Study of Osteopathic Manipulation in the Management of Angina (SOMMA)

April 13, 2011 updated by: University of New England
The purpose of this study is to assess the effectiveness of osteopathic manipulation in decreasing angina pectoris symptoms.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maine
      • Saco, Maine, United States, 04072
        • University Health Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Canadian Cardiovascular Society Class II, III for a minimum of 6 months
  • documented coronary artery disease via previous myocardial infarction, abnormal stress test, or abnormal coronary angiogram of greater than or equal to 50% luminal obstruction of at least one epicardial vessel.

Exclusion Criteria:

  • severe left ventricular dysfunction
  • symptomatic heart failure
  • symptomatic aortic stenosis or any valvular disease
  • significant pulmonary disease
  • unstable angina
  • major surgery or angioplasty in the past three months
  • acute myocardial infarction within past three months
  • insulin dependent diabetes mellitus
  • uncontrolled hypertension
  • acute renal or hepatic failure
  • currently being treated with osteopathic manipulation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
After establishing a baseline for the first 4 weeks of trial involvement, thereby providing their own control group, all participants begin the intervention phase of osteopathic manipulation.
Procedure: Osteopathic manipulation
Participant will be evaluated and treated for somatic dysfunction utilizing osteopathic manipulation once a week for 3 weeks, then once every 3 weeks for three more visits; a total of 6 interventions in 3 months.
Other Names:
  • osteopathic manipulative medicine
  • structural exam
  • viscero-somatic reflexes
  • circulatory-respirtatory model
  • musculoskeletal model

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Decrease in angina symptoms
Time Frame: over 4 month period
over 4 month period

Secondary Outcome Measures

Outcome Measure
Time Frame
Improvement in quality of life
Time Frame: over 4 month period
over 4 month period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of New England

Collaborators

Osteopathic Heritage Foundations

Investigators

  • Principal Investigator: Joy L. Palmer, D.O., University of New England

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

June 30, 2008

First Submitted That Met QC Criteria

July 1, 2008

First Posted (Estimate)

July 2, 2008

Study Record Updates

Last Update Posted (Estimate)

April 14, 2011

Last Update Submitted That Met QC Criteria

April 13, 2011

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F-07-04 SOMMA
  • F-07-04 AOA/OHF Fellowship (Other Identifier: American Osteopathic Association - Osteopathic Heritage Fund)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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