The Effect of Postural Correction On Gastroesophageal Reflux Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Spinal Strengthening Exercises, Thoracic Spine Stretching, Thoracic Spine Mobilization, Sham Postural Correction.
- Who it may be relevant to
- Registry conditions: Gastro Esophageal Reflux, Gastro Esophageal Reflux Disease. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Lebanon
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effect of Postural Correctional Interventions on the Quality of Life of Patients With Gastroesophageal Reflux Disease.
Overview
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.
Interventions
- Other Spinal Strengthening Exercises
Individuals 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). - Other Thoracic Spine Stretching
Participants 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 back - Other Thoracic Spine Mobilization
The 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 th - Other Sham Postural Correction
comprised 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.
Primary outcome measures
- 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.]
Secondary outcome measures (3)
- Kyphosis Cobb Angle Assessment Using X-ray Radiographs: [Time frame: Taken initially before intervention process, at 6 months follow up and at 12 months follow up.]
- GERD Quality of Life Questionnaire (GERD QOL) [Time frame: Taken initially before intervention process, at 6 months follow up and at 12 months follow up.]
- Short Forum Suvery SF-12v2: [Time frame: Taken initially before intervention process, at 6 months follow up and at 12 months follow up.]
Eligibility criteria
Inclusion criteria
- 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.
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Factorial
- Masking
- Double blind
- Primary purpose
- Other
Study locations
Lebanon · 1 center
- Beirut Arab University — Beirut
Identifiers
NCT: NCT06564558 · GERD QoL