TENS Treatment Plus Ibuprofen for the Treatment of Acute Back Pain in the ED

The study is a double blind, randomized, placebo controlled trial. One group will receive ibuprofen and TENS. The comparison group will receive ibuprofen and sham TENS. The study primary endpoint is change in pain level on Visual Analog Scale score at 45-60 minutes after TENS start. This is a two-arm, double blind, randomized control trial evaluating the patient perceived improvement in back pain. Patients will first fill out a Visual Analog Scale (VAS). Patients will be randomized to one of two arms. Ibuprofen 800 mg, plus sham TENS for 45 minutes Ibuprofen 800 mg, plus TENS for 45 minutes Patients will be given a 2nd VAS scale up to 15 minutes after the end of the TENS session. After the second VAS the patients will be finished with the study procedures and can be continued to be cared as per the discretion of their treating physician. Our intention is to detect a 20% reduction in pain by VAS with a common standard deviation equal to the difference at the p = 0.05 level with a power of 80% using an analysis of variance (ANOVA). The calculated sample size required 28 patients per group. Considering the uncertain dropout rate, the investigators decided to enroll at least 66 patients. Baseline characteristics will be calculated to determine if groups are equal. A two-way repeated-measures ANOVA will be used to test both a trial effect and a group effect (SPSS 20, SPSS Inc., Chicago, IL). Data will be presented as means with standard deviations with 95% confidence intervals. A p\< 0.05 was considered statistically significant.