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Clinical Trials/NCT06564558
NCT06564558
Recruiting
N/A

The Effect of Postural Correctional Interventions on the Quality of Life of Patients With Gastroesophageal Reflux Disease.

Cairo University1 site in 1 country30 target enrollmentSeptember 1, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Gastro Esophageal Reflux
Sponsor
Cairo University
Enrollment
30
Locations
1
Primary Endpoint
Frequency Scale for the Symptoms of GERD (FSSG)
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

The main aim of this randomized controlled trial is to investigate the effects of postural correctional exercises and interventions on the severity of symptoms of gastroesophageal reflux disease (GERD) as well as the quality of life of patients afflicated with this disease. The main questions this study aims to answer is:

  1. Do postural correctional exercises reduce the symptoms of GERD?
  2. Do postural correctional exercises improve the quality of life of individuals afflicted with GERD?

The experimental group in this study will undergo real postural correctional exercises whereas the control group will undergo sham postural correctional interventions and then the two groups will be compared post-treatment based on GERD severity of symptoms as well as quality of life of the patients afflicted with GERD.

Detailed Description

Gastroesophageal reflux disease (GERD) is a disease that occurs when the normal physiological process termed gastroesophageal reflux (GER) begins to cause painful, harmful, or irritating signs and symptoms to certain individuals. This happens when the defence lines composed mainly of the lower esophageal sphincter (LES) and the angle of His are affected by a multitude of factors. These include abnormal resting pressure of the LES, increase intra-abdominal pressure compared to the resting pressure of the LES, certain medication side effects, and certain body positioning. The latter combined with posture has also been pointed out as a factor that might affect GERD by affecting the angle of His that acts similar to a valve between the esophagus and the curvature of the stomach. Several works of literature have found a link between GERD and postural abnormalities or deformities. Scoliosis, defined as a spinal deformity consisting of a lateral curvature with or without rotation of the vertebra, has been shown to be a risk factor of GERD. More specifically, a left-sided thoracolumbar or lumbar lateral curvature, especially when greater than 30 degrees, has been cited by several studies as a risk factor for consideration with regards to GERD. Accordingly, a certain relationship might be present between spinal deformities and/or abnormal spinal positioning, more specifically in the thoracic and thoracolumbar regions, and severity as well as prevalence of GERD. As such, the aim of this study is to investigate the effect of postural correctional interventions (PCI) on severity of GERD symptoms and quality of life in patients afflicted with the disease. The experimental group in this study will undergo real postural correctional exercises whereas the control group will undergo sham postural correctional interventions and then the two groups will be compared post-treatment based on GERD severity of symptoms as well as quality of life of the patients afflicted with GERD.

Registry
clinicaltrials.gov
Start Date
September 1, 2024
End Date
September 1, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ahmed ElMelhat

Associate Professor of Physical Therapy

Cairo University

Eligibility Criteria

Inclusion Criteria

  • Ages between 18 and
  • Diagnosed with GERD by a primary medical doctor.
  • Patients with a kyphosis angle greater than 30 degrees.
  • A score of 8 or greater on the Frequency Scale for the Symptoms of GERD (FSSG) which is considered positive.

Exclusion Criteria

  • Individuals with recent spinal surgery.
  • Recent spinal trauma in the thoracic or lumbar regions
  • A score less than 8 on the FSSG
  • Having no associated thoracic or thoracolumbar deformity or abnormal alignment.

Outcomes

Primary Outcomes

Frequency Scale for the Symptoms of GERD (FSSG)

Time Frame: Taken initially before intervention process, at 6 months follow up and at 12 months follow up.

The Frequency Scale for the Symptoms of GERD is a scale comprised of 12 questions targeted at assessing the severity of GERD symptoms. Each question is scored on an ordinal basis as follows: never=0; occasionally=1; sometimes=2; often=3; and always=4. The questions include statements such as: "do you get heartburn" and "do you get a bitter liquid (acid) coming up into your throat. This scale has been used widely in the literature that had similar aims to this study in assessing the severity of GERD.

Secondary Outcomes

  • Kyphosis Cobb Angle Assessment Using X-ray Radiographs:(Taken initially before intervention process, at 6 months follow up and at 12 months follow up.)
  • GERD Quality of Life Questionnaire (GERD QOL)(Taken initially before intervention process, at 6 months follow up and at 12 months follow up.)
  • Short Forum Suvery SF-12v2:(Taken initially before intervention process, at 6 months follow up and at 12 months follow up.)

Study Sites (1)

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