Ask to take part

Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Ms Karen Charlesworth
+44 (0)1904 343305
kc1206@york.ac.uk


More information about this study, what is involved and how to take part can be found on the study website.

Study Location:

Skip to Main Content
English | Cymraeg
Be Part of Research - Trial Details - A study to assess the feasibility of a future trial on the effect of acupuncture and nutritional therapy in addition to usual care for people with atrial fibrillation

A study to assess the feasibility of a future trial on the effect of acupuncture and nutritional therapy in addition to usual care for people with atrial fibrillation

Not Recruiting

Open to: All Genders

Age: Adult

Medical Conditions

Atrial fibrillation


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.



Background and study aims
Atrial fibrillation (AF) is a common cardiac rhythm disorder which carries an increased risk of stroke. Risk factors include age, lifestyle factors, other conditions such as diabetes or high blood pressure, and heart failure. The incidence of AF in the UK is increasing rapidly in line with an ageing population and unhelpful lifestyle choices, and current costs are estimated at up to 2.4% of total NHS expenditure. Current treatment options are not always successful in reducing symptoms, with up to 50% of patients experiencing recurrence of symptoms within three months of some treatments. Adverse effects of treatment may affect quality of life for some. Management of AF increasingly focuses on improving quality of life and relieving symptoms.

A small body of evidence suggests that traditional acupuncture and nutritional therapy may reduce symptoms and increase quality of life. This feasibility study will test some aspects of a future large-scale trial.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

06 Sep 2021 31 Mar 2022

Publications

2025 Results article in https://pubmed.ncbi.nlm.nih.gov/40001242/ (added 26/02/2025)

Participants are randomly allocated to one of three groups: Acupuncture + usual care; Nutritional Therapy + usual care; Usual care alone. In the Acupuncture group, participants will receive up to eight weekly acupuncture treatments with a private acupuncturist while they continue their usual care for AF; in the Nutritional Therapy group, participants will receive up to three monthly nutrition consultations with a private Nutritional Therapy practitioner while they continue their usual care for AF; in the Usual care group, participants receive their usual NHS care for AF only.

The study is aiming to determine the feasibility of a future larger-scale trial, and this means all assessments from the future trial will be carried out at two measurement points. These are at pre-treatment stage three months. The assessments include: measurements of hip and waist, height, weight and blood pressure; monitoring of medications; questionnaires; takeaway symptom diaries completed over a 7-day period; SMS polling via participants’ mobile phones; and interviews for a sub-set of participants who are willing to be interviewed. 33% of all participants will be randomly chosen to wear a small ECG monitor, the CardioSTAT®, for 7 days, twice during the study.

What are the possible benefits and risks of participating?
Participants in the study are contributing to our knowledge about future potential treatments for AF that may help people with AF to have a better quality of life and fewer symptoms. We cannot promise that people who receive acupuncture or nutritional therapy on the study will definitely experience improved quality of life or reduced symptoms – but the information they give will help us to know whether it is feasible to carry out a large-scale trial to understand the effect of these treatments for people with AF.

There are minimal risks for participants in this study. Acupuncture has a good safety record, although there is a risk of superficial bleeding or bruising particularly if you are taking anti-coagulant drugs. Acupuncturists are trained to adapt treatment to maintain safety. Nutritional Therapy does not have an established safety record, but there are few risks that we have been able to discover in the published literature. Nutritional therapy practitioners are also trained to adapt dietary advice to maintain safety.

Where is the study run from?
The Northern College of Acupuncture (UK). Private practitioners of acupuncture and nutritional therapy participating in the study are located within five miles of central York.

When is the study starting and how long is it expected to run for?
From October 2018 to May 2022

Who is funding the study?
The National Institute of Health Research (NIHR), the British Acupuncture Council (BAcC), and the Northern College of Acupuncture (NCA) (UK)

Who is the main contact?
Ms Karen Charlesworth
kc1206@york.ac.uk

_____

Previous plain English summary:

Background and study aims
Atrial fibrillation (AF) is a common cardiac rhythm disorder which carries an increased risk of stroke. Risk factors include age, lifestyle factors, other conditions such as diabetes or high blood pressure, and heart failure. The incidence of AF in the UK is increasing rapidly in line with an ageing population and unhelpful lifestyle choices, and current costs are estimated at up to 2.4% of total NHS expenditure. Current treatment options are not always successful in reducing symptoms, with up to 50% of patients experiencing recurrence of symptoms within three months of some treatments. Adverse effects of treatment may affect quality of life for some. Management of AF increasingly focuses on improving quality of life and relieving symptoms.

A small body of evidence suggests that traditional acupuncture and nutritional therapy may reduce symptoms and increase quality of life. This feasibility study will test some aspects of a future large-scale trial.

Who can participate?
Patients, aged between 45 and 70 years, with paroxysmal AF that they are aware of (can feel).

What does the study involve?
Participants are randomly allocated to one of three groups: Acupuncture + usual care; Nutritional Therapy + usual care; Usual care alone. In the Acupuncture group, participants will receive up to eight weekly acupuncture treatments with a private acupuncturist while they continue their usual care for AF; in the Nutritional Therapy group, participants will receive up to three monthly nutrition consultations with a private Nutritional Therapy practitioner while they continue their usual care for AF; in the Usual care group, participants receive their usual NHS care for AF only.

The study is aiming to determine the feasibility of a future larger-scale trial, and this means all assessments from the future trial will be carried out at three measurement points. These are at pre-treatment stage, three months and six months. The assessments include: measurements of hip and waist, height, weight and blood pressure; monitoring of medications; questionnaires; takeaway symptom diaries completed over a 7-day period; SMS polling via participants’ mobile phones; and interviews for a sub-set of participants who are willing to be interviewed. 33% of all participants will be randomly chosen to wear a small ECG monitor, the CardioSTAT®, for 7 days, three times during the study.


Patients, aged between 45 and 70 years, with paroxysmal AF that they are aware of (can feel).
Patients, aged between 45 and 70 years, with paroxysmal AF that they are aware of (can feel).

You can take part if:


Current inclusion criteria as of 22/02/2021:

1. Aged between 45 and 70 years
2. Diagnosis of paroxysmal AF between 6 months and years before enrolment
3. Stroke prevention measures offered/applied where indicated
4. Perceptible paroxysmal atrial fibrillation of at least weekly frequency despite current treatment regime
5. Owner of, and able to use, a mobile phone, and willing to use this to receive and respond to study communications
6. Home broadband of sufficient capacity to sustain NT appointments and study assessments
7. Owner of, and able to use, a device equipped with Microsoft Teams video-calling software OR happy to use study iPad
8. Willing to have traditional acupuncture or nutritional therapy adjunctively to usual treatment for AF, or usual treatment alone
9. Willing to travel up to five miles from York Hospital to attend appointments for acupuncture (£5 flat travel costs offset paid per visit)
10. Willing to wear a CardioSTAT® ambulatory ECG device (AED) for 2 x 7 day periods over the course of approximately 3 months, then return it by freepost to the manufacturer for data analysis
11. Speak/understand English well enough to engage meaningfully with interventions and assessments
12.


You may not be able to take part if:


Current exclusion criteria as of 22/02/2021:

1. Diagnosed with valvular AF2. Pacemaker, implantable defibrillator, neurostimulator, any other type of active implantable device fitted3. Diagnosed with kidney disease levels 4 or 54. Diagnosed with terminal or severe illness of any kind5. Diagnosed with any blood clotting disorder6. Diagnosed (including self-diagnosis) with any condition or disorder contraindicating suitable moderate exercise7. Diagnosed (including self-diagnosis) with any eating disorder past or present8. Pregnant or trying to conceive9. Currently taking part in other research rendering the participant unable to have either intervention, or which is likely to affect study outcomes, or which renders it unsafe for the participant to continue10. Currently having or have had in the last six months a course of acupuncture or nutritional therapy11. Classified as shielding, clinically vulnerable or clinically extremely vulnerable with regard to COVID-19, or living with or bubbled with anyone in any of these categories12. Regularly using a TENS machine or receiving any kind of energy delivery therapy to the upper torso (diathermy therapy, diagnostic or therapeutic ultrasound, radiation therapy, electrosurgery or x-ray)13. Any other clinical reason why patient should be excluded, in the clinical judgement of the patient's GP

_____

Previous exclusion criteria:

1. Diagnosed with valvular or permanent AF2. Pacemaker fitted3. Diagnosed with kidney disease levels 4 or 54. Diagnosed with terminal or severe illness of any kind5. Diagnosed with any blood clotting disorder6. Diagnosed (including self-diagnosis) with any condition or disorder contraindicating suitable moderate exercise7. Diagnosed (including self-diagnosis) with any eating disorder past or present8. Pregnant or trying to conceive9. Currently taking part in other research rendering the participant unable to have either intervention, or which is likely to affect study outcomes, or which renders it unsafe for the participant to continue


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • The Northern College of Acupuncture
    61 Micklegate
    York
    YO1 6LJ
  • Priory Medical Group
    Priory Medical Centre Cornlands Road Acomb
    York
    YO24 3WX
  • Jorvik Gillygate Practice
    Woolpack House The Stonebow
    York
    YO1 7NP
  • Pocklington Group Practice
    The Beckside Centre 1 Amos Drive Pocklington
    York
    YO42 2BS
  • MyHealth Strensall
    Southfields Road Strensall
    York
    YO32 5UA

Participants in the study are contributing to our knowledge about future potential treatments for AF that may help people with AF to have a better quality of life and fewer symptoms. We cannot promise that people who receive acupuncture or nutritional therapy on the study will definitely experience improved quality of life or reduced symptoms – but the information they give will help us to know whether it is feasible to carry out a large-scale trial to understand the effect of these treatments for people with AF.
There are minimal risks for participants in this study. Acupuncture has a good safety record, although there is a risk of superficial bleeding or bruising particularly if you are taking anti-coagulant drugs. Acupuncturists are trained to adapt treatment to maintain safety. Nutritional Therapy does not have an established safety record, but there are few risks that we have been able to discover in the published literature. Nutritional therapy practitioners are also trained to adapt dietary advice to maintain safety.
Participants in the study are contributing to our knowledge about future potential treatments for AF that may help people with AF to have a better quality of life and fewer symptoms. We cannot promise that people who receive acupuncture or nutritional therapy on the study will definitely experience improved quality of life or reduced symptoms – but the information they give will help us to know whether it is feasible to carry out a large-scale trial to understand the effect of these treatments for people with AF.
There are minimal risks for participants in this study. Acupuncture has a good safety record, although there is a risk of superficial bleeding or bruising particularly if you are taking anti-coagulant drugs. Acupuncturists are trained to adapt treatment to maintain safety. Nutritional Therapy does not have an established safety record, but there are few risks that we have been able to discover in the published literature. Nutritional therapy practitioners are also trained to adapt dietary advice to maintain safety.

Ms Karen Charlesworth
+44 (0)1904 343305
kc1206@york.ac.uk



More information about this study, what is involved and how to take part can be found on the study website.


The study is sponsored by University of York and funded by National Institute for Health Research; The British Acupuncture Council; Northern College of Acupuncture.




We'd like your feedback

Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.


Is this study information helpful?

What will you do next?

Read full details for Trial ID: ISRCTN13671984

Or CPMS 45473

Last updated 26 February 2025

This page is to help you find out about a research study and if you may be able to take part

You can print or share the study information with your GP/healthcare provider or contact the research team directly.