Efficacy of Osteopathic Manipulation in Chronic Obstructive Pulmonary Disease
Primary Purpose
Emphysema
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
osteopathic manipulative treatment
Sponsored by
About this trial
This is an interventional treatment trial for Emphysema focused on measuring chronic obstructive pulmonary disease, combination therapy,, emphysema, exercise, human therapy evaluation, rehabilitation, respiratory disease /disorder therapy, respiratory function, biomechanics, body movement, diaphragm, dyspnea, muscle tension, musculoskeletal system, outcomes research, quality of life, somatic reflex
Eligibility Criteria
Sites / Locations
- Kirksville College of Osteopathic Medicine
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00034112
First Posted
April 22, 2002
Last Updated
August 17, 2006
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
1. Study Identification
Unique Protocol Identification Number
NCT00034112
Brief Title
Efficacy of Osteopathic Manipulation in Chronic Obstructive Pulmonary Disease
Official Title
Efficacy of Osteopathic Manipulation in Chronic Obstructive Pulmonary Disease
Study Type
Interventional
2. Study Status
Record Verification Date
July 2006
Overall Recruitment Status
Completed
Study Start Date
April 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2002 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Center for Complementary and Integrative Health (NCCIH)
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine if osteopathic manipulative treatment (OMT) is effective for persons with emphysema as a component of their chronic obstructive pulmonary disease.
Detailed Description
OMT sessions are designed to improve chest wall compliance and diaphragmatic function which produce an immediate positive change in pulmonary function parameters and chest wall mobility. This research project will be a significant step in expanding the understanding of the role of OMT in the treatment of chronic lung disease. It is expected to yield evidence that OMT is an important adjunctive modality that improves pulmonary function, increases exercise tolerance, relieves dyspnea, and improves quality of life in those with COPD, and that would have widespread clinical application plus significant economic benefits.
Participants in this study will be randomly assigned to receive either OMT or sham treatments once a week for 13 weeks. Outcome measures will be obtained at baseline; immediately following the first treatment; at 4, 8, and 12 weeks after initiation of treatment; and 4 weeks after termination of the treatment. Outcome variables include pulmonary function tests; quality-of-life questionnaires (including emotional functioning, fatigue, and dyspnea); and measurements of exercise tolerance and chest wall mobility.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emphysema
Keywords
chronic obstructive pulmonary disease, combination therapy,, emphysema, exercise, human therapy evaluation, rehabilitation, respiratory disease /disorder therapy, respiratory function, biomechanics, body movement, diaphragm, dyspnea, muscle tension, musculoskeletal system, outcomes research, quality of life, somatic reflex
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
osteopathic manipulative treatment
10. Eligibility
Accepts Healthy Volunteers
No
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donald R. Noll
Organizational Affiliation
Kirksville College of Osteopathic Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kirksville College of Osteopathic Medicine
City
Kirksville
State/Province
Missouri
ZIP/Postal Code
63501
Country
United States
12. IPD Sharing Statement
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Efficacy of Osteopathic Manipulation in Chronic Obstructive Pulmonary Disease
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