Efficacy of Osteopathic Manipulative Techniques in Patients With Chronic Obstructive Pulmonary Disease

Not Applicable

Not yet recruiting

• Conditions: Copd

• Registration Number: NCT06865703
• Lead Sponsor: Beni-Suef University

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

Study Timeline

• Study First Submitted: 2025-02-24
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-05
• Last Update Submitted: 2025-03-05
• Study First Posted: 2025-03-10
• Last Update Posted: 2025-03-10
• Study Start: 2025-03-20
• Primary Completion: 2025-06-20
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 66

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Diaphragmatic Excursion	all assessment will be performed two times one pretreatment and will be repeated post treatment almost 2 months	ultrasonography device applied on chest and used to measure the vertical movement of diaphragm; unite of measure is centimeter (cm)
Level of Dyspnea	all assessment will be performed two times one pretreatment and then will be repeated post treatment almost 2 months	Modified BORG Dyspnea Scale which measures level of dyspnea - Patients are asked "How much difficulty is your breathing?" and got a score 0 Nothing at all, 0.5 very very slight (just noticeable), 1 Very slight, 2 Slight, 3 Moderate, 4 Somewhat severe, 5 Severe, 7 Very severe, 9 Very, very severe (almost maximal), 10 Maximal.
Diaphragmatic thickness	all assessment will be performed two times one pretreatment and will be repeated post treatment almost 2 months	ultrasonography device applied on chest and used to measure diaphragmatic thickness and change of flexibility of the diaphragm; unite of measure is millimeter (mm)
Pulmonary function test (spirometry)	all assessment will be performed two times one pretreatment and will be repeated post treatment almost 2 months	* patients will be asked to breathe in slowly and as deeply as possible, a breath out forcefully, then repeat 3 trials and will take the highest score during this will measure the following: Forced vital capacity (FVC) ,Forced expiratory volume first second (FEV1) as a percentage from predicted ,(FEV1/FVC) ratio ,Vital capacity (VC) ,Peak expiratory flow ,Forced expiratory flow 25%to75%; * And ask patient to breath in and out as deep and fast as possible for 12 to 15 seconds to measure maximum voluntary ventilation; unite of measurements: all measurements are taken as a percentage from predicted

Trial Locations

Locations (1)

Faculty of Physical Therapy Beni Suef University; 🇪🇬 Cairo, Egypt