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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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29 April 2013 |
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Main ID: |
RBR-7cb9yc |
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Date of registration:
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06/11/2011 |
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Primary sponsor: |
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Public title:
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Effects of two physiotherapy approaches in patients with low back pain
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Scientific title:
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Immediate effects of specific or inespecific spinal manipulation in patients with chronic low back pain: a randomized controlled trial |
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Date of first enrolment:
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07/11/2011 |
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Target sample size:
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148 |
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Recruitment status: |
recruiting |
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URL:
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http://www.ensaiosclinicos.gov.br/rg/RBR-7cb9yc/ |
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Study type:
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Study design:
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Randomized controlled trial, two-arm, single blinded
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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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Leonardo
Costa |
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Address:
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Rua Cesário Galeno 448 Tatuapé
03071000
São Paulo
Brazil |
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Telephone:
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(11) 2178 1564 |
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Email:
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lcosta@edu.unicid.br |
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Affiliation:
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Universidade Cidade de São Paulo |
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Name:
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Leonardo
Costa |
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Address:
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Rua Cesário Galeno 448 Tatuapé
03071000
São Paulo
Brazil |
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Telephone:
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(11) 2178 1564 |
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Email:
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lcosta@edu.unicid.br |
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Affiliation:
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Universidade Cidade de São Paulo |
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Key inclusion & exclusion criteria
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Inclusion criteria: We will include patients who will be seeking care for chronic low back pain as well as patients with chronic low back pain from the community with a pain intensity level of at least 3 points on a 0-10 Pain Numerical Rating Scale.
Exclusion criteria: Patients with any contra-indication for manual therapy will be excluded (i.e. lumbar stenosis, spinal fractures, cancer, acute infections, lumbar osteoporosis, acute rheumatic conditions, any bleeding diseases, spinal tuberculosis, and deep venous trombosis).
Age minimum:
18Y
Age maximum:
80Y
Gender:
-
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Health Condition(s) or Problem(s) studied
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Chronic low back pain (i.e. pain lasting for 12 weeks or more) C10.597.617.152.400
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Intervention(s)
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High velocity spinal manipulation will be used as an intervention in both groups. One group of patients will receive manipulation in a specific lumbar spine level according to the physical examination performed by a skilled physiotherapist (i.e. specific manipulation group). The other group (i.e. non-specific manipulation group) will receive spinal manipulation on a random level (upper toracic spine). All participants will receive only one session of manipulation during the study. The outcomes (pain and pressure pain threshold) will be measured immediately after the interventions.
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Primary Outcome(s)
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Pain intensity will be measured by the Brazilian_portuguese version of the Pain Numerical Rating Scale (Pain NRS). The pain NRS is an 11-point scale ranging from 0 (no pain) to 10 (maximum pain possible).
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Secondary Outcome(s)
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The pressure pain threshold will be measured by a simple pressure clinical algometer.
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Secondary ID(s)
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PP13601854
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Source(s) of Monetary Support
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Universidade Cidade de São Paulo - Brazil
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