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	https://doi.org/10.1186/ISRCTN94142364
Secondary identifying numbers	N/A

Submission date: 16/05/2006
Registration date: 23/06/2006
Last edited: 21/10/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Suzanne McDonough
Scientific

Room 01F118
School of Health Sciences
University of Ulster
Jordanstown campus
Shore Road
Newtownabbey
Co. Antrim
BT37 0QB
Northern Ireland
BT37 0QB
United Kingdom

Study information

Study design	Single-blind, feasibility, randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title	Exercise and manual auricular acupuncture: a pilot assessor-blind randomised controlled trial. (The acupuncture and personalised exercise programme (APEP) Trial)
Study acronym	APEP
Study objectives	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?
Ethics approval(s)	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
Health condition(s) or problem(s) studied	Chronic low back pain
Intervention	Patients are randomised to receive individually-tailored and supervised exercise with or without manual auricular acupuncture
Intervention type	Other
Primary outcome measure	None - as this is a feasibility study
Secondary outcome measures	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
Overall study start date	01/06/2006
Completion date	31/05/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	65 Years
Sex	Both
Target number of participants	80
Key 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
Key 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
Date of first enrolment	01/06/2006
Date of final enrolment	31/05/2008

Locations

Countries of recruitment

Northern Ireland
United Kingdom

Study participating centre

Room 01F118

Northern Ireland
BT37 0QB
United Kingdom

Sponsor information

University of Ulster (UK)
University/education

c/o Mr Nick Curry (Research Office)
Room 01H12
University of Ulster
Shore Road
Newtownabbey
County Antrim
Northern Ireland
BT37 0QB
Northern Ireland
United Kingdom

Website	http://www.ulster.ac.uk/
"ROR"	https://ror.org/01yp9g959

Funders

Funder type

Government

Department for Employment and Learning (Strategic Priority Fund), Northern Ireland, UK

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	06/03/2008		Yes	No