Asthma and Osteopathic Manipulative Treatment

March 4, 2019 updated by: Des Moines University

The Immediate, Intermediate, and Long-Term Effects of Osteopathic Manipulative Treatment on Pulmonary Function in Adults With Asthma

The effect of Osteopathic Manipulative Treatment (OMT) has been studied in adult patients with chronic obstructive pulmonary disease (COPD) and children with asthma, however, to the authors' knowledge, no current studies have evaluated the non-immediate effects of OMT on pulmonary function in adults with chronic asthma using spirometry. The objective of the current study was to quantify the immediate, intermediate, and long-term effects of OMT on adult patients with a history of asthma. The quantitative effects were measured with a spirometry device and include the forced expiratory volume in one second (FEV1), the forced vital capacity (FVC), the FEV1/FVC ratio, and the peak expiratory flow (PEF). These four values are used clinically in the diagnosis and management of asthma. The long-term, subjective effects were measured via the Asthma Quality of Life Questionnaire with Standardized Activities (AQLQ(S)).

The study was conducted over a period of eight weeks. During week 0, participants completed the initial AQLQ and performed baseline spirometry testing. During weeks 1, 2, and 3 of the study, a standard OMT protocol was performed on each participant, followed by spirometry testing to measure the immediate effect. Spirometry testing was then performed again three days after each treatment to measure the intermediate effect of OMT. During week 7, participants completed the post-OMT AQLQ(S) and performed spirometry testing once more to measure the long-term effects of OMT. The OMT protocol performed on each patient included treatments to address somatic dysfunctions of the head, cervical spine, thoracic spine, ribs, and respiratory diaphragm. The authors hypothesized that OMT would improve pulmonary function, both subjectively and objectively. The authors predicted an increased overall mean AQLQ(S) score as well as an increased mean score within each domain, including symptoms, activity limitations, emotional function, and environmental stimuli. The authors also predicted a significant increase in the mean FEV1/FVC ratio, and PEF three days after each OMT session and a significant increase four weeks after the final OMT session, but no increase immediately after OMT.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Iowa
      • Des Moines, Iowa, United States, 50312
        • Des Moines University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants included members of the Des Moines University community.

Description

Inclusion Criteria:

  • 18 years of age or older
  • previously diagnosed with asthma

Exclusion Criteria:

  • Current smoker
  • Diagnosed with any other respiratory disease besides asthma
  • Receiving OMM from a licensed physician, chiropractic treatment, or massage therapy for 30 days prior to and during the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Participants
Participants were adults with a diagnosis of asthma, treated using a standardized Osteopathic Manipulative Treatment protocol.
Procedure: Osteopathic Manipulative Treatment
Osteopathic Manipulative Treatment (OMT) is a cost-effective, noninvasive treatment that is used to optimize the body's structure and function. By improving the biomechanical, autonomic, and circulatory mechanisms involved in the disease process of asthma, OMT can help maximize respiratory function. The specific OMT protocol used in this study included the following: supine OA joint myofascial release (MFR), supine cervical spine Still technique, supine thoracic inlet MFR, supine rib raising soft tissue, supine rib MFR, supine abdominal diaphragm MFR, seated thoracic spine Still technique, and seated posterior rib Still technique. Treatments were performed by Predoctoral Osteopathic Manipulative Medicine (OMM) Fellows at Des Moines University (DMU) and supervised and checked by one of two board-certified OMM/NMM physicians from the OMM Department at DMU. The treatment lasted an average of 21 minutes and repeated three times, spaced one week apart.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Forced expiratory volume in one second (FEV1) measured in liters by a spirometer
Time Frame: Measured during weeks 0 (at baseline), 1, 2, 3, and 7 of the study to assess the change over time. During weeks 1, 2, and 3, spirometry was performed immediately after the OMT protocol was completed as well as three days later.
Measured during weeks 0 (at baseline), 1, 2, 3, and 7 of the study to assess the change over time. During weeks 1, 2, and 3, spirometry was performed immediately after the OMT protocol was completed as well as three days later.
Asthma Quality of Life Questionnaire with Standardized Activities (AQLQ(S))
Time Frame: Participants completed the survey at baseline and four weeks after the last treatment to compare the change.
The AQLQ asks about a participant's past 2 weeks as they relate to their symptoms, activity limitations, emotional function, and environmental stimuli. Each item is a 7-point Likert scale, with 1 being severely impaired and 7 not impaired at all.
Participants completed the survey at baseline and four weeks after the last treatment to compare the change.
Forced vital capacity (FVC) measured in liters by a spirometer
Time Frame: Measured during weeks 0 (at baseline), 1, 2, 3, and 7 of the study to assess the change over time. During weeks 1, 2, and 3, spirometry was performed immediately after the OMT protocol was completed as well as three days later.
Measured during weeks 0 (at baseline), 1, 2, 3, and 7 of the study to assess the change over time. During weeks 1, 2, and 3, spirometry was performed immediately after the OMT protocol was completed as well as three days later.
Forced expiratory flow in one second to forced vital capacity ratio (FEV1/FVC ratio) by a spirometer
Time Frame: Measured during weeks 0 (at baseline), 1, 2, 3, and 7 of the study to assess the change over time. During weeks 1, 2, and 3, spirometry was performed immediately after the OMT protocol was completed as well as three days later.
Measured during weeks 0 (at baseline), 1, 2, 3, and 7 of the study to assess the change over time. During weeks 1, 2, and 3, spirometry was performed immediately after the OMT protocol was completed as well as three days later.
Peak expiratory flow (PEF) measured in liters per minute by a spirometer
Time Frame: Measured during weeks 0 (at baseline), 1, 2, 3, and 7 of the study to assess the change over time. During weeks 1, 2, and 3, spirometry was performed immediately after the OMT protocol was completed as well as three days later.
Measured during weeks 0 (at baseline), 1, 2, 3, and 7 of the study to assess the change over time. During weeks 1, 2, and 3, spirometry was performed immediately after the OMT protocol was completed as well as three days later.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Des Moines University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 5, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 10, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 10, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 20, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 6, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 6, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Asthma and OMT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The investigator's study is a pilot study. If members of the OMM department at DMU choose to continue researching the effects of OMT on asthma in the future, then the data collected in the present study would be shared with those department members.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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