The efficacy of Botulinum Toxin injection between Fiber Optic Laryngoscopy-guided and EMG-guided technic in patient with adductor spasmodic dysphonia

Phase 3

Recruiting

• Conditions: Adductor spasmodic dysphonia; Spastic dysphonia; Botulinum Toxins; Laryngoscopic Surgical Procedure; Electromyography

• Registration Number: TCTR20210206003
• Lead Sponsor: Faculty Of Medicine Research Grant, Khon Kaen University, Thailand

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-06
• Study Completion: 2022-12-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

1. Patients with Adductor Spasmodic dysphonia diagnosed by voice specialist doctor at Srinagarind hospital, Thailand.
2. Previously injected with Botulinum toxin at least 2 times with the same dosages.

Exclusion Criteria

1. Adductor Spasmodic dysphonia patients with other vocal diseases, such as vocal nodule, vocal polyp, malignancy.
2. Allergy to Botulinum toxin or anaesthetic
3. Previous vocal surgery
4. Severe complications from Botulinum toxin injection, such as aspiration, breathiness

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Jitter (Voice parameter) before, 6 week,4-6 month after injection % (by computerized speech lab)

Secondary Outcome Measures

Name	Time	Method
Shimmer (Voice parameter) before, 6 week,4-6 month after injection % (by computerized speech lab),Maximum Phonation Time(pronounce /a/) before, 6 week,4-6 month after injection seconds,Hoarseness before, 6 week,4-6 month after injection visual analog scale,Hoarseness before, 6 week,4-6 month after injection GIRBAS scale,Hoarseness before, 6 week,4-6 month after injection voice handicap index-30 questionnaire,Pain while injection the day of injection visual analog scale,Uncomfortable feeling while injection the day of injection visual analog scale,duration of complication(aspiration,breathiness,aphonia) 4-6 month after injection Patient reported duration(days)