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Trial registered on ANZCTR
Registration number
ACTRN12617000188336
Ethics application status
Approved
Date submitted
9/12/2016
Date registered
3/02/2017
Date last updated
21/06/2019
Date data sharing statement initially provided
21/06/2019
Date results provided
21/06/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
changes in neck mobility and pressure pain threshold levels in patients with gastroesophageal reflux disease after osteopathic technique.
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Scientific title
changes in neck mobility and pressure pain threshold levels in patients with gastroesophageal reflux disease after osteopathic technique.
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Secondary ID [1]
289191
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none
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Universal Trial Number (UTN)
U1111-1181-7839
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Gastroesophageal reflux disease
298746
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Condition category
Condition code
Oral and Gastrointestinal
298798
298798
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Physical Medicine / Rehabilitation
298799
298799
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0
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Physiotherapy
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The patient keeps sitted. The osteopath will contact with his hands over the esophagogastric junction (on the abdomen) sliding it down. The aim of these technique is to improve distensibility and range of motion. The patient is required to take deep breaths during the intervention
The technique will be applied 10 motion repeated, during 5 minutes in two sessions.
Second session will take place one week later. Patients are expected to adhere the study over those two sessions. If any of them leave the study, without appearing to any of the sessions in the time agreed, they will be excluded.
There won´t be any strategies in order to maintain fidelity.
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Intervention code [1]
294745
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Treatment: Other
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Comparator / control treatment
the osteopath puts his hands over the ribs and the patient just breathes. Also during 5 minutes.
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Control group
Placebo
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Outcomes
Primary outcome [1]
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change in severity of gastroesophageal reflux disease symptoms, assessed using the GerdQ questionnaire
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Assessment method [1]
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Timepoint [1]
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baseline and at 1 week after the intervention commencement
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Primary outcome [2]
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Determine the changes in range of motion of cervical spine, measured with CROM goniometer
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Assessment method [2]
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Timepoint [2]
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before and immediately following each treatment session
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Secondary outcome [1]
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pressure pain threshold level in 4th cervical vertebra, 3rd and 5th toracic vertebras, upper trapezius trigger points and external auditory canal sensibility measured with digital algometer
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Assessment method [1]
323832
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Timepoint [1]
323832
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immediately pre and post- intervention.
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Eligibility
Key inclusion criteria
- Patients must be previously diagnosed of gastroesophageal reflux disease.
- Patients must be 18 years old at least and under 70 years old, and be able to understand and answer the questionnaire.
- They must have signed the informed consent to take part of the study.
- Patients must tolerate cervical movements (flexoextension, sidebending, rotation)
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Minimum age
18
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
They will be excluded:
- Patients with ulcus peptic, irritable bowel sindrome, gastric cancer or gastric surgery during the last year.
- Patients with recent vertebral fracture or trauma.
- Patients under physiotherapy for cervical or dorsal spine in the moment of the study.
- Patients with systemic diseases affecting cervical or dorsal spine, such as reumathoid arthritis.
- Prengant women or women trying to get pregnant.
- Patients who are taking part in other clinical study.
- Patients undergoing through chemotherapy or radiotherapy
- Patients with psychiatric problems
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be concealed with Sealed opaque envelopes. Patients will choose the envelope, those who take number one will be allocated into Control Group, those who take number two into Treatment Group.
Patients won´t know at any time the group they are allocated in.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
To create the random order for the allocation of patients into each group it will be used a simple randomisation table.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
One group will receive the osteopathic technique.
The other group will be control group and won´t receive the osteopathic treatment, they will receive a sham technique
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Phase
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
15/02/2017
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Actual
24/10/2017
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Date of last participant enrolment
Anticipated
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Actual
28/02/2018
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Date of last data collection
Anticipated
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Actual
7/03/2018
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Sample size
Target
60
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Accrual to date
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Final
60
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Recruitment outside Australia
Country [1]
7883
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Spain
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State/province [1]
7883
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Navarra
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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University of Zaragoza
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Address [1]
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Maria Angeles Franco
University of Zaragoza
CALLE DOMINGO MIRAL S/N
50009 ZARAGOZA
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Country [1]
293611
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Spain
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Primary sponsor type
Other
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Name
NURIA EGUARAS SAINZ DE MURIETA
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Address
C/ SANCHO EL FUERTE 35 BAJO
31007 PAMPLONA, NAVARRA
SPAIN
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Country
Spain
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Secondary sponsor category [1]
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University
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Name [1]
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ESCUELA OSTEOPATIA DE MADRID
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Address [1]
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ESCUELA OSTEOPATIA DE MADRID
C/ San Felix de Alcala 4
28007 Alcala de Henares ,Madrid
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Country [1]
292430
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Spain
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Camilo Jose Cela University
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Ethics committee address [1]
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C/ Castillo de Alarcon, 49 Urb. Villafranca del Castillo 28692 Madrid
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Ethics committee country [1]
296500
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Spain
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Date submitted for ethics approval [1]
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01/06/2016
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Approval date [1]
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05/10/2016
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Ethics approval number [1]
296500
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Summary
Brief summary
The aim of the study is to verify the positive effect of one osteopathic technique in patients suffering from Gastroesophageal Reflux Disease. The technique consists on deep breathings of the patient while the osteopath with his fingers slides down the esophagogastric junction. The patient keeps sitted during the process. In order to measure and evaluate the evolution: - patients will answer the GERDQ(gastroesophageal reflux disease questionnaire), - algometer will evaluate pain threshold in external auditory canal, dorsal vertebras and upper trapezious muscle. - goniometer will study neck mobility These measurements will take place before and after the first treatment session. This will be repeated one week later in the second session. The GERDq will be answered in each session. At least 40 patients will be recruited. Then statistic analysis will be developed in order to confirm or refuse the technique utility.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Miss Nuria Eguaras
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Address
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Madrid school of osteopathy.
Nuria Eguaras
C/ Sancho el Fuerte 35 bajo
31007 Pamplona
Navarra
Spain
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Country
65798
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Spain
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Phone
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+34660211003
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Nuria Eguaras
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Address
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Madrid school of osteopathy.
Nuria eguaras
c/Sancho el Fuerte 35 bajo
31007 Pamplona
Navarra
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Country
65799
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Spain
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Phone
65799
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+34660211003
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Fax
65799
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Email
65799
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[email protected]
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Contact person for scientific queries
Name
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nuria eguaras
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Address
65800
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Madrid school of osteopathy.
Nuria eguaras
c/Sancho el Fuerte nº35 bajo
31007 Pamplona
Navarra
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Country
65800
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Spain
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Phone
65800
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+34660211003
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Fax
65800
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Email
65800
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
results will be published without individual data
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
Effects of osteopathic visceral treatment in patients with gastroesophageal reflux: A randomized controlled trial.
2019
https://dx.doi.org/10.3390/jcm8101738
N.B. These documents automatically identified may not have been verified by the study sponsor.
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