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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | April 22, 2002 | ||||
| Last Updated Date | August 17, 2006 | ||||
| Start Date ICMJE | April 2001 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00034112 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Efficacy of Osteopathic Manipulation in Chronic Obstructive Pulmonary Disease | ||||
| Official Title ICMJE | Efficacy of Osteopathic Manipulation in Chronic Obstructive Pulmonary Disease | ||||
| 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. |
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| 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. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Placebo Control | ||||
| Condition ICMJE | Emphysema | ||||
| Intervention ICMJE | Procedure: osteopathic manipulative treatment | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | |||||
| Completion Date | March 2002 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | |||||
| Gender | |||||
| Ages | |||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00034112 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | R21 AT000207-01A1 | ||||
| Study Sponsor ICMJE | National Center for Complementary and Alternative Medicine (NCCAM) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Center for Complementary and Alternative Medicine (NCCAM) | ||||
| Verification Date | July 2006 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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