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
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.