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

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ClinicalTrials.gov Identifier: NCT01582958
Recruitment Status : Completed
First Posted : April 23, 2012
Last Update Posted : October 8, 2015
Sponsor:
Information provided by (Responsible Party):
Sherman Gorbis, DO, FAAO, Michigan State University

Tracking Information
First Submitted Date  ICMJE April 14, 2012
First Posted Date  ICMJE April 23, 2012
Last Update Posted Date October 8, 2015
Study Start Date  ICMJE April 2013
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 20, 2012)
  • Change from baseline in spirometry at 6 weeks and 12 weeks [ Time Frame: baseline, 6 weeks, 12 weeks ]
    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 ]
    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 ]
    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 ]
    representing an indirect evaluation of chest wall excursion
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2012)
  • Change from baseline in exercise tolerance at 6 weeks and 12 weeks. [ Time Frame: baseline, 6 weeks, 12 weeks ]
    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 ]
    shortness of breath questionnaire
  • Change from baseline in quality of life at 6 weeks and 12 weeks. [ Time Frame: baseline, 6 weeks, 12 weeks ]
    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 ]
    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 ]
    antibody microarray analysis (particularly targeting the inflammatory/anti-inflammatory cytokines)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of OMT on Patients With COPD: Correlating Pulmonary Function Tests With Biochemical Alterations
Official Title  ICMJE The Effect of Osteopathic Manipulative Treatment on Patients With Chronic Obstructive Pulmonary Disease:Correlating Pulmonary Function Tests With Biochemical Alterations
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Chronic Obstructive Pulmonary Disease
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Experimental: Treatment
    This arm will receive the usual Pulmonary Rehabilitation Program plus OMT, the intervention.
    Intervention: Procedure: Osteopathic Manipulative Treatment (OMT)
  • Placebo Comparator: placebo
    Receives normal pulmonary rehabilitation care plus positioned to receive OMT but OMT is not provided.
    Intervention: Other: sham omt
  • No Intervention: Control
    This arm receives only pulmonary rehabilitation care.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 6, 2015)
45
Original Estimated Enrollment  ICMJE
 (submitted: April 20, 2012)
60
Actual Study Completion Date  ICMJE August 2015
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 49 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01582958
Other Study ID Numbers  ICMJE 122470
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sherman Gorbis, DO, FAAO, Michigan State University
Study Sponsor  ICMJE Michigan State University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sherman Gorbis, DO Michigan State University
PRS Account Michigan State University
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP