Main
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Note: This record shows only 22 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:
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ANZCTR |
Last refreshed on:
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11 November 2019 |
Main ID: |
ACTRN12618000495224 |
Date of registration:
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05/04/2018 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Visceral osteopathy in patients with neck pain and bad digestion with the aim of reducing these troubles.
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Scientific title:
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effects of visceral osteopathy and thoracic manipulation in patients with dyspepsia |
Date of first enrolment:
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30/04/2018 |
Target sample size:
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60 |
Recruitment status: |
Completed |
URL:
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https://anzctr.org.au/ACTRN12618000495224.aspx |
Study type:
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Interventional |
Study design:
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Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;
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Phase:
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Not Applicable
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Countries of recruitment
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Spain
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Contacts
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Name:
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Miss laura argüelles movillo
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Address:
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Clínica Manso
c/ ceán bermúdez 22-24
33208
Gijón, Asturias
Spain |
Telephone:
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+34 654717835 |
Email:
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laura_movillo@hotmail.com |
Affiliation:
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Name:
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Miss laura argüelles movillo
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Address:
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Clínica Manso
c/ ceán bermúdez 22-24
33208
Gijón, Asturias
Spain |
Telephone:
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+34 654717835 |
Email:
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laura_movillo@hotmail.com |
Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Patients with functional dyspepsia.
patients with neck pain.
patients with index of body mass < 30.
Exclusion criteria: Be pregnant.
have diagnosed medical pathology like hiatal hernia, helicobacter pylori, duodenal ulcers.... any infection, tumor, vascular or neurological involvement.
take medication
abdominal or dorsolumbar surgeries.
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
Both males and females
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Health Condition(s) or Problem(s) studied
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Alternative and Complementary Medicine - Other alternative and complementary medicine
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functional dyspepsia; functional dyspepsia
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Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention(s)
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The study is divided into two groups. The study is done in a private clinic ( " Clínica Manso " ) once a week for 4 weeks, the duration of each session is one hour and a half.
1. Experimental Group. · first session: we give the patient the information about the study. He must complete the clinical history, sign the informed consent and perform two scales of quality of life ( Dyspepsia related health scale and Gastrointestinal quality of life scale ). Then, the baropodometry and algometry in the spinous of the fourth, fifth and sixth thoracic vertebrae and the trigger points of the upper trapezius are performed. After the measurements we do the treatment. The treatment consists of: - 20 minutes of TENS currents. We place 2 electrodes to the patient on both sides of the spine of the seventh cervical vertebra. The TENS current is continuous with a frequency of 100 Hertz. The patient's sensation will be tingling. The purpose of the TENS is to produce analgesia. - dog technique in the fifth thoracic vertebrae: the patient is in the supine decubitus, he brings his right hand to his left shoulder and his left hand to his right shoulder so that his elbows form a V. The therapist makes contact with his hand in the patient's fifth thoracic vertebra, his other hand and his abdomen rest on the elbows of the patient. Finally, a single manipulative impulse is made at the end of the exhalation. - 2 visceral osteopathy techniques ( stretch of the diaphragm and global hemodynamic abdomen technique ) When the treatment is finished the measurements of baropodometry and algometry are repeated. · second and third session: we repeat the measurements before and after treatment as well as the treatment already described. · fourth session: the patient
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Primary Outcome(s)
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pain in the dorsal spines ( T4, T5, T6). We measure it with an algometer.[In the first session we measure the pain in the dorsal spines immediately before and immediately after treatment. we repeat the process: -after a week of the first session. -after two weeks of the first session. -after 3 weeks of the first session (primary endpoint).]
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changes at the center of gravity. We measure it in a platform of pressures. [In the first session we measure the center of gravity immediately before and immediately after treatment. We repeat the process: -after a week of the first session. -after two weeks of the first session. -after 3 weeks of the first session (primary endpoint).]
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pain in trigger points of upper trapezius. We measure it with an algometer.[In the first session we measure the pain in trigger points of upper trapezius immediately before and immediately after treatment. we repeat the process: -after a week of the first session. -after two weeks of the first session. -after 3 weeks of the first session (primary endpoint).]
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Secondary Outcome(s)
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Gastrointestinal quality of life questionnaire.[immediately before of the treatment at the first session.
3 weeks after the first session.]
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Dyspepsia Related Health Scale.[It is done only in the first session.]
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Secondary ID(s)
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Nil known
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Source(s) of Monetary Support
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Laura Argüelles Movillo
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Ethics review
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Status: Approved
Approval date:
Contact:
Comité de Ética de la Investigación del Principado de Asturias
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Results
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Results available:
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Yes |
Date Posted:
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29/08/2019 |
Date Completed:
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24/05/2019 |
URL:
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