- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06907407
Effect Of Different Diaphragmatic Myofascial Release Approaches On Low Back Pain And Quality Of Life Among Young Females With Irritable Bowel Syndrome (IBS)
June 3, 2025 updated by: Noha Hamdy Abd El-Khaleq Teama, Cairo University
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
Study Overview
Status
Completed
Conditions
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 Type
Interventional
Enrollment (Actual)
90
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Giza, Egypt, 11251
- Faculty of Physical Therapy
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
- 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 )
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Diaphragmatic Myofascial Release
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
|
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
the patients will receive irritable bowel syndrome medication
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Experimental: visceral mobilization techniques
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
|
the patients will receive irritable bowel syndrome medication
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
|
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Active Comparator: irritable bowel syndrome medication
thirty female will receive irritable bowel syndrome medication under supervision of a physician for 50 minutes twice a week for 4 weeks
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the patients will receive irritable bowel syndrome medication
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Lumbar spine mobility
Time Frame: up to four weeks
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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
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up to four weeks
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low back disability
Time Frame: up to four weeks
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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
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up to four weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2025
Primary Completion (Actual)
May 30, 2025
Study Completion (Actual)
May 30, 2025
Study Registration Dates
First Submitted
March 26, 2025
First Submitted That Met QC Criteria
March 26, 2025
First Posted (Actual)
April 2, 2025
Study Record Updates
Last Update Posted (Actual)
June 4, 2025
Last Update Submitted That Met QC Criteria
June 3, 2025
Last Verified
June 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/003707
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Irritable Bowel Syndrome
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ProgenaBiomeWithdrawnIrritable Bowel Syndrome | Irritable Bowel Syndrome With Diarrhea | Irritable Bowel Syndrome With Constipation | Irritable Bowel Syndrome Characterized by Constipation | Irritable Bowel Syndrome Mixed | Irritable Bowel Syndrome Without Diarrhea | Irritable Bowel | Irritable Bowel Syndrome Aggravated and other conditionsUnited States
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