The Effect of Postural Correction On Gastroesophageal Reflux Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorCairo University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Ages between 18 and 60.
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.
Disqualifiers
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.
Trial design
Design model
Factorial
Treatments tested in this trial
Spinal Strengthening Exercises
Other interventionIndividuals in the experimental group will carry out 3 sets of 10 repetitions or what is tolerated within a Borg scale intensity of 4-5 with 70-80% of perceived exertion with appropriately picked elastic bands. The exercises include: Shoulder horizontal abduction; Shoulder elevation; Back Extensions over a plinth; Shoulder extension exercises; One arm and opposite leg lifts from quadruped; and finally bilateral arm lifts with upper thoracic extension from prone (superman exercise).
Thoracic Spine Stretching
Other interventionParticipants will be instructed to do two exercises: Firstly, to lay supine with and hinge the thoracic spine over a roller placed in a way that would ensure the patient is forward lying and not completely supine. The participant will be instructed to maintain hinging until a stretch or pressure feeling is felt in the midback and hold this position for 3 sets of 30 seconds. Secondly, the patient was asked to be in a seated position, clasp the hands together and behind the head while arching backward over the chair and looking up. This exercise will be done for 3 sets of 20-30 repetitions with a slight hold time at the end of the movement. All interventions will be carried out for 45 minute sessions 3 times per week.
Thoracic Spine Mobilization
Other interventionThe patient will be seated with both hands clasped at shoulder level. An experienced and blinded therapist standing homolateral to the patient supports the clasped hands with one arm while placing the other hand was placed at different thoracic regions until the thoracolumbar junction. Specifically, the dorsal aspect of the index finger and pad of the thumb were used to create a fixation point at the junction. Following that, gentle extension-directed glides (postero-anterior) will be done by the therapist for 3 sets of 10 repetitions or until tolerated by the patient.
Sham Postural Correction
Other interventioncomprised an hour of social interaction with similar participants where a blinded therapist will provide educational tips for dealing with kyphosis along with educational reading material for each participant.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Real Postural Correction GroupExperimental treatment 3 interventions
Group B: Sham Postural Correction GroupSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Taken initially before intervention process, at 6 months follow up and at 12 months follow up.Secondary outcomes
1
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.
Time frame
Taken initially before intervention process, at 6 months follow up and at 12 months follow up.2
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.
Time frame
Taken initially before intervention process, at 6 months follow up and at 12 months follow up.3
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.
Time frame
Taken initially before intervention process, at 6 months follow up and at 12 months follow up.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov