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Trial record 2 of 3 for:    8283197 [PUBMED-IDS]

Asthma and Osteopathic Manipulative Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03864354
Recruitment Status : Completed
First Posted : March 6, 2019
Last Update Posted : March 6, 2019
Sponsor:
Information provided by (Responsible Party):
Des Moines University

Brief Summary:

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.


Condition or disease Intervention/treatment
Asthma Procedure: Osteopathic Manipulative Treatment

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Study Type : Observational [Patient Registry]
Actual Enrollment : 25 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 8 Weeks
Official Title: The Immediate, Intermediate, and Long-Term Effects of Osteopathic Manipulative Treatment on Pulmonary Function in Adults With Asthma
Actual Study Start Date : November 5, 2018
Actual Primary Completion Date : January 10, 2019
Actual Study Completion Date : January 10, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Group/Cohort Intervention/treatment
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.




Primary Outcome Measures :
  1. 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. ]
  2. 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.

  3. 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. ]
  4. 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. ]
  5. 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. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants included members of the Des Moines University community.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03864354


Locations
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United States, Iowa
Des Moines University
Des Moines, Iowa, United States, 50312
Sponsors and Collaborators
Des Moines University
  Study Documents (Full-Text)

Documents provided by Des Moines University:

Additional Information:
Publications:

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Responsible Party: Des Moines University
ClinicalTrials.gov Identifier: NCT03864354     History of Changes
Other Study ID Numbers: Asthma and OMT
First Posted: March 6, 2019    Key Record Dates
Last Update Posted: March 6, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Des Moines University:
osteopathic manipulative medicine
Spirometry
Respiratory
OMM
OMT
osteopathic manual medicine
osteopathic manipulative treatment
osteopathic manual treatment
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases