Efficacy of manual therapy on somatic tinnitus dual modulatory factors: A study protocol

Abstract

| BACKGROUND AND PURPOSE: The literature has shown promising effect of manual therapy in improving the severity of somatic tinnitus. However, no previous study which has demonstrated the effect of manual therapy on dual modulatory factors (Temporomandibular disorders and cervical spine muscles). The purpose of the study is to evaluate the efficacy of manual therapy on somatic tinnitus dual modulatory factors (TMD and cervical spine). METHODS/DESIGN: Thirty nine patients with somatic tinnitus will be randomly assigned to one of the three groups i.e., A(Cervicogenic somatic tinnitus),B(TMD induced somatic tinnitus) and C(Dual modulatory factors induced somatic tinnitus) respectively. This multi group, parallel arms, pre-test post-test, single centre, randomized clinical trial with three parallel groups will receive six treatment sessions of integrated manual therapy on alternate days for two weeks. Postural re-education exercises will be advised to the patients as home exercises.The primary outcome measure will be Tinnitus Handicap Inventory (THI) and secondary outcome measures include Visual Analogue Scale (VAS) and Digitalized Calibrated Algometer (DCA) to measure pre and post intervention effect of the treatments. DISCUSSION: The efficacy of manual therapy in patients with somatic tinnitus in each group will be established with this study. TRIAL REGISTRATION: Clinical Trials Registry-India. (CTRI/2020/03/024394) Universal trial number-U1111-1248-3141.