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Study of Osteopathic Manipulation in the Management of Angina (SOMMA)
This study has been completed.
Sponsors and Collaborators: University of New England
Osteopathic Heritage Foundations
Information provided by: University of New England
ClinicalTrials.gov Identifier: NCT00708279
  Purpose

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


Condition Intervention
Angina Pectoris
 Procedure: Osteopathic manipulation

MedlinePlus related topics: Angina
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Single Group Assignment, Efficacy Study
Official Title: Study of Osteopathic Manipulation in the Management of Angina

Further study details as provided by University of New England:

Primary Outcome Measures:
  • Decrease in angina symptoms [ Time Frame: over 4 month period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement in quality of life [ Time Frame: over 4 month period ] [ Designated as safety issue: No ]

Enrollment: 1
Study Start Date: August 2007
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Experimental
After establishing a baseline for the first 4 weeks of trial involvement, 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.

  Eligibility

Ages Eligible for Study:   18 Years to 81 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00708279

Locations
United States, Maine
University Health Care
Saco, Maine, United States, 04072
Sponsors and Collaborators
University of New England
Osteopathic Heritage Foundations
Investigators
Principal Investigator: Joy L. Palmer, D.O. University of New England
  More Information

Responsible Party: University of New England ( Joy L. Palmer, D.O., Principal investigator )
Study ID Numbers: F-07-04 SOMMA, F-07-04 AOA/OHF Fellowship
Study First Received: June 30, 2008
Last Updated: July 1, 2008
ClinicalTrials.gov Identifier: NCT00708279  
Health Authority: United States: Institutional Review Board

Keywords provided by University of New England:
angina pectoris, osteopathic manipulation

Study placed in the following topic categories:
Signs and Symptoms
Heart Diseases
Myocardial Ischemia
Vascular Diseases
 Angina Pectoris
Pain
Ischemia
Chest Pain

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009



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