Abstract
Background: Chronic low back pain (cLBP) is a global health complaint. Acupuncture is an effective therapy for cLBP; however, evidence for an optimal acupuncture practice scheme is limited.
Objective: This study aimed to determine the feasibility of conducting a randomized controlled trial (RCT) to assess the effectiveness of two acupuncture regimes (sensitized-points acupuncture and routine integrative acupuncture package) for cLBP.
Methods: This was a two-arm, assessor-blind, randomized-controlled feasibility study. Thirty adult participants with cLBP were randomly assigned into two groups. Each group received 8 sessions of either sensitized-points acupuncture or routine integrative acupuncture package, respectively. Treatments were conducted twice per week. Outcomes were assessed at baseline (week 0), on a weekly basis for four weeks (week 1, 2, 3, 4), and follow-up (week 12). Student's t-tests, Mann-Whitney U tests, Fisher's exact tests, descriptive analyses, and power analyses were used for statistics.
Results: Participants were recruited over 10 weeks with a recruitment rate of 12 participants per month. The treatment plan in both groups was well accepted and tolerated. Besides, the study was characterized by low adverse event rates (8.0% in Group A, 11.7% in Group B), high completion of the outcome measures (97.8% in Group A, 94.3% in Group B), and high participant retention rate (100% in Group A, 93.8% in Group B). Furthermore, preliminary analyses showed that both regimes of acupuncture were potentially efficacious and safe.
Conclusions: Conducting a fully powered RCT to evaluate efficacy and safety of two acupuncture regimes in the management of cLBP is feasible.