A comparative study of the effect of systemic and intratympanic corticosteroid treatment in improving vestibular tests in patients with sudden sensorineural hearing loss SSNHL with vestibular disorders

Determining and comparing the effect of systemic and intratympanic corticosteroid treatment in improving balance tests in SSNHL patients with balance disorders

Clinical trial with control group, with parallel groups, without blinding, randomized, phase 2 on 40 patients. A table of random numbers was used for randomization.

This clinical trial will be conducted in 1402 in Kashani hospital in Isfahan city. People will be randomly divided into two groups. Oral treatment with prednisolone is at a dose of 1 mg per kilogram of body weight per day and with a maximum of 60 mg, which is done for 7 days and then stopped. Intratympanic treatment is in the form of injecting one ampoule of methylprednisolone once every other day up to 3 times. The time to start the treatment immediately after the diagnosis of the disease is at most 72 hours after the sensation of sudden hearing loss. Blinding was not done in this study.

This study is conducted on people with SSNHL who meet the inclusion criteria including unilateral symptoms and informed consent and do not have exclusion criteria such as underlying problems and bilateral symptoms.

group under intratympanic treatment and group under systemic treatment. Oral treatment with prednisolone is at a dose of 1 mg per kilogram of body weight per day and with a maximum of 60 mg, which is done for 7 days and then stopped. Intratympanic treatment is in the form of injecting one ampoule of methylprednisolone once every other day up to 3 times. The time to start the treatment immediately after the diagnosis of the disease is at most 72 hours after the sensation of sudden hearing loss.

vestibular function

Randomization was done with the help of a table of random numbers and in a simple way. In this way, according to the number of participants in the study, the researcher puts his finger on a table number and moves up and left and generates random numbers. Then, based on the sample size of the research, a number of envelopes with aluminum wrappers, preparation and each of the random sequences created are recorded on a card and the cards are placed inside the envelopes in order. In order to maintain a random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lid of the letter envelopes is glued and placed in a box. At the time of registration of the participants, based on the order of entry of eligible participants into the study, one of the envelopes will be opened and the assigned group of that participant will be revealed. If the number is odd, the person is placed in the first group, and if the number is even, the person is placed in the second group.

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