The Effect of Postural Correction On Gastroesophageal Reflux Disease
NCT Number: NCT06564558
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Gastro Esophageal Reflux|Gastro Esophageal Reflux Disease
Interventions: OTHER: Spinal Strengthening Exercises|OTHER: Thoracic Spine Stretching|OTHER: Thoracic Spine Mobilization|OTHER: Sham Postural Correction
Sponsor: Cairo University
Sex: ALL
Age: ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2024-09-01
Completion Date: 2025-09-01
Locations: Beirut Arab University, Beirut, 0000, Lebanon

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.

Primary Outcome Measures: Frequency Scale for the Symptoms of GERD (FSSG), 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., Taken initially before intervention process, at 6 months follow up and at 12 months follow up.
Secondary Outcome Measures: Kyphosis Cobb Angle Assessment Using X-ray Radiographs:, Initially the Cobb angle was created to measure scoliosis, however with the adjustment of the patient position and plane of radiography it has been proven useful to assess kyphosis and hyperkyphosis. At this time, the Cobb angle assessed using X-ray radiographs is considered the golden standard for kyphosis assessment. The patient will be standing with the X-ray taken at the side by a licensed and experienced technician. The Cobb angle will then be computed and given to the outcome assessors., Taken initially before intervention process, at 6 months follow up and at 12 months follow up.|GERD Quality of Life Questionnaire (GERD QOL), The GERD Quality of Life Questionnaire is a 16-item questionnaire encompassing 4 different areas daily activity, treatment effect, diet, and psychological well-being. Each are is scored on a scale of 0 to 4 meaning the following: 0= Strongly Agree, 1= Agree, 2= Neutral, 3= Disagree, 4= Strongly Disagree. The higher the score the lesser the impact of GERD on quality of life and thus the better score. After answering each question, all the questions corresponding to each aspect are summed and divided by the maximum score attainable and divided by 100. The total scores for each aspect are then added up and divided by 4 to get a final score. This questionnaire was proven to have good validity and reliability in assessing the impact of GERD on patient quality of life., Taken initially before intervention process, at 6 months follow up and at 12 months follow up.|Short Forum Suvery SF-12v2:, General health related quality of life will be assessed using the SF-12v2 questionnaire which is a simplified and shortened version of the SF-36 questionnaire. The questionnaire contains 12 questions over eight different health-related domains. Each of the 8 domains or subscales is scored from 0-100 with higher scores indicating better health. In addition to the 8 subscale scores, the SF12v2 is reportedly capable of reporting summary scores for physical and mental health individually with scores also ranging from 0-100 and higher scores indicating better health. The questionnaire was described as both valid and reliable in recent literature., Taken initially before intervention process, at 6 months follow up and at 12 months follow up.