To Assess the Prevalence of Spasticity and the Impact on the Quality of Life in Multiple Sclerosis Patients

Observational Study to Assess the Prevalence of Spasticity and the Impact on the Quality of Life in Patients With Multiple Sclerosis in Argentina

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01080040

Enrollment

150

Registered

2010-03-03

Start date

2008-08-31

Completion date

2013-03-31

Last updated

2013-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis, Relapsing Remitting

Keywords

Multiple Sclerosis, Relapsing Remitting, Quality of life

Brief summary

This study is observational, non-controlled, multicentric and prospective, without experimental intervention or control. As part of the usual management of the subjects, scales will be used for the assessment of the spasticity and the quality of life (QoL). The purpose of this observational study is to assess the incidence of spasticity in a group of subjects with Relapsing Remitting Multiple Sclerosis (RRMS) in Argentina and the way it affects the QoL of these subjects.

Detailed description

One of most frequently observed symptoms in subjects with MS is spasticity. Spasticity is defined as an abnormal velocity-dependent increase in muscle tonic stretch reflexes due to an amplified reactivity of motor segments to sensory input. It is part of one of the components of the superior motoneurone syndrome and it may cause muscle rigidity and disability. The spasticity, which could be measured in electrophysiological, biomechanical and clinical terms, has a significant prevalence. It is a frequent cause for consultation among subjects with MS and, consequently, has a significant impact on the QoL. Men and those subjects with MS of longer duration are the most affected by spasticity. The aim of this study is to assess the impact that spasticity has on the QoL of subjects with MS. The total duration of the study is 24 months. The recruiting period will be 12 months. Once the recruiting time is over, the collection of data will continue during the full 24 months period that was planned.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

21 Years to 60 Years

Healthy volunteers

Inclusion criteria

* Subjects aged from 21 60 years of age * Subjects with established diagnosis of RRMS according to the revised McDonald criteria - 2005 * Subjects with a diagnosis of RRMS for more than one year * The subject who have signed the Informed Consent

Exclusion criteria

* Subjects with other causes of spasticity * Subjects with other clinical forms of MS (different from relapsing-remitting)

Design outcomes

Primary

Measure	Time frame	Description
Assess the prevalence of spasticity in subjects with RRMS	Initial visit (Day 0) to 24 months	Ashworth Scale (AS) (Spasticity) Expanded Disability status scale (EDSS) SF 36

Secondary

Measure	Time frame
Evaluation of the impact of spasticity on the quality of life of subjects with RRMS	Initial visit (Day 0) to 24 months
Evaluation of the changes in spasticity after 24 months	Initial visit (Day 0) to 24 months

Countries

Argentina

Outcome results