Gastro Esophageal RefluxNCT06564558
The Effect of Postural Correction On Gastroesophageal Reflux Disease
A study testing Spinal Strengthening Exercises, Thoracic Spine Stretching and Thoracic Spine Mobilization in people with Gastro Esophageal Reflux and Gastro Esophageal Reflux Disease, run by Cairo University at 1 site in Lebanon.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Gastro Esophageal Reflux, Gastro Esophageal Reflux Disease
- What is being tested?
- Spinal Strengthening Exercises, Thoracic Spine Stretching and Thoracic Spine Mobilization
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteLebanon
- Study dates
- 1 Sep 2024to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Lebanon1 site, 1 recruiting
- Recruiting
Beirut Arab University
Beirut, 0000
Ahmed Mohammed El Melhat, PhD, 20 1112595022, a.melhat@bau.edu.lb
About this study
Official title: The Effect of Postural Correctional Interventions on the Quality of Life of Patients With Gastroesophageal Reflux Disease.
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:
- Do postural correctional exercises reduce the symptoms of GERD?
- 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.
Read the 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.
- Being tested
- Spinal Strengthening Exercises, Thoracic Spine Stretching, Thoracic Spine Mobilization, Sham Postural Correction
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal Strengthening ExercisesOther
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 StretchingOther
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 MobilizationOther
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 CorrectionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Sham Postural Correction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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:
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.
Measured: Taken initially before intervention process, at 6 months follow up and at 12 months follow up.
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.
Measured: Taken initially before intervention process, at 6 months follow up and at 12 months follow up.
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.
Measured: Taken initially before intervention process, at 6 months follow up and at 12 months follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2024
- Study start1 Sep 2024 (estimated)
- Primary completion25 Dec 2024 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastro Esophageal RefluxStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed ElMelhat, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06564558
- Sponsor's protocol ID
- GERD QoL
- Status last verified
- Aug 2024
- First submitted
- 7 Jul 2024
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Postural Correctional Interventions on the Quality of Life of Patients With Gastroesophageal Reflux Disease.
- ClinicalTrials.gov ID
- NCT06564558
- Acronym / sponsor ID
- GERD QoL
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 25 Dec 2024 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 21 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Do postural correctional exercises reduce the symptoms of GERD?
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Real Postural Correction Group | Experimental | Other: Spinal Strengthening Exercises, Other: Thoracic Spine Stretching, Other: Thoracic Spine MobilizationThe 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. |
| Sham Postural Correction Group | Sham comparator | Other: Sham Postural CorrectionThe 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal Strengthening ExercisesIndividuals 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 | Real Postural Correction Group |
| Thoracic Spine StretchingParticipants 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. | Other | Real Postural Correction Group |
| Thoracic Spine MobilizationThe 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. | Other | Real Postural Correction Group |
| Sham Postural Correctioncomprised 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 Group |
Primary outcome
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.
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.
3 secondary outcomes
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal Strengthening Exercises, Thoracic Spine Stretching and Thoracic Spine Mobilization in people with Gastro Esophageal Reflux and Gastro Esophageal Reflux Disease, run by Cairo University at 1 site in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed M ElMelhat, PhD (+20 111 259 5022, a.melhat@bau.edu.lb), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2024.