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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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REBEC |
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Last refreshed on:
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27 May 2013 |
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Main ID: |
RBR-58yq52 |
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Date of registration:
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16/04/2012 |
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Primary sponsor: |
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Public title:
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Acupuncture in Multiple Sclerosis
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Scientific title:
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Impact of electroacupuncture on quality of life for patients with Relapsing-Remitting Multiple Sclerosis under treatment with immunomodulators |
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Date of first enrolment:
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01/01/2011 |
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Target sample size:
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31 |
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Recruitment status: |
data analysis completed |
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URL:
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http://www.ensaiosclinicos.gov.br/rg/RBR-58yq52/ |
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Study type:
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Intervention |
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Study design:
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Randomized, parallel, single blinded with two arms clinical trial.
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Juan
Quispe-Cabanillas |
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Address:
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Lab.Neuroimunologia, Departamento de Genética, Evolução e Bioagentes do Instituto de Biologia da Unicamp
13083-970
Campinas
Brazil |
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Telephone:
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(19)35216263 |
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Email:
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juangqc@fcm.unicamp.br |
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Affiliation:
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Departamento de Clinica Médica, Faculdade de Ciências Médicas, Universidade Estadual de Campinas - UNICAMP |
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Name:
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Juan
Quispe-Cabanillas |
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Address:
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Lab.Neuroimunologia, Departamento de Genética, Evolução e Bioagentes do Instituto de Biologia da Unicamp
13083-970
Campinas
Brazil |
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Telephone:
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(19)35216263 |
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Email:
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juangqc@fcm.unicamp.br |
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Affiliation:
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Departamento de Clinica Médica, Faculdade de Ciências Médicas, Universidade Estadual de Campinas - UNICAMP |
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Key inclusion & exclusion criteria
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Inclusion criteria: Patients with a confirmed diagnosis of RRMS according to the revised 2005 McDonald criteria and under treatment with immunomodulatory drugs (interferon-beta and glatiramer acetate) were selected.
Exclusion criteria: Those individuals who had previously received acupuncture treatment were excluded.
Age minimum:
18
Age maximum:
0
Gender:
-
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Health Condition(s) or Problem(s) studied
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Quality of life in Relapsing-Remitting Multiple Sclerosis
G35
I01.800
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Intervention(s)
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the study had two groups:
1.eletroacupuncture true (n=16)
2.eletroacupuncture sham (n=15).
The protocol consisted of 30 minutes of acupuncture (either true or sham electroacupuncture) once a week for six consecutive months.
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Primary Outcome(s)
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Clinical status, especially mobility, was assessed prior to the treatment, as well as after six months, using the Expanded Disability Status Scale (EDSS). Quality of life was also assessed prior to the initiation of treatment, as well as after three and six months; It was measured by the Functional Assessment of Multiple Sclerosis (FAMS) instrument, validated for Portuguese as (DEFU). Briefly, this is self-report questionnaire investigating patient perception of the quality of their lives, The six sub-scales assess mobility, symptoms, emotional well being/depression, general contentment, thinking/fatigue, and family/social well being, using a 5-point Likert-type scale ranging from “not at all” to “very much”, which yields a score between 0 (for not at all) and 4 (for very much) for each of the items. Pain was evaluated using the 10-point Visual Analogue Scale (VAS), 0= Worst possible pain and 10= No pain, applied just before the FAMS.
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Secondary Outcome(s)
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Occasionally, patients reported improvement in spasticity, sleep and bowel function.
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Secondary ID(s)
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0775.0.146.000-08
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976/2008
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Source(s) of Monetary Support
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Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES) - Brasilia, DF, Brazil
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