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ISRCTN
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ISRCTN80764175
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ClinicalTrials.gov identifier
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Public title
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Longer term clinical and economic benefits of offering acupuncture to patients with chronic low back pain
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Scientific title
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Acronym
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YACBAC
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Serial number at source
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HTA 96/40/07
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Study hypothesis
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Acupuncture is widely used in NHS primary care for a variety of pain related conditions. Evidence of the clinical cost effectiveness of its use in this context is sparse, particularly relating to its longer term effectiveness in the relief of chronic pain. More research is needed to ensure the appropriate use of NHS resources. The proposed study is a pragmatic randomised controlled trial (n=200) to evaluate the longer term clinical and economic benefits of offering acupuncture to patients assessed as suitable for primary care management with reported low back pain of more than four weeks duration. The study aims to test the hypothesis that a population of patients offered traditional acupuncture for chronic low back pain gain as much or more relief from pain as those offered normal management only by their GP, for equal or less cost. The study aims to provide appropriate evidence for future NHS purchasing decisions. The research is a collaboration between a University research department, and accredited Acupuncture College and Research Foundation and a GP consortium. It builds on previously completed work, including a pilot of the outcome measures proposed and the feasibility of the GP referral service to traditional acupuncture treatment.
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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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A pragmatic, two parallel group, 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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Chronic low back pain
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Participants - inclusion criteria
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Patients with low back pain. Age 20-65 years with low back pain or sciatica, greater than 4 weeks and less than 12-months pain this episode
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Participants - exclusion criteria
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Past spinal surgery, severe or progressive motor weakness or central disc prolapse, possible spinal pathology (eg carcinoma)
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Anticipated start date
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12/04/1999
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Anticipated end date
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11/05/2003
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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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200
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Interventions
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1. Traditional Chinese acupuncture, up to 10 treatments
2. Standard care offered by GP only
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Primary outcome measure(s)
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1. Relief of chronic pain
2. Cost effectiveness
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Secondary outcome measure(s)
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Secondary outcomes included the McGill Present Pain Index (PPI), Oswestry Pain Disability Index (ODI), all other SF-36 dimensions, medication use, pain-free months in the past year, worry about back pain, satisfaction with care received, and safety and acceptability of acupuncture care.
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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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http://www.ftcm.org.uk/low_back_pain.htm
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Publications
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HTA monograph: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16095547
Results in: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=retrieve&db=pubmed&list_uids=16980316
Results in: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=retrieve&db=pubmed&list_uids=16980315
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Contact name
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Ms
Kate
Thomas
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Address
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School of Health Care
University of Leeds
Baines Wing
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City/town
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Leeds
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Zip/Postcode
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LS2 9UT
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Country
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United Kingdom
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Tel
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+44 (0)113 343 5635
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Email
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k.thomas@leeds.ac.uk
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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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07/02/2008
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Date ISRCTN assigned
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25/04/2003
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