World Health Organization site
Skip Navigation Links

Main
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.
Register: REBEC
Last refreshed on: 27 May 2013
Main ID:  RBR-5g7xqh
Date of registration: 26/10/2011
Primary sponsor: Centro Universitário Augusto Motta - Brazil
Public title: Effects of acupuncture on muscle strength of healthy subjects and stroke patients
Scientific title: Immediate effects of manual acupuncture on the biceps brachii muscle function in healthy subjects and chronic hemiparetic patients
Date of first enrolment: 12/04/2011
Target sample size: 80
Recruitment status: data analysis completed
URL:  http://www.ensaiosclinicos.gov.br/rg/RBR-5g7xqh/
Study type:  Intervention
Study design:  Clinical trial, randomized, four parallel groups, single-blinded  
Countries of recruitment
Brazil
Contacts
Name: Arthur  Ferreira
Address:  Av. Paris, 72 Bonsucesso 240410-21 Rio de Janeiro Brazil
Telephone: (21)38685063
Email: arthur_sf@ig.com.br
Affiliation:  Centro Universitário Augusto Motta
Name: Arthur  Ferreira
Address:  Av. Paris, 72 Bonsucesso 240410-21 Rio de Janeiro Brazil
Telephone: (21)38685063
Email: arthur_sf@ig.com.br
Affiliation:  Centro Universitário Augusto Motta
Key inclusion & exclusion criteria
Inclusion criteria: Control group: Absence of pain, trauma or musculoskeletal injuries in the upper limbs, neuromuscular diseases, pregnancy or some sort of unconfortable reaction to needling; Informed written consent signature after reading of the text and explanation of the objectives, risks and potential benefits from the participation in this research.
Hemiplegic group: Clinical diagnosis of upper neuron lesion due to stroke for at least 6 months, confirmed by image exams, both ischemic of hemorragic; Partial motor impairment of the upper limb function (hemiparesis); Absence of pain, trauma or musculoskeletal injuries in the upper limbs, neuromuscular diseases, pregnancy or some sort of unconfortable reaction to needling; Informed written consent signature after reading of the text and explanation of the objectives, risks and potential benefits from the participation in this research.

Exclusion criteria: Incomplete realization of any electromyographic signal acquisition; Low quality of electromyographic signal (less than 2-out-of-3 visible contraction events).

Age minimum: 20Y
Age maximum: 60Y
Gender: -
Health Condition(s) or Problem(s) studied
Stroke-related motor impairment
C10.228.140.300.775
C10.597.613.550
Intervention(s)
The intervention will consist in a unique treatment session (day). All subjects from both groups (healthy control and stroke patients) will be in a sitting position with their upper limb supported during all procedure. The following procedure will be performed only once for each subjects: Location of the acupuncture points according to the modern pattern, followed by skin assepsia with 70% alchohol and saline solution hydration; Electrode positioning for recording of the surface electromyogram according to the Surface Electromyography for the Non-Invasive Assessment of Muscles (SENIAM) protocol for the biceps brachii muscle; Electromyographic signal acquisition during dynamometry; Needle insertion (45º angle) directed to the qi circulation with sterilized, disposable needles (0,20 x 13 mm) at approximately 1.5 cm deepth, followed by rotating maneuvers until the subjects reported the de qi sensation; At 5, 10, 15 and 20 minutes, manual stimulation will be performed during 10 seconds; After 20 minutes, the needle will be withdraw and the signal acquisition repeated.
Primary Outcome(s)
Proportion of individuals with reduced muscle strength. Isometric muscle strength will be measured by the average of three maximal isometric voluntary contractions, each lasting 5 seconds, performed in the interval of 3 minutes each.
Proportion of subjects with reduced motor unit recruitment. Muscle recruitment will be measured by the average of RMS values of three maximal isometric voluntary contractions, each lasting 5 seconds, performed in the interval of 3 minutes each.
Secondary Outcome(s)
Prevalence of clinical manifestations in each subtype of clinical presentation. Clinical manifestations will be collected by interview with a clinical questionnaire.
Prevalence of subtypes of clinical presentations according to Chinese medicine. Subtypes will be classified by multivariate logistic regression based on the reported symptons.
Secondary ID(s)
CAAE-0006.0.307.000-10
Source(s) of Monetary Support
Centro Universitário Augusto Motta - Brazil
Secondary Sponsor(s)
Centro Universitário Augusto Motta - Brazil
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.1 - Version history