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

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.

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)