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The Effect of Osteopathic Manipulative Treatment on Recovery of Coronary Bypass Patients (CABGOMT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00504179
Recruitment Status : Completed
First Posted : July 19, 2007
Last Update Posted : July 19, 2007
Sponsor:
Information provided by:
Michigan State University

Tracking Information
First Submitted Date  ICMJE July 17, 2007
First Posted Date  ICMJE July 19, 2007
Last Update Posted Date July 19, 2007
Study Start Date  ICMJE April 2001
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: July 17, 2007)
Recovery of mobility, bowel function, and reduced length of hospital stay.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Osteopathic Manipulative Treatment on Recovery of Coronary Bypass Patients
Official Title  ICMJE The Effect of Osteopathic Manipulative Treatment on Post-Operative Medical and Functional Recovery of Coronary Artery Bypass Graft Patients
Brief Summary The purpose of the study was to determine the effect on recovery after surgery of patients who received a standardized daily protocol of osteopathic manipulative treatment.Patients undergoing elective coronary artery bypass surgery were voluntarily enrolled in the study and assigned to one of three groups.One group received a standardized daily treatment protocol along with conventional care, another received daily similar placebo treatment with conventional care, and a final group received only conventional post surgical care.The research hypothesis was that daily treatment with osteopathic manipulative treatment would reduce hospital stay and hasten recovery from surgery.Persons in the treatment group had earlier discharge, and faster recovery of bowel function and basic mobility.
Detailed Description Fifty-three persons were voluntarily enrolled into this randomized, double-blinded placebo controlled trial to examine the effects of osteopathic manipulative treatment (OMT) on the post operative recovery of persons undergoing elective coronary artery bypass graft (CABG) surgery. Participants were assigned randomly to one of three cohorts: one with only conventiobnal treatment, one with a daily standardized protocol of OMT and a third with a daily time matched placebo OMT protocol.All patients received standard state of the art care consistent with national standards of post CABG care. The study showed favorable trends in terms of hospital length of stay , return of bowel function, and mobility.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Cardiovascular Disease
Intervention  ICMJE Procedure: Osteopathic Manipulative Treatment
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 17, 2007)
53
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adults undergoing elective coronary artery bypass graft surgery who were patients of the same surgeon

Exclusion Criteria:

  • prior coronary artery bypass graft procedure
  • unstable psychiatric illness
  • chronic pain
  • open chest phenomenon
  • unforeseen peri or postoperative complications
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00504179
Other Study ID Numbers  ICMJE WIETING061855
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Michigan State University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael Wieting Michigan State University
PRS Account Michigan State University
Verification Date July 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP