The Effect of Postural Correction On Gastroesophageal Reflux Disease

NCT06564558 | Recruiting

• 1 other identifier: GERD QoL
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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. 1.Do postural correctional exercises reduce the symptoms of GERD?
2. 2.Do postural correctional exercises improve the quality of life of individuals afflicted with GERD?

Conditions

Gastro Esophageal Reflux; Gastro Esophageal Reflux Disease

Outcome Measures

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.

  Taken initially before intervention process, at 6 months follow up and at 12 months follow up.

Secondary Outcomes (3)

• Kyphosis Cobb Angle Assessment Using X-ray Radiographs:

  Taken initially before intervention process, at 6 months follow up and at 12 months follow up.

• GERD Quality of Life Questionnaire (GERD QOL)

  Taken initially before intervention process, at 6 months follow up and at 12 months follow up.

• Short Forum Suvery SF-12v2:

  Taken initially before intervention process, at 6 months follow up and at 12 months follow up.

Study Arms (2)

Real Postural Correction Group

EXPERIMENTAL

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.

Other: Spinal Strengthening Exercises; Other: Thoracic Spine Stretching; Other: Thoracic Spine Mobilization

Sham Postural Correction Group

SHAM COMPARATOR

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.

Other: Sham Postural Correction

Interventions

Spinal Strengthening Exercises 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).

Real Postural Correction Group

Thoracic Spine Stretching 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.

Real Postural Correction Group

Thoracic Spine Mobilization 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.

Real Postural Correction Group

Sham Postural Correction 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.

Sham Postural Correction Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Beirut Arab University

Beirut, 0000, Lebanon

RECRUITING

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Central Study Contacts

Ahmed M ElMelhat, PhD

CONTACT

+20 111 259 5022; a.melhat@bau.edu.lb

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Physical Therapy

Model Details: 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.

Study Record Dates

• First Submitted: July 7, 2024
• First Posted: August 21, 2024
• Study Start: September 1, 2024
• Primary Completion: December 25, 2024
• Study Completion: September 1, 2025
• Last Updated: August 21, 2024

Record last verified: 2024-08

Locations

LE (1)