Irritable Bowel SyndromeIBSNCT06907407
Effect Of Different Diaphragmatic Myofascial Release Approaches On Low Back Pain And Quality Of Life Among Young Females With Irritable Bowel Syndrome
A study testing Diaphragmatic Myofascial Release, visceral mobilization techniques and irritable bowel syndrome medication in people with Irritable Bowel Syndrome, run by Cairo University at 1 site in Egypt.
Trial summary
this study will be conducted to investigate the effect of different diaphragmatic myofascial release approaches on low back pain and quality of life among young females with irritable bowel syndrome Read more about this study
- Who is it for?
- Ages 18 to 30 years, women only
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Diaphragmatic Myofascial Release, visceral mobilization techniques and irritable bowel syndrome medication
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2025to 30 May 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 30 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Subjects with irritable bowel syndrome
- Young female subjects
- All patients will have low back pain.
- All subjects will be clinically and medically stable when attending the study
Who cannot join
- Lack of attention and cooperation
- History of cancer and any systemic disease
- Pregnancy
- History of any structural gastrointestinal pathology or surgery
- History of repeated inflammatory gastrointestinal pathology
- Diabetes mellitus and lactose intolerance.
Show all 13Show fewer
- Abuse of laxative
- Depression
- Celiac disease
- Endocrine disorders as hypothyroidism and hyperthyroidism.
- Gastrinoma
- Recent/unhealed rib fracture
- History of any lumbar spine serious pathology ( tumor, infection fracture, osteoporosis , long term use of steroid, rheumatoid arthritis and surgery )
Trial locations and contacts
1 site in 1 country.
About this study
this study will be conducted to investigate the effect of different diaphragmatic myofascial release approaches on low back pain and quality of life among young females with irritable bowel syndrome
Read the detailed description
Irritable bowel syndrome (IBS) is a functional gastrointestinal disorder linked to disruptions in autonomic nervous system regulation, gut inflammation, alterations in stool frequency, and visceral hypersensitivity. Irritable bowel syndrome (IBS) is a chronic condition affects 7 to 21% of the general population.The symptoms usually include abdominal cramping, discomfort or pain, bloating, loose or frequent stools and constipation.The diaphragm has a fundamental role in defining posture, its maintenance, and body position changes; dysfunction of the diaphragm is one of the recognized be causes of low back and sacroiliac joint pain. People with low back pain often experience early fatigue of the diaphragm muscle, altered and reduced excursion during respiration, and inadequate proprioceptive activation.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Diaphragmatic Myofascial Release, visceral mobilization techniques, irritable bowel syndrome medication
- Keywords
- Diaphragmatic Myofascial Release, Low Back Pain, Irritable Bowel Syndrome
- Medical subject headings
- Irritable Bowel Syndrome, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diaphragmatic Myofascial ReleaseOther
six technique will be applied; 1-Diaphragmatic transverse plane, 2-Anteroposterior equilibrium technique, 3-Supra and infrahyoid fascial induction, 4-Psoas fascial induction,5-Diaphragm stretching technique and 6-Phrenic centre inhibition. diaphragmatic breathing, Mobilization of the ascending colon, descending colon, sigmoid colon, and sphincters (cardiac, pyloric, Oddi, duodenojejunal and ileocecal) with the patient in the supine position, knees flexed, feet supported and abdomen exposed. Contact was made with the region to be treated, leading it in the direction of immobility, with pressure maintained for one minute on each region with intensity based on the sensitivity to tension observed on the feedback of the individual plus medication
visceral mobilization techniquesOther
Mobilization of the ascending colon, descending colon, sigmoid colon, and sphincters (cardiac, pyloric, Oddi, duodenojejunal and ileocecal) with the patient in the supine position, knees flexed, feet supported and abdomen exposed. Contact was made with the region to be treated, leading it in the direction of immobility, with pressure maintained for one minute on each region with intensity based on the sensitivity to tension observed on the feedback of the individual plus medication
irritable bowel syndrome medicationOther
the patients will receive irritable bowel syndrome medication
| Study group | Role | What they receive |
|---|---|---|
| Diaphragmatic Myofascial Release | Experimental | thirty female will receive diaphragmatic breathing exercise, different diaphragmatic myofascial release approaches, visceral mobilization techniques, irritable bowel syndrome medication under supervision of a physician for 50 minutes twice a week for 4 weeks Receives: Other: Diaphragmatic Myofascial Release; Other: irritable bowel syndrome medication |
| visceral mobilization techniques | Experimental | thirty female will receive visceral mobilization techniques and irritable bowel syndrome medication under supervision of a physician for 50 minutes twice a week for 4 weeks Receives: Other: visceral mobilization techniques; Other: irritable bowel syndrome medication |
| irritable bowel syndrome medication | Active comparator | thirty female will receive irritable bowel syndrome medication under supervision of a physician for 50 minutes twice a week for 4 weeks Receives: Other: irritable bowel syndrome medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lumbar spine mobility
shober's test will be used to assess sine mobility. • Patient is standing, examiner marks on the midpoint between the posterior superior iliac spines by drawing a horizontal line across the patient's back. a second line is marked 10 cm above the first line. Patient is then instructed to flex forward as if attempting to touch his/her toes, examiner remeasures distance between two lines with patient fully flexed. The difference between the measurements in erect and flexion positions indicates the outcome of the lumbar flexion Elongation of 5 cm or more between the two marks during forward flexion is considered to be normal lumbar spine movement
Measured: up to four weeks
low back disability
The Oswestry Disability Index will be used.It is self-completed questionnaire contains ten topics concerning intensity of pain, lifting, ability to care for one self, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel, Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage. Thus, for every question not answered, the denominator is reduced by 5. If a patient marks more than one statement in a question, the highest scoring statement is recorded as a true indication of disability. Then the score classified into mild 5 -14, moderate 15-24, sever 25-34, disabled 35 -50 The questionnaire takes 3.5-5 min to complete and approximately 1 min to score
Measured: up to four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study start1 Apr 2025
- Primary completion30 May 2025
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- diaphragmatic myofascial release and visceral mobilization
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha Hamdy Abd El-Khaleq Teama, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06907407
- Sponsor's protocol ID
- P.T.REC/012/003707
- Acronym
- IBS
- Status last verified
- Jun 2025
- First submitted
- 26 Mar 2025
- Last updated
- 4 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Different Diaphragmatic Myofascial Release Approaches On Low Back Pain And Quality Of Life Among Young Females With Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT06907407
- Acronym / sponsor ID
- IBS / P.T.REC/012/003707
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Diaphragmatic Myofascial Release, Low Back Pain, Irritable Bowel Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 2 Apr 2025 (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.
this study will be conducted to investigate the effect of different diaphragmatic myofascial release approaches on low back pain and quality of life among young females with irritable bowel syndrome
Detailed description
Irritable bowel syndrome (IBS) is a functional gastrointestinal disorder linked to disruptions in autonomic nervous system regulation, gut inflammation, alterations in stool frequency, and visceral hypersensitivity. Irritable bowel syndrome (IBS) is a chronic condition affects 7 to 21% of the general population.The symptoms usually include abdominal cramping, discomfort or pain, bloating, loose or frequent stools and constipation.The diaphragm has a fundamental role in defining posture, its maintenance, and body position changes; dysfunction of the diaphragm is one of the recognized be causes of low back and sacroiliac joint pain. People with low back pain often experience early fatigue of the diaphragm muscle, altered and reduced excursion during respiration, and inadequate proprioceptive activation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- diaphragmatic myofascial release and visceral mobilization
| Arm | Type | Receives |
|---|---|---|
| Diaphragmatic Myofascial Release | Experimental | Other: Diaphragmatic Myofascial Release, Other: irritable bowel syndrome medicationthirty female will receive diaphragmatic breathing exercise, different diaphragmatic myofascial release approaches, visceral mobilization techniques, irritable bowel syndrome medication under supervision of a physician for 50 minutes twice a week for 4 weeks |
| visceral mobilization techniques | Experimental | Other: visceral mobilization techniques, Other: irritable bowel syndrome medicationthirty female will receive visceral mobilization techniques and irritable bowel syndrome medication under supervision of a physician for 50 minutes twice a week for 4 weeks |
| irritable bowel syndrome medication | Active comparator | Other: irritable bowel syndrome medicationthirty female will receive irritable bowel syndrome medication under supervision of a physician for 50 minutes twice a week for 4 weeks |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subjects with irritable bowel syndrome
- Young female subjects
- All patients will have low back pain.
- All subjects will be clinically and medically stable when attending the study
Key exclusion criteria (13 listed)
- Lack of attention and cooperation
- History of cancer and any systemic disease
- Pregnancy
- History of any structural gastrointestinal pathology or surgery
- History of repeated inflammatory gastrointestinal pathology
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 |
|---|---|---|
| Diaphragmatic Myofascial Releasesix technique will be applied; 1-Diaphragmatic transverse plane, 2-Anteroposterior equilibrium technique, 3-Supra and infrahyoid fascial induction, 4-Psoas fascial induction,5-Diaphragm stretching technique and 6-Phrenic centre inhibition. diaphragmatic breathing, Mobilization of the ascending colon, descending colon, sigmoid colon, and sphincters (cardiac, pyloric, Oddi, duodenojejunal and ileocecal) with the patient in the supine position, knees flexed, feet supported and abdomen exposed. Contact was made with the region to be treated, leading it in the direction of immobility, with pressure maintained for one minute on each region with intensity based on the sensitivity to tension observed on the feedback of the individual plus medication | Other | Diaphragmatic Myofascial Release |
| visceral mobilization techniquesMobilization of the ascending colon, descending colon, sigmoid colon, and sphincters (cardiac, pyloric, Oddi, duodenojejunal and ileocecal) with the patient in the supine position, knees flexed, feet supported and abdomen exposed. Contact was made with the region to be treated, leading it in the direction of immobility, with pressure maintained for one minute on each region with intensity based on the sensitivity to tension observed on the feedback of the individual plus medication | Other | visceral mobilization techniques |
| irritable bowel syndrome medicationthe patients will receive irritable bowel syndrome medication | Other | Diaphragmatic Myofascial Release, irritable bowel syndrome medication, visceral mobilization techniques |
Primary outcome
Lumbar spine mobility
Time frame: up to four weeks
shober's test will be used to assess sine mobility. • Patient is standing, examiner marks on the midpoint between the posterior superior iliac spines by drawing a horizontal line across the patient's back. a second line is marked 10 cm above the first line. Patient is then instructed to flex forward as if attempting to touch his/her toes, examiner remeasures distance between two lines with patient fully flexed. The difference between the measurements in erect and flexion positions indicates the outcome of the lumbar flexion Elongation of 5 cm or more between the two marks during forward flexion is considered to be normal lumbar spine movement
low back disability
Time frame: up to four weeks
The Oswestry Disability Index will be used.It is self-completed questionnaire contains ten topics concerning intensity of pain, lifting, ability to care for one self, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel, Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage. Thus, for every question not answered, the denominator is reduced by 5. If a patient marks more than one statement in a question, the highest scoring statement is recorded as a true indication of disability. Then the score classified into mild 5 -14, moderate 15-24, sever 25-34, disabled 35 -50 The questionnaire takes 3.5-5 min to complete and approximately 1 min to score
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diaphragmatic Myofascial Release, visceral mobilization techniques and irritable bowel syndrome medication in people with Irritable Bowel Syndrome, run by Cairo University at 1 site in Egypt.
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 13 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: finished, as of the sponsor's last update on 4 Jun 2025. 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 Egypt. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lumbar spine mobility (time frame: up to four weeks). The study lists 2 primary outcomes in all. 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 4 Jun 2025.