The Effect of OMT on Patients With COPD: Correlating Pulmonary Function Tests With Biochemical Alterations

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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

Official Title
-----------------
The Effect of Osteopathic Manipulative Treatment on Patients With Chronic Obstructive Pulmonary Disease:Correlating Pulmonary Function Tests With Biochemical Alterations

Conditions
-----------------
Chronic Obstructive Pulmonary Disease

Intervention / Treatment
-----------------
* Procedure: Osteopathic Manipulative Treatment (OMT)
* Other: sham omt


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: postbronchodilator FEV1/FVC <0.7 and FEV1 <80% predicted [FEV1 =volume that has been exhaled at the end of the first second of forced expiration] and FVC volume of air that can be forcibly blown out after full inspiration] history of smoking >20 pack-years stable condition at inclusion with no infection or exacerbation for at least two months optimal medical therapy for at least eight weeks with no change Exclusion Criteria: history of active pulmonary disease such as asthma positive bronchodilator test treatment with N-acetylcysteine previous diagnosis of hypertension or current anti-hypertensive treatment known unstable or moderate to severe heart disease (arrhythmia, ischemic heart disease, or cardiomyopathy) previous diagnosis of chronic illness such as diabetes, renal failure, hypercholesterolemia, hepatic cirrhosis, cancer, rheumatoid arthritis or any other systemic inflammatory disease neuromuscular or disabling cognitive problems engagement in any exercise-training program during the past three months substance abuse in the preceding six months

Ages Eligible for Study
-----------------
Minimum Age: 49 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>This arm will receive the usual Pulmonary Rehabilitation Program plus OMT, the intervention. | Procedure: Osteopathic Manipulative Treatment (OMT)<br>* Osteopathic Manipulative Treatment (OMT) is the therapeutic application of manually guided forces by an Osteopathic physician to improve physiologic function.<br>* Other names: Other names are not applicable.;|
| Placebo Comparator: placebo<br>Receives normal pulmonary rehabilitation care plus positioned to receive OMT but OMT is not provided. | Other: sham omt<br>* Hands are placed on subjects the same as omt arm but no omt is provided.<br>* Other names: Other names are not applicable.;|
| No Intervention: Control<br>This arm receives only pulmonary rehabilitation care. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteopathic Manipulative Treatment, Pulmonary Function Tests, Biochemical Alterations