ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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.

Scientific title

changes in neck mobility and pressure pain threshold levels in patients with gastroesophageal reflux disease after osteopathic technique.

Secondary ID [1]

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

Condition category

Condition code

Oral and Gastrointestinal

Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Physical Medicine / Rehabilitation

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]

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]

change in severity of gastroesophageal reflux disease symptoms, assessed using the GerdQ questionnaire

Timepoint [1]

baseline and at 1 week after the intervention commencement

Primary outcome [2]

Determine the changes in range of motion of cervical spine, measured with CROM goniometer

Timepoint [2]

before and immediately following each treatment session

Secondary outcome [1]

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]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

Spain

State/province [1]

Navarra

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Zaragoza

Address [1]

Maria Angeles Franco
University of Zaragoza
CALLE DOMINGO MIRAL S/N
50009 ZARAGOZA

Country [1]

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]

University

Name [1]

ESCUELA OSTEOPATIA DE MADRID

Address [1]

ESCUELA OSTEOPATIA DE MADRID
C/ San Felix de Alcala 4
28007 Alcala de Henares ,Madrid

Country [1]

Spain

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Camilo Jose Cela University

Ethics committee address [1]

C/ Castillo de Alarcon, 49
Urb. Villafranca del Castillo
28692 Madrid

Ethics committee country [1]

Spain

Date submitted for ethics approval [1]

01/06/2016

Approval date [1]

05/10/2016

Ethics approval number [1]

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

Miss Nuria Eguaras

Address

Madrid school of osteopathy.
Nuria Eguaras
C/ Sancho el Fuerte 35 bajo
31007 Pamplona
Navarra
Spain

Country

Spain

Phone

+34660211003

Fax

nurieguaras@yahoo.es

Contact person for public queries

Name

Nuria Eguaras

Address

Madrid school of osteopathy.
Nuria eguaras
c/Sancho el Fuerte 35 bajo
31007 Pamplona
Navarra

Country

Spain

Phone

+34660211003

Fax

nurieguaras@yahoo.es

Contact person for scientific queries

Name

nuria eguaras

Address

Madrid school of osteopathy.
Nuria eguaras
c/Sancho el Fuerte nº35 bajo
31007 Pamplona
Navarra

Country

Spain

Phone

+34660211003

Fax

nurieguaras@yahoo.es

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

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.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically