Randomised Study to Investigate the Effectiveness of Acupuncture for the Relief of Long COVID-19 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. 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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Royal Marsden NHS Foundation Trust

Sutton, Surrey, SM2 5PT, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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 criteria

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

Treatment and study plan

Acupuncture

Other

Weekly treatment of 15 minutes for 6 weeks using Seirin 36 g 30 mm needles applied to two upper midline sternal points, thoracic paravertebral points, 5 pairs, 2 bilateral Trapezius trigger points, LI4, TE5, ST36, GB34, SP6, LR3 bilaterally, GV20 & GV24 midline.

Active Control

Other

Weekly contact once per week for 6 weeks for a semi-structured telephone consultation.

Primary outcomes

General Fatigue Score

Time frame: 6 weeks

The primary outcome will be the difference in General Fatigue scores, as self-reported by patients using the MFI ( Multidimensional Fatigue Inventory)

, at 6 weeks. The MFI is a brief 20 item validated scale measuring general fatigue and other dimensions of physical and mental fatigue, activity and motivation.

Sponsors and collaborators

Lead sponsor

Royal Marsden NHS Foundation Trust

Other

Registry information

Official study title

A Randomised Phase II Study to Investigate the Effectiveness of ACUpuncture for the Relief of Long COVID Related Fatigue.

Acronym: ACU-COVID

Important dates

Study start: 2022
Primary completion: 2024
Study completion: 2024
First posted: Jan 28, 2022
Registry last updated: Oct 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed