Is Osteopathic Manipulative Treatment (OMT) Beneficial for Elderly Patients Hospitalized With Pneumonia? (MOPSE)
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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) |
- 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
- 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:
|
|
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:
|
|
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 |
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| 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 | |
| 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 May 23, 2013