Condition category
Circulatory System
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
26/01/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr George Lewith

ORCID ID

Contact details

School of Medicine
Centre Block
University of Southampton
Tremona Road
Southampton
SO16 6YD
United Kingdom
+44 (0)2380794594
gl3@soton.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

SPGS816

Study information

Scientific title

Acronym

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Phase

Not Applicable

Drug names

Primary outcome measures

1. Motricity Index
2. Nottingham Health Profile
3. Standard Barthel Index

Secondary outcome measures

Not provided at time of registration

Overall trial start date

02/01/1997

Overall trial end date

31/12/2001

Reason abandoned

Eligibility

Participant inclusion criteria

Patients who have recently suffered a stroke.

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

105 patients randomised (5 centres) (added 26/01/10; see publication

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

United Kingdom

Trial participating centre

School of Medicine
Southampton
SO16 6YD
United Kingdom

Sponsor information

Organisation

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

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Executive South East (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18465110

Publication citations

  1. Results

    Hopwood V, Lewith G, Prescott P, Campbell MJ, Evaluating the efficacy of acupuncture in defined aspects of stroke recovery: a randomised, placebo controlled single blind study., J. Neurol., 2008, 255, 6, 858-866, doi: 10.1007/s00415-008-0790-1.

Additional files

Editorial Notes