OBJECTIVE: To assess the efficacy of Yamamoto's acupuncture method on pain, drug intake, functional capacity and quality of life for the treatment of acute non-specific low back pain (ANLBP). METHODS: A prospective, randomised, parallel-group, double-blind, placebo-controlled trial was performed in 80 men and women with ANLBP who were randomly assigned to five acupuncture sessions (intervention group (IG), n = 40) and to five non-penetrating acupuncture sessions (sham group (SG), n = 40). Patients were evaluated at baseline and at 3, 7, 14, 21 and 28 days. The measurements used were: visual analogue scale (VAS) for cumulative pain (before intervention, VAS1) and immediate pain (after intervention, VAS2); function (Roland-Morris Disability Questionnaire (RM)); quality of life (SF-36); improvement rating; and number of anti-inflammatory tablets taken. The primary endpoint was a decrease of at least 2 cm in VAS1. RESULTS: Pain VAS improved significantly in the IG from day 14 onwards compared with the SG, but the difference did not reach the prespecified clinically relevant value of 2 cm. The IG was significantly superior to the SG in the following outcomes: cumulative pain, function, pain (SF-36) and vitality (SF-36) at days 14, 21 and 28 (p < 0.05); limitation in physical aspects (SF-36) at all times (p = 0.007 and p = 0.02); and functional capacity (SF-36) at days 21 and 28 (p < 0.05). The IG also took significantly fewer anti-inflammatory tablets than the SG (p = 0.004) at all evaluation times and the improvement rating was better than the SG (p < 0.001). CONCLUSIONS: Yamamoto's new scalp acupuncture was more effective than sham treatment with regard to decrease in pain and anti-inflammatory intake as well as improving functional status and quality of life for patients with ANLBP. ClinicalTrials.gov NCT01124955.

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