Acupuncture in a group setting for chronic knee pain: ScrutiKnee

Plain English summary of protocol

Background and study aims
Osteoarthritis (OA) is a common cause of pain and disability, affecting one in five people aged over 50 in the UK. Previous studies show that acupuncture (a form of ancient Chinese medicine in which fine needles are inserted into the skin at certain points on the body) is effective in treating pain in people with mild to moderate OA of the knee. Studies also show that every person with osteoarthritis of the knee should be offered exercise and advice. What we don’t yet know is whether exercise, advice and acupuncture can help people with severely painful knee osteoarthritis, who may otherwise be considered for joint replacement surgery. Another issue is cost. In some clinics in the NHS, acupuncture is being given to a group of patients at the same time to reduce its cost. There has been no research on how well acupuncture works when it is given to people who are part of a group, nor whether or not this reduces the cost of treatment. ScrutiKnee is a initial small study. So it is not designed to see if exercise, advice and acupuncture are effective, but it is designed to provide information for a larger study which will test whether these treatments are effective and cost-effective. ScrutiKnee will find out whether patients are interested in participating, and how we can best measure the changes we want to measure, such as pain and the use of health services.

Who can participate?
Men and women over the age of 45 can take part in ScrutiKnee, if they have had painful OA knees for at least a year, and if the pain has troubled them for most days in the previous month. The pain must be of a particular severity, as scored by the common scale, the Oxford Knee Score.

What does the study involve?
Patients who might be eligible are identified from their general practitioner's (GPs) databases and sent a letter. If patients are interested in taking part and seem eligible, they are phoned and sent an information leaflet about the study. Those still interested are invited to attend the research centre and consented to have their knees examined by a research nurse. Participants are selected at random to receive one of three treatments. All participants receive a booklet on self-management advice and exercises which is considered ‘standardised care’. The three treatment groups are:
1. The standardised care on its own
2. Standardised care plus acupuncture as part of a group with other participants, and
3. Standardised care plus acupuncture one-to-one with the practitioner.
The acupuncture clinic is in Plymouth (Teaching) Primary Care Trust. The acupuncture is provided by a Chartered Physiotherapist trained in acupuncture. A course of acupuncture consists of six to ten treatments over 12 weeks – the treatment stops at six weeks if there is no improvement in the symptoms.
Participants are asked at the start and at the end of the treatment period to complete questionnaires about the impact their knee pain has on their life.
In addition, since this is a initial study arranged to help design the main study, participants are asked to write comments on their experiences in the study. Some participants are also invited for interview to report their experiences in greater detail.

What are the possible benefits and risks of participating?
Stuides shows that advice and exercise can produce long-term benefit for people with OA knee. It is not clear whether acupuncture provides any additional pain relief for people with severely painful OA knee. However there could be benefits to future patients by showing whether or not acupuncture is worth providing in the NHS for people with severely painful OA knee. The risks of taking part are minimal. Acupuncture is a very safe treatment when given by properly trained clinicians. Occasionally acupuncture can make people feel nauseous or faint or experience a temporary increase in pain either during or after treatment. Participants are warned of these potential side-effects before consenting to have acupuncture.

Where is the study run from?
The study is run from the Peninsula Medical School, University of Plymouth, and the Peninsula Clinical Trials Unit (PenCTU) based in Plymouth.

When is the study starting and how long is it expected to run?
February 2012 to September 2012

Who is funding the study?
National Institute for Health Research, Research for Patient Benefit (NIHR-RfPB) (UK)

Who is the main contact?
Dr Adrian White
Adrian.white@plymouth.ac.uk

Study website

Contact information

Dr Adrian White
Scientific

I T T C Building
1 Tamar Science Park
Davy Road
Plymouth
PL6 8BX
United Kingdom

ORCID ID	0000-0002-9002-0907
Email	Adrian.white@plymouth.ac.uk

Study information

Eligibility

Locations

Countries of recruitment

• England
• United Kingdom

Study participating centre

Sponsor information

Funders

Funder type

Government

Results and Publications

Study outputs

Editorial Notes

20/10/2017: PubMed address added/
22/02/2016: Publication reference added.