## Protocol Section
### Identification Module
**NCT ID:** NCT00708279

**Acronym:** SOMMA

**Brief Title:** Study of Osteopathic Manipulation in the Management of Angina

**Official Title:** Study of Osteopathic Manipulation in the Management of Angina

#### Organization Study ID Info
**ID:** F-07-04 SOMMA
#### Organization
**Class:** OTHER
**Full Name:** University of New England
#### Secondary ID Infos
**Domain:** American Osteopathic Association - Osteopathic Heritage Fund
**ID:** F-07-04 AOA/OHF Fellowship
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2008-07

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2011-04-14

**Type:** ESTIMATED

**Last Update Submit Date:** 2011-04-13

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2008-04

**Type:** ACTUAL

#### Start Date
**Date:** 2007-08

**Status Verified Date:** 2010-06

#### Study First Post Date
**Date:** 2008-07-02
**Type:** ESTIMATED
**Study First Submit Date:** 2008-06-30
**Study First Submit QC Date:** 2008-07-01
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Osteopathic Heritage Foundations

#### Lead Sponsor

**Class:** OTHER

**Name:** University of New England

#### Responsible Party

**Old Name Title:** Joy L. Palmer, D.O., Principal investigator

**Old Organization:** Edward Via College of Osteopathic Medicine

### Oversight Module

**Oversight Has DMC:** False

### Description Module

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

### Conditions Module

**Conditions:**

- Angina Pectoris

**Keywords:**

- angina pectoris, osteopathic manipulation

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 1

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**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 Names:**

- Procedure: Osteopathic manipulation

**Label:** A

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- A

**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.

**Name:** Osteopathic manipulation

**Other Names:**

- osteopathic manipulative medicine

- structural exam

- viscero-somatic reflexes

- circulatory-respirtatory model

- musculoskeletal model

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Measure:** Decrease in angina symptoms

**Time Frame:** over 4 month period

#### Secondary Outcomes

**Measure:** Improvement in quality of life

**Time Frame:** over 4 month period

### Eligibility Module

**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

**Maximum Age:** 81 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Saco

**Country:** United States

**Facility:** University Health Care

**State:** Maine

**Zip:** 04072

#### Overall Officials

**Official 1:**

**Affiliation:** University of New England

**Name:** Joy L. Palmer, D.O.

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000017202

- Term: Myocardial Ischemia

- ID: D000006331

- Term: Heart Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002637

- Term: Chest Pain

- ID: D000010146

- Term: Pain

- ID: D000009461

- Term: Neurologic Manifestations

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

### Condition Browse Module - Browse Leaves

- ID: M4117

- Name: Angina Pectoris

- Relevance: HIGH

- As Found: Angina Pectoris

- ID: M10543

- Name: Ischemia

- Relevance: LOW

- As Found: Unknown

- ID: M6546

- Name: Coronary Artery Disease

- Relevance: LOW

- As Found: Unknown

- ID: M19506

- Name: Myocardial Ischemia

- Relevance: LOW

- As Found: Unknown

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M5882

- Name: Chest Pain

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000000787

- Term: Angina Pectoris

### Misc Info Module

- Version Holder: 2024-05-24
