- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06621667
Diaphragmatic Myofascial Release for Hyperkyphotic Subjects
September 30, 2024 updated by: Marwa Shafiek Mustafa Saleh, Cairo University
Response of Lung Function, Chest Mobility, and Kyphotic Curve to Diaphragmatic Myofascial Release in Hyperkyphotic Subjects: A Randomized Controlled Trial
kyphotic subjects have respiratory disturbances due to weakening of the diaphragm, responsible for inhalation, which lead to abnormalities in respiratory mechanics and abnormal gas exchange, leading to respiratory complications.
Myofascial release of the diaphragm is an intervention intended to indirectly stretch the diaphragm muscle fibers to reduce muscle tension, normalize fiber length, and promote the efficiency of muscle contraction.
Although diaphragm myofascial release has been used in clinical practice, to the best of the authors' knowledge, the current study is the first research investigating the effect of diaphragmatic myofascial release on lung function, chest mobility and kyphotic curve in hyperkyphotic subjects.
Study Overview
Status
Not yet recruiting
Conditions
Study Type
Interventional
Enrollment (Estimated)
42
Phase
- Not Applicable
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:
- The participant's age ranged from 20 to 40 years.
- kyphosis angle 40-50◦
- reporting pain on palpation of the diaphragm
Exclusion Criteria:
- A history of respiratory diseases, heart disease, vascular disease, central nervous system disorder, psychiatric disorders, hypertension.
- History of any trauma or fracture to the thoracic spine.
- inflammatory diseases such as rheumatoid arthritis, musculoskeletal problem and neurological deficit
- Restrictive respiratory disease, smokers.
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 |
|---|---|
|
Active Comparator: control group
|
traditional physical therapy exercises for hyperkyphosis
|
|
Experimental: study group
|
diaphragmatic myofascial release
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
maximum voluntary ventilation
Time Frame: change from base line at 4 weeks.
|
the maximum voluntary ventilation will be measured using spirometer
|
change from base line at 4 weeks.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Chest expansion
Time Frame: change from base line at 4 weeks.
|
the chest expansion will be measured using tap measurement
|
change from base line at 4 weeks.
|
|
kyphotic angle
Time Frame: change from base line at 4 weeks.
|
the kyphotic angle will be measured with flexicurve
|
change from base line at 4 weeks.
|
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 (Estimated)
October 10, 2024
Primary Completion (Estimated)
December 20, 2024
Study Completion (Estimated)
December 30, 2024
Study Registration Dates
First Submitted
September 29, 2024
First Submitted That Met QC Criteria
September 30, 2024
First Posted (Actual)
October 1, 2024
Study Record Updates
Last Update Posted (Actual)
October 1, 2024
Last Update Submitted That Met QC Criteria
September 30, 2024
Last Verified
September 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- myorelease for hyperkyphosis
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.
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