NCT05212688

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 119 (actual)
• Sponsor: Royal Marsden NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• COVID-19

Interventions

Type	Name	Description
OTHER	Acupuncture	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.
OTHER	Active Control	Weekly contact once per week for 6 weeks for a semi-structured telephone consultation.

Timeline

• Start date: 2022-07-19
• Primary completion: 2024-09-25
• Completion: 2024-09-25
• First posted: 2022-01-28
• Last updated: 2024-10-18

Locations

1 site across 1 country: United Kingdom