PneumoniaMOPSENCT00258661
Is Osteopathic Manipulative Treatment (OMT) Beneficial for Elderly Patients Hospitalized With Pneumonia?
A study testing Osteopathic Manipulative Treatment and Light-touch Treatment in people with Pneumonia, run by A.T. Still University of Health Sciences at 7 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 50 to 100 years
- Conditions the study is for
- Pneumonia
- What is being tested?
- Osteopathic Manipulative Treatment and Light-touch Treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 406 participants
- Where
- 7 sitesUnited States
- Study dates
- Mar 2004to Apr 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 10Show fewer
- 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)
Who cannot join
- Lung abscess
- Advancing pulmonary fibrosis
- Bronchiectasis
- Pulmonary tuberculosis
- Lung Cancer
- Metastatic malignancy
Show all 11Show fewer
- 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)
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Doctors Hospital
Columbus, Ohio, 43228
John Peter Smith Health Network
Fort Worth, Texas, 76107
Plaza Medical Center
Fort Worth, Texas, 76107
UNTHSC Osteopathic Medical Center
Fort Worth, Texas, 76107
Northeast Regional Medical Center
Kirksville, Missouri, 63501
Mount Clemens General Hospital
Mount Clemens, Michigan, 48043
UNDNJ in association with Kennedy Memorial Hospitals- University Medical Center
Stratford, New Jersey, 08084
About this study
Official title: Multicenter Osteopathic Pneumonia Study in the Elderly (MOPSE)
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.
Read the 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.
- Conditions
- Pneumonia
- Being tested
- Osteopathic Manipulative Treatment, Light-touch Treatment
- Keywords
- Pneumonia, Osteopathic, Manipulation, Multi-center, Elderly
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic Manipulative TreatmentProcedure or surgery
Also called OMT, OMM, Osteopathic Manipulative Medicine, Manipulation
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 TreatmentProcedure or surgery
Also called Sham manipulation, Placebo manipulation
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.
| Study group | Role | What they receive |
|---|---|---|
| Osteopathic Manipulative Treatment | Experimental | 10-minute standardized OMT protocol + 5-minute nonstandardized component, twice daily for duration of hospitalization Receives: 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Hospital Stay
Number of days from admission order to discharge order
Measured: 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
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2005 (estimated)
- Study startMar 2004
- Primary completionApr 2007
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 406 participants (actual)
Sponsor and investigators
- Lead sponsor
- A.T. Still University of Health Sciences
- Sponsor type
- University, hospital or other
- 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)
- Responsible party
- Sponsor
- Investigators
- Donald R Noll, D.O., FACOI, Principal investigator, A.T. Still University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00258661
- Sponsor's protocol ID
- 501-202
- Acronym
- MOPSE
- Status last verified
- Oct 2026
- First submitted
- 23 Nov 2005
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 18806080Noll 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.
PubMed 20302619Noll 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.
PubMed 27571294
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Osteopathic Pneumonia Study in the Elderly (MOPSE)
- ClinicalTrials.gov ID
- NCT00258661
- Acronym / sponsor ID
- MOPSE / 501-202
- Conditions
- Pneumonia
- Keywords
- Pneumonia, Osteopathic, Manipulation, Multi-center, Elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 406 participants (actual)
- Lead sponsor
- A.T. Still University of Health SciencesUniversity, hospital or other
- 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)
- Study start
- Mar 2004
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 28 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Osteopathic Manipulative Treatment | Experimental | Procedure: Osteopathic Manipulative Treatment10-minute standardized OMT protocol + 5-minute nonstandardized component, twice daily for duration of hospitalization |
| Light-touch Treatment | Sham comparator | Procedure: Light-touch Treatment10-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 |
| Conventional Care Only | No intervention | –No intervention specific to the research study provided. Only conventional treatment as per attending physician orders. |
Who may qualify
- Ages
- 50 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (11 listed)
- Lung abscess
- Advancing pulmonary fibrosis
- Bronchiectasis
- Pulmonary tuberculosis
- Lung Cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osteopathic Manipulative TreatmentAlso: OMT, OMM, Osteopathic Manipulative Medicine, ManipulationIn 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. | Procedure or surgery | Osteopathic Manipulative Treatment |
| Light-touch TreatmentAlso: Sham manipulation, Placebo manipulationIn 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. | Procedure or surgery | Light-touch Treatment |
Primary outcome
Length of Hospital Stay
Time frame: End of hospital stay
Number of days from admission order to discharge order
Time to Clinical Stability
Time frame: Daily for the duration of the hospital stay
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
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
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Background: PubMed 18806080Noll 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.
- Results publication: PubMed 20302619Noll 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.
- Derived from this study: PubMed 27571294Noll 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donald R Noll, D.O., FACOI principal investigator
A.T. Still University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteopathic Manipulative Treatment and Light-touch Treatment in people with Pneumonia, run by A.T. Still University of Health Sciences at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of Hospital Stay (time frame: End of hospital stay). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00258661, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.