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ISRCTN
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ISRCTN96537534
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ClinicalTrials.gov identifier
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Public title
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Acupuncture for migraine and headache in primary care: a pragmatic, randomised trial
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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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HTA 96/40/15
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Study hypothesis
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Acupuncture is widely if inconsistently used in primary care, particularly for the treatment of pain. Migraine and headache are common conditions which incur high health, economic and social costs. There is evidence from randomised trials which suggests that acupuncture is superior to placebo in the treatment and prophylaxis of headache and migraine. We aim to conduct a 'pragmatic' randomised trial comparing the policy of 'use acupuncture' to that of 'avoid acupuncture' in 400 headache and migraine patients recruited in primary care. The acupuncture treatment will be given by appropriately trained physiotherapists.
Such a trial design aims to reflect the real world of clinical practice so as to provide a test of service as it is provided and thus ease implementation of the results. The information provided by the trial, for example, on resource use and effect sizes, will be more applicable to the NHS than that from a placebo-controlled trial. The use of chartered physiotherapists ensures high standards of clinical competence: simpler integration of the service in the NHS: established channels for inter-disciplinary liaison and appropriate treatment, especially in cases where acupuncture might not be appropriate. Our overall question will be: what are the effects of an acupuncture service provided by physiotherapists in primary care on pain, well-being, days off work and resource use in patients with migraine or headache?
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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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Headache and migraine
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Participants - inclusion criteria
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Headache and migraine patients in primary care
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Participants - exclusion criteria
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Not provided at time of registration.
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Anticipated start date
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01/10/1998
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Anticipated end date
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01/05/2002
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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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401
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Interventions
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1. Acupuncture
2. Standard care
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Primary outcome measure(s)
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Pain, well being, days off work and resource use
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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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NIHR Health Technology Assessment Programme - HTA (UK)
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Trial website
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Publications
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Results in: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15023828
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Contact name
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Mr
Andrew
Vickers
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Address
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Integrative Medicine
Memorial Sloan-Kettering Cancer Centre
1275 York Avenue
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City/town
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New York
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Zip/Postcode
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10021
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Country
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United States of America
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Tel
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+1 212 639 6556
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Fax
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+1 212 794 5851
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Email
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vickersa@MSKCC.org
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Sponsor
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Department of Health (UK)
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Address
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Quarry House
Quarry Hill
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City/town
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Leeds
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Zip/Postcode
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LS2 7UE
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Country
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United Kingdom
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Email
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Sheila.Greener@doh.gsi.gov.uk
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Sponsor website:
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http://www.dh.gov.uk/en/index.htm
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Date applied
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25/04/2003
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Last edited
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25/01/2008
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Date ISRCTN assigned
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25/04/2003
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