Effect of OMT on Asthma Symptoms in Southwest Virginia

Asthma Clinical Trial

Official title:

The Use of Osteopathic Manipulation in a Clinic and Home Setting to Address Pulmonary Distress as Related to Asthma in Southwest Virginia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00545376
• Other study ID #: F-12
• Status: Completed
• Phase: N/A
• Start date: October 2007
• Est. completion date: February 2008

Study information

• Verified date: July 2019
• Source: Edward Via Virginia College of Osteopathic Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

In this study, participants will be recruited from several family practice, pulmonologist, and asthma specialist offices in southwest Virginia. These participants will undergo two visits. At the first visit, a lung assessment comprised of three components will be performed, then a 10 minute OMT session, then the lung assessment will be repeated. The lung assessment includes a patient symptom survey, a thoracic excursion measurement, and spirometry. The participants will then be divided into one of two groups. Group 1 will have no further instruction while group 2 will be taught some simple home OMT techniques and asked to do them at home. Both groups will return two weeks later for a follow up lung assessment. Results when then be studied to determine the effect of OMT on lung function in asthmatics as well as the effect of incorporating home OMT. In addition, physicians will be involved in learning about OMT and these techniques and they will be assessed for a change in attitude, awareness, and willingness to incorporate OMT when applicable.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: February 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 55 Years

Eligibility

Inclusion Criteria:

• Age 5-55

• mild intermittent, mild persistent, or moderate persistent asthma

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Asthma

Intervention

Procedure:
• Osteopathic Manipulative Treatment - in clinic
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.
• Osteopathic Manipulative Treatment - at home
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.

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

Locations

Country	Name	City	State
United States	VCOM	Blacksburg	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Edward Via Virginia College of Osteopathic Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mini-AQLQ		2 weeks
Primary	patient symptoms		pre and post OMT and follow-up
Primary	thoracic excursion		pre and post OMT and follow up
Primary	spirometry		pre and post OMT and follow up
Secondary	physician acceptance survey		pre and post study