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
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
-
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.