Ignite Creation Date:
2025-12-24 @ 7:41 PM
Ignite Modification Date:
2025-12-31 @ 10:05 AM
Study NCT ID:
NCT06865703
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-03-10
First Post:
2025-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Osteopathic Manipulative Techniques in Patients With Chronic Obstructive Pulmonary Disease
Sponsor:
Beni-Suef University
Organization:
Study Overview
Official Title:
Efficacy of Different Osteopathic Manipulative Techniques Combined With Diaphragmatic Release in Patients With Chronic Obstructive Pulmonary Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will test the efficiency of rib rising technique and thoracic lymphatic pump technique combining with manual diaphragmatic release technique in patients with chronic obstructive pulmonary disease
Detailed Description:
Chronic obstructive pulmonary disease (COPD) is a complex and constantly evolving pathology which is characterized by a progressive and constant limitation of the available air volume.
The Global Initiative for Chronic Obstructive Lung Disease (GOLD) identifies COPD as: a common, preventable and treatable disease that is characterized by persistent respiratory symptoms and airflow limitation that is due to airway and/or alveolar abnormalities usually caused by significant exposure to noxious particles or gases.
COPD could become the third leading cause of death for the population by 2030.
Exacerbation 0f COPD leads to hospital admission, high mortality and a decline in the ability to carry out daily activities' worse quality of life and increased disability.
Cigarette smoking consider the most important risk factors air pollution, occupational chemicals and dusts, and frequent lower respiratory infections during childhood and not curable.
Symptom of COPD is the chronic and progressive shortness of breath which is most characteristic of the condition, wheezing, chest tightness and cough.
Thoracic hyperinflation caused by air trapping changes diaphragm muscle fibers orientation in a zone of apposition (ZOA), which makes the contraction less effective at lower rib cage expansion, The remodeling results in flattening of the muscle and subsequent decreased diaphragmatic excursion
Osteopathic manipulative treatments (OMT) are hands-on manipulations of different body structures to increase systemic homeostasis and patient well-being include manipulation of the lymphatics, rib raising, diaphragmatic manipulations This treatment is used to stretch tight muscles, reduce pain, and improve circulation and lymphatic flow throughout the body
The diaphragmatic release technique is a manual technique that has beneficial effect on elongating tight diaphragmatic muscle fiber, improve perception of breathing assist in return doming shape to diaphragm, this lead to enhance pulmonary function, and to improve diaphragmatic mobility in both healthy individuals and patients with COPD
Rib raising is a manual technique increases thoracic mobility and lessens somatic dysfunctions of the area treated through normalized Parathoracic sympathetic ganglia.
The Thoracic Lymphatic Pumping Technique promote relaxation, facilitate blood flow and lymphatic drainage, reduce pain, normalize muscular tone and increase rib cage mobility .
this study aim to find out the effect of adding thoracic lymphatic pumping or rib raising manual techniques to diaphragmatic release in patients with COPD
This study will be conducted on 66 males of moderate to severe COPD patients. F tests - ANOVA: Fixed effects, omnibus, one-way F tests - ANOVA: Fixed effects, omnibus, one-way Analysis: A priori: Compute required sample size
Input:
Effect size f = 0.5 α err prob = 0.05 Power (1-β err prob) = 0.95 Number of groups = 3
Output:
Noncentrality parameter λ = 16,5000000 Critical F = 3,1428085 Numerator df = 2 Denominator df = 63 Total sample size = 66 Actual power = 0.9534748
The Global Initiative for Chronic Obstructive Lung Disease (GOLD) identifies COPD as: a common, preventable and treatable disease that is characterized by persistent respiratory symptoms and airflow limitation that is due to airway and/or alveolar abnormalities usually caused by significant exposure to noxious particles or gases.
COPD could become the third leading cause of death for the population by 2030.
Exacerbation 0f COPD leads to hospital admission, high mortality and a decline in the ability to carry out daily activities' worse quality of life and increased disability.
Cigarette smoking consider the most important risk factors air pollution, occupational chemicals and dusts, and frequent lower respiratory infections during childhood and not curable.
Symptom of COPD is the chronic and progressive shortness of breath which is most characteristic of the condition, wheezing, chest tightness and cough.
Thoracic hyperinflation caused by air trapping changes diaphragm muscle fibers orientation in a zone of apposition (ZOA), which makes the contraction less effective at lower rib cage expansion, The remodeling results in flattening of the muscle and subsequent decreased diaphragmatic excursion
Osteopathic manipulative treatments (OMT) are hands-on manipulations of different body structures to increase systemic homeostasis and patient well-being include manipulation of the lymphatics, rib raising, diaphragmatic manipulations This treatment is used to stretch tight muscles, reduce pain, and improve circulation and lymphatic flow throughout the body
The diaphragmatic release technique is a manual technique that has beneficial effect on elongating tight diaphragmatic muscle fiber, improve perception of breathing assist in return doming shape to diaphragm, this lead to enhance pulmonary function, and to improve diaphragmatic mobility in both healthy individuals and patients with COPD
Rib raising is a manual technique increases thoracic mobility and lessens somatic dysfunctions of the area treated through normalized Parathoracic sympathetic ganglia.
The Thoracic Lymphatic Pumping Technique promote relaxation, facilitate blood flow and lymphatic drainage, reduce pain, normalize muscular tone and increase rib cage mobility .
this study aim to find out the effect of adding thoracic lymphatic pumping or rib raising manual techniques to diaphragmatic release in patients with COPD
This study will be conducted on 66 males of moderate to severe COPD patients. F tests - ANOVA: Fixed effects, omnibus, one-way F tests - ANOVA: Fixed effects, omnibus, one-way Analysis: A priori: Compute required sample size
Input:
Effect size f = 0.5 α err prob = 0.05 Power (1-β err prob) = 0.95 Number of groups = 3
Output:
Noncentrality parameter λ = 16,5000000 Critical F = 3,1428085 Numerator df = 2 Denominator df = 63 Total sample size = 66 Actual power = 0.9534748
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: