Effect of OMT on Asthma Symptoms in Southwest Virginia

NCT00545376 | Completed DMC

• 1 other identifier: F-12
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

There is a high prevalence of asthma in southwest Virginia and there are multiple osteopathic manipulative techniques (OMT) which are thought to improve lung function. However, there are inadequate studies regarding the effectiveness of using osteopathic manipulative treatment (OMT) as an office treatment or a home treatment to address obstructive lung disease. In addition, there is little information on the level of acceptance, use, and cost effectiveness of using OMT in rural southwest Virginia. The purpose of this study is to determine the viability of OMT treatment with asthma, the level of acceptance in selected clinics in southwest Virginia, and the effectiveness of home OMT education in order to implement a program to improve asthma control. The study hypotheses are: 1. Osteopathic manipulation delivered to the asthmatic patient will significantly improve spirometry values, thoracic excursion, and subjective asthma symptoms. (.05 alpha) 2.Patients who are taught and use a home treatment regime for asthma will significantly improve spirometry values, thoracic excursion, and subjective asthma symptoms after two weeks, compare with those who do not have home treatment. 3.Physicians educated on the use of OMT for asthma will increase their perceived future use of OMT as an adjunct to treat this disorder.

Conditions

Asthma

Outcome Measures

Primary Outcomes (4)

• Mini-AQLQ

  2 weeks

• patient symptoms

  pre and post OMT and follow-up

• thoracic excursion

  pre and post OMT and follow up

• spirometry

  pre and post OMT and follow up

Secondary Outcomes (1)

• physician acceptance survey

  pre and post study

Study Arms (3)

1

NO INTERVENTION

This group will leave after the first visit without additional instruction and will be asked to return in two weeks for a follow up lung assessment.

2

EXPERIMENTAL

This group, at the first visit, will be taught three home OMT techniques that a family member or friend can administer to them. They will be asked to do these techniques at least 4 times a week, up to every day, for two weeks before returning for a follow up lung assessment.

Procedure: Osteopathic Manipulative Treatment - in clinic; Procedure: Osteopathic Manipulative Treatment - at home

3

EXPERIMENTAL

This arm is the physicians that I will recruit participants through. They will be exposed to education about the use of OMT for asthma.

Other: Education to physicians

Interventions

Osteopathic Manipulative Treatment - in clinic PROCEDURE

I will do a thoracic/rib screening and treatment with muscle energy or facilitated positional release, a diaphragm soft tissue release, suboccipital release, and a thoracic compression. This treatment takes 10 minutes and is only done at the first visit.

2

Osteopathic Manipulative Treatment - at home PROCEDURE

One group will learn how to do three home OMT techniques: suboccipital release, pectoral traction, and rib raising. They will be asked to do this at least 4 times a week for two weeks.

2

Education to physicians OTHER

I will educate physicians using demonstration and reading material as to the possible benefits of incorporating it into the treatment of asthma.

3

Eligibility Criteria

• Age: 5 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age 5-55
• mild intermittent, mild persistent, or moderate persistent asthma

You may not qualify if:

• severe persistent asthma
• congestive heart failure
• active pulmonary infection
• oral steroid burst in past month
• hospitalization for pulmonary causes in past three months
• OMT treatment directed towards thoracic and ribs in past three months

Sponsors & Collaborators

• Edward Via Virginia College of Osteopathic Medicine: lead

Study Sites (1)

VCOM

Blacksburg, Virginia, 24060, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

Manipulation, Osteopathic; Ambulatory Care Facilities

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Health Facilities; Health Care Facilities Workforce and Services

Study Officials

• Macy L Latter

  VCOM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2007
• First Posted: October 17, 2007
• Study Start: October 1, 2007
• Primary Completion: January 1, 2008
• Study Completion: February 1, 2008
• Last Updated: July 22, 2019

Record last verified: 2019-07

Locations

US (1)