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ISRCTN
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ISRCTN48408850
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ClinicalTrials.gov identifier
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Public title
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Evaluating the effectiveness of acupuncture in defined aspects of stroke recovery.
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Scientific title
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Acronym
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N/A
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Serial number at source
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SPGS816
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Study hypothesis
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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.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Cerebrovascular disease
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Participants - inclusion criteria
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Patients who have recently suffered a stroke.
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Participants - exclusion criteria
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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
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Anticipated start date
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02/01/1997
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Anticipated end date
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31/12/2001
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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105 patients randomised (5 centres) (added 26/01/10; see publication
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Interventions
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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.
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Primary outcome measure(s)
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1. Motricity Index
2. Nottingham Health Profile
3. Standard Barthel Index
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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NHS Executive South East (UK)
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Trial website
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Publications
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2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18465110
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Contact name
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Dr
George
Lewith
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Address
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School of Medicine
Centre Block
University of Southampton
Tremona Road
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City/town
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Southampton
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Zip/Postcode
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SO16 6YD
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Country
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United Kingdom
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Tel
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+44 (0)2380794594
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Fax
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+44 (0)2380798444
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Email
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gl3@soton.ac.uk
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Sponsor
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NHS R&D Regional Programme Register - Department of Health (UK)
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Address
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The Department of Health
Richmond House
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Fax
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+44 (0)20 7307 2623
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.doh.gov.uk
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Date applied
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23/01/2004
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Last edited
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26/01/2010
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Date ISRCTN assigned
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23/01/2004
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