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Exercise and manual auricular acupuncture: a single-blind, feasibility, randomised controlled trial exploring the effectiveness of a combined approach for chronic low back pain
ISRCTN ISRCTN94142364
DOI 10.1186/ISRCTN94142364
ClinicalTrials.gov identifier
EudraCT number
Public title Exercise and manual auricular acupuncture: a single-blind, feasibility, randomised controlled trial exploring the effectiveness of a combined approach for chronic low back pain
Scientific title Exercise and manual auricular acupuncture: a pilot assessor-blind randomised controlled trial. (The acupuncture and personalised exercise programme (APEP) Trial)
Acronym APEP
Serial number at source N/A
Study hypothesis Does the addition of manual auricular acupuncture to an individually tailored and supervised exercise programme improve treatment outcomes for people with chronic low back pain?
Lay summary
Ethics approval To be submitted to the Office for Research Ethics Committees Norther Ireland (ORECNI) and has been reviewed and approved by the relevant filter committee of the University of Ulster, Northern Ireland
Study design Single-blind, feasibility, randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Chronic low back pain
Participants - inclusion criteria 1. Patients with chronic or recurrent low back pain (LBP), with or without radiation to lower limb
2. Males or females between 18-65 years
3. No spinal surgery within previous 12 months
4. Patients suitable for exercise and acupuncture treatment
5. Patients willing to attend for six weeks of exercise +/- manual auricular acupuncture
6. Fluency in English
7. Access to a telephone
Participants - exclusion criteria 1. Patients currently or having received treatment for chronic low back pain (CLBP) in last three months
2. Red flags indicating serious spinal pathology
3. Radicular pain indicative of nerve root compression, spinal stenosis, spondylolisthesis, fibromyalgia, systemic or inflammatory disease
4. Contraindications to acupuncture treatment
5. Acute or sub-acute LBP patients
6. Patients having previously received auricular acupuncture
7. Any other confounding conditions
8. Patients with multiple body and/or ear piercings
Anticipated start date 01/06/2006
Anticipated end date 31/05/2008
Status of trial Completed
Patient information material
Target number of participants 80
Interventions Patients are randomised to receive individually-tailored and supervised exercise with or without manual auricular acupuncture
Primary outcome measure(s) None - as this is a feasibility study
Secondary outcome measure(s) 1. Baseline questionnaire
2. Numeric rating scale (NRS) (0-10 cm)
3. Oswestry disability questionnaire
4. Physical activity monitoring
5. Holistic complementary and alternative health questionnaire
6. Fear avoidance beliefs questionnaire
7. Back beliefs questionnaire
8. Seven-day recall questionnaire
9. Daily activity or analgesic intake log book
10. Exit questionnaire
Sources of funding Department for Employment and Learning (Strategic Priority Fund), Northern Ireland, UK
Trial website
Publications 2008 results in: http://www.ncbi.nlm.nih.gov/pubmed/18325114
Contact name Prof  Suzanne  McDonough
  Address Room 01F118
School of Health Sciences
University of Ulster
Jordanstown campus
Shore Road
Newtownabbey
Co. Antrim
BT37 0QB
  City/town Northern Ireland
  Zip/Postcode BT37 0QB
  Country United Kingdom
Sponsor University of Ulster (UK)
  Address c/o Mr Nick Curry (Research Office)
Room 01H12
University of Ulster
Shore Road
Newtownabbey
County Antrim
  City/town Northern Ireland
  Zip/Postcode BT37 0QB
  Country United Kingdom
  Sponsor website: http://www.ulster.ac.uk/
Date applied 16/05/2006
Last edited 21/10/2010
Date ISRCTN assigned 23/06/2006
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