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

Completed · Not applicable · Has a placebo group

Conditions studied: Chronic Obstructive Pulmonary Disease

In brief

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.

Key facts

Study ID

NCT01582958

Run by

Michigan State University

People needed

45

Starts

2013-04-01

Expected to finish

2015-08-01

Last updated by the study team

2015-10-08

Who can join

Age: 49 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• McClaren Greater Lansing — Lansing, Michigan, United States

Full record on ClinicalTrials.gov

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