[Laser acupuncture for chronic back pain. A double-blind clinical study]

BACKGROUND: The goal of this study was to evaluate the efficacy of laser acupuncture for the clinical picture of chronic back pain under everyday conditions using a randomized, double-blind, placebo-controlled study design. A further aim was to analyze to what extent placebo effects also influence the outcome of acupuncture under these conditions.

PATIENTS AND METHODS: The study included male and female patients with chronic back pain (lasting longer than 6 months) aged between 30 and 77 years with a pain score of at least 5 on a visual analog scale. The main criterion was achieving alleviation of pain by at least 50% 3 months after the start of treatment. The assessment tools used were the Von Korff questionnaire supplemented by the FFbH, FABQ, and SF-12. In addition, the participants were questioned about whether they perceived anything during the treatment and how certain they were that they had received treatment with active or inactive lasers.

RESULTS: A total of 111 patients were included in the study and were treated according to the randomization list in two groups each consisting of 51 subjects. The study was completed as scheduled by 102 participants. Analysis of the primary outcome measure, improvement of the pain score by more than 50% over baseline, revealed improvements in both treatment groups between the time points used for measurement. The placebo group exhibited better levels than the group that received laser treatment. No efficacy advantage of laser acupuncture over placebo treatment could be determined.

CONCLUSION: It was possible to completely blind the acupuncture forms with the study design employed. Perhaps the consistent exclusion of nonspecific treatment effects contributed to this result. It cannot be ruled out that the effects of acupuncture are based on a strong placebo effect.