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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01582958
• Other study ID #: 122470
• Status: Completed
• Phase: N/A
• First received: April 14, 2012
• Last updated: October 6, 2015
• Start date: April 2013
• Est. completion date: August 2015

Study information

• Verified date: October 2015
• Source: Michigan State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 49 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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

Other:
• sham omt
Hands are placed on subjects the same as omt arm but no omt is provided.

Locations

Country	Name	City	State
United States	McClaren Greater Lansing	Lansing	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Michigan State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	Change from baseline in exercise tolerance at 6 weeks and 12 weeks.	6-minute walk test	baseline, 6 weeks, 12 weeks	No
Secondary	Change from baseline in dyspnea (shortness of breath) at 6 weeks and 12 weeks.	shortness of breath questionnaire	baseline, 6 weeks, 12 weeks	No
Secondary	Change from baseline in quality of life at 6 weeks and 12 weeks.	Short Form 36 questionnaire	baseline, 6 weeks, 12 weeks	No
Secondary	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	No
Secondary	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	No