How OMT Benefits Newly Diagnosed Patients With Respiratory Illness When Given Alongside Other Standard Care.

Not Applicable

Recruiting

• Conditions: Pneumonia; Respiratory Disease; Respiratory Tract Infections; Sinusitis; Bronchitis
• Interventions: Procedure: Lymphatic Pump Osteopathic Manipulative Therapy

• Registration Number: NCT06495021
• Lead Sponsor: Geisinger Clinic

Brief Summary

This study is to see Osteopathic Manipulative Therapy, or OMT, can aid in treating patients being seen for respiratory illness and associated symptoms. The hypothesis is that the addition of OMT therapy, alongside other standard care (such as a medication), can help lessen patient symptoms sooner than just other treatment alone, and the duration of the condition will shorten as well.

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 Timeline

• Study First Submitted: 2024-07-03
• Study First Submitted QC: 2024-07-03
• Study First Posted: 2024-07-10
• Study Start: 2024-12-31
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-12
• Last Update Posted: 2025-02-14
• Primary Completion: 2026-01
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 68

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	Lymphatic Pump Osteopathic Manipulative Therapy	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.)

Primary Outcome Measures

Name	Time	Method
To address the magnitude in which lymphatic pump OMT improves respiratory illness symptom severity and overall sickness duration when combined with standard care treatment.	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

Trial Locations

Locations (1)

Geisinger 65-Forward, Buckhorn; 🇺🇸 Bloomsburg, Pennsylvania, United States