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Effect of OMT on Asthma Symptoms in Southwest Virginia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00545376
Recruitment Status : Completed
First Posted : October 17, 2007
Last Update Posted : July 22, 2019
Sponsor:
Information provided by (Responsible Party):
Edward Via Virginia College of Osteopathic Medicine

Tracking Information
First Submitted Date  ICMJE October 16, 2007
First Posted Date  ICMJE October 17, 2007
Last Update Posted Date July 22, 2019
Study Start Date  ICMJE October 2007
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 16, 2007)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 16, 2007)
physician acceptance survey [ Time Frame: pre and post study ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of OMT on Asthma Symptoms in Southwest Virginia
Official Title  ICMJE The Use of Osteopathic Manipulation in a Clinic and Home Setting to Address Pulmonary Distress as Related to Asthma in Southwest Virginia
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Asthma
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Interventions:
    • Procedure: Osteopathic Manipulative Treatment - in clinic
    • Procedure: Osteopathic Manipulative Treatment - at home
  • 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.
    Intervention: Other: Education to physicians
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 11, 2008)
32
Original Estimated Enrollment  ICMJE
 (submitted: October 16, 2007)
50
Actual Study Completion Date  ICMJE February 2008
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 55 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00545376
Other Study ID Numbers  ICMJE F-12
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Edward Via Virginia College of Osteopathic Medicine
Study Sponsor  ICMJE Edward Via Virginia College of Osteopathic Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Macy L Latter VCOM
PRS Account Edward Via Virginia College of Osteopathic Medicine
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP