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

October 3, 2018 updated by: A.T. Still University of Health Sciences

Multicenter Osteopathic Pneumonia Study in the Elderly (MOPSE)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

406

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Mount Clemens, Michigan, United States, 48043
        • Mount Clemens General Hospital
    • Missouri
      • Kirksville, Missouri, United States, 63501
        • Northeast Regional Medical Center
    • New Jersey
      • Stratford, New Jersey, United States, 08084
        • UNDNJ in association with Kennedy Memorial Hospitals- University Medical Center
    • Ohio
      • Columbus, Ohio, United States, 43228
        • Doctors Hospital
    • Texas
      • Fort Worth, Texas, United States, 76107
        • John Peter Smith Health Network
      • Fort Worth, Texas, United States, 76107
        • Plaza Medical Center
      • Fort Worth, Texas, United States, 76107
        • UNTHSC Osteopathic Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
  • Manipulation
  • OMM
  • Osteopathic Manipulative Medicine
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of Hospital Stay
Time Frame: End of hospital stay
Number of days from admission order to discharge order
End of hospital stay
Time to Clinical Stability
Time Frame: Daily for the duration of the hospital stay

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
Time Frame: 14, 30, and 60 days post-admission

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
Patient Satisfaction
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

A.T. Still University of Health Sciences

Collaborators

Osteopathic Heritage Foundations
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)
Quad City Osteopathic Foundation (Iowa)

Investigators

  • Principal Investigator: Donald R Noll, D.O., FACOI, A.T. Still University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2004

Primary Completion (Actual)

April 1, 2007

Study Completion (Actual)

April 1, 2007

Study Registration Dates

First Submitted

November 23, 2005

First Submitted That Met QC Criteria

November 23, 2005

First Posted (Estimate)

November 28, 2005

Study Record Updates

Last Update Posted (Actual)

October 4, 2018

Last Update Submitted That Met QC Criteria

October 3, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 501-202

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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