COVID-19 Clinical Trial
Official title:
A Randomised Phase II Study to Investigate the Effectiveness of ACUpuncture for the Relief of Long COVID Related Fatigue
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 COVID-19 infection and characterised frequently by fatigue and breathlessness. Randomised studies have shown that both these symptoms can be helped by acupuncture in both cancer patients and non cancer situations. Fatigue in the largest study, was assessed by the multiple functional inventory (MFI) score, assessing 5 domains of health, to give a single score. Full Set of Project Data IRAS Version 6.1 5 DRAFT Patients have been taught to self administer acupuncture in one study. Dyspnoea in the UK acupuncture study was assessed by a visual analogue scale (VAS) and a modified Borg score. This is a randomised study in 160 people with and without cancer, who fit the definition of Long COVID and have a fatigue score of >5, on the UK developed, COVID-19 Yorkshire Rehabilitation Screen. After baseline workup as per national Long COVID guidelines, participants who consent will be randomised to either acupuncture given weekly for 6 weeks or telephone consultation and advice weekly for 6 weeks. A number of other questionnaires will be completed by both groups at baseline, 2, 6 and 12 weeks, including the MFI, modified Borg and VASs. The primary endpoint is General Fatigue scores, as self-reported by patients using the MFI, at 6 weeks. A 2-unit difference between groups (Acupuncture vs Active Control) in General Fatigue score is considered clinically important. The secondary endpoints will include differences in scores of various questionnaires and tests.
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| NCT number | NCT05212688 |
| Study type | Interventional |
| Source | Royal Marsden NHS Foundation Trust |
| Contact | Imogen Locke |
| Phone | 0208664011 |
| [email protected] | |
| Status | Not yet recruiting |
| Phase | Phase 2 |
| Start date | March 1, 2022 |
| Completion date | March 1, 2025 |
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