The Effect of Postural Correction On Gastroesophageal Reflux Disease

NCT ID: NCT06564558

Last Updated: 2024-08-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2025-09-01

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.

Conditions

Gastro Esophageal Reflux; Gastro Esophageal Reflux Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Real Postural Correction Group

The experimental group will receive real thoracic spine hyperkyphosis treatment. This treatment is focused around impairments that are linked with spinal kyphosis such as spinal extensor muscle weakness, anterior muscle chain tightness, and thoracic spine hypomobility. The participants will undergo spinal strengthening exercises, thoracic spine tight musculature stretching, and finally thoracic spine mobility exercises. All exercises will follow a 3 set parameter rule with patient tolerance kept in mind.

Group Type: EXPERIMENTAL

Spinal Strengthening Exercises

Intervention Type: OTHER

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).

Thoracic Spine Stretching

Intervention Type: OTHER

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 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

Intervention Type: OTHER

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 the therapist for 3 sets of 10 repetitions or until tolerated by the patient.

Sham Postural Correction Group

The control group will receive sham thoracic kyphosis treatment 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.

Group Type: SHAM_COMPARATOR

Sham Postural Correction

Intervention Type: OTHER

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.

Interventions

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).

Intervention Type: 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 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.

Intervention Type: 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 the therapist for 3 sets of 10 repetitions or until tolerated by the patient.

Intervention Type: 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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed ElMelhat

Associate Professor of Physical Therapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beirut Arab University

Beirut, , Lebanon

Site Status: RECRUITING

Countries

Lebanon

Central Contacts

Ahmed M ElMelhat, PhD

Role: CONTACT

a.melhat@bau.edu.lb

+20 111 259 5022

Facility Contacts

Ahmed Mohammed El Melhat, PhD

Role: primary

a.melhat@bau.edu.lb

20 1112595022

Other Identifiers

GERD QoL

Identifier Type: -

Identifier Source: org_study_id