NCT00504179

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2001

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2001

Completed
4.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

July 17, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 19, 2007

Completed
Last Updated

July 19, 2007

Status Verified

July 1, 2007

First QC Date

July 17, 2007

Last Update Submit

July 17, 2007

Conditions

Cardiovascular Disease

Keywords

coronary artery bypass graftosteopathic manipulative treatmentcardiovascular disease

Outcome Measures

Primary Outcomes (1)

  • Recovery of mobility, bowel function, and reduced length of hospital stay.

Interventions

Osteopathic Manipulative TreatmentPROCEDURE

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • prior coronary artery bypass graft procedure
  • unstable psychiatric illness
  • chronic pain
  • open chest phenomenon
  • unforeseen peri or postoperative complications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ingham Regional Medical Center

Lansing, Michigan, 48910, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Manipulation, Osteopathic

Intervention Hierarchy (Ancestors)

Musculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Michael Wieting

    Michigan State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 17, 2007

First Posted

July 19, 2007

Study Start

April 1, 2001

Study Completion

October 1, 2005

Last Updated

July 19, 2007

Record last verified: 2007-07

Locations

US(1)