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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Procedure: Osteopathic Manipulative Treatment (OMT); Other: sham omt

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

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Lansing, Michigan, United States, 48910
      • McClaren Greater Lansing

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 49 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Treatment; This arm will receive the usual Pulmonary Rehabilitation Program plus OMT, the 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 Names: Other names are not applicable.
PLACEBO_COMPARATOR: placebo; Receives normal pulmonary rehabilitation care plus positioned to receive OMT but OMT is not provided.	Other: sham omt; Hands are placed on subjects the same as omt arm but no omt is provided.; Other Names: Other names are not applicable.
NO_INTERVENTION: Control; 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

Collaborators and Investigators

• Sponsor: Michigan State University
• Investigators: Principal Investigator: Sherman Gorbis, DO, Michigan State University

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (ACTUAL): August 1, 2015
• Study Completion (ACTUAL): August 1, 2015

Study Registration Dates

• First Submitted: April 14, 2012
• First Submitted That Met QC Criteria: April 20, 2012
• First Posted (ESTIMATE): April 23, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): October 8, 2015
• Last Update Submitted That Met QC Criteria: October 6, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: Osteopathic Manipulative Treatment; Pulmonary Function Tests; Biochemical Alterations
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 122470