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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
45
Osteopathic Manipulative Treatment (OMT) is the therapeutic application of manually guided forces by an Osteopathic physician to improve physiologic function.
Hands are placed on subjects the same as omt arm but no omt is provided.
McClaren Greater Lansing
Lansing, Michigan, United States
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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: baseline, 6 weeks, 12 weeks
Change from baseline in exercise tolerance at 6 weeks and 12 weeks.
6-minute walk test
Time frame: baseline, 6 weeks, 12 weeks
Change from baseline in dyspnea (shortness of breath) at 6 weeks and 12 weeks.
shortness of breath questionnaire
Time frame: baseline, 6 weeks, 12 weeks
Change from baseline in quality of life at 6 weeks and 12 weeks.
Short Form 36 questionnaire
Time frame: 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
Time frame: 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)
Time frame: baseline, 6 weeks, 12 weeks
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