The Effect of Osteopathic Manipulative Treatment on Recovery of Coronary Bypass Patients

Cardiovascular Disease Clinical Trial

— CABGOMT  

Official title:

The Effect of Osteopathic Manipulative Treatment on Post-Operative Medical and Functional Recovery of Coronary Artery Bypass Graft Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00504179
• Other study ID #: WIETING061855
• Status: Completed
• Phase: N/A
• First received: July 17, 2007
• Last updated: July 17, 2007
• Start date: April 2001
• Est. completion date: October 2005

Study information

• Verified date: July 2007
• Source: Michigan State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: October 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Procedure:
• Osteopathic Manipulative Treatment

Locations

Country	Name	City	State
United States	Ingham Regional Medical Center	Lansing	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Michigan State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recovery of mobility, bowel function, and reduced length of hospital stay.