Clinical trial NCT00258661: Is Osteopathic Manipulative Treatment (OMT) Beneficial for Elderly Patients Hospitalized With Pneumonia?
Official title: Multicenter Osteopathic Pneumonia Study in the Elderly (MOPSE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pneumonia
Keywords: Pneumonia
Osteopathic
Manipulation
Multi-center
Elderly
Lead sponsor: A.T. Still University of Health Sciences
Sponsor class: OTHER
Collaborators: name: Brentwood Foundation
name: Colorado Springs Osteopathic Foundation
name: Foundation for Osteopathic Health Services (Maryland)
name: Muskegon General Osteopathic Foundation (Michigan)
name: Northwest Oklahoma Osteopathic Foundation (Oklahoma)
name: Osteopathic Founders Foundation (Oklahoma)
name: Osteopathic Institute of the South (Georgia)
name: Osteopathic Heritage Foundations
name: Quad City Osteopathic Foundation (Iowa)
First posted: 2005-11-28
Enrollment: 406
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Length of Hospital Stay
timeFrame: End of hospital stay
measure: Time to Clinical Stability
timeFrame: Daily for the duration of the hospital stay
measure: Symptomatic and Functional Recovery Score
timeFrame: 14, 30, and 60 days post-admission
Secondary outcomes:
measure: Duration of IV and oral antibiotic usage in the hospital
measure: Number of complications and deaths secondary to pneumonia
measure: Duration and severity of fever
measure: Duration and severity of leukocytosis
measure: Patient Satisfaction
Other outcomes:
Locations:
city: Mount Clemens
country: United States
facility: Mount Clemens General Hospital
state: Michigan
city: Kirksville
country: United States
facility: Northeast Regional Medical Center
state: Missouri
city: Stratford
country: United States
facility: UNDNJ in association with Kennedy Memorial Hospitals- University Medical Center
state: New Jersey
city: Columbus
country: United States
facility: Doctors Hospital
state: Ohio
city: Fort Worth
country: United States
facility: John Peter Smith Health Network
state: Texas
city: Fort Worth
country: United States
facility: Plaza Medical Center
state: Texas
city: Fort Worth
country: United States
facility: UNTHSC Osteopathic Medical Center
state: Texas
Study officials:
affiliation: A.T. Still University
name: Donald R Noll, D.O., FACOI
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.