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

NCT ID: NCT06865703

Last Updated: 2025-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-20

Study Completion Date

2025-07-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Copd

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

moderate to severe copd
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

group A

Combination between rib raising and diaphragmatic release technique

Group Type OTHER

diaphragmatic release technique

Intervention Type OTHER

The participant lay in the supine position and the therapist stood at the participant's head, the therapist passed his hands (the hypothenar and the lateral 3 fingers) under the costal cartilage of the seventh to the tenth ribs bilaterally, with the therapist's forearm aligned up toward the subject's shoulder. Then, the therapist quietly drew the diaphragm in and upward during the inspiratory phase. The therapist then went deeply with both hands toward the inner costal margin during the expiratory phase to resist the rebounding movement of the thoracic cage. The depth of this manual contact was progressively increased in subsequent respiratory cycles. The maneuver was repeated in 4 sets, each of which consisted of 5 deep breaths with 2-min intervals in between if needed

rib raising technique in group A

Intervention Type OTHER

• The patient is in supine position and therapist hand under the thorax The fingertips take up contact with the angular costae and move it up and in lateral traction and maintained and this will repeated until all ribs on the side are mobilized. This movement will be repeated several times until perceives an improvement in the rib flexibility

group B

combination between thoracic lymphatic pump and diaphragmatic release technique

Group Type OTHER

diaphragmatic release technique

Intervention Type OTHER

The participant lay in the supine position and the therapist stood at the participant's head, the therapist passed his hands (the hypothenar and the lateral 3 fingers) under the costal cartilage of the seventh to the tenth ribs bilaterally, with the therapist's forearm aligned up toward the subject's shoulder. Then, the therapist quietly drew the diaphragm in and upward during the inspiratory phase. The therapist then went deeply with both hands toward the inner costal margin during the expiratory phase to resist the rebounding movement of the thoracic cage. The depth of this manual contact was progressively increased in subsequent respiratory cycles. The maneuver was repeated in 4 sets, each of which consisted of 5 deep breaths with 2-min intervals in between if needed

THORACIC LYMPHATIC PUMP TECHNIGUE

Intervention Type OTHER

* Patient in the supine position and therapist will stand the participant's head, facing The therapist places the thenar eminence of each hand to the pectoral region and infra clavicular and the other fingers were spread around the thoracic cage and angled toward the body's side to create consistent, compressive force across the thoracic cage The participant was then allowed to breathe in deeply and breath out. The therapist slowly reduced the compressive force and withdrew the participant.
* During breath out rhythmic oscillatory compression in the posterior and caudal direction was applied to the chest wall.
* By the end of the expiratory phase, the compressive force was maintained, and ask to take another deep breath. In this way, the participant encountered some resistance equivalent to the chest-wall movement during inspiration. The maneuver was repeated for 5 respiratory cycles, then hands to allow for full inspiration.

group C (control group)

Diaphragmatic release technique (control group)

Group Type OTHER

diaphragmatic release technique

Intervention Type OTHER

The participant lay in the supine position and the therapist stood at the participant's head, the therapist passed his hands (the hypothenar and the lateral 3 fingers) under the costal cartilage of the seventh to the tenth ribs bilaterally, with the therapist's forearm aligned up toward the subject's shoulder. Then, the therapist quietly drew the diaphragm in and upward during the inspiratory phase. The therapist then went deeply with both hands toward the inner costal margin during the expiratory phase to resist the rebounding movement of the thoracic cage. The depth of this manual contact was progressively increased in subsequent respiratory cycles. The maneuver was repeated in 4 sets, each of which consisted of 5 deep breaths with 2-min intervals in between if needed

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

diaphragmatic release technique

The participant lay in the supine position and the therapist stood at the participant's head, the therapist passed his hands (the hypothenar and the lateral 3 fingers) under the costal cartilage of the seventh to the tenth ribs bilaterally, with the therapist's forearm aligned up toward the subject's shoulder. Then, the therapist quietly drew the diaphragm in and upward during the inspiratory phase. The therapist then went deeply with both hands toward the inner costal margin during the expiratory phase to resist the rebounding movement of the thoracic cage. The depth of this manual contact was progressively increased in subsequent respiratory cycles. The maneuver was repeated in 4 sets, each of which consisted of 5 deep breaths with 2-min intervals in between if needed

Intervention Type OTHER

rib raising technique in group A

• The patient is in supine position and therapist hand under the thorax The fingertips take up contact with the angular costae and move it up and in lateral traction and maintained and this will repeated until all ribs on the side are mobilized. This movement will be repeated several times until perceives an improvement in the rib flexibility

Intervention Type OTHER

THORACIC LYMPHATIC PUMP TECHNIGUE

* Patient in the supine position and therapist will stand the participant's head, facing The therapist places the thenar eminence of each hand to the pectoral region and infra clavicular and the other fingers were spread around the thoracic cage and angled toward the body's side to create consistent, compressive force across the thoracic cage The participant was then allowed to breathe in deeply and breath out. The therapist slowly reduced the compressive force and withdrew the participant.
* During breath out rhythmic oscillatory compression in the posterior and caudal direction was applied to the chest wall.
* By the end of the expiratory phase, the compressive force was maintained, and ask to take another deep breath. In this way, the participant encountered some resistance equivalent to the chest-wall movement during inspiration. The maneuver was repeated for 5 respiratory cycles, then hands to allow for full inspiration.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion 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
Minimum Eligible Age

55 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Beni-Suef University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Shimaa Mokhtar

Physiotherapist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

SHERIN Hassan, PROF.DR.

Role: PRINCIPAL_INVESTIGATOR

FACULTY OF PHYSICAL THERAPY Beni suef university

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Faculty of Physical Therapy Beni Suef University

Cairo, , Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Shimaa Mokhtar, Pt

Role: CONTACT

+01201461152

Mahmoud Ibrahim, Lecturer

Role: CONTACT

01142998414

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

. Sherine Hassan, PROF.DR.

Role: primary

01003378217

Mahmoud Ibrahim, Lecturer

Role: backup

01142998414

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 17506903 (View on PubMed)

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.

Reference Type RESULT
PMID: 8407387 (View on PubMed)

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.

Reference Type RESULT
PMID: 35098602 (View on PubMed)

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.

Reference Type RESULT
PMID: 31673990 (View on PubMed)

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.

Reference Type RESULT
PMID: 32722750 (View on PubMed)

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.

Reference Type RESULT
PMID: 27794081 (View on PubMed)

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.

Reference Type RESULT
PMID: 30368336 (View on PubMed)

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.

Reference Type RESULT
PMID: 29062228 (View on PubMed)

Global Initiative for chronic obstructive lung disease (GOLD).

Reference Type RESULT

Ragab K. Elnaggar PhD & Mohammed A. Shendy Bulletin of Faculty of Physical Therapy

Reference Type RESULT

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.

Reference Type RESULT
PMID: 36403049 (View on PubMed)

Bordoni B. Lymphatic Pump Manipulation in Patients with Chronic Obstructive Pulmonary Disease. Cureus. 2019 Mar 11;11(3):e4232. doi: 10.7759/cureus.4232.

Reference Type RESULT
PMID: 31123654 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Osteopathic Techniques in COPD

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.