- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00545376
Effect of OMT on Asthma Symptoms in Southwest Virginia
The Use of Osteopathic Manipulation in a Clinic and Home Setting to Address Pulmonary Distress as Related to Asthma in Southwest Virginia
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Virginia
-
Blacksburg, Virginia, United States, 24060
- VCOM
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: 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.
|
|
Experimental: 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.
|
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.
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.
|
Experimental: 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.
|
I will educate physicians using demonstration and reading material as to the possible benefits of incorporating it into the treatment of asthma.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mini-AQLQ
Time Frame: 2 weeks
|
2 weeks
|
patient symptoms
Time Frame: pre and post OMT and follow-up
|
pre and post OMT and follow-up
|
thoracic excursion
Time Frame: pre and post OMT and follow up
|
pre and post OMT and follow up
|
spirometry
Time Frame: pre and post OMT and follow up
|
pre and post OMT and follow up
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
physician acceptance survey
Time Frame: pre and post study
|
pre and post study
|
Collaborators and Investigators
Investigators
- Principal Investigator: Macy L Latter, VCOM
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- F-12
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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