PURPOSE: The primary purpose of this trial is to evaluate the effectiveness of Transcutaneous Electrical Nerve Stimulation (TENS) therapy application in the emergency department.
METHODS: The patients were divided into 2 groups: a sham group, and a verum group. Patients in the verum group include those who use the device for the first time. Both groups were connected to visually indistinguishable devices. Both groups underwent therapy for a total of 20 min. Using the Visual Analog Scale (VAS), the patients' perceived changes in pain intensity were recorded at the 20th and 120th minutes after initiation therapy. After the 120th minute, patients' individual needs for additional treatment were assessed. Additionally, their self-reported well-being was assessed using a Likert-type verbal scale.
RESULTS: In total 151 patients that were admitted to the emergency ward were assessed, with the sham and verum group being assigned 39 patients each from this pool. For the verum group the VAS change from 0 to 120 min was -65 ± 25 and for the sham group it was -9 ± 2 (p < 0.001). Verbal scores in the 120th minute were found to be 1.2 for sham group and 4.5 in the verum group (p < 0.001). Thirty patients (76.92%) in the sham group and 1 (2%) in the verum group had additional analgesic requirement after 120 min.
CONCLUSION: TENS therapy is a fast-acting, effective therapy for the treatment of acute migraine in the emergency department.
The design of this study is problematical in that the sham group certainly were able to figure out that they were getting no treatment at all for the 2 hour duration of the protocol. This likely created a 'negative placebo effect' inflating the apparent effectiveness of the TENS treatment.