diagnosis of significant and varying ongoing symptoms at least 12 weeks following COVI...
Eligibility Criteria
Inclusion
- Able to give informed consent.
- Male or female, age \> 18 years.
- Female patients of childbearing age must confirm their intention not to fall pregnant during the study period of 6 weeks.
- A clinical diagnosis of Long COVID a fatigue score of ≥ 5 on the C19-YRS First Assessment
- A self-reported fatigue score on the C19-YRS ≥ 2 points more severe than their pre-COVID baseline
- More than 12 weeks following a positive COVID-19 swab test (lateral flow or PCR) or an illness in keeping with COVID-19 infection in the opinion of the Chief Investigator, despite the absence of swab confirmation (not tested or test negative).
- Where applicable, have completed any other therapeutic rehabilitation intervention for Long COVID-related fatigue.
- Willing and able to attend for a course of 6 once per week acupuncture treatments
- Co-existing reversible causes of fatigue and/or breathlessness medically optimized
- If a patient has ongoing breathlessness a chest X-ray should have been performed
- If on steroids should be on stable dose for at least two weeks at time of study entry
- If taking other dietary/vitamin interventions should be on a stable regimen for at least two weeks at the time of study entry
- If vaccinated should be a least two weeks post last vaccine dose or booster
- Participants with a history of cancer must be on a stable dose of treatments such as oral TKIs, or antiestrogen therapies or be more than 2 years from diagnosis and completion of radical treatment
- Where applicable, participants on aspirin, clopidogrel or oral anticoagulants are on a stable dose and discussed with the acupuncture clinician (Dr Jacqueline Filshie or a suitably qualified member of her team) before study entry.
Exclusion
- Recent acupuncture in the last 4 weeks
- Contraindication to acupuncture in the opinion of the acupuncture clinician (Dr Jacqueline Filshie or a suitably qualified member of her team).
- Patients currently receiving chemotherapy or immunotherapy at regular intervals likely to induce cyclical fatigue or within the last 12 months.
- Patients currently receiving radiotherapy or within the last 12 months
- Pregnancy
- Patients with heart valve pathology/dysfunction are contra-indicated from using semi-permanent acupuncture studs for maintenance
Key Trial Info
Start Date :
July 19 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 25 2024
Estimated Enrollment :
119 Patients enrolled
Trial Details
Trial ID
NCT05212688
Start Date
July 19 2022
End Date
September 25 2024
Last Update
October 18 2024
Active Locations (1)
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1
The Royal Marsden NHS Foundation Trust
Sutton, Surrey, United Kingdom, SM2 5PT