BACKGROUND: Microcurrent therapy (MCT) is a novel electrotherapy modality with very low current-levels that may reduce pain especially in joints and muscles. AIM: To explore potential effects of MCT on pain in patients with knee osteoarthritis, to explore effects of different treatment parameters and to distinguish them from placebo-effects. DESIGN: Randomized four arms controlled clinical trial. SETTING: Outpatient tertiary medical care center. POPULATION: 56 patients with knee OA (K and L-Score II or III), 14 male and 38 female, mean age 71.7 (+/- 7.3), pain intensity higher than NRS 3 from 10. METHODS: Patients were randomized into four groups: MCT with 100 micro-A (group A), MCT with 25 micro-A (group B), sham-treatment (group C) and a control-group without intervention. Treatment groups received 10 sessions of MCT for 30 min each over a period of 22 days. The primary outcome was daily pain intensity throughout the treatment period measured by a NRS from 0 to 10. Second outcome measurements were the KOOS (Knee Osteoarthritis Outcome Score), the SF-36-questionnaire, the 6-min-walking-test and the Get-Up-and-Go-Test. RESULTS: Evening pain was reduced significantly in the verum-groups compared to sham group (group A versus group C p < 0.001, group B versus group C p = 0.006) and to no intervention (group A versus group D p < 0.001, group B versus group D p = 0.002). The difference between sham-therapy and no therapy was not significant. In the pre-post analysis of the KOOS group A improved significantly in the subscale Symptoms. Group A and B and D improved in the subscale ADL. CONCLUSIONS: The results of this RCT suggest that MCT has beneficial effects on pain in patients with knee osteoarthritis that are not explained by a placebo effect. Due to the explorative, pilot character of the study, further confirmation is needed before clear recommendations can be given.

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