Y. Katsnelson1, V. Leosko2, V. Udalov3, R. Pizinger1, D. Rice1, V. Kovalchuk3, V. Pechenkina3, T. Malkova1
1Kalaco Scientific, Inc, Scottsdale, United States,
2Medical Academy for Postgraduate Education, Department of Anesthesiology and Resuscitation, S. Petersburg, Russian Federation, 3Rail Road Hospital, Department of Anesthesiology and Resuscitation, S. Petersburg, Russian Federation
Background and aims: Activation of the beta-endorphinergic system could decrease the intensity of post-surgery pain (PSP) and dosage of post-surgery analgesics required. Studies have shown that cranial electrostimulation (CES) activates the beta-endorphinergic system. Nexalin Therapy (NT) has been shown effective for the treatment of chronic pain syndromes. The aim is to decrease PSP levels and the amount of analgesics taken post-surgery using the “NEXALIN” device.
Methods: The study population consisted of 60 subjects randomized into three groups, stratified by gender and body mass index. Group A received NT two days prior to surgery and post-surgery. Group B received NT only post surgery. Group C received the current analgesic standard of care – Ketonal (Ketoprofen) 100 mg, up to four times/day. For 72hrs post surgery, subjects in Group A and B were given NT for pain management (up to 8 times/day). If NT after surgery wasn’t effective, the subject was offered Ketonal.
Assessment methods: pain level (PL), patient global self-assessment (PGA), physician’s assessment (PA) via visual scales, and Analgesic Medication Logs. Results: Decreased PL and the dynamics of PGA and PA were not statistically different among the 3 groups. Administration of Ketonal was higher in Group C than in the NT groups p< .000 (Group C ~160% > Group A, and ~285% > Group B). There was no significant difference between the two Nexalin Therapy groups.
Conclusions: Nexalin Therapy provided a decreased intensity of PSP and a statistically significant decrease in the amount of analgesics used post-surgery.