Asthma and Osteopathic Manipulative Treatment

Completed

• Conditions: Asthma
• Interventions: Procedure: Osteopathic Manipulative Treatment

• Registration Number: NCT03864354
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-05
• Primary Completion: 2019-01-10
• Study Completion: 2019-01-10
• Study First Submitted: 2019-02-20
• Status Verified: 2019-03
• Study First Submitted QC: 2019-03-04
• Last Update Submitted: 2019-03-04
• Study First Posted: 2019-03-06
• Last Update Posted: 2019-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants	Osteopathic Manipulative Treatment	Participants were adults with a diagnosis of asthma, treated using a standardized Osteopathic Manipulative Treatment protocol.

Primary Outcome Measures

Name	Time	Method
Asthma Quality of Life Questionnaire with Standardized Activities (AQLQ(S))	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.
Forced expiratory flow in one second to forced vital capacity ratio (FEV1/FVC ratio) by a spirometer	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 vital capacity (FVC) measured in liters by a spirometer	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	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 volume in one second (FEV1) measured in liters by a spirometer	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.

Trial Locations

Locations (1)

Des Moines University; 🇺🇸 Des Moines, Iowa, United States