Condition category
Circulatory System
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
29/10/2012
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 Jongbae Park

ORCID ID

Contact details

University of Exeter
Department of Complementary Medicine
25 Victoria Park Road
Exeter
EX2 4NT
United Kingdom
+44 (0)1392 439035
Jongbae.Park@pms.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0203092386

Study information

Scientific title

Acronym

Study hypothesis

Is manual acupuncture superior to sham manual acupuncture for improving the recovery from stroke in respect of functional and psychological status when given to established cases? The objectives of this study are to compare the changes of outcomes of stroke patients between baseline and post-treatment, and 6 months follow up.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled clinical trial with 2 parallel arms

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Cardiovascular: Stroke

Intervention

152 chronic stoke patients will be invited to participate. They will be randomly divided to manual acupuncture group and sham acupuncture group and will be given 12 manual acupuncture treatments (tailored by constitution) in 12 weeks. All subjects will be assessed 3 times: baseline assessment before randomisation, post-treatment, and 6 month follow-up.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Primary outcome of this study is changes of Action Research Arm Test between baseline and post-treatment. Data will be analysed by statistical procedure like the Mann-Whittney test.

Secondary outcome measures

Other outcome measures are Fugl-Meyer Assessment Scale, Ashworth spasticity Scale, 9-hole peg test, Timed 10-metre walk, and EuroQoL.

Overall trial start date

15/01/2001

Overall trial end date

31/03/2004

Reason abandoned

Eligibility

Participant inclusion criteria

1. All patients of any age with stroke due to infarction or haemorrhage at any brain location scanned computed tomography (CT) or magnetic resonance imaging (MRI)
2. Physically capable of travelling to hospital for treatment
3. Giving informed consent.

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

152

Participant exclusion criteria

1. Patients who do not have capacity to communicate and give consent
2. History of serious diseases such as cancer, auto-immune disease and Acquired Immunodeficiency Syndrome (AIDS)
3. Fear of needling
4. History of surgery under general anaesthetic within 6 months
4. Major bleeding diseases

Recruitment start date

15/01/2001

Recruitment end date

31/03/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Exeter
Exeter
EX2 4NT
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Royal Devon and Exeter NHS Trust

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

1. 2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16186474

Publication citations

  1. Results

    Park J, White AR, James MA, Hemsley AG, Johnson P, Chambers J, Ernst E, Acupuncture for subacute stroke rehabilitation: a Sham-controlled, subject- and assessor-blind, randomized trial., Arch. Intern. Med., 2005, 165, 17, 2026-2031, doi: 10.1001/archinte.165.17.2026.

Additional files

Editorial Notes