To evaluate the feasibility of a randomized-controlled trial (RCT) investigating the effects of adding auricular acupuncture (AA) to exercise for participants with chronic low-back pain (CLBP).
Participants with CLBP were recruited from primary care and a university population and were randomly allocated (n=51) to 1 of 2 groups: (1) “Exercise Alone (E)”—12-week program consisting of 6 weeks of supervised exercise followed by 6 weeks unsupervised exercise (n=27); or (2) “Exercise and AA (EAA)”—12-week exercise program and AA (n=24). Outcome measures were recorded at baseline, week 8, week 13, and 6 months. The primary outcome measure was the Oswestry Disability Questionnaire.
Participants in the EAA group demonstrated a greater mean improvement of 10.7% points (95% confidence interval, –15.3,−5.7) (effect size=1.20) in the Oswestry Disability Questionnaire at 6 months compared with 6.7% points (95% confidence interval, −11.4,−1.9) in the E group (effect size=0.58). There was also a trend towards a greater mean improvement in quality of life, LBP intensity and bothersomeness, and fear-avoidance beliefs in the EAA group. The dropout rate for this trial was lower than anticipated (15% at 6 mo), adherence with exercise was similar (72% E; 65% EAA). Adverse effects for AA ranged from 1% to 14% of participants.
Findings of this study showed that a main RCT is feasible and that 56 participants per group would need to be recruited, using multiple recruitment approaches. AA was safe and demonstrated additional benefits when combined with exercise for people with CLBP, which requires confirmation in a fully powered RCT.
*Health and Rehabilitation Sciences Research Institute and School of Health Sciences
∥Psychology Research Institute, University of Ulster
‡Sports Medicine, Sports Institute Northern Ireland
§Department of General Practice, Queen's University Belfast, Belfast, Northern Ireland
†Frontier Science Ltd, Inverness-shire, UK
¶School of Public Health, Physiotherapy and Population Sciences, University College Dublin, Dublin, Ireland
#Department of Physical Medicine and Rehabilitation, University of North Carolina, Chapel Hill, NC
**Department of Physical Therapy, University of Pittsburgh, Pittsburgh, PA
††Centre for Physiotherapy Research, University of Otago, Otago, New Zealand
Supported by the Research and Development Office, Northern Ireland, Strategic Priority Funding and Department for Employment and Learning, Northern Ireland. The authors declare no conflict of interest.
Ruth F. Hunter and Suzanne M. McDonough are joint first authors.
Reprints: Suzanne M. McDonough, PhD, Room 1F118, Health and Rehabilitation Sciences Research Institute, University of Ulster, Shore Road, Co. Antrim, Northern Ireland, BT37 0QB (e-mail: email@example.com).
Received November 1, 2010
Accepted June 1, 2011