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

This study has been completed.
Sponsor:
Collaborators:
Brentwood Foundation
Colorado Springs Osteopathic Foundation
Foundation for Osteopathic Health Services (Maryland)
Muskegon General Osteopathic Foundation (Michigan)
Northwest Oklahoma Osteopathic Foundation (Oklahoma)
Osteopathic Founders Foundation (Oklahoma)
Osteopathic Institute of the South (Georgia)
Osteopathic Heritage Foundations
Quad City Osteopathic Foundation (Iowa)
Information provided by:
A.T. Still University of Health Sciences
ClinicalTrials.gov Identifier:
NCT00258661
First received: November 23, 2005
Last updated: July 22, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention
Pneumonia
Procedure: Osteopathic Manipulative Treatment
Procedure: Light-touch Treatment
Procedure: Conventional Care Only

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multicenter Osteopathic Pneumonia Study in the Elderly (MOPSE)

Resource links provided by NLM:


Further study details as provided by A.T. Still University of Health Sciences:

Primary Outcome Measures:
  • Length of Hospital Stay [ Time Frame: End of hospital stay ] [ Designated as safety issue: No ]
    Number of days from admission order to discharge order

  • Time to Clinical Stability [ Time Frame: Daily for the duration of the hospital stay ] [ Designated as safety issue: No ]

    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


  • Symptomatic and Functional Recovery Score [ Time Frame: 14, 30, and 60 days post-admission ] [ Designated as safety issue: No ]

    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



Secondary Outcome Measures:
  • 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

Enrollment: 406
Study Start Date: March 2004
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Osteopathic Manipulative Treatment
10-minute standardized OMT protocol + 5-minute nonstandardized component, twice daily for duration of hospitalization
Procedure: 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.
Other Names:
  • OMT
  • OMM
  • Osteopathic Manipulative Medicine
  • Manipulation
Sham Comparator: 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
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.
Other Names:
  • Sham manipulation
  • Placebo manipulation
No Intervention: Conventional Care Only
No intervention specific to the research study provided. Only conventional treatment as per attending physician orders.
Procedure: Conventional Care Only
No intervention specific to the research study provided. Only conventional treatment as per attending physician orders.
Other Name: Treatment-as-usual

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00258661

Locations
United States, Michigan
Mount Clemens General Hospital
Mount Clemens, Michigan, United States, 48043
United States, Missouri
Northeast Regional Medical Center
Kirksville, Missouri, United States, 63501
United States, New Jersey
UNDNJ in association with Kennedy Memorial Hospitals- University Medical Center
Stratford, New Jersey, United States, 08084
United States, Ohio
Doctors Hospital
Columbus, Ohio, United States, 43228
United States, Texas
Plaza Medical Center
Fort Worth, Texas, United States, 76107
John Peter Smith Health Network
Ft Worth, Texas, United States, 76107
UNTHSC Osteopathic Medical Center
Ft Worth, Texas, United States, 76107
Sponsors and Collaborators
A.T. Still University of Health Sciences
Brentwood Foundation
Colorado Springs Osteopathic Foundation
Foundation for Osteopathic Health Services (Maryland)
Muskegon General Osteopathic Foundation (Michigan)
Northwest Oklahoma Osteopathic Foundation (Oklahoma)
Osteopathic Founders Foundation (Oklahoma)
Osteopathic Institute of the South (Georgia)
Osteopathic Heritage Foundations
Quad City Osteopathic Foundation (Iowa)
Investigators
Principal Investigator: Donald R Noll, D.O., FACOI A.T. Still University
  More Information

Publications:
Responsible Party: Brian F Degenhardt, DO, A.T. Still University - A.T. Still Research Institute
ClinicalTrials.gov Identifier: NCT00258661     History of Changes
Other Study ID Numbers: 501-202
Study First Received: November 23, 2005
Last Updated: July 22, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by A.T. Still University of Health Sciences:
Pneumonia
Osteopathic
Manipulation
Multi-center
Elderly

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on July 20, 2014