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

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

406 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2007-04-30

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.

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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.

Conditions

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Pneumonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Osteopathic Manipulative Treatment

10-minute standardized OMT protocol + 5-minute nonstandardized component, twice daily for duration of hospitalization

Group Type EXPERIMENTAL

Osteopathic Manipulative Treatment

Intervention Type PROCEDURE

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.

Light-touch Treatment

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

Group Type SHAM_COMPARATOR

Light-touch Treatment

Intervention Type PROCEDURE

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.

Conventional Care Only

No intervention specific to the research study provided. Only conventional treatment as per attending physician orders.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Osteopathic Manipulative Treatment

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.

Intervention Type PROCEDURE

Light-touch Treatment

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.

Intervention Type PROCEDURE

Other Intervention Names

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OMT OMM Osteopathic Manipulative Medicine Manipulation Sham manipulation Placebo manipulation

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)

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No