Clinical trial NCT06564558: The Effect of Postural Correction On Gastroesophageal Reflux Disease
Official title: The Effect of Postural Correctional Interventions on the Quality of Life of Patients With Gastroesophageal Reflux Disease.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastro Esophageal Reflux
Gastro Esophageal Reflux Disease
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-08-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: The study will follow a randomized controlled clinical trial design. Participants will be recruited from the physical therapy outpatient clinic at Beirut Arab University as well as several outpatient and private physical therapy clinics around Beirut, Lebanon. After recruitment and screening for eligibility, the participants will be divided randomly using a computer randomization program into a control and experimental group. After the completion of the program, the two groups will be compared based on selected outcome measures.
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Frequency Scale for the Symptoms of GERD (FSSG)
timeFrame: Taken initially before intervention process, at 6 months follow up and at 12 months follow up.
Secondary outcomes:
measure: Kyphosis Cobb Angle Assessment Using X-ray Radiographs:
timeFrame: Taken initially before intervention process, at 6 months follow up and at 12 months follow up.
measure: GERD Quality of Life Questionnaire (GERD QOL)
timeFrame: Taken initially before intervention process, at 6 months follow up and at 12 months follow up.
measure: Short Forum Suvery SF-12v2:
timeFrame: Taken initially before intervention process, at 6 months follow up and at 12 months follow up.
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: Beirut Arab University
Study officials:
References: