Effect of OMT on Asthma Symptoms in Southwest Virginia

This study has been completed.
Sponsor:
Information provided by:
Edward Via Virginia College of Osteopathic Medicine
ClinicalTrials.gov Identifier:
NCT00545376
First received: October 16, 2007
Last updated: February 11, 2008
Last verified: September 2007
  Purpose

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.


Condition Intervention
Asthma
Procedure: Osteopathic Manipulative Treatment - in clinic
Procedure: Osteopathic Manipulative Treatment - at home
Other: Education to physicians

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Use of Osteopathic Manipulation in a Clinic and Home Setting to Address Pulmonary Distress as Related to Asthma in Southwest Virginia

Resource links provided by NLM:


Further study details as provided by Edward Via Virginia College of Osteopathic Medicine:

Primary Outcome Measures:
  • Mini-AQLQ [ Time Frame: 2 weeks ]
  • patient symptoms [ Time Frame: pre and post OMT and follow-up ]
  • thoracic excursion [ Time Frame: pre and post OMT and follow up ]
  • spirometry [ Time Frame: pre and post OMT and follow up ]

Secondary Outcome Measures:
  • physician acceptance survey [ Time Frame: pre and post study ]

Enrollment: 32
Study Start Date: October 2007
Study Completion Date: February 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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.
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.
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.
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.
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.

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

Ages Eligible for Study:   5 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00545376

Locations
United States, Virginia
VCOM
Blacksburg, Virginia, United States, 24060
Sponsors and Collaborators
Edward Via Virginia College of Osteopathic Medicine
Investigators
Principal Investigator: Macy L Latter VCOM
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00545376     History of Changes
Other Study ID Numbers: F-12
Study First Received: October 16, 2007
Last Updated: February 11, 2008
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on August 28, 2014