Chronic Obstructive Pulmonary DiseaseNCT01582958
The Effect of OMT on Patients With COPD: Correlating Pulmonary Function Tests With Biochemical Alterations
A study testing Osteopathic Manipulative Treatment (OMT) in people with Chronic Obstructive Pulmonary Disease, run by Michigan State University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 49 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Osteopathic Manipulative Treatment (OMT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 49 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- neuromuscular or disabling cognitive problems
- engagement in any exercise-training program during the past three months
- substance abuse in the preceding six months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Osteopathic Manipulative Treatment (OMT), sham omt
- Keywords
- Osteopathic Manipulative Treatment, Pulmonary Function Tests, Biochemical Alterations
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic Manipulative Treatment (OMT)Procedure or surgery
Also called Other names are not applicable.
Osteopathic Manipulative Treatment (OMT) is the therapeutic application of manually guided forces by an Osteopathic physician to improve physiologic function.
sham omtOther
Also called Other names are not applicable.
Hands are placed on subjects the same as omt arm but no omt is provided.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | This arm will receive the usual Pulmonary Rehabilitation Program plus OMT, the intervention. Receives: Procedure: Osteopathic Manipulative Treatment (OMT) |
| placebo | Placebo comparator | Receives normal pulmonary rehabilitation care plus positioned to receive OMT but OMT is not provided. Receives: Other: sham omt |
| Control | No intervention | This arm receives only pulmonary rehabilitation care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 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
Measured: 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
Measured: baseline, 6 weeks, 12 weeks
Secondary outcomes (5)
Change from baseline in exercise tolerance at 6 weeks and 12 weeks.
6-minute walk test
Measured: baseline, 6 weeks, 12 weeks
Change from baseline in dyspnea (shortness of breath) at 6 weeks and 12 weeks.
shortness of breath questionnaire
Measured: baseline, 6 weeks, 12 weeks
Change from baseline in quality of life at 6 weeks and 12 weeks.
Short Form 36 questionnaire
Measured: 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
Measured: 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)
Measured: baseline, 6 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2012 (estimated)
- Study startApr 2013
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michigan State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherman Gorbis, DO, FAAO, Michigan State University
- Investigators
- Sherman Gorbis, DO, Principal investigator, Michigan State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01582958
- Sponsor's protocol ID
- 122470
- Status last verified
- Oct 2015
- First submitted
- 14 Apr 2012
- Last updated
- 8 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Osteopathic Manipulative Treatment on Patients With Chronic Obstructive Pulmonary Disease:Correlating Pulmonary Function Tests With Biochemical Alterations
- ClinicalTrials.gov ID
- NCT01582958
- Acronym / sponsor ID
- 122470
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Osteopathic Manipulative Treatment, Pulmonary Function Tests, Biochemical Alterations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Michigan State UniversityUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 23 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Procedure: Osteopathic Manipulative Treatment (OMT)This arm will receive the usual Pulmonary Rehabilitation Program plus OMT, the intervention. |
| placebo | Placebo comparator | Other: sham omtReceives normal pulmonary rehabilitation care plus positioned to receive OMT but OMT is not provided. |
| Control | No intervention | –This arm receives only pulmonary rehabilitation care. |
Who may qualify
- Ages
- 49 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osteopathic Manipulative Treatment (OMT)Also: Other names are not applicable.Osteopathic Manipulative Treatment (OMT) is the therapeutic application of manually guided forces by an Osteopathic physician to improve physiologic function. | Procedure or surgery | Treatment |
| sham omtAlso: Other names are not applicable.Hands are placed on subjects the same as omt arm but no omt is provided. | Other | placebo |
Primary outcome
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
5 secondary outcomes
Change from baseline in exercise tolerance at 6 weeks and 12 weeks.
Time frame: baseline, 6 weeks, 12 weeks
Change from baseline in dyspnea (shortness of breath) at 6 weeks and 12 weeks.
Time frame: baseline, 6 weeks, 12 weeks
Change from baseline in quality of life at 6 weeks and 12 weeks.
Time frame: baseline, 6 weeks, 12 weeks
Change from baseline in profiling of the plasma metabolome at 6 weeks and 12 weeks.
Time frame: baseline, 6 weeks, 12 weeks
Change from baseline in profiling of plasma proteins at 6weeks and 12 weeks.
Time frame: baseline, 6 weeks, 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sherman Gorbis, DO principal investigator
Michigan State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteopathic Manipulative Treatment (OMT) in people with Chronic Obstructive Pulmonary Disease, run by Michigan State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in spirometry at 6 weeks and 12 weeks (time frame: baseline, 6 weeks, 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2015.