EmphysemaPhase 2NCT00034112
Efficacy of Osteopathic Manipulation in Chronic Obstructive Pulmonary Disease
A Phase 2 study testing osteopathic manipulative treatment in people with Emphysema, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
Trial summary
The purpose of this study is to determine if osteopathic manipulative treatment (OMT) is effective for persons with emphysema as a component of their chronic obstructive pulmonary disease. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Emphysema
- What is being tested?
- osteopathic manipulative treatment
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Apr 2001to Mar 2002
- Phase
- Phase 2
- 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 Any age
- No healthy volunteers
- Child, Adult, Older adult
Trial locations and contacts
1 site in 1 country.
United States1 site
Kirksville College of Osteopathic Medicine
Kirksville, Missouri, 63501
About this study
The purpose of this study is to determine if osteopathic manipulative treatment (OMT) is effective for persons with emphysema as a component of their chronic obstructive pulmonary disease.
Read the detailed description
OMT sessions are designed to improve chest wall compliance and diaphragmatic function which produce an immediate positive change in pulmonary function parameters and chest wall mobility. This research project will be a significant step in expanding the understanding of the role of OMT in the treatment of chronic lung disease. It is expected to yield evidence that OMT is an important adjunctive modality that improves pulmonary function, increases exercise tolerance, relieves dyspnea, and improves quality of life in those with COPD, and that would have widespread clinical application plus significant economic benefits.
Participants in this study will be randomly assigned to receive either OMT or sham treatments once a week for 13 weeks. Outcome measures will be obtained at baseline; immediately following the first treatment; at 4, 8, and 12 weeks after initiation of treatment; and 4 weeks after termination of the treatment. Outcome variables include pulmonary function tests; quality-of-life questionnaires (including emotional functioning, fatigue, and dyspnea); and measurements of exercise tolerance and chest wall mobility.
- Conditions
- Emphysema
- Being tested
- osteopathic manipulative treatment
- Keywords
- chronic obstructive pulmonary disease, combination therapy,, emphysema, exercise, human therapy evaluation, rehabilitation, respiratory disease /disorder therapy, respiratory function, biomechanics, body movement, diaphragm, dyspnea, muscle tension, musculoskeletal system, outcomes research, quality of life, somatic reflex
- Medical subject headings
- Emphysema, Pulmonary Disease, Chronic Obstructive, Motor Activity, Respiratory Aspiration, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
osteopathic manipulative treatmentProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2002 (estimated)
- Study startApr 2001
- Study completionMar 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmphysemaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
Sponsor and investigators
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Sponsor type
- US National Institutes of Health
- Investigators
- Donald R. Noll, Principal investigator, Kirksville College of Osteopathic Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00034112
- Sponsor's protocol ID
- R21AT000207-01A1
- Status last verified
- Jul 2006
- First submitted
- 22 Apr 2002
- Last updated
- 18 Aug 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Osteopathic Manipulation in Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT00034112
- Acronym / sponsor ID
- R21AT000207-01A1
- Conditions
- Emphysema
- Keywords
- chronic obstructive pulmonary disease, combination therapy,, emphysema, exercise, human therapy evaluation, rehabilitation, respiratory disease /disorder therapy, respiratory function
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- Study start
- Apr 2001
- Study completion
- Mar 2002
- First posted
- 23 Apr 2002 (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.
The purpose of this study is to determine if osteopathic manipulative treatment (OMT) is effective for persons with emphysema as a component of their chronic obstructive pulmonary disease.
Detailed description
OMT sessions are designed to improve chest wall compliance and diaphragmatic function which produce an immediate positive change in pulmonary function parameters and chest wall mobility. This research project will be a significant step in expanding the understanding of the role of OMT in the treatment of chronic lung disease. It is expected to yield evidence that OMT is an important adjunctive modality that improves pulmonary function, increases exercise tolerance, relieves dyspnea, and improves quality of life in those with COPD, and that would have widespread clinical application plus significant economic benefits.
Participants in this study will be randomly assigned to receive either OMT or sham treatments once a week for 13 weeks. Outcome measures will be obtained at baseline; immediately following the first treatment; at 4, 8, and 12 weeks after initiation of treatment; and 4 weeks after termination of the treatment. Outcome variables include pulmonary function tests; quality-of-life questionnaires (including emotional functioning, fatigue, and dyspnea); and measurements of exercise tolerance and chest wall mobility.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 18 Aug 2006.
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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.
Donald R. Noll principal investigator
Kirksville College of Osteopathic Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing osteopathic manipulative treatment in people with Emphysema, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2006. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
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 18 Aug 2006.