Study of Osteopathic Manipulation in the Management of Angina

NCT00708279 | Completed

• 2 other identifiers: F-07-04 SOMMAF-07-04 AOA/OHF Fellowship
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Angina Pectoris

Keywords

angina pectoris, osteopathic manipulation

Outcome Measures

Primary Outcomes (1)

• Decrease in angina symptoms

  over 4 month period

Secondary Outcomes (1)

• Improvement in quality of life

  over 4 month period

Study Arms (1)

A

EXPERIMENTAL

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

Interventions

Osteopathic manipulation PROCEDURE

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.

Also known as: osteopathic manipulative medicine, structural exam, viscero-somatic reflexes, circulatory-respirtatory model, musculoskeletal model

A

Eligibility Criteria

• Age: 18 Years - 81 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of New England: lead
• Osteopathic Heritage Foundations: collaborator

Study Sites (1)

University Health Care

Saco, Maine, 04072, United States

Location

MeSH Terms

Conditions

Angina Pectoris

Interventions

Manipulation, Osteopathic

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Joy L. Palmer, D.O.

  University of New England

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 30, 2008
• First Posted: July 2, 2008
• Study Start: August 1, 2007
• Primary Completion: April 1, 2008
• Study Completion: July 1, 2008
• Last Updated: April 14, 2011

Record last verified: 2010-06

Locations

US (1)