Clinical Trials Logo

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


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
See also
  Status Clinical Trial Phase
Completed NCT02135107 - A Double-blind Comparative Study of the Efficacy and Safety of E3810 10mg Once and Twice Daily in Maintenance Therapy for PPI Resistant Gastroesophageal Reflux Disease Patients Phase 3
Completed NCT01432392 - Symptom Control and Impact on Daily Life in Patients With Gastroesophageal Reflux Disease N/A
Recruiting NCT01249482 - Symptom Assessment for GERD Patients Receiving H. Pylori Eradication N/A
Completed NCT01200550 - The Study to Describe Symptom Control and Impact on Daily Life in Gastroesophageal Reflux Disease (GERD) Patients N/A
Completed NCT01578642 - Feasibility Study for Evaluating the Effect of Electrical Stimulation on Lower Esophageal Sphincter Pressure and Esophageal Acid Exposure in Patients With Gastroesophageal Reflux Disease Phase 2
Completed NCT00998244 - Study to Evaluate the Effect of a Very Low Carbohydrate Diet on Gastroesophageal Reflux Disease N/A
Completed NCT00978016 - A Study to Evaluate the Efficacy and Safety of Arbaclofen Placarbil (XP19986) as Adjunctive Therapy in Subjects With Gastroesophageal Reflux Disease (GERD) Phase 2
Unknown status NCT01128608 - The Effect of High PCO2 Solution on Esophageal Acid Sensation N/A
Completed NCT00768196 - Prevalence of EED and Quality of Life Evaluated by Gastroesophageal Reflux Disease (GERD)-Q in Korean GERD Patients N/A
Completed NCT00768443 - Symptoms and Management Strategies in Gastroesophageal Reflux Disease (GERD) N/A
Recruiting NCT00498082 - Determinants of Efficacy of EsophyX Treatment in Gastro-Esophageal Reflux Disease N/A
Completed NCT00886197 - Diagnostic Efficacy of Narrow Band Imaging in Patients With Gastroesophageal Reflux Disease N/A
Completed NCT00378898 - Feasibility of Placing Bravo PH Capsule in Proximal Esophagus N/A
Completed NCT00507377 - Foreshortened Esophagus and Its Surgical Therapy
Completed NCT00217347 - Evaluation of Efficiency of Esophageal Capsule Endoscopy in the Screening of Patients With Gastroesophageal Reflux Disease or Dyspepsia as Compared to Upper Endoscopy N/A
Completed NCT00165022 - Development of a Novel Disease-Specific Quality of Life Questionnaire for Gastroesophageal Reflux Disease (GERD) Patients in Chinese Population N/A
Completed NCT00214552 - Evaluate the Effects on Asthma Control of Rabeprazole Given Twice Daily in Subjects With Asthma. Phase 3
Completed NCT00625495 - Study Comparing the Effects of Esomeprazole Adminstered Orally and Intravenously on Basal and Pentrigastrin-stimulated Acid Output in Subjects With Symptoms of Gastroesophageal Reflux Disease (GERD) Phase 4
Completed NCT00618150 - Patient Education in Gastroesophageal Reflux Disease N/A
Completed NCT03299985 - Diaphragmatic Myofascial Release in Gastroesophageal Reflux Disease N/A