Is Osteopathic Manipulative Treatment (OMT) Beneficial for Elderly Patients Hospitalized With Pneumonia?

Study Overview
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Brief Summary
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Osteopathic Manipulative Treatment (OMT) were used in the 1800s and 1900s to treat pneumonia before the introduction of antibiotics in the mid-1900s. The purpose of this study is to determine if OMT, when used in conjunction with antibiotics and other usual care, will improve the recovery of elderly pneumonia patients.

Detailed Description
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This study is a multi-center study conducted across five sites in the United States to determine the efficacy of combining Osteopathic Manipulative Treatment(OMT)with antibiotics as a treatment regimen for elderly patients with pneumonia. The study is a prospective, randomized, controlled clinical trial, in which 360 subjects will be randomly assigned to three different groups to test the primary hypothesis that the combination of OMT and antibiotics will decrease the length of hospital stay for elderly patients with pneumonia. The first group (OMT Group) will receive a series of eight osteopathic manipulative techniques in combination with conventional antibiotic care. The second group (Light Touch Control Group) will receive a light touch mimic treatment in combination with conventional antibiotic care to control for the doctor-patient interaction. The third group (Conventional Care Only Group) will receive only the conventional antibiotic care normally given to elderly patients with pneumonia. The first two groups will receive two 15-20 minute treatments per day, at least six hours apart, for the duration of their stay in the acute care facility. The primary outcomes for measuring efficacy are: Length of Hospital Stay, Time to Clinical Stability, and Rate of Symptomatic and Functional Recovery. The secondary outcomes are: duration of IV and oral antibiotic usage in the hospital, number of complications and deaths secondary to pneumonia, re-admission rate within 60 days of hospitalization admission date, duration and severity of fever, duration and severity of leukocytosis, and patient satisfaction.

Official Title
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Multicenter Osteopathic Pneumonia Study in the Elderly (MOPSE)

Conditions
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Pneumonia

Intervention / Treatment
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* Procedure: Osteopathic Manipulative Treatment
* Procedure: Light-touch Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 50 Years old or older Subject is hospitalized in an acute care facility Subject must exhibit at least two of the classic symptoms of pneumonia, to include: Respiration Rate greater than or equal to 25 respirations per minute New or increased cough Fever greater than or equal to 100.4 degrees F (38 degrees C) Pleuritic chest pain Worsening of mental or functional status Leukocytosis (WBC greater than 12,000 cells per cubic millimeter) New or increased physical findings (rales, wheezing, bronchial breath sounds) Exclusion Criteria: Lung abscess Advancing pulmonary fibrosis Bronchiectasis Pulmonary tuberculosis Lung Cancer Metastatic malignancy Uncontrolled metabolic bone disease that places subject at risk for pathologic bone fracture (i.e. Paget's Disease or hypoparathyroidism) Acute or unhealed rib or vertebral fracture History of pathologic bone fracture Previous participants as subject in the study Respiratory failure (intubation)

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Osteopathic Manipulative Treatment<br>10-minute standardized OMT protocol + 5-minute nonstandardized component, twice daily for duration of hospitalization | Procedure: Osteopathic Manipulative Treatment<br>* In addition to conventional treatment for pneumonia, a 10-minute standardized OMT protocol + 5-minute nonstandardized component was performed twice daily for the duration of hospitalization.<br>* Other names: Manipulation;|
| Sham Comparator: Light-touch Treatment<br>10-minute standardized light-touch protocol (designed to mimic OMT standardized protocol) + 5-minute auscultation of carotid bruits, heart, and lungs, twice daily for duration of hospitalization | Procedure: Light-touch Treatment<br>* In addition to conventional treatment for pneumonia, a 10-minute standardized light-touch protocol (designed to mimic OMT standardized protocol) + 5-minute auscultation of carotid bruits, heart, and lungs was performed twice daily for the duration of hospitalization.<br>* Other names: Placebo manipulation;|
| No Intervention: Conventional Care Only<br>No intervention specific to the research study provided. Only conventional treatment as per attending physician orders. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Hospital Stay | Number of days from admission order to discharge order | End of hospital stay | 
| Time to Clinical Stability | Halm EA, Fine MJ, Marrie TJ, Coley CM, Kapoor WN, Obrosky DS, et al.: Time to clinical stability in patients hospitalized with community-acquired pneumonia: implications for practice guidelines. JAMA 1998, 279:1452-1457 | Daily for the duration of the hospital stay | 
| Symptomatic and Functional Recovery Score | Metlay JP, Fine MJ, Schulz R, Marrie TJ, Coley CM, Kapoor WN, et al.: Measuring symptomatic and functional recovery in patients with communityacquired pneumonia. J Gen Intern Med 1997, 12:423-430 | 14, 30, and 60 days post-admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of IV and oral antibiotic usage in the hospital |  |  | 
| Number of complications and deaths secondary to pneumonia |  |  | 
| Duration and severity of fever |  |  | 
| Duration and severity of leukocytosis |  |  | 
| Patient Satisfaction |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Elderly, Pneumonia, Osteopathic, Manipulation, Multi-center