CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 25 enrolled
Drug / intervention
Osteopathic Manipulative Treatmentprocedure
Likely dose
Not stated in record
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Search/NCT03864354
NCT03864354N/ACompleted

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

Des Moines University·observational·Posted Mar 6, 2019·Updated Mar 6, 2019

In Brief

An observational study evaluating Osteopathic Manipulative Treatment for Asthma. Completed, enrolled 25 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedMar 6, 2019
Enrollment StartNov 5, 2018
Primary CompletionJan 10, 2019
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 7.3 years ago

Interventions

Osteopathic Manipulative Treatmentprocedure

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.