NCT00258661

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
406

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2004

Typical duration for not_applicable

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

November 23, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 28, 2005

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

October 4, 2018

Status Verified

October 1, 2018

Enrollment Period

3.1 years

First QC Date

November 23, 2005

Last Update Submit

October 3, 2018

Conditions

Pneumonia

Keywords

PneumoniaOsteopathicManipulationMulti-centerElderly

Outcome Measures

Primary Outcomes (3)

  • Length of Hospital Stay

    Number of days from admission order to discharge order

    End of hospital stay

  • 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

  • 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 Outcomes (5)

  • 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

Study Arms (3)

Osteopathic Manipulative Treatment

EXPERIMENTAL

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

Procedure: Osteopathic Manipulative Treatment

Light-touch Treatment

SHAM COMPARATOR

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

Conventional Care Only

NO INTERVENTION

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

Interventions

Osteopathic Manipulative TreatmentPROCEDURE

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.

Also known as: OMT, OMM, Osteopathic Manipulative Medicine, Manipulation
Osteopathic Manipulative Treatment
Light-touch TreatmentPROCEDURE

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.

Also known as: Sham manipulation, Placebo manipulation
Light-touch Treatment

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Mount Clemens General Hospital

Mount Clemens, Michigan, 48043, United States

Location

Northeast Regional Medical Center

Kirksville, Missouri, 63501, United States

Location

UNDNJ in association with Kennedy Memorial Hospitals- University Medical Center

Stratford, New Jersey, 08084, United States

Location

Doctors Hospital

Columbus, Ohio, 43228, United States

Location

John Peter Smith Health Network

Fort Worth, Texas, 76107, United States

Location

Plaza Medical Center

Fort Worth, Texas, 76107, United States

Location

UNTHSC Osteopathic Medical Center

Fort Worth, Texas, 76107, United States

Location

Related Publications (3)

  • 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.

    PMID: 18806080BACKGROUND

  • 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.

    PMID: 20302619RESULT

  • 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.

    PMID: 27571294DERIVED

MeSH Terms

Conditions

Pneumonia

Interventions

Manipulation, Osteopathic

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Musculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Donald R Noll, D.O., FACOI

    A.T. Still University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 23, 2005

First Posted

November 28, 2005

Study Start

March 1, 2004

Primary Completion

April 1, 2007

Study Completion

April 1, 2007

Last Updated

October 4, 2018

Record last verified: 2018-10

Locations

US(7)