Study of Osteopathic Manipulation in the Management of Angina

Angina Pectoris Clinical Trial

— SOMMA  

Official title:

Study of Osteopathic Manipulation in the Management of Angina

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00708279
• Other study ID #: F-07-04 SOMMA
• Secondary ID: F-07-04 AOA/OHF
• Status: Completed
• Phase: N/A
• First received: June 30, 2008
• Last updated: April 13, 2011
• Start date: August 2007
• Est. completion date: July 2008

Study information

• Verified date: June 2010
• Source: University of New England
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: July 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 81 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angina Pectoris

Intervention

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.

Locations

Country	Name	City	State
United States	University Health Care	Saco	Maine

Sponsors (2)

Lead Sponsor	Collaborator
University of New England	Osteopathic Heritage Foundations

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease in angina symptoms		over 4 month period	No
Secondary	Improvement in quality of life		over 4 month period	No