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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-6864tj |
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Date of registration:
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04/07/2011 |
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Primary sponsor: |
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Public title:
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Treatment for pain reduction and the size of heel spur
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Scientific title:
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Evaluation of effects of iontophoresis and phonophoresis whit acetic acid in the treatment of plantar fasciitis calcifying |
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Date of first enrolment:
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Target sample size:
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30 |
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Recruitment status: |
recruitment completed |
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URL:
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http://www.ensaiosclinicos.gov.br/rg/RBR-6864tj/ |
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Study type:
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Study design:
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Clinical trial, double-blind, randomized, 2-arm, phase 2-3
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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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Angélica
Araújo |
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Address:
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Avenida Trinta e Um de Março, Acesso 7, Prédio 46 - Bairro Dom Cabral
30.535-000
Belo Horizonte
Brazil |
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Telephone:
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(31)3319-4425 |
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Email:
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angelica@bios.srv.br |
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Affiliation:
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PUC Minas |
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Name:
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Angélica
Araújo |
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Address:
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Avenida Trinta e Um de Março, Acesso 7, Prédio 46 - Bairro Dom Cabral
30.535-000
Belo Horizonte
Brazil |
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Telephone:
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(31)3319-4425 |
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Email:
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angelica@bios.srv.br |
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Affiliation:
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PUC Minas |
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Key inclusion & exclusion criteria
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Inclusion criteria: Medical diagnosis of plantar fasciitis associated with the presence of limestone deposits in the plantar fascia and / or Achilles tendon, which was confirmed by radiological examination.
Exclusion criteria: Exclusion criteria consisted of allergy to acetic acid; history of cancer, trauma, and recent surgery on his ankle, as well as open lesions and alteration of pain sensitivity in the same region, pregnant or lactating, using any kind of treatment for plantar fasciitis calcifying , Presence of rheumatoid arthritis and osteoporosis
Age minimum:
18
Age maximum:
0
Gender:
-
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Health Condition(s) or Problem(s) studied
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PLANTAR FASCIITIS CALCIFYING E02.319.267.650 E02.319.267.720 D02.241.081.038.208.025 A02.340
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Intervention(s)
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Manual therapy: All segments were subjected to a standard intervention that consisted of joint mobilization techniques of talocrural (slip anteroposterior and posteroanterior), grade I or II of Maitland, seeking relief from pain. We performed two types of mobilization, once every two seconds, one minute, with 4 series and repetition interval of 30 seconds between each set, as described below: - Mobilization of the posterior talus: a patient positioned supine with the segment to be treated outside of the litter. One of the hands of the therapist holds the proximal tibia and fibula to stabilize the leg and the other clings to the anterior talus and applies a force in the anteroposterior direction. - Mobilization of the anterior talus: a patient in the prone position with the segment to be treated outside of the litter. The therapist holds with one hand to the anterior proximal tibia and fibula and the other grabs the heel and carries a force in the posterior-anterior direction. Iontophoresis Iontophoresis was applied after the intervention of standard manual therapy, using a galvanic current generator. Silicon electrodes were used, and the negative pole active 6.0 x 6.0 cm and the positive pole dispersive 10.5 x 6.0 cm. The first was positioned in the region of calcification with 5% acetic acid concentration and the second on the back of the calf. The current was applied to the sensory threshold (maximum amplitude equal to 18 mA), with exposure time of 8 minutes. Phonophoresis: After the standard intervention (manual therapy), phonophoresis was performed using the apparatus of therapeutic ultrasound, properly calibrated. It was applied in the region of calcification of the calcaneus and / or Achilles tendon with a frequency of 1 MHz, intensity of 2.0 Wcm2, continuous mode for 15 minutes with the patient in the supine position.
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Primary Outcome(s)
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Size of calcification: the area of the calcaneus was used as reference to estimate the size of calcification. For the calculation, X-rays of the ankle before and after study were used. The x-ray images were digitized and created a script in Matlab was used to measure the area. The three measurements and average used for analysis, and measurements were performed by two investigators blinded with regard to the research group that belonged to each segment of the ankle.
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Secondary Outcome(s)
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Pain: pain intensity at rest and in motion, was assessed using a Visual Numerical Scale (VNS). The VNS was applied at initial assessment and each session (pre and post treatment), by the same evaluator, previously trained to perform the procedure. Pain was also measured by the McGill Pain Questionnaire, which was applied at baseline and last treatment session, by the same evaluator.
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Secondary ID(s)
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CAAE 0125.0.213.000-08
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Source(s) of Monetary Support
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FIP PUC Minas - Brazil
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