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

Pneumonia Clinical Trial

— MOPSE  

Official title:

Multicenter Osteopathic Pneumonia Study in the Elderly (MOPSE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00258661
• Other study ID #: 501-202
• Status: Completed
• Phase: N/A
• Start date: March 2004
• Est. completion date: April 2007

Study information

• Verified date: October 2018
• Source: A.T. Still University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 406
• Est. completion date: April 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Pneumonia

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Doctors Hospital	Columbus	Ohio
United States	John Peter Smith Health Network	Fort Worth	Texas
United States	Plaza Medical Center	Fort Worth	Texas
United States	UNTHSC Osteopathic Medical Center	Fort Worth	Texas
United States	Northeast Regional Medical Center	Kirksville	Missouri
United States	Mount Clemens General Hospital	Mount Clemens	Michigan
United States	UNDNJ in association with Kennedy Memorial Hospitals- University Medical Center	Stratford	New Jersey

Sponsors (10)

Lead Sponsor	Collaborator
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 Heritage Foundations, Osteopathic Institute of the South (Georgia), Quad City Osteopathic Foundation (Iowa)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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 C — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of Hospital Stay	Number of days from admission order to discharge order	End of hospital stay
Primary	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	Daily for the duration of the hospital stay
Primary	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	14, 30, and 60 days post-admission
Secondary	Duration of IV and oral antibiotic usage in the hospital
Secondary	Number of complications and deaths secondary to pneumonia
Secondary	Duration and severity of fever
Secondary	Duration and severity of leukocytosis
Secondary	Patient Satisfaction