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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-4hb6f6 |
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Date of registration:
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02/07/2011 |
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Primary sponsor: |
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Public title:
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Evaluation of electroacupuncture on the treatment of neck and sholder pain
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Scientific title:
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Evaluation of Electroacupuncture on the myofascial pain treatment of the upper trapezius muscle |
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Date of first enrolment:
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Target sample size:
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20 |
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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-4hb6f6/ |
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Study type:
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Study design:
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Clinical trial, one arm, non randomized, opened, phase 4.
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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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maria
gavião |
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Address:
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Av. Limeira, 901 Caixa Postal 52
13414-903
piracicaba
Brazil |
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Telephone:
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019 21065368 |
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Email:
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mbgaviao@fop.unicamp.br |
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Affiliation:
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Faculdade de Odontologia de Piracicaba/UNICAMP |
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Name:
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maria
gavião |
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Address:
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Av. Limeira, 901 Caixa Postal 52
13414-903
piracicaba
Brazil |
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Telephone:
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019 21065368 |
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Email:
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mbgaviao@fop.unicamp.br |
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Affiliation:
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Faculdade de Odontologia de Piracicaba/UNICAMP |
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Key inclusion & exclusion criteria
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Inclusion criteria: Female, age range from 18 to 40 years, at least one MTrPs in the upper trapezius muscle, local or referred persistent pain for at least six months, regular menstrual cycles controlled by the use of oral contraceptive, and right-handed.
Exclusion criteria: Accentuated postural abnormalities, verified by the physiotherapist (MFMA), fibromyalgia syndrome, cervical radiculopathy, systemic disease or therapeutic interventions for physical myofascial pain within the past month before the study, pregnancy, chronic pacemaker or electronic implants, the last ones informed by the subject. The continuous use of medications to treat headache and muscular pain was also an exclusion criterion. Moreover, if evident cognitive impairment or communication difficulties were observed by the examiner (MFMA) at the first meeting, the subject was not included.
Age minimum:
18Y
Age maximum:
40Y
Gender:
F
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Health Condition(s) or Problem(s) studied
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Myofascial pain C05.651.550
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Intervention(s)
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Electroacupuncture was applied to 20 females. Each volunteer received two sessions weekly and all nine sessions were scheduled at the same time of the day. The SF-36 questionnare was applied in the beginning of the first and the ninth sessions, following by the Visual analog Scale (VAS); electromyography (EMG) and pain pressure threshold (PPT) were assessed after VAS during the first, fifth and ninth sessions. During EA application, the patient remained sited in a chair. Needles were inserted bilaterally in the points GB21, GB20, LI4, LV3 and directly in the region of the MTrPs (maximum of four needles). The equipment was programmed as follows: alternating frequency F1=2Hz, T1=5 seconds, F2=100 Hz, T2=5 seconds; total time: 30 minutes; intensity: maximum supported by the patient without pain. EA was performed in the same manner in all sessions. To assess PPT, the algometry was first demonstrated on the forearm, so the volunteers could familiarize with the equipment and feel the pressure, which would be exerted on the trapezius muscles. After, the digital algometer was applied on upper trapezius, midway between the seventh cervical vertebra and the tip of the acromion bilaterally, increasing the pressure at a rate of 0.5 kgf/s until the volunteer had reported a painful sensation. The procedure was repeated three times, and the mean value was considered. EMG electrodes were placed in the upper trapezius muscle midway between the seventh cervical vertebra (C7) and acromion. The exam was conducted with the subject seated in a chair during trapezius muscle at rest and during isometric contraction (raising of the shoulders, keeping this position). The volunteers had been previously trained to perform the required tasks. Each task was requested three times (with one minute interval) and the mean rms values were used.
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Primary Outcome(s)
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It was expected that electroacupuncture would decrease the volunteers myofascial pain. The measures used due to evaluate the results were: pain intensity , using visual analog scale; pain pressure threshold, using digital algometry; muscle electrical activity, using electromyography. Due to the pain relief, it was also expected that the quality of life enhancing. This variable mas measured by the SF-36 questionnare. The results showed that accupuncture was effective on myofacial pain of the studied sample. The pain intensity decreased, the pain pressure threshold increased, the muscle electrical activity during right upper trapezius isometric contraction increased after the nine sessions. That was also observed after the last session at the left upper trapezius, suggesting muscle function enhancement provided by EA. Furthermore, the quality of life was improved, related to physical components domain of the SF-36 questionnaire. Large randomized blinded controlled trials might be carried out to confirm these results. In accordance with these preliminary findings, the electroacupuncture can be considered a relevant tool for the management of myofascial pain.
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Secondary ID(s)
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088/2008
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CAAE-0089.0.167.000-08
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Source(s) of Monetary Support
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Fundação de Amparo à Pesquisa do Estado de São Paulo - FAPESP - Brazil
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