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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Michigan State University.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Sherman Gorbis, DO, FAAO, Michigan State University
ClinicalTrials.gov Identifier:
NCT01582958
First received: April 14, 2012
Last updated: April 20, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention
Chronic Obstructive Pulmonary Disease
Procedure: Osteopathic Manipulative Treatment (OMT)
Other: sham omt

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: The Effect of Osteopathic Manipulative Treatment on Patients With Chronic Obstructive Pulmonary Disease:Correlating Pulmonary Function Tests With Biochemical Alterations

Resource links provided by NLM:


Further study details as provided by Michigan State University:

Primary Outcome Measures:
  • Change from baseline in spirometry at 6 weeks and 12 weeks [ Time Frame: baseline, 6 weeks, 12 weeks ] [ Designated as safety issue: No ]
    amount (volume) and/or speed (flow) of air that can be inhaled and exhaled

  • Change from baseline in P100 at 6 weeks and 12 weeks [ Time Frame: baseline, 6 weeks, 12 weeks ] [ Designated as safety issue: No ]
    an index of diaphragm and inspiratory muscle efficiency (endurance)

  • Change from baseline in MIP (maximum inspiratory pressure) and MEP (maximum expiratory pressure)at 6 weeks and 12 weeks. [ Time Frame: baseline, 6 weeks, 12 weeks ] [ Designated as safety issue: No ]
    assessments of inspiratory and expiratory muscle function, respectively

  • Change from baseline in inspiratory capacity at 6 weeks and 12 weeks. [ Time Frame: baseline, 6 weeks, 12 weeks ] [ Designated as safety issue: No ]
    representing an indirect evaluation of chest wall excursion


Secondary Outcome Measures:
  • Change from baseline in exercise tolerance at 6 weeks and 12 weeks. [ Time Frame: baseline, 6 weeks, 12 weeks ] [ Designated as safety issue: No ]
    6-minute walk test

  • Change from baseline in dyspnea (shortness of breath) at 6 weeks and 12 weeks. [ Time Frame: baseline, 6 weeks, 12 weeks ] [ Designated as safety issue: No ]
    shortness of breath questionnaire

  • Change from baseline in quality of life at 6 weeks and 12 weeks. [ Time Frame: baseline, 6 weeks, 12 weeks ] [ Designated as safety issue: No ]
    Short Form 36 questionnaire

  • Change from baseline in profiling of the plasma metabolome at 6 weeks and 12 weeks. [ Time Frame: baseline, 6 weeks, 12 weeks ] [ Designated as safety issue: No ]
    mass spectrometry (both non-targeted profiling of entire suite of metabolites and targeted profiling of oxylipins and endocannabinoid metabolites

  • Change from baseline in profiling of plasma proteins at 6weeks and 12 weeks. [ Time Frame: baseline, 6 weeks, 12 weeks ] [ Designated as safety issue: No ]
    antibody microarray analysis (particularly targeting the inflammatory/anti-inflammatory cytokines)


Estimated Enrollment: 60
Study Start Date: September 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Other names are not applicable.
No Intervention: Control
This arm receives only pulmonary rehabilitation care.

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

  Eligibility

Ages Eligible for Study:   49 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01582958

Contacts
Contact: John Morlock, DO (517) 975-8617 tadams197598@yahoo.com
Contact: Sherman Gorbis, DO (517) 353-9110 gorbis@msu.edu

Locations
United States, Michigan
McClaren-Greater Lansing Not yet recruiting
Lansing, Michigan, United States, 48910
Contact: John Morlock, DO    517-975-8617    tadams197598@yahoo.com   
Contact: Tammy Adams    (517)    tadams197598@yahoo.com   
Principal Investigator: Sherman Gorbis, DO         
Sub-Investigator: John Morlock, DO         
Sponsors and Collaborators
Michigan State University
Investigators
Principal Investigator: Sherman Gorbis, DO Michigan State University
  More Information

No publications provided

Responsible Party: Sherman Gorbis, DO, FAAO, Principal Investigator, Michigan State University
ClinicalTrials.gov Identifier: NCT01582958     History of Changes
Other Study ID Numbers: 122470
Study First Received: April 14, 2012
Last Updated: April 20, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Michigan State University:
Osteopathic Manipulative Treatment
Pulmonary Function Tests
Biochemical Alterations

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 23, 2014