ABSTRACT
[Objective] To compare the effectiveness of electro-acupuncture with that of transcutaneous electrical nerve stimulation (TENS) in the treatment of lower back pain and to investigate problems with conducting rigorous trials in Japan. [Design] A multi-center, randomized, observer-blinded, controlled trial with two parallel arms. [Setting] Four medical facilities affiliated with universities or colleges in Japan. [Subjects and methods] Low back pain patients without sciatica suffering for at least two weeks were randomly assigned to either an acupuncture with electro stimulation group (Group A) or a TENS group (Group T). Plans called to recruit 80 patients in the protocol. Patients in both groups were treated twice a week for 2 weeks with 1 Hz electro-stimulation for 15 minutes. Visual analogue scale (VAS) of pain relief and the scores recommended by the Japanese Orthopaedic Association (JOA Score) were measured. Primary endpoint was improvement of pain that was assessed from the changes in VAS. [Results] Three patients were withdrawn after one-week run-in period and one patient was withdrawn from Group A during treatment the period. Consequently, 31 in group A and 33 in group T completed the trials and were available for evaluation. There was no difference between the groups in primary endpoint and JOA scores. [Discussion] Problem of patient recruitment should be resolved by strategically selecting facilities or by advertising for participants. Future investigation with attentive trials using adequate intervention is required to conclude whether or not acupuncture exceeds TENS in efficacy. [Conclusion] There was no statistical difference between electro-acupuncture and TENS for lumbago in this study.