The efficacy of combined facial exercise with botulinum toxin treatment in clinical practice in Thai patients with hemifacial spasm: A randomized controlled pilot crossover study

Phase 2

Recruiting

• Conditions: Hemifacial spasmon botolinum toxin; Hemifacial spasm; Botolinum toxin; Facial massage; facail exercise

• Registration Number: TCTR20180403002
• Lead Sponsor: Faculty of Medicine, Siriraj Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-03
• Study Completion: 2018-11-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

-Patients with diagnosis of hemifacial spasm by authorized neurologist in Siriraj Hospital, Mahidol University, Bangkok, Thailand
-Patients are currently treated with BTX-A in the clinic with any degree of response
-Age 18-80 years

Exclusion Criteria

-Patients who have other neurological problems e.g. stroke, blepharospasm, dementia
-Patients who are physically dependent
-Patients who are illiterate
-Patients who are blind
-Patients who cannot squeeze his/her own face
-Patients currently treated with oral anticoagulants (NOACs, Vitamin K antagonists)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The efficacy of treatment measured by QoL with HFS-30 severity score 3 months HFS 30 score,Time to onset of drug 3 months Days

Secondary Outcome Measures

Name	Time	Method
SMC grading system, time to peak effect, duration of BTX-A effect 3 months days