Comparison the Effects of Modified Combined-Modality Treatment approach with Botox-Injection on Voices of Patients with Adductor Spasmodic Dysphonia

Objective: To evaluate the effects of combined modality therapy on patients with spasmodic dysphonia voice and comparison with Botox alone Inclusion and exclusion criteria: All patients with a diagnosis of spasmodic dysphonia and no history of Botox injections are enrolled. Patients with a history of neurological disorders or symptoms of dystonia in other areas of the body are excluded. Study Type: Parallel- single blind- Randomized clinical trial Sample size: Patients with spasmodic dysphonia admitted to Amir-alam hospital - 10 patients' allocated to intervention and control groups. Interventions: Both groups of patients undergoing Botox injections. Ten Semi-intensive Voice Therapy sessions administered to patients in interventional group. A comprehensive voice assessment will be done at following time points: before injection, 1, 3 and 6 months after injection. Time of interventions: Voice Therapy starts immediately after the injection in the intervention group. If Voice Therapy proved sufficient in intervention group, patients in the control will enrolled to Voice Therapy in order to eliminate the effects of treatment deprivation, at the end of the study. Primary outcome: It is expected that all patients benefit more comfortable phonation process after injection ; and after the Voice Therapy sessions, patients in the intervention group expected to achieve a better voice quality. Study: Randomized Clinical Trial – Parallel - Single blind Participants: all ADSD patients referred to Amir-Alam hospital- 10 patients with ADSD will randomly assigned to the interventional and control groups. Method: Both groups will go under Botox injection. After injections, patients in intervention group will have 10 semi-intensive sessions of Voice Therapy. All patients' voices will be assessed before injections, 1-3-and 6 months after injection. Interventional Timing: Voice Therapy sessions will be begin 2 days after injection in intervention group. Patients in Control group will receive all Voice Therapy techniques and sessions if the positive effects will be identified after 6 months. Primary outcome: We expect all patients experience more comfortable phonation, after Botox injection; and also in patients in interventional group, have a better voice quality after following Voice Therapy.

Iran University of Medical Scineces (IUMS)