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NCT Number: NCT01582958

The Effect of OMT on Patients With COPD: 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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

49 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McClaren Greater Lansing

Lansing, Michigan, 48910, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Osteopathic manipulative treatment (OMT)

Procedure

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.

sham omt

Other

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

Other names: Other names are not applicable.

Primary outcomes

  1. 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

  2. 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)

  3. 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

  4. 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

Secondary outcomes

  1. Change from baseline in exercise tolerance at 6 weeks and 12 weeks.

    Time frame: baseline, 6 weeks, 12 weeks

    6-minute walk test

  2. 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

  3. Change from baseline in quality of life at 6 weeks and 12 weeks.

    Time frame: baseline, 6 weeks, 12 weeks

    Short Form 36 questionnaire

  4. 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

  5. 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)

Sponsors and collaborators

Lead sponsor

Michigan State University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Apr 23, 2012
Registry last updated
Oct 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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