Condition category
Musculoskeletal Diseases
Date applied
16/05/2006
Date assigned
23/06/2006
Last edited
21/10/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Suzanne McDonough

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Exercise and manual auricular acupuncture: a pilot assessor-blind randomised controlled trial. (The acupuncture and personalised exercise programme (APEP) Trial)

Acronym

APEP

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?

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

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

Patients are randomised to receive individually-tailored and supervised exercise with or without manual auricular acupuncture

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/06/2006

Overall trial end date

31/05/2008

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

80

Participant 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

Recruitment start date

01/06/2006

Recruitment end date

31/05/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Room 01F118
Northern Ireland
BT37 0QB
United Kingdom

Sponsor information

Organisation

University of Ulster (UK)

Sponsor details

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

Sponsor type

University/education

Website

http://www.ulster.ac.uk/

Funders

Funder type

Government

Funder name

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

2008 results in: http://www.ncbi.nlm.nih.gov/pubmed/18325114

Publication citations

  1. Results

    McDonough SM, Liddle SD, Hunter R, Walsh DM, Glasgow P, Gormley G, Hurley D, Delitto A, Park J, Bradbury I, Baxter GD, Exercise and manual auricular acupuncture: a pilot assessor-blind randomised controlled trial. (The acupuncture and personalised exercise programme (APEP) trial)., BMC Musculoskelet Disord, 2008, 9, 31, doi: 10.1186/1471-2474-9-31.

Additional files

Editorial Notes