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

• Register: ANZCTR
• Last refreshed on: 15 July 2019
• Main ID: ACTRN12617000188336
• Date of registration: 03/02/2017
• Prospective Registration: Yes
• Primary sponsor: NURIA EGUARAS SAINZ DE MURIETA
• 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.
• Date of first enrolment: 24/10/2017
• Target sample size: 60
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12617000188336.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;

Countries of recruitment

Spain

Contacts

• Name: Miss nuria eguaras

• Name: Miss Nuria Eguaras

Key inclusion & exclusion criteria

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)
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


Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Gastroesophageal reflux disease;
Gastroesophageal reflux disease

Physical Medicine / Rehabilitation - Physiotherapy

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

Intervention(s)

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.

Primary Outcome(s)

change in severity of gastroesophageal reflux disease symptoms, assessed using the GerdQ questionnaire[baseline and at 1 week after the intervention commencement]

Determine the changes in range of motion of cervical spine, measured with CROM goniometer[before and immediately following each treatment session ]

Secondary Outcome(s)

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[immediately pre and post- intervention. ]

Secondary ID(s)

none

Source(s) of Monetary Support

University of Zaragoza

Secondary Sponsor(s)

ESCUELA OSTEOPATIA DE MADRID

Ethics review

Status: Approved
Approval date:
Contact:

Camilo Jose Cela University

Results

• Results available: Yes
• Date Posted: 21/06/2019
• Date Completed: 07/03/2018