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

NCT01582958 | Completed

• 1 other identifier: 122470
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Osteopathic Manipulative Treatment; Pulmonary Function Tests; Biochemical Alterations

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

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

  baseline, 6 weeks, 12 weeks

• Change from baseline in dyspnea (shortness of breath) at 6 weeks and 12 weeks.

  baseline, 6 weeks, 12 weeks

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

  baseline, 6 weeks, 12 weeks

• Change from baseline in profiling of the plasma metabolome at 6 weeks and 12 weeks.

  baseline, 6 weeks, 12 weeks

• Change from baseline in profiling of plasma proteins at 6weeks and 12 weeks.

  baseline, 6 weeks, 12 weeks

Study Arms (3)

Treatment

EXPERIMENTAL

This arm will receive the usual Pulmonary Rehabilitation Program plus OMT, the intervention.

Procedure: Osteopathic Manipulative Treatment (OMT)

placebo

PLACEBO COMPARATOR

Receives normal pulmonary rehabilitation care plus positioned to receive OMT but OMT is not provided.

Other: sham omt

Control

NO INTERVENTION

This arm receives only pulmonary rehabilitation care.

Interventions

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.

Also known as: Other names are not applicable.

Treatment

sham omt OTHER

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

Also known as: Other names are not applicable.

placebo

Eligibility Criteria

• Age: 49 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• optimal medical therapy for at least eight weeks with no change

You may not qualify if:

• 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

Sponsors & Collaborators

• Michigan State University: lead

Study Sites (1)

McClaren Greater Lansing

Lansing, Michigan, 48910, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Manipulation, Osteopathic

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Sherman Gorbis, DO

  Michigan State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 14, 2012
• First Posted: April 23, 2012
• Study Start: April 1, 2013
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: October 8, 2015

Record last verified: 2015-10

Locations

US (1)