- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06495021
How OMT Benefits Newly Diagnosed Patients With Respiratory Illness When Given Alongside Other Standard Care.
OMT and Respiratory Illness
Study Overview
Status
Intervention / Treatment
Detailed Description
Respiratory illness is a common complaint seen routinely in primary care. Illness is a common cause of reduced productivity, general discomfort and missed time from work. Osteopathic manual therapy (OMT) and the lymphatic pump is used frequently among osteopathic physicians to treat patients with infections. Many osteopathic physicians have anecdotal reports of patient having reduced respiratory symptoms reported in follow up care from patients. OMT is a useful, low-cost treatment and can help reduce duration of illness symptoms, improve patients' comfort and accelerate their return to their productive lives.
There have been few studies on an outpatient level quantifying this improvement. Previous research in other models have showed benefits of OMT to help reduce illness. Studies in a rat model have shown reduced S. pneumonia bacterial load in the lung after lymphatic pump. Additional rat studies demonstrated improved benefit with lymphatic pump in addition to antibiotic treatment. In a dog model, lymphatic pump has been shown to increase cytokine flow to the thoracic duct. In humans, OMT has shown to improve secretory immunoglobulin A levels in stressed student population. In the hospital setting, OMT for patients with pneumonia has shown to decrease hospital length of stay 5. OMT has been a known useful additional treatment to pneumonia, however there are few prospective studies on treatment of pneumonia and respiratory illness in the outpatient setting.
This study is designed to support evidence that patients with a recent diagnosis of upper respiratory illness, sinusitis, bronchitis, or pneumonia who receive lymphatic pump OMT experience reduced severity and length of symptoms. After informed consent, patients of ages 65-100 years of age who are diagnosed with a respiratory illness will be randomized to either standard care without OMT, or standard care plus OMT. Patients will be provided an electronic survey to quantify symptoms of cough, congestion, and malaise on both the day of illness diagnosis followed by the same survey 5 days later. Survey results comparing day of diagnosis and 5 days later will be recorded in a secure database and analyzed with appropriate statistical testing. The goal of this study is to show how the lymphatic pump can reduce both severity and duration of symptoms related to respiratory illness.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Margaret Moore, DO
- Phone Number: (570) 416-5435
- Email: Mmoore9@geisinger.edu
Study Contact Backup
- Name: Andrew Ackerman, MS
- Phone Number: (570) 214-4215
- Email: aackerman1@geisinger.edu
Study Locations
-
-
Pennsylvania
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Bloomsburg, Pennsylvania, United States, 17815
- Recruiting
- Geisinger 65-Forward, Buckhorn
-
Contact:
- Margaret Moore, DO
- Phone Number: 570-416-5435
- Email: Mmoore9@geisinger.edu
-
Principal Investigator:
- Margaret Moore, DO
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients being seen for respiratory illness symptoms at Geisinger 65-Forward Buckhorn, PA clinic for care.
- Patients age of 65-100
- New diagnosis of upper respiratory illness, sinusitis, bronchitis, or pneumonia during outpatient visit.
Exclusion Criteria:
- Patients that have a healing fracture, including the spine, pelvis, shoulder, ribs, vertebrae, or extremities.
- Patients actively receiving any type of cancer treatment
- Patients with active or previously diagnosed liver disease.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
Patients in the control group will receive normal standard care, including any prescriptions, follow-up instructions, etc., as given by the provider to help treat their condition.
|
|
|
Experimental: Treatment
Patients will receive lymphatic pump OMT therapy in addition to other standard care (similar to the control patients, this would be a medication, follow-up instructions, etc.)
|
OMT is a series of manual pressure and physical stimulation among various parts of the body to stimulate fluid movement and immune response in patients with various symptoms and disease.
This may help with conditions such as edema, clearance of infections, facilitate healing and circulation, and bolster the immune response.
Specifically, the lymphatic pump type of OMT targets the head, neck, thoracic region, lumbar and sacral regions, pelvis, arms, legs, and abdomen.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To address the magnitude in which lymphatic pump OMT improves respiratory illness symptom severity and overall sickness duration when combined with standard care treatment.
Time Frame: Through study completion of up to one year.
|
Survey given to patients will provide feedback to capture their symptom severity at the time of diagnosis and 5 days post-diagnosis
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Through study completion of up to one year.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Margaret Moore, DO, Physician
Publications and helpful links
General Publications
- Noll DR, Degenhardt BF, Johnson JC. Multicenter Osteopathic Pneumonia Study in the Elderly: Subgroup Analysis on Hospital Length of Stay, Ventilator-Dependent Respiratory Failure Rate, and In-hospital Mortality Rate. J Am Osteopath Assoc. 2016 Sep 1;116(9):574-87. doi: 10.7556/jaoa.2016.117.
- Saggio G, Docimo S, Pilc J, Norton J, Gilliar W. Impact of osteopathic manipulative treatment on secretory immunoglobulin a levels in a stressed population. J Am Osteopath Assoc. 2011 Mar;111(3):143-7.
- Knott EM, Tune JD, Stoll ST, Downey HF. Increased lymphatic flow in the thoracic duct during manipulative intervention. J Am Osteopath Assoc. 2005 Oct;105(10):447-56.
- Creasy C, Schander A, Orlowski A, Hodge LM. Thoracic and abdominal lymphatic pump techniques inhibit the growth of S. pneumoniae bacteria in the lungs of rats. Lymphat Res Biol. 2013 Sep;11(3):183-6. doi: 10.1089/lrb.2013.0007. Epub 2013 Sep 11.
- Yao S, Hassani J, Gagne M, George G, Gilliar W. Osteopathic manipulative treatment as a useful adjunctive tool for pneumonia. J Vis Exp. 2014 May 6;(87):50687. doi: 10.3791/50687.
- Becker AD. Osteopathic treatment of the common cold. 1937. J Am Osteopath Assoc. 2001 Aug;101(8):461-3. No abstract available.
- Hodge LM, Creasy C, Carter K, Orlowski A, Schander A, King HH. Lymphatic pump treatment as an adjunct to antibiotics for pneumonia in a rat model. J Am Osteopath Assoc. 2015 May;115(5):306-16. doi: 10.7556/jaoa.2015.061.
- Noll DR, Degenhardt BF, Fossum C, Hensel K. Clinical and research protocol for osteopathic manipulative treatment of elderly patients with pneumonia. J Am Osteopath Assoc. 2008 Sep;108(9):508-16.
- Noll DR. The short-term effect of a lymphatic pump protocol on blood cell counts in nursing home residents with limited mobility: a pilot study. J Am Osteopath Assoc. 2013 Jul;113(7):520-8. doi: 10.7556/jaoa.2013.003.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-0453
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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