Multiple Sclerosis
Conditions
Interventions
This research will be characterized as quantitative, and the study design will be experimental, prospective, about the effect of an intervention. - Clinical trial, randomized, parallel, unicex, with t
Other
E02.190.599.750.500
E02.760.169.063.500.387.750
E02.190.599.750.750
Sponsors
Centro Universitário Filadélfia
Centro Universitário Filadélfia
Eligibility
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Volunteers with diagnosis of multiple sclerosis; of both sexes; older than 18 years; with staging of 0 to 6; were not classified during the 3-month period prior to the start of the study.
Exclusion criteria
Exclusion criteria: Volunteers with neurological diagnosis besides multiple sclerosis; unable to understand or perform the tests proposed in the study; the physical or psychological impossibility of individuals; being hospitalized at the time of data collection or outbreak at the time of data collection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Outcomes Pain:The DN4 questionnaire, originally in French, was duly translated and validated into Portuguese, and was used to identify non-neuropathic neuropathies and neuropathic pain patients. It consists of 10 items subdivided into two parts: sensory descriptors (seven items) and related signs for sensory examination (three items) (VAL et al 2011). 2. Visual Analog Pain Scale;The Modified Fatigue Impact Scale (MFIS) is a subjective scale for the evaluation of fatigue, being a questionnaire where the information obtained is self-reported. It has a multidimensional character, and it is composed of 21 items, subdivided into 3 domains (physical, cognitive and psychosocial), obtaining scores from 0 to 4 for each item, totaling a total score of 84 points. The determination of fatigue is verified when the scores are equal to or greater than 38, so a score of less than 38 indicates the absence of fatigue;The first table will contain the first expected outcome. This will be identified as Expected outcome - pain. Pain reduction is expected in at least 50% of patients with multiple sclerosis.;In the second table, the outcome found for what was presented.;Expected outcome - fatigue It is expected to reduce at least 25% of fatigue.;Outcome found regarding what was presented - fatigue. | — |
Secondary
| Measure | Time frame |
|---|---|
| Pittsburg Scale is used to assess sleep quality in patients with possible sleep disorders during the last month. The questionnaire contains 19 questions, divided into seven components with a classification from 0 to 3, which are composed of component 1 subjective quality of sleep, component 2 sleep latency, component 3 sleep duration, component 4 sleep efficiency, component 5 disturbance of sleep, component 6 use of medication to sleep and component 7 dysfunction during the day, these values ??obtained of each component is summed until obtaining a score of each item, from 0 to 21, the totalized sum has as indicative the greater the greater value will be dysfunction of sleep quality.;The Multiple Sclerosis Impact Scale (MSIS-29-BR) is composed of 29 questions subdivided into two domains: physical (20 items) and psychological (9 items), with a score of 0 to 4 for each item. The sum of the two domains has a total score of 116 points, and the higher the score the greater the impact of MS on the patient's health and thus a poorer quality of life;Expected outcome - sleep The sleep condition is expected to improve by at least 4 points.;Outcome found regarding what was presented - sleep.;Expected outcome - quality of life The quality of life is expected to improve by at least 25% of the initial score.;Outcome found regarding what was presented - quality of life. | — |
Countries
Brazil
Contacts
Public ContactMichelle Fillis
Centro Universitário Filadélfia
Outcome results
None listed