Manual Therapy Effects on Upper and Lower Esophageal Sphi... | NCT03871426

Studies
Manual Therapy Effects on Upper and Lower Esophageal Sphincter Pressures

NCT03871426

Sponsor

University Hospital, Motol

Status

Completed

Last Update Posted

Jun 14, 2019Actual

Enrollment

54Actual

Phase

Not provided

Conditions

Gastroesophageal Reflux Disease
Globus Pharyngeus

Interventions

manual therapy

Countries

Czechia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 18, 2019Actual

Primary Completion Date

Jun 13, 2019Actual

Completion Date

Jun 13, 2019Actual

First Submitted Date

Mar 8, 2019

First Submission Date that Met QC Criteria

Mar 11, 2019

First Posted Date

Mar 12, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 13, 2019

Last Update Posted Date

Jun 14, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

54Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
manual therapy	Procedure	Manual Cervical Traction, Trunk Stabilization Maneuver

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Gastroesophageal reflux disease

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Alena Kobesova, MD, PhD	Department of Rehabilitation and Sports Medicine, University Hospital Motol, Prague, Czech Republic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Rehabilitation and Sports Medicine, University Hospital Motol, Prague, Czech Republic		Prague		15006	Czechia

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27634073	Background	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.

ID	Term
D005764	Gastroesophageal Reflux
D000079564	Globus Sensation

ID	Term
D015154	Esophageal Motility Disorders
D003680	Deglutition Disorders
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases

ID	Term
D000529	Complementary Therapies
D013812	Therapeutics
D026741	Physical Therapy Modalities
D012046	Rehabilitation