Effect of OMT on Asthma Symptoms in Southwest Virginia

NCT ID: NCT00545376

Last Updated: 2019-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2008-02-29

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.

Detailed 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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

2

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.

Group Type: EXPERIMENTAL

Osteopathic Manipulative Treatment - in clinic

Intervention Type: 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.

Osteopathic Manipulative Treatment - at home

Intervention Type: 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.

3

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

Group Type: EXPERIMENTAL

Education to physicians

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Edward Via Virginia College of Osteopathic Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Macy L Latter

Role: PRINCIPAL_INVESTIGATOR

VCOM

Locations

VCOM

Blacksburg, Virginia, United States

Countries

United States

Other Identifiers

F-12

Identifier Type: -

Identifier Source: org_study_id