Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Brentwood Foundation | OTHER |
| Colorado Springs Osteopathic Foundation | OTHER |
| Foundation for Osteopathic Health Services (Maryland) | UNKNOWN |
| Muskegon General Osteopathic Foundation (Michigan) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Osteopathic Manipulative Treatment | Experimental | 10-minute standardized OMT protocol + 5-minute nonstandardized component, twice daily for duration of hospitalization |
|
| 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 |
|
| Conventional Care Only | No Intervention | No intervention specific to the research study provided. Only conventional treatment as per attending physician orders. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Osteopathic Manipulative Treatment | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of IV and oral antibiotic usage in the hospital | ||
| Number of complications and deaths secondary to pneumonia | ||
| Duration and severity of fever |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Donald R Noll, D.O., FACOI | A.T. Still University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Clemens General Hospital | Mount Clemens | Michigan | 48043 | United States | ||
| Northeast Regional Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18806080 | Background | 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. | |
| 20302619 | Result | 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. |
Not provided
Not provided
Not provided
| UNKNOWN |
| Northwest Oklahoma Osteopathic Foundation (Oklahoma) | UNKNOWN |
| Osteopathic Founders Foundation (Oklahoma) | UNKNOWN |
| Osteopathic Institute of the South (Georgia) | UNKNOWN |
| Osteopathic Heritage Foundations | OTHER |
| Quad City Osteopathic Foundation (Iowa) | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
|
| Light-touch Treatment | Procedure | 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. |
|
|
| Duration and severity of leukocytosis |
| Patient Satisfaction |
| Kirksville |
| Missouri |
| 63501 |
| United States |
| UNDNJ in association with Kennedy Memorial Hospitals- University Medical Center | Stratford | New Jersey | 08084 | United States |
| Doctors Hospital | Columbus | Ohio | 43228 | United States |
| John Peter Smith Health Network | Fort Worth | Texas | 76107 | United States |
| Plaza Medical Center | Fort Worth | Texas | 76107 | United States |
| UNTHSC Osteopathic Medical Center | Fort Worth | Texas | 76107 | United States |
| 27571294 | Derived | 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. |
| ID | Term |
|---|---|
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D026301 | Manipulation, Osteopathic |
| ID | Term |
|---|---|
| D026201 | Musculoskeletal Manipulations |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
Not provided
Not provided