Clinical trial NCT05212688: Randomised Study to Investigate the Effectiveness of Acupuncture for the Relief of Long COVID-19 Related Fatigue
Official title: A Randomised Phase II Study to Investigate the Effectiveness of ACUpuncture for the Relief of Long COVID Related Fatigue.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: COVID-19
Lead sponsor: Royal Marsden NHS Foundation Trust
Sponsor class: OTHER
First posted: 2022-01-28
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Acupuncture vs Control
Primary purpose: TREATMENT

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 COVID-19 infection and characterised frequently by fatigue and breathlessness. Acupuncture has been shown to help breathlessness and fatigue in other conditions including in patients with cancer. Cancer related fatigue in the largest study, was assessed by the multiple functional inventory (MFI) score, assessing 5 domains of health, to give a single score.

We aim to randomise 160 patients, 80 in each arm. Randomisation and recruitment should take 24 months.

Each patient will be offered 6 weeks of weekly acupuncture treatment with a structured questionnaire on wellbeing or no acupuncture with a structure questionnaire on well-being. Both groups of patients will be given continued general advice on management of their symptoms. The next point of involvement will be at 12 weeks which will also be the final visit unless patients in Arm B (Active Control) chose crossover to receive acupuncture. Data at this point will correspond to the end of the participants participation. Over the next 3 months data will be cleaned and analysed.

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.


Eligibility criteria: Inclusion Criteria:

1. Able to give informed consent.
2. Male or female, age \> 18 years.
3. Female patients of childbearing age must confirm their intention not to fall pregnant during the study period of 6 weeks.
4. A clinical diagnosis of Long COVID a fatigue score of ≥ 5 on the C19-YRS First Assessment
5. A self-reported fatigue score on the C19-YRS ≥ 2 points more severe than their pre-COVID baseline
6. 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).
7. Where applicable, have completed any other therapeutic rehabilitation intervention for Long COVID-related fatigue.
8. Willing and able to attend for a course of 6 once per week acupuncture treatments
9. Co-existing reversible causes of fatigue and/or breathlessness medically optimized
10. If a patient has ongoing breathlessness a chest X-ray should have been performed
11. If on steroids should be on stable dose for at least two weeks at time of study entry
12. If taking other dietary/vitamin interventions should be on a stable regimen for at least two weeks at the time of study entry
13. If vaccinated should be a least two weeks post last vaccine dose or booster
14. 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
15. 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 Criteria:

1. Recent acupuncture in the last 4 weeks
2. Contraindication to acupuncture in the opinion of the acupuncture clinician (Dr Jacqueline Filshie or a suitably qualified member of her team).
3. Patients currently receiving chemotherapy or immunotherapy at regular intervals likely to induce cyclical fatigue or within the last 12 months.
4. Patients currently receiving radiotherapy or within the last 12 months
5. Pregnancy
6. Patients with heart valve pathology/dysfunction are contra-indicated from using semi-permanent acupuncture studs for maintenance

Primary outcomes:
measure: General Fatigue Score
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Sutton
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust
state: Surrey
Study officials:
References: