Comparative efficacy of carbamazepine therapy with and without transcutaneous electrical nerve stimulation therapy for the management of trigeminal neuralgia: A Randomized Controlled Trial.

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 second-line treatments such as clonazepam, valproic acid, baclofen, gabapentin, lamotrigine, and baclofen. 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. There few studies on TENS therapy used to treat pain in TN. These studies lacked control groups, had inadequate study designs, and provided ambiguous information about the kind of drug therapy being taken concurrently.

Need of the study: 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:Once diagnosed and enrolled, 38 individuals between the ages of 20 and 80 will receive a primary diagnosis of TN based on IHS diagnostic criteria (IHS, 2004). Then these patients will randomly be allocated to one of the following groups,19 subjects in each groups respectively:

1)     Group 1:  CBZ Therapy

2)     Group 2: CBZ with TENS therapy

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.

Group 2 (CBZ with TENS therapy): The pulse duration will be 125 µs. The TENS will be applied during the first twenty minutes at a low frequency (2–10 Hz) and the last twenty minutes at a high frequency (50–100 Hz), with no break in between.

Outcomes: 1. The severity of pain may be reduced, which will be evaluated using a VAS score.

Duration of pain episodes measured in minutes may be reduced.

3.Frequency (Number of pain episodes) per day may be reduced.