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CompletedNCT03871426Updated Jun 14, 2019

Manual Therapy Effects on Upper and Lower Esophageal Sphincter Pressures

An observational study in Gastroesophageal Reflux Disease and Globus Pharyngeus, sponsored by University Hospital, Motol. Completed at 1 site in Czechia. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-06-14.

Sponsored by University Hospital, Motol · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
54
Ages
18 Years to 70 Years
Sex
All
01

Study summary

The aim of this study is to test the influence of manual cervical traction and chest stabilization maneuvers on pressures in upper and lower esophageal sphincters.

Read the detailed description

High Resolution Manometry (HRM) will be used to measure pressure changes in upper esophageal sphincter (UES) and lower esophageal sphincter (LES) during manual cervical traction and trunk stabilization maneuvers. 50-55 gastroesophageal reflux disease (GERD) subjects will participate in the study. UES and pressures will first be measured in relaxed supine position then, during manual cervical traction and finally, the subjects will undergo manual positioning of the trunk into neutral position and LES and UES pressures will be measured again.

02

Conditions studied

  • Gastroesophageal Reflux Disease
  • Globus Pharyngeus

Keywords

  • High resolution manometry
  • globus pharyngeus
  • gastroesophageal reflux disease
  • manual cervical traction
  • trunk stabilization maneuver
03

In context

Gastroesophageal Reflux

1,067 studies on the registry are indexed under Gastroesophageal Reflux; 188 are open to participants now.

This study's enrollment of 54 is below the median of 180 across 298 observational studies indexed under Gastroesophageal Reflux.

Browse Gastroesophageal Reflux studies →

Lead sponsor

University Hospital, Motol is the lead sponsor of 45 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Sampling method
Probability sample

Study population

Gastroesophageal reflux disease

Inclusion criteria

  • Gastroesophageal reflux disease

Exclusion criteria

Exclusion Criteria:

  • Previous gastro- esophageal surgery
  • Concomitant other chronic disease that would affect esophageal motility
  • Esophageal structural pathology
  • Massive hiatus hernia
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
54 participants (actual)
Patient registry
No

Interventions

  • Proceduremanual therapy

    Manual Cervical Traction, Trunk Stabilization Maneuver

06

What researchers measure

Primary outcomes

  1. Pressure in upper and lower esophageal sphincter

    Pressure in upper and lower esophageal sphincter at rest, during cervical manual traction, and during trunk stabilization maneuver

    Time frame: up to 6 months

07

Study locations

1 site
  • Department of Rehabilitation and Sports Medicine, University Hospital Motol, Prague, Czech Republic
    Prague, 15006, Czechia
08

References and documents

Publications

  • Bitnar P, Stovicek J, Andel R, Arlt J, Arltova M, Smejkal M, Kolar P, Kobesova A. Leg raise increases pressure in lower and upper esophageal sphincter among patients with gastroesophageal reflux disease. J Bodyw Mov Ther. 2016 Jul;20(3):518-24. doi: 10.1016/j.jbmt.2015.12.002. Epub 2015 Dec 17. PubMed 27634073 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 14, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03871426
Lead sponsor
University Hospital, Motol
Responsible party
Alena Kobesova (Clinical Professor, University Hospital, Motol) — Principal investigator
First posted
Mar 12, 2019
Start date
Mar 18, 2019
Primary completion
Jun 13, 2019
Completion
Jun 13, 2019
Last update
Jun 14, 2019

Study contacts

Alena Kobesova, MD, PhD
principal investigator · Department of Rehabilitation and Sports Medicine, University Hospital Motol, Prague, Czech Republic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.

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