NCT06907407

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

April 1, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 2, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2025

Completed
Last Updated

June 4, 2025

Status Verified

June 1, 2025

Enrollment Period

2 months

First QC Date

March 26, 2025

Last Update Submit

June 3, 2025

Conditions

Keywords

Diaphragmatic Myofascial ReleaseLow Back PainIrritable Bowel Syndrome

Outcome Measures

Primary Outcomes (2)

  • 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

    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

    up to four weeks

Study Arms (3)

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

Other: Diaphragmatic Myofascial ReleaseOther: 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

Other: visceral mobilization techniquesOther: 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

Other: irritable bowel syndrome medication

Interventions

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

Diaphragmatic Myofascial Release

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 techniques

the patients will receive irritable bowel syndrome medication

Diaphragmatic Myofascial Releaseirritable bowel syndrome medicationvisceral mobilization techniques

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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 )

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of physical therapy

Giza, 11251, Egypt

Location

MeSH Terms

Conditions

Irritable Bowel SyndromeLow Back Pain

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesBack PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
opaque sealed envelope
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: diaphragmatic myofascial release and visceral mobilization
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator : noha hamdy abd elkhaleq

Study Record Dates

First Submitted

March 26, 2025

First Posted

April 2, 2025

Study Start

April 1, 2025

Primary Completion

May 30, 2025

Study Completion

May 30, 2025

Last Updated

June 4, 2025

Record last verified: 2025-06

Locations