Cardiovascular DiseaseCABGOMTNCT00504179
The Effect of Osteopathic Manipulative Treatment on Recovery of Coronary Bypass Patients
A study testing Osteopathic Manipulative Treatment in people with Cardiovascular Disease, run by Michigan State University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Osteopathic Manipulative Treatment
- Type of treatment
- Surgery or procedure
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2001to Oct 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults undergoing elective coronary artery bypass graft surgery who were patients of the same surgeon
Who cannot join
- prior coronary artery bypass graft procedure
- unstable psychiatric illness
- chronic pain
- open chest phenomenon
- unforeseen peri or postoperative complications
Trial locations and contacts
1 site in 1 country.
United States1 site
Ingham Regional Medical Center
Lansing, Michigan, 48910
About this study
Official title: The Effect of Osteopathic Manipulative Treatment on Post-Operative Medical and Functional Recovery of Coronary Artery Bypass Graft Patients
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.
Read the 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.
- Conditions
- Cardiovascular Disease
- Being tested
- Osteopathic Manipulative Treatment
- Keywords
- coronary artery bypass graft, osteopathic manipulative treatment, cardiovascular disease
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic Manipulative TreatmentProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery of mobility, bowel function, and reduced length of hospital stay.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2007 (estimated)
- Study startApr 2001
- Study completionOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michigan State University
- Sponsor type
- University, hospital or other
- Investigators
- Michael Wieting, Principal investigator, Michigan State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00504179
- Sponsor's protocol ID
- WIETING061855
- Acronym
- CABGOMT
- Status last verified
- Jul 2007
- First submitted
- 17 Jul 2007
- Last updated
- 19 Jul 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Osteopathic Manipulative Treatment on Post-Operative Medical and Functional Recovery of Coronary Artery Bypass Graft Patients
- ClinicalTrials.gov ID
- NCT00504179
- Acronym / sponsor ID
- CABGOMT / WIETING061855
- Conditions
- Cardiovascular Disease
- Keywords
- coronary artery bypass graft, osteopathic manipulative treatment, cardiovascular disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Michigan State UniversityUniversity, hospital or other
- Study start
- Apr 2001
- Study completion
- Oct 2005 (actual)
- First posted
- 19 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults undergoing elective coronary artery bypass graft surgery who were patients of the same surgeon
Key exclusion criteria (5 listed)
- prior coronary artery bypass graft procedure
- unstable psychiatric illness
- chronic pain
- open chest phenomenon
- unforeseen peri or postoperative complications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osteopathic Manipulative Treatment | Procedure or surgery | – |
Primary outcome
Recovery of mobility, bowel function, and reduced length of hospital stay.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Wieting principal investigator
Michigan State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteopathic Manipulative Treatment in people with Cardiovascular Disease, run by Michigan State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recovery of mobility, bowel function, and reduced length of hospital stay.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2007.