Trial Review

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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 information initially 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.
Scientific title
changes in neck mobility and pressure pain threshold levels in patients with gastroesophageal reflux disease after osteopathic technique.
Secondary ID [1] 289191 0
none
Universal Trial Number (UTN)
U1111-1181-7839
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastroesophageal reflux disease 298746 0
Condition category
Condition code
Oral and Gastrointestinal 298798 298798 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Physical Medicine / Rehabilitation 298799 298799 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 294745 0
Treatment: Other
Comparator / control treatment
the osteopath puts his hands over the ribs and the patient just breathes. Also during 5 minutes.
Control group
Placebo

Outcomes
Primary outcome [1] 298314 0
change in severity of gastroesophageal reflux disease symptoms, assessed using the GerdQ questionnaire
Timepoint [1] 298314 0
baseline and at 1 week after the intervention commencement
Primary outcome [2] 298315 0
Determine the changes in range of motion of cervical spine, measured with CROM goniometer
Timepoint [2] 298315 0
before and immediately following each treatment session
Secondary outcome [1] 323832 0
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
Timepoint [1] 323832 0
immediately pre and post- intervention.

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)
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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.
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.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
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
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/02/2017
Actual
24/10/2017
Date of last participant enrolment
Anticipated
Actual
28/02/2018
Date of last data collection
Anticipated
Actual
7/03/2018
Sample size
Target
60
Accrual to date
Final
60
Recruitment outside Australia
Country [1] 7883 0
Spain
State/province [1] 7883 0
Navarra

Funding & Sponsors
Funding source category [1] 293611 0
University
Name [1] 293611 0
University of Zaragoza
Country [1] 293611 0
Spain
Primary sponsor type
Other
Name
NURIA EGUARAS SAINZ DE MURIETA
Address
C/ SANCHO EL FUERTE 35 BAJO
31007 PAMPLONA, NAVARRA
SPAIN
Country
Spain
Secondary sponsor category [1] 292430 0
University
Name [1] 292430 0
ESCUELA OSTEOPATIA DE MADRID
Address [1] 292430 0
ESCUELA OSTEOPATIA DE MADRID
C/ San Felix de Alcala 4
28007 Alcala de Henares ,Madrid
Country [1] 292430 0
Spain

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296500 0
Camilo Jose Cela University
Ethics committee address [1] 296500 0
C/ Castillo de Alarcon, 49
Urb. Villafranca del Castillo
28692 Madrid
Ethics committee country [1] 296500 0
Spain
Date submitted for ethics approval [1] 296500 0
01/06/2016
Approval date [1] 296500 0
05/10/2016
Ethics approval number [1] 296500 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 65798 0
Miss Nuria Eguaras
Address 65798 0
Madrid school of osteopathy.
Nuria Eguaras
C/ Sancho el Fuerte 35 bajo
31007 Pamplona
Navarra
Spain
Country 65798 0
Spain
Phone 65798 0
+34660211003
Fax 65798 0
Email 65798 0
[email protected]
Contact person for public queries
Name 65799 0
Miss Nuria Eguaras
Address 65799 0
Madrid school of osteopathy.
Nuria eguaras
c/Sancho el Fuerte 35 bajo
31007 Pamplona
Navarra
Country 65799 0
Spain
Phone 65799 0
+34660211003
Fax 65799 0
Email 65799 0
[email protected]
Contact person for scientific queries
Name 65800 0
Miss nuria eguaras
Address 65800 0
Madrid school of osteopathy.
Nuria eguaras
c/Sancho el Fuerte nº35 bajo
31007 Pamplona
Navarra
Country 65800 0
Spain
Phone 65800 0
+34660211003
Fax 65800 0
Email 65800 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
results will be published without individual data


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Basic resultsNo 370685-(Uploaded-21-06-2019-06-15-14)-Basic results summary.docx
Plain language summaryNo The scores of the GerdQ test decreased in the EG c... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEffects of osteopathic visceral treatment in patients with gastroesophageal reflux: A randomized controlled trial.2019https://dx.doi.org/10.3390/jcm8101738
N.B. These documents automatically identified may not have been verified by the study sponsor.