Study design: Multicenter, randomized, patient-assessor blind, sham-controlled clinical trial.
Objective: To investigate the efficacy of acupuncture treatment with individualized setting for reduction of bothersomeness in participants with chronic low back pain (cLBP).
Summary of background data: Low back pain is one of the main reasons of disability among adults of working age. Acupuncture is known as an effective treatment of cLBP, but it remains unclear whether acupuncture is superior to placebo.
Methods: One hundred thirty adults aged 18 to 65 years with nonspecific LBP lasting for at least last 3 months prior to the trial participated in the study from 3 Korean medical hospitals. Participants received individualized real acupuncture treatments or sham acupuncture treatments for more than 6 weeks (twice a week) from Korean Medicine doctors. Primary outcome was change of visual analogue scale (VAS) score for bothersomeness of cLBP. Secondary outcomes included VAS score for pain intensity and questionnaires including Oswestry Disability Index, general health status (Short Form-36), and Beck Depression Inventory (BDI).
Results: There were no baseline differences observed between the 2 groups, except in the Oswestry Disability Index. One hundred sixteen participants finished the treatments and 3- and 6-month follow-ups, with 14 subjects dropping out. Significant difference in VAS score for bothersomeness and pain intensity score of cLBP has been found between the 2 groups (P < 0.05) at the primary end point (8 wk). In addition, those 2 scores improved continuously until 3-month follow-up (P = 0.011, P = 0.005, respectively). Oswestry Disability Index, the Beck Depression Inventory, and Short Form-36 scores were also improved in both groups without group difference.
Conclusion: This randomized sham-controlled trial suggests that acupuncture treatment shows better effect on the reduction of the bothersomeness and pain intensity than sham control in participants with cLBP.