NCT03871426

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 12, 2019

Completed
6 days until next milestone

Study Start

First participant enrolled

March 18, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 13, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 13, 2019

Completed
Last Updated

June 14, 2019

Status Verified

June 1, 2019

Enrollment Period

3 months

First QC Date

March 8, 2019

Last Update Submit

June 13, 2019

Conditions

Gastroesophageal Reflux DiseaseGlobus Pharyngeus

Keywords

High resolution manometryglobus pharyngeusgastroesophageal reflux diseasemanual cervical tractiontrunk stabilization maneuver

Outcome Measures

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

    up to 6 months

Interventions

manual therapyPROCEDURE

Manual Cervical Traction, Trunk Stabilization Maneuver

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Gastroesophageal reflux disease

You may qualify if:

  • Gastroesophageal reflux disease

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Rehabilitation and Sports Medicine, University Hospital Motol, Prague, Czech Republic

Prague, 15006, Czechia

Location

Related 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.

    PMID: 27634073BACKGROUND

MeSH Terms

Conditions

Gastroesophageal RefluxGlobus Sensation

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesConversion DisorderSomatoform DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Alena Kobesova, MD, PhD

    Department of Rehabilitation and Sports Medicine, University Hospital Motol, Prague, Czech Republic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

March 8, 2019

First Posted

March 12, 2019

Study Start

March 18, 2019

Primary Completion

June 13, 2019

Study Completion

June 13, 2019

Last Updated

June 14, 2019

Record last verified: 2019-06

Locations

CZ(1)