| Source of record | UK Trials |
| ISRCTN | ISRCTN80764175 |
| Date ISRCTN assigned | 25/04/2003 |
| Local reference number(s) | HTA 96/40/07 |
| Public title | Longer term clinical and economic benefits of offering acupuncture to patients with chronic low back pain |
| Scientific title |
|
| Acronym | YACBAC |
| Disease/condition/study domain | Chronic low back pain |
| 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. |
| Design/methodology | A pragmatic, two parallel group, randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| 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) |
| Patient information material | Not provided at time of registration |
| Anticipated start date | 12/04/1999 |
| Anticipated end date | 11/05/2003 |
| Status of trial | Completed |
| 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. |
| Trial website | http://www.ftcm.org.uk/low_back_pain.htm |
| Publications | 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 |
| Sources of funding | NIHR Health Technology Assessment Programme - HTA (UK) |
| Sponsor name | Department of Health (UK) |
| Sponsor details | Quarry House
Quarry Hill
Leeds
United Kingdom
LS2 7UE |
| Sponsor email | Sheila.Greener@doh.gsi.gov.uk |
| Sponsor website | http://www.dh.gov.uk/en/index.htm |
| Contact name | Ms Kate Thomas |
| Contact details | School of Health Care
University of Leeds
Baines Wing
Leeds
United Kingdom
LS2 9UT |
| Contact telephone | +44 (0)113 343 5635 |
| Contact email | k.thomas@leeds.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN80764175 |
| Date last extracted from ISRCTN register | 17/04/2008 |
