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

NCT ID: NCT01582958

Last Updated: 2015-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2015-08-31

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

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Treatment

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

Group Type: EXPERIMENTAL

Osteopathic Manipulative Treatment (OMT)

Intervention Type: PROCEDURE

Osteopathic Manipulative Treatment (OMT) is the therapeutic application of manually guided forces by an Osteopathic physician to improve physiologic function.

placebo

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

Group Type: PLACEBO_COMPARATOR

sham omt

Intervention Type: OTHER

Hands are placed on subjects the same as omt arm but no omt is provided.

Control

This arm receives only pulmonary rehabilitation care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Osteopathic Manipulative Treatment (OMT)

Osteopathic Manipulative Treatment (OMT) is the therapeutic application of manually guided forces by an Osteopathic physician to improve physiologic function.

Intervention Type: PROCEDURE

sham omt

Hands are placed on subjects the same as omt arm but no omt is provided.

Intervention Type: OTHER

Other Intervention Names

Other names are not applicable.; Other names are not applicable.

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

• Minimum Eligible Age: 49 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Michigan State University

OTHER

Sponsor Role: lead

Responsible Party

Sherman Gorbis, DO, FAAO

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sherman Gorbis, DO

Role: PRINCIPAL_INVESTIGATOR

Michigan State University

Locations

McClaren Greater Lansing

Lansing, Michigan, United States

Countries

United States

Other Identifiers

122470

Identifier Type: -

Identifier Source: org_study_id