Clinical trial NCT06865703: Efficacy of Osteopathic Manipulative Techniques in Patients With Chronic Obstructive Pulmonary Disease
Official title: Efficacy of Different Osteopathic Manipulative Techniques Combined With Diaphragmatic Release in Patients With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Copd
Keywords: diaphragmatic release
rib raising
thoracic lymphatic pump
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2025-03-10
Enrollment: 66
Sex: MALE
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: moderate to severe copd
Primary purpose: TREATMENT

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

Eligibility criteria: * include Stable COPD patients
* include Constant medication between the treatments.
* include Aged from 55TO 75 YEARS OLD
* include moderate to severe COPD
* include Smoker index \<400
* exclude Rib or vertebral fracture
* exclude Skin disorder or scar in chest region or recent abdominal surgery.
* exclude Unwilling to complete in study
* exclude Cancer
* exclude Cognitive impairment to understand orders
* exclude severe osteoporosis
* exclude Smoker index \>400

Primary outcomes:
measure: Diaphragmatic Excursion
timeFrame: all assessment will be performed two times one pretreatment and will be repeated post treatment almost 2 months
measure: Level of Dyspnea
timeFrame: all assessment will be performed two times one pretreatment and then will be repeated post treatment almost 2 months
measure: Diaphragmatic thickness
timeFrame: all assessment will be performed two times one pretreatment and will be repeated post treatment almost 2 months
measure: Pulmonary function test (spirometry)
timeFrame: all assessment will be performed two times one pretreatment and will be repeated post treatment almost 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Physical Therapy Beni Suef University
Study officials:
affiliation: FACULTY OF PHYSICAL THERAPY Beni suef university
name: SHERIN Hassan, PROF.DR.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Spencer LM, Alison JA, McKeough ZJ. Do supervised weekly exercise programs maintain functional exercise capacity and quality of life, twelve months after pulmonary rehabilitation in COPD? BMC Pulm Med. 2007 May 16;7:7. doi: 10.1186/1471-2466-7-7.
citation: Sleszynski SL, Kelso AF. Comparison of thoracic manipulation with incentive spirometry in preventing postoperative atelectasis. J Am Osteopath Assoc. 1993 Aug;93(8):834-8, 843-5.
citation: Fei F, J Siegert R, Zhang X, Gao W, Koffman J. Symptom clusters, associated factors and health-related quality of life in patients with chronic obstructive pulmonary disease: A structural equation modelling analysis. J Clin Nurs. 2023 Jan;32(1-2):298-310. doi: 10.1111/jocn.16234. Epub 2022 Jan 30.
citation: O'Donnell DE, Milne KM, James MD, de Torres JP, Neder JA. Dyspnea in COPD: New Mechanistic Insights and Management Implications. Adv Ther. 2020 Jan;37(1):41-60. doi: 10.1007/s12325-019-01128-9. Epub 2019 Oct 30.
citation: Koch J, Tsui C, Talsma J, Pierce-Talsma S. Osteopathic Manipulative Treatment for Inhaled Rib Somatic Dysfunction. J Am Osteopath Assoc. 2020 Jul 28. doi: 10.7556/jaoa.2020.109. Online ahead of print. No abstract available.
citation: Kaneko H, Shiranita S, Horie J, Hayashi S. Reduced Chest and Abdominal Wall Mobility and Their Relationship to Lung Function, Respiratory Muscle Strength, and Exercise Tolerance in Subjects With COPD. Respir Care. 2016 Nov;61(11):1472-1480. doi: 10.4187/respcare.04742. Epub 2016 Oct 18.
citation: Marizeiro DF, Florencio ACL, Nunes ACL, Campos NG, Lima POP. Immediate effects of diaphragmatic myofascial release on the physical and functional outcomes in sedentary women: A randomized placebo-controlled trial. J Bodyw Mov Ther. 2018 Oct;22(4):924-929. doi: 10.1016/j.jbmt.2017.10.008. Epub 2017 Oct 25.
citation: Halpin DM, Miravitlles M, Metzdorf N, Celli B. Impact and prevention of severe exacerbations of COPD: a review of the evidence. Int J Chron Obstruct Pulmon Dis. 2017 Oct 5;12:2891-2908. doi: 10.2147/COPD.S139470. eCollection 2017.
citation: Global Initiative for chronic obstructive lung disease (GOLD).
citation: Ragab K. Elnaggar PhD & Mohammed A. Shendy Bulletin of Faculty of Physical Therapy
citation: Feizi H, Alizadeh M, Nejadghaderi SA, Noori M, Sullman MJM, Ahmadian Heris J, Kolahi AA, Collins GS, Safiri S. The burden of chronic obstructive pulmonary disease and its attributable risk factors in the Middle East and North Africa region, 1990-2019. Respir Res. 2022 Nov 19;23(1):319. doi: 10.1186/s12931-022-02242-z.
citation: Bordoni B. Lymphatic Pump Manipulation in Patients with Chronic Obstructive Pulmonary Disease. Cureus. 2019 Mar 11;11(3):e4232. doi: 10.7759/cureus.4232.