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NCT03871426 Clinical Trial

Manual Therapy Effects on Upper and Lower Esophageal Sphincter Pressures

Gastroesophageal Reflux Disease Clinical Trial

Official title:
Manual Cervical Traction and Trunk Stabilization Causes Significant Changes in Lower and Upper Esophageal Sphincter

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03871426
Other study ID # GERD2_2019
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 18, 2019
Est. completion date June 13, 2019

Study information
Verified date June 2019
Source University Hospital, Motol
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 54
Est. completion date June 13, 2019
Est. primary completion date June 13, 2019
Accepts healthy volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Gastroesophageal reflux disease

Exclusion Criteria:

- Previous gastro- esophageal surgery

- Concomitant other chronic disease that would affect esophageal motility

- Esophageal structural pathology

- Massive hiatus hernia

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• manual therapy
Manual Cervical Traction, Trunk Stabilization Maneuver

Locations
Country Name City State
Czechia Department of Rehabilitation and Sports Medicine, University Hospital Motol, Prague, Czech Republic Prague

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Motol

Country where clinical trial is conducted

Czechia, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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 up to 6 months
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