The Impact of Botulinum Toxin Treatment in Quality of Life of Cervical Dystonia Patients

Roongroj Bhidayasiri20 enrolled

Overview

The purpose of this study is to investigate the impact of botulinum toxin treatment in quality of life(QoL) in cervical dystonia patients

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Botulinum Toxin Quality of Life Cervical Dystonia

Interventions

NuronoxDRUG

Reconstituted Neuronox® is injected at a dose determined by the physician based upon his/her clinical experience with botulinum toxin.Actual dose and injection site should be adjusted individually considering the muscle mass, degree of spasticity, body weight, and response to any previous botulinum toxin injections.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * aged ≥ 18 years to 75 years * Subjects requiring treatment for a clinical diagnosis of cervical dystonia * Willing to provide written informed consent before any study-related procedures. Exclusion Criteria: * Patients with pure anterocollis * Patients with an anaphlyactic response history to botulinum toxin type A. * Patients who have been treated with botulinum toxin type A within 3 month. * Females who are pregnant, planning pregnancy, unable to use contraception or lactating. * Any medical condition that may put the subject at increased risk with exposure to botulinum toxin at the discrimination of investigators.

Locations (1)

Roongroj Bhidayasiri

Pathumwan, Bangkok, Thailand

RECRUITING

Outcomes

Primary Outcomes

To investigate the change of quality of life of cervical dystonia patients after botulinum toxin treatment measured by CDQ-24.

To investigate the change of quality of life of cervical dystonia patients from baseline at 6 weeks after botulinum toxin treatment measured by CDQ-24.

Time frame: 6 weeks

Secondary Outcomes

To investigate the change of QoL of cervical dystonia patientsafter botulinum toxin treatment measured by SF-36 (Thai version)

To investigate the change of QoL of cervical dystonia patients at 6weeks after botulinum toxin treatment from baseline measured by SF-36 (Thai version).

Time frame: 6 weeks

To Investigate the change of symptom after botulinum toxin treatment measured by TWSTRS score

To Investigate the change of symptom at 6weeks after botulinum toxin treatment from baseline measured by TWSTRS score

Time frame: 6 weeks

Central Contacts

Roongroj Bhidayasiri, MD

CONTACT

+662 2564630 rbh1@ucla.edu

Data from ClinicalTrials.gov

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