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 |
| Protocol serial number | N/A |
| Sponsor | University of Ulster (UK) |
| Funder | Department for Employment and Learning (Strategic Priority Fund), Northern Ireland, UK |
- 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
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
| Primary study design | Interventional |
|---|---|
| Study design | Single-blind, feasibility, randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) | None - as this is a feasibility study |
| Key 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 |
| Completion date | 31/05/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- Northern Ireland
Study participating centre
Room 01F118
Northern Ireland
BT37 0QB
United Kingdom
BT37 0QB
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
