- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06865703
Efficacy of Osteopathic Manipulative Techniques in Patients With Chronic Obstructive Pulmonary Disease
Efficacy of Different Osteopathic Manipulative Techniques Combined With Diaphragmatic Release in Patients With Chronic Obstructive Pulmonary Disease
Study Overview
Status
Conditions
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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Cairo, Egypt
- Faculty of Physical Therapy Beni Suef University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
- include Stable COPD patients
- include Constant medication between the treatments.
- include Aged from 60 TO 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
Study Plan
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 |
|---|---|
|
Other: group A
Combination between rib raising and 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
• 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
|
|
Other: group B
combination between thoracic lymphatic pump and 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
|
|
Other: group C (control group)
Diaphragmatic release technique (control group)
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Diaphragmatic Excursion
Time Frame: 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) |
all assessment will be performed two times one pretreatment and will be repeated post treatment almost 2 months
|
|
Diaphragmatic thickness
Time Frame: 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) |
all assessment will be performed two times one pretreatment and will be repeated post treatment almost 2 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Level of Dyspnea
Time Frame: 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.
|
all assessment will be performed two times one pretreatment and then will be repeated post treatment almost 2 months
|
|
Pulmonary function test (spirometry)
Time Frame: all assessment will be performed two times one pretreatment and will be repeated post treatment almost 2 months
|
unite of measurements: all measurements are taken as a percentage from predicted |
all assessment will be performed two times one pretreatment and will be repeated post treatment almost 2 months
|
|
Oxygen saturation (%)
Time Frame: assessment will be performed two times one pretreatment and will be repeated post treatment almost 2 months
|
Oxygen saturation (%)
|
assessment will be performed two times one pretreatment and will be repeated post treatment almost 2 months
|
|
Resting Heart rate
Time Frame: assessment will be performed two times one pretreatment and will be repeated post treatment almost 2 months
|
Resting Heart rate
|
assessment will be performed two times one pretreatment and will be repeated post treatment almost 2 months
|
|
maximum heart rate
Time Frame: assessment will be performed two times one pretreatment and will be repeated post treatment almost 2 months
|
maximum heart rate
|
assessment will be performed two times one pretreatment and will be repeated post treatment almost 2 months
|
|
heart rate recovery at first and second minutes
Time Frame: assessment will be performed two times one pretreatment and will be repeated post treatment almost 2 months
|
heart rate recovery
|
assessment will be performed two times one pretreatment and will be repeated post treatment almost 2 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: SHERIN Hassan, PROF.DR., Faculty of Physical Therapy Beni Suef University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Global Initiative for chronic obstructive lung disease (GOLD).
- Ragab K. Elnaggar PhD & Mohammed A. Shendy Bulletin of Faculty of Physical Therapy
- 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.
- Bordoni B. Lymphatic Pump Manipulation in Patients with Chronic Obstructive Pulmonary Disease. Cureus. 2019 Mar 11;11(3):e4232. doi: 10.7759/cureus.4232.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Osteopathic Techniques in COPD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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