Clinical trial NCT00545376: Effect of OMT on Asthma Symptoms in Southwest Virginia
Official title: The Use of Osteopathic Manipulation in a Clinic and Home Setting to Address Pulmonary Distress as Related to Asthma in Southwest Virginia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Lead sponsor: Edward Via Virginia College of Osteopathic Medicine
Sponsor class: OTHER
First posted: 2007-10-17
Enrollment: 32
Sex: ALL
Minimum age (years): 5
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Mini-AQLQ
timeFrame: 2 weeks
measure: patient symptoms
timeFrame: pre and post OMT and follow-up
measure: thoracic excursion
timeFrame: pre and post OMT and follow up
measure: spirometry
timeFrame: pre and post OMT and follow up
Secondary outcomes:
measure: physician acceptance survey
timeFrame: pre and post study
Other outcomes:
Locations:
city: Blacksburg
country: United States
facility: VCOM
state: Virginia
Study officials:
affiliation: VCOM
name: Macy L Latter
role: PRINCIPAL_INVESTIGATOR
References: