A pilot study to evaluate whether acupuncture is likely to reduce symptoms of breathlessness and anxiety during acute exacerbations of Chronic Obstructive Disease (COPD) - a single blind, placebo controlled trial

ISRCTN	ISRCTN61381178
DOI	https://doi.org/10.1186/ISRCTN61381178
Protocol serial number	N0295136390
Sponsor	Department of Health
Funder	University Hospitals Coventry and Warwickshire NHS Trust (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Mandy Barnett
Scientific

Radiotherapy Department
UHCW NHS Trust
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom

Phone	+44 (0)2476 602020 Ext 8779
Email	m.m.barnett@warwick.ac.uk

Primary study design	Interventional
Study design	Single blind placebo controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Is acupuncture likely to reduce symptoms of breathlessness and anxiety during acute exacerbations of COPD?
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Respiratory: Chronic obstructive pulmonary disease (COPD)
Intervention	Acupunture vs placebo
Intervention type	Other
Primary outcome measure(s)	1. Reduction in breathlessness measured using a 10 cm visual analogue scale and the Borg score of perceived breathlessness 2. Reduction in anxiety using a 10 cm visual analogue scale
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/01/2005

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	40
Key inclusion criteria	Population of patients admitted to Walsgrave Hospital with an acute exacerbation of COPD during a 4-month period.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	15/01/2004
Date of final enrolment	31/01/2005

Radiotherapy Department

Coventry
CV2 2DX
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/03/2009		Yes	No