Evaluating the effectiveness of acupuncture in defined aspects of stroke recovery.

ISRCTN	ISRCTN48408850
DOI	https://doi.org/10.1186/ISRCTN48408850
Secondary identifying numbers	SPGS816

Submission date: 23/01/2004
Registration date: 23/01/2004
Last edited: 26/01/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Contact information

Dr George Lewith
Scientific

School of Medicine
Centre Block
University of Southampton
Tremona Road
Southampton
SO16 6YD
United Kingdom

Phone	+44 (0)2380794594
Email	gl3@soton.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study hypothesis	Acupuncture in addition to conventional treatment will have a greater effect on recovery from stroke than intervention by a placebo/control. Background: Acute stroke counts for 12% of all death in Britain and an expected incidence of 500 per 250000 head of population, 40% of which will be admitted to hospital.
Ethics approval(s)	Not provided at time of registration
Condition	Cerebrovascular disease
Intervention	Both groups will receive rehabilitative care and one of two treatment groups. 1. Acupuncture treatment will consist of dry needling to 3 out of 4 points in the upper limb chosen from; LI4, LI10, SJ5, LI15 with GB20 and 4 out of 5 in the lower limb GB43, BG39, GB34, GB30, ST36. Scalp acupuncture will also be used. The scalp over the motor cortex being stimulated with dry needles to which a direct current of high frequency is applied. Treatment will last 40 minutes and be given 3 times a week for 4 weeks. 2. The control group will receive a mock transcutaneous electrical nerve stimulation (TENS) treatment with adhesive electrodes applied to the same points as in 1. The TENS machine will be adjusted at the output jack so no current flows but it will still retain visual signs of function. Standard physiotherapy will be given to both groups, receiving treatment 5 times a week sometimes twice a day.
Intervention type	Other
Primary outcome measure	1. Motricity Index 2. Nottingham Health Profile 3. Standard Barthel Index
Secondary outcome measures	Not provided at time of registration
Overall study start date	02/01/1997
Overall study end date	31/12/2001

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	Both
Target number of participants	105 patients randomised (5 centres) (added 26/01/10; see publication
Participant inclusion criteria	Patients who have recently suffered a stroke.
Participant exclusion criteria	1. History of previous stroke 2. Computed Tomography (CT) scan showing haemorrhage 3. Stroke without limb weakness 4. Unable to co-operate with treatments 5. Initial coma 6. Pacemaker 7. Significant co-morbidity
Recruitment start date	02/01/1997
Recruitment end date	31/12/2001

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

School of Medicine

Southampton
SO16 6YD
United Kingdom

Sponsor information

NHS R&D Regional Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.doh.gov.uk

Funders

Funder type

Government

NHS Executive South East (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/06/2008		Yes	No