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This project proposes to test the hypothesis that osteopathic manipulative treatment (OMT) given to patients with moderate to severe chronic obstructive pulmonary disease (COPD) enrolled in a 12-week pulmonary rehabilitation program (PRP) will result in improved respiratory pump function over and above that seen in sham and control groups. Specifically, we will study the effects of three OMT techniques: (a) thoracic inlet indirect myofascial release; (b) rib raising with continued stretch of the paraspinal muscle to the L2 level; and (c) cervical paraspinal muscle stretch with suboccipital muscle release. The key clinical readouts will include: spirometry, P100 (and index of diaphragm and inspiratory muscle efficiency), maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP), as well as laser evaluation of chest wall excursion. Supplementing these objective parameters will be several more subjective clinical outcome measures: exercise tolerance (6-minute walk test), dyspnea (shortness of breath questionnaire), and quality of life questionnaire. Finally, an attempt will be made to correlate biochemical alterations that may shed light on the biological mechanism underlying the OMT procedures.
According to the above directions (provide a more extensice description, if desired), I am choosing to just submit the brief summary.
Thank you, Sherman Gorbis, DO
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | This arm will receive the usual Pulmonary Rehabilitation Program plus OMT, the intervention. |
|
| placebo | Placebo Comparator | Receives normal pulmonary rehabilitation care plus positioned to receive OMT but OMT is not provided. |
|
| Control | No Intervention | This arm receives only pulmonary rehabilitation care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Osteopathic Manipulative Treatment (OMT) | Procedure | Osteopathic Manipulative Treatment (OMT) is the therapeutic application of manually guided forces by an Osteopathic physician to improve physiologic function. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in spirometry at 6 weeks and 12 weeks | amount (volume) and/or speed (flow) of air that can be inhaled and exhaled | baseline, 6 weeks, 12 weeks |
| Change from baseline in P100 at 6 weeks and 12 weeks | an index of diaphragm and inspiratory muscle efficiency (endurance) | baseline, 6 weeks, 12 weeks |
| Change from baseline in MIP (maximum inspiratory pressure) and MEP (maximum expiratory pressure)at 6 weeks and 12 weeks. | assessments of inspiratory and expiratory muscle function, respectively | baseline, 6 weeks, 12 weeks |
| Change from baseline in inspiratory capacity at 6 weeks and 12 weeks. | representing an indirect evaluation of chest wall excursion | baseline, 6 weeks, 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in exercise tolerance at 6 weeks and 12 weeks. | 6-minute walk test | baseline, 6 weeks, 12 weeks |
| Change from baseline in dyspnea (shortness of breath) at 6 weeks and 12 weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sherman Gorbis, DO | Michigan State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McClaren Greater Lansing | Lansing | Michigan | 48910 | United States |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D026301 | Manipulation, Osteopathic |
| ID | Term |
|---|---|
| D026201 | Musculoskeletal Manipulations |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
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|
| sham omt | Other | Hands are placed on subjects the same as omt arm but no omt is provided. |
|
|
shortness of breath questionnaire
| baseline, 6 weeks, 12 weeks |
| Change from baseline in quality of life at 6 weeks and 12 weeks. | Short Form 36 questionnaire | baseline, 6 weeks, 12 weeks |
| Change from baseline in profiling of the plasma metabolome at 6 weeks and 12 weeks. | mass spectrometry (both non-targeted profiling of entire suite of metabolites and targeted profiling of oxylipins and endocannabinoid metabolites | baseline, 6 weeks, 12 weeks |
| Change from baseline in profiling of plasma proteins at 6weeks and 12 weeks. | antibody microarray analysis (particularly targeting the inflammatory/anti-inflammatory cytokines) | baseline, 6 weeks, 12 weeks |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012046 | Rehabilitation |