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Longer term clinical and economic benefits of offering acupuncture to patients with chronic low back pain
ISRCTN ISRCTN80764175
DOI 10.1186/ISRCTN80764175
ClinicalTrials.gov identifier
EudraCT number
Public title Longer term clinical and economic benefits of offering acupuncture to patients with chronic low back pain
Scientific title
Acronym YACBAC
Serial number at source HTA 96/40/07
Study hypothesis 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.
Lay summary
Ethics approval Not provided at time of registration
Study design A pragmatic, two parallel group, randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Chronic low back pain
Participants - inclusion criteria 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
Participants - exclusion criteria Past spinal surgery, severe or progressive motor weakness or central disc prolapse, possible spinal pathology (eg carcinoma)
Anticipated start date 12/04/1999
Anticipated end date 11/05/2003
Status of trial Completed
Patient information material
Target number of participants 200
Interventions 1. Traditional Chinese acupuncture, up to 10 treatments
2. Standard care offered by GP only
Primary outcome measure(s) 1. Relief of chronic pain
2. Cost effectiveness
Secondary outcome measure(s) 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.
Sources of funding NIHR Health Technology Assessment Programme - HTA (UK)
Trial website http://www.ftcm.org.uk/low_back_pain.htm
Publications 2005 HTA monograph in http://www.ncbi.nlm.nih.gov/pubmed/16095547
2006 main results in http://www.ncbi.nlm.nih.gov/pubmed/16980316
2006 cost effectiveness analysis in http://www.ncbi.nlm.nih.gov/pubmed/16980315
Contact name Ms  Kate  Thomas
  Address School of Health Care
University of Leeds
Baines Wing
  City/town Leeds
  Zip/Postcode LS2 9UT
  Country United Kingdom
  Tel +44 (0)113 343 5635
  Email k.thomas@leeds.ac.uk
Sponsor Department of Health (UK)
  Address Quarry House
Quarry Hill
  City/town Leeds
  Zip/Postcode LS2 7UE
  Country United Kingdom
  Tel +44 (0)1132 545 843
  Email Sheila.Greener@doh.gsi.gov.uk
  Sponsor website: http://www.dh.gov.uk/en/index.htm
Date applied 25/04/2003
Last edited 26/08/2009
Date ISRCTN assigned 25/04/2003
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