Comparative Efficacy of Carbamazepine Therapy With and Without Transcutaneous Electrical Nerve Stimulation Therapy in Trigeminal Neuralgia Patients: A Randomised Controlled Trial Protocol

Introduction: Trigeminal Neuralgia (TN) is one of the most painful diseases. Typically, medication therapy starts at an initial titrated dose of 100 mg every other day of Carbamazepine (CBZ) 200-1200 mg/day. There is less evidence to support secondline treatments such as clonazepam, valproic acid, baclofen, gabapentin, lamotrigine, and baclofen. Transcutaneous Electrical Nerve Stimulation (TENS) is a widespread technique used for managing neuropathic pain. TENS therapy, which involves the transmission of an electric current across the intact skin surface to activate deeper nerves in an attempt to relieve pain, is a recent and promising alternative for the treatment of both acute and chronic pain. Need of the Study: Few research has been done on TENS therapy for pain management in TN. These studies have poor study designs, no control groups, and unclear information regarding the type of concurrent pharmacological therapy. TENS in combination with CBZ may reduce the dose of CBZ therapy, therefore, there is a need to conduct the study on “Comparative efficacy of CBZ therapy with and without TENS therapy for the management of TN”. Aim: To evaluate and compare the efficacy of CBZ therapy with and without TENS therapy for the management of TN. Materials and Methods: A Randomised Controlled Trial (RCT) will be conducted in the Outpatient Department (OPD) of Oral Medicine and Radiology at Sharad Pawar Dental College and Hospital, Wardha, Maharashatra, India between July 2024 and May 2026. Once diagnosed and enrolled, 38 individuals between the ages of 20 years and 80 years will receive a primary diagnosis of TN will be included and they will receive further treatment, based on International Headache Soceity (IHS) diagnostic criteria (IHS, 2018). Then these patients will randomly be allocated to one of the following groups, 19 subjects in each group, respectively: Group 1 (CBZ therapy): The baseline parameters of patients will be evaluated who will be treated with CBZ Initially at 100 mg TDS per day (300 mg), the patient will receive an additional titrated dose 100 mg of CBZ every 48 hours until they reach the maximum tolerated dose or total relief and Group 2 (CBZ with TENS therapy): CBZ initially, at 100 mg TDS per day (300 mg), the patient will receive an additional titrated dose 100 mg of CBZ every 48 hours until they reach the maximum tolerated dose or total relief. The pulse duration of TENS therapy will be 125 µS. The TENS will be applied during the first twenty minutes at a low frequency (2 to 10 Hz) and the last twenty minutes at a high frequency (50 to 100 Hz), with no break in between, for a total of 40 minutes per session. The outcome of Group 2 will be more efficacious in reduction of Visual Analogue Scale (VAS) score as compare to Group 1. The statistical analysis will be performed using Chi-square test at 5% level of significance (p<=0.05).