A Randomised Phase II Study to Investigate the Effectiveness of ACUpuncture for the Relief of Long COVID Related Fatigue.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 119
- 试验地点
- 2
- 主要终点
- General Fatigue Score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
- •Patients with heart valve pathology/dysfunction are contra-indicated from using semi-permanent acupuncture studs for maintenance
结局指标
主要结局
General Fatigue Score
时间窗: 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.
次要结局
未报告次要终点