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

Primary Purpose

Pneumonia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Osteopathic Manipulative Treatment
Light-touch Treatment
Sponsored by
A.T. Still University of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pneumonia focused on measuring Pneumonia, Osteopathic, Manipulation, Multi-center, Elderly

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Mount Clemens General Hospital
  • Northeast Regional Medical Center
  • UNDNJ in association with Kennedy Memorial Hospitals- University Medical Center
  • Doctors Hospital
  • John Peter Smith Health Network
  • Plaza Medical Center
  • UNTHSC Osteopathic Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

No Intervention

Arm Label

Osteopathic Manipulative Treatment

Light-touch Treatment

Conventional Care Only

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Length of Hospital Stay
Number of days from admission order to discharge order
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
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

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

Full Information

First Posted
November 23, 2005
Last Updated
October 3, 2018
Sponsor
A.T. Still University of Health Sciences
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)
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1. Study Identification

Unique Protocol Identification Number
NCT00258661
Brief Title
Is Osteopathic Manipulative Treatment (OMT) Beneficial for Elderly Patients Hospitalized With Pneumonia?
Acronym
MOPSE
Official Title
Multicenter Osteopathic Pneumonia Study in the Elderly (MOPSE)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
April 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
A.T. Still University of Health Sciences
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)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia
Keywords
Pneumonia, Osteopathic, Manipulation, Multi-center, Elderly

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
406 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Osteopathic Manipulative Treatment
Arm Type
Experimental
Arm Description
10-minute standardized OMT protocol + 5-minute nonstandardized component, twice daily for duration of hospitalization
Arm Title
Light-touch Treatment
Arm Type
Sham Comparator
Arm Description
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
Arm Title
Conventional Care Only
Arm Type
No Intervention
Arm Description
No intervention specific to the research study provided. Only conventional treatment as per attending physician orders.
Intervention Type
Procedure
Intervention Name(s)
Osteopathic Manipulative Treatment
Other Intervention Name(s)
OMT, OMM, Osteopathic Manipulative Medicine, Manipulation
Intervention Description
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
Intervention Name(s)
Light-touch Treatment
Other Intervention Name(s)
Sham manipulation, Placebo manipulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Length of Hospital Stay
Description
Number of days from admission order to discharge order
Time Frame
End of hospital stay
Title
Time to Clinical Stability
Description
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
Time Frame
Daily for the duration of the hospital stay
Title
Symptomatic and Functional Recovery Score
Description
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
Time Frame
14, 30, and 60 days post-admission
Secondary Outcome Measure Information:
Title
Duration of IV and oral antibiotic usage in the hospital
Title
Number of complications and deaths secondary to pneumonia
Title
Duration and severity of fever
Title
Duration and severity of leukocytosis
Title
Patient Satisfaction

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donald R Noll, D.O., FACOI
Organizational Affiliation
A.T. Still University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Clemens General Hospital
City
Mount Clemens
State/Province
Michigan
ZIP/Postal Code
48043
Country
United States
Facility Name
Northeast Regional Medical Center
City
Kirksville
State/Province
Missouri
ZIP/Postal Code
63501
Country
United States
Facility Name
UNDNJ in association with Kennedy Memorial Hospitals- University Medical Center
City
Stratford
State/Province
New Jersey
ZIP/Postal Code
08084
Country
United States
Facility Name
Doctors Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43228
Country
United States
Facility Name
John Peter Smith Health Network
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76107
Country
United States
Facility Name
Plaza Medical Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76107
Country
United States
Facility Name
UNTHSC Osteopathic Medical Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76107
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18806080
Citation
Noll DR, Degenhardt BF, Fossum C, Hensel K. Clinical and research protocol for osteopathic manipulative treatment of elderly patients with pneumonia. J Am Osteopath Assoc. 2008 Sep;108(9):508-16. Erratum In: J Am Osteopath Assoc. 2008 Nov;108(11):670.
Results Reference
background
PubMed Identifier
20302619
Citation
Noll DR, Degenhardt BF, Morley TF, Blais FX, Hortos KA, Hensel K, Johnson JC, Pasta DJ, Stoll ST. Efficacy of osteopathic manipulation as an adjunctive treatment for hospitalized patients with pneumonia: a randomized controlled trial. Osteopath Med Prim Care. 2010 Mar 19;4:2. doi: 10.1186/1750-4732-4-2.
Results Reference
result
PubMed Identifier
27571294
Citation
Noll DR, Degenhardt BF, Johnson JC. Multicenter Osteopathic Pneumonia Study in the Elderly: Subgroup Analysis on Hospital Length of Stay, Ventilator-Dependent Respiratory Failure Rate, and In-hospital Mortality Rate. J Am Osteopath Assoc. 2016 Sep 1;116(9):574-87. doi: 10.7556/jaoa.2016.117.
Results Reference
derived

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

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