Ignite Creation Date:
2025-12-24 @ 11:46 AM
Ignite Modification Date:
2025-12-28 @ 4:16 AM
Study NCT ID:
NCT00258661
Status:
COMPLETED
Last Update Posted:
2018-10-04
First Post:
2005-11-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Is Osteopathic Manipulative Treatment (OMT) Beneficial for Elderly Patients Hospitalized With Pneumonia?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011014', 'term': 'Pneumonia'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D026301', 'term': 'Manipulation, Osteopathic'}], 'ancestors': [{'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 406}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-03', 'studyFirstSubmitDate': '2005-11-23', 'studyFirstSubmitQcDate': '2005-11-23', 'lastUpdatePostDateStruct': {'date': '2018-10-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-11-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Length of Hospital Stay', 'timeFrame': 'End of hospital stay', 'description': 'Number of days from admission order to discharge order'}, {'measure': 'Time to Clinical Stability', 'timeFrame': 'Daily for the duration of the hospital stay', 'description': 'Halm EA, Fine MJ, Marrie TJ, Coley CM, Kapoor WN, Obrosky DS, et al.:\n\nTime to clinical stability in patients hospitalized with community-acquired pneumonia: implications for practice guidelines. JAMA 1998, 279:1452-1457'}, {'measure': 'Symptomatic and Functional Recovery Score', 'timeFrame': '14, 30, and 60 days post-admission', 'description': 'Metlay JP, Fine MJ, Schulz R, Marrie TJ, Coley CM, Kapoor WN, et al.:\n\nMeasuring symptomatic and functional recovery in patients with communityacquired pneumonia. J Gen Intern Med 1997, 12:423-430'}], 'secondaryOutcomes': [{'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'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pneumonia', 'Osteopathic', 'Manipulation', 'Multi-center', 'Elderly'], 'conditions': ['Pneumonia']}, 'referencesModule': {'references': [{'pmid': '18806080', 'type': 'BACKGROUND', '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.'}, {'pmid': '20302619', 'type': 'RESULT', '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.'}, {'pmid': '27571294', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 50 Years old or older\n* Subject is hospitalized in an acute care facility\n* Subject must exhibit at least two of the classic symptoms of pneumonia, to include:\n* Respiration Rate greater than or equal to 25 respirations per minute\n* New or increased cough\n* Fever greater than or equal to 100.4 degrees F (38 degrees C)\n* Pleuritic chest pain\n* Worsening of mental or functional status\n* Leukocytosis (WBC greater than 12,000 cells per cubic millimeter)\n* New or increased physical findings (rales, wheezing, bronchial breath sounds)\n\nExclusion Criteria:\n\n* Lung abscess\n* Advancing pulmonary fibrosis\n* Bronchiectasis\n* Pulmonary tuberculosis\n* Lung Cancer\n* Metastatic malignancy\n* Uncontrolled metabolic bone disease that places subject at risk for pathologic bone fracture (i.e. Paget's Disease or hypoparathyroidism)\n* Acute or unhealed rib or vertebral fracture\n* History of pathologic bone fracture\n* Previous participants as subject in the study\n* Respiratory failure (intubation)"}, 'identificationModule': {'nctId': 'NCT00258661', 'acronym': 'MOPSE', 'briefTitle': 'Is Osteopathic Manipulative Treatment (OMT) Beneficial for Elderly Patients Hospitalized With Pneumonia?', 'organization': {'class': 'OTHER', 'fullName': 'A.T. Still University of Health Sciences'}, 'officialTitle': 'Multicenter Osteopathic Pneumonia Study in the Elderly (MOPSE)', 'orgStudyIdInfo': {'id': '501-202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Osteopathic Manipulative Treatment', 'description': '10-minute standardized OMT protocol + 5-minute nonstandardized component, twice daily for duration of hospitalization', 'interventionNames': ['Procedure: Osteopathic Manipulative Treatment']}, {'type': 'SHAM_COMPARATOR', 'label': 'Light-touch Treatment', 'description': '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', 'interventionNames': ['Procedure: Light-touch Treatment']}, {'type': 'NO_INTERVENTION', 'label': 'Conventional Care Only', 'description': 'No intervention specific to the research study provided. Only conventional treatment as per attending physician orders.'}], 'interventions': [{'name': 'Osteopathic Manipulative Treatment', 'type': 'PROCEDURE', 'otherNames': ['OMT', 'OMM', 'Osteopathic Manipulative Medicine', 'Manipulation'], 'description': '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.', 'armGroupLabels': ['Osteopathic Manipulative Treatment']}, {'name': 'Light-touch Treatment', 'type': 'PROCEDURE', 'otherNames': ['Sham manipulation', 'Placebo manipulation'], 'description': '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.', 'armGroupLabels': ['Light-touch Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48043', 'city': 'Mount Clemens', 'state': 'Michigan', 'country': 'United States', 'facility': 'Mount Clemens General Hospital', 'geoPoint': {'lat': 42.59726, 'lon': -82.87798}}, {'zip': '63501', 'city': 'Kirksville', 'state': 'Missouri', 'country': 'United States', 'facility': 'Northeast Regional Medical Center', 'geoPoint': {'lat': 40.19475, 'lon': -92.58325}}, {'zip': '08084', 'city': 'Stratford', 'state': 'New Jersey', 'country': 'United States', 'facility': 'UNDNJ in association with Kennedy Memorial Hospitals- University Medical Center', 'geoPoint': {'lat': 39.82678, 'lon': -75.01545}}, {'zip': '43228', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Doctors Hospital', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '76107', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'John Peter Smith Health Network', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '76107', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Plaza Medical Center', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '76107', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'UNTHSC Osteopathic Medical Center', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}], 'overallOfficials': [{'name': 'Donald R Noll, D.O., FACOI', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'A.T. Still University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'A.T. Still University of Health Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'Brentwood Foundation', 'class': 'OTHER'}, {'name': 'Colorado Springs Osteopathic Foundation', 'class': 'OTHER'}, {'name': 'Foundation for Osteopathic Health Services (Maryland)', 'class': 'UNKNOWN'}, {'name': 'Muskegon General Osteopathic Foundation (Michigan)', 'class': 'UNKNOWN'}, {'name': 'Northwest Oklahoma Osteopathic Foundation (Oklahoma)', 'class': 'UNKNOWN'}, {'name': 'Osteopathic Founders Foundation (Oklahoma)', 'class': 'UNKNOWN'}, {'name': 'Osteopathic Institute of the South (Georgia)', 'class': 'UNKNOWN'}, {'name': 'Osteopathic Heritage Foundations', 'class': 'OTHER'}, {'name': 'Quad City Osteopathic Foundation (Iowa)', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Brian F Degenhardt, DO', 'oldOrganization': 'A.T. Still University - A.T. Still Research Institute'}}}}