Condition category
Musculoskeletal Diseases
Date applied
25/04/2003
Date assigned
25/04/2003
Last edited
26/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.ftcm.org.uk/low_back_pain.htm

Contact information

Type

Scientific

Primary contact

Ms Kate Thomas

ORCID ID

Contact details

School of Health Care
University of Leeds
Baines Wing
Leeds
LS2 9UT
United Kingdom
+44 (0)113 343 5635
k.thomas@leeds.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 96/40/07

Study information

Scientific title

Acronym

YACBAC

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.

Ethics approval

Not provided at time of registration

Study design

A pragmatic, two parallel group, randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Chronic low back pain

Intervention

1. Traditional Chinese acupuncture, up to 10 treatments
2. Standard care offered by GP only

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Relief of chronic pain
2. Cost effectiveness

Secondary outcome measures

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.

Overall trial start date

12/04/1999

Overall trial end date

11/05/2003

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

200

Participant exclusion criteria

Past spinal surgery, severe or progressive motor weakness or central disc prolapse, possible spinal pathology (eg carcinoma)

Recruitment start date

12/04/1999

Recruitment end date

11/05/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

School of Health Care
Leeds
LS2 9UT
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
+44 (0)1132 545 843
Sheila.Greener@doh.gsi.gov.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/en/index.htm

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (UK)

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

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

Publication citations

  1. Cost effectiveness analysis

    Ratcliffe J, Thomas KJ, MacPherson H, Brazier J, A randomised controlled trial of acupuncture care for persistent low back pain: cost effectiveness analysis., BMJ, 2006, 333, 7569, 626, doi: 10.1136/bmj.38932.806134.7C.

  2. Thomas KJ, MacPherson H, Ratcliffe J, Thorpe L, Brazier J, Campbell M, Fitter M, Roman M, Walters S, Nicholl JP, Longer term clinical and economic benefits of offering acupuncture care to patients with chronic low back pain., Health Technol Assess, 2005, 9, 32, iii-iv, ix-x, 1-109.

  3. Thomas KJ, MacPherson H, Thorpe L, Brazier J, Fitter M, Campbell MJ, Roman M, Walters SJ, Nicholl J, Randomised controlled trial of a short course of traditional acupuncture compared with usual care for persistent non-specific low back pain., BMJ, 2006, 333, 7569, 623, doi: 10.1136/bmj.38878.907361.7C.

Additional files

Editorial Notes