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

Primary Purpose

Angina Pectoris

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Osteopathic manipulation
Sponsored by
University of New England
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Angina Pectoris focused on measuring angina pectoris, osteopathic manipulation

Eligibility Criteria

18 Years - 81 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Health Care

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

A

Arm Description

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.

Outcomes

Primary Outcome Measures

Decrease in angina symptoms

Secondary Outcome Measures

Improvement in quality of life

Full Information

First Posted
June 30, 2008
Last Updated
April 13, 2011
Sponsor
University of New England
Collaborators
Osteopathic Heritage Foundations
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1. Study Identification

Unique Protocol Identification Number
NCT00708279
Brief Title
Study of Osteopathic Manipulation in the Management of Angina
Acronym
SOMMA
Official Title
Study of Osteopathic Manipulation in the Management of Angina
Study Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of New England
Collaborators
Osteopathic Heritage Foundations

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to assess the effectiveness of osteopathic manipulation in decreasing angina pectoris symptoms.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Angina Pectoris
Keywords
angina pectoris, osteopathic manipulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Osteopathic manipulation
Other Intervention Name(s)
osteopathic manipulative medicine, structural exam, viscero-somatic reflexes, circulatory-respirtatory model, musculoskeletal model
Intervention Description
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.
Primary Outcome Measure Information:
Title
Decrease in angina symptoms
Time Frame
over 4 month period
Secondary Outcome Measure Information:
Title
Improvement in quality of life
Time Frame
over 4 month period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
81 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joy L. Palmer, D.O.
Organizational Affiliation
University of New England
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Health Care
City
Saco
State/Province
Maine
ZIP/Postal Code
04072
Country
United States

12. IPD Sharing Statement

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Study of Osteopathic Manipulation in the Management of Angina

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