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

Michigan State University

Status: Completed

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Other: sham omt; Procedure: Osteopathic Manipulative Treatment (OMT)

Study type: Interventional

Funder types: Other

Identifiers

NCT01582958

122470

Details and patient eligibility

About

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.

Full 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

Enrollment: 45 patients

Sex: All

Ages: 49 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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45 participants in 3 patient groups, including a placebo group

Treatment

Experimental group

Description:

This arm will receive the usual Pulmonary Rehabilitation Program plus OMT, the intervention.

Treatment:

Procedure: Osteopathic Manipulative Treatment (OMT)

placebo

Placebo Comparator group

Description:

Receives normal pulmonary rehabilitation care plus positioned to receive OMT but OMT is not provided.

Treatment:

Other: sham omt

Control

No Intervention group

Description:

This arm receives only pulmonary rehabilitation care.