Clinical trial NCT03864354: Asthma and Osteopathic Manipulative Treatment
Official title: The Immediate, Intermediate, and Long-Term Effects of Osteopathic Manipulative Treatment on Pulmonary Function in Adults With Asthma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: osteopathic manipulative medicine
Spirometry
Respiratory
OMM
OMT
osteopathic manual medicine
osteopathic manipulative treatment
osteopathic manual treatment
Lead sponsor: Des Moines University
Sponsor class: OTHER
First posted: 2019-03-06
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants included members of the Des Moines University community.

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.


Eligibility 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

Primary outcomes:
measure: Forced expiratory volume in one second (FEV1) measured in liters by a spirometer
timeFrame: 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.
measure: Asthma Quality of Life Questionnaire with Standardized Activities (AQLQ(S))
timeFrame: Participants completed the survey at baseline and four weeks after the last treatment to compare the change.
measure: Forced vital capacity (FVC) measured in liters by a spirometer
timeFrame: 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.
measure: Forced expiratory flow in one second to forced vital capacity ratio (FEV1/FVC ratio) by a spirometer
timeFrame: 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.
measure: Peak expiratory flow (PEF) measured in liters per minute by a spirometer
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Des Moines
country: United States
facility: Des Moines University
state: Iowa
Study officials:
References:
citation: Bockenhauer SE, Julliard KN, Lo KS, Huang E, Sheth AM. Quantifiable effects of osteopathic manipulative techniques on patients with chronic asthma. J Am Osteopath Assoc. 2002 Jul;102(7):371-5; discussion 375.
citation: McCracken JL, Veeranki SP, Ameredes BT, Calhoun WJ. Diagnosis and Management of Asthma in Adults: A Review. JAMA. 2017 Jul 18;318(3):279-290. doi: 10.1001/jama.2017.8372.
citation: Thiadens HA, De Bock GH, Van Houwelingen JC, Dekker FW, De Waal MW, Springer MP, Postma DS. Can peak expiratory flow measurements reliably identify the presence of airway obstruction and bronchodilator response as assessed by FEV(1) in primary care patients presenting with a persistent cough? Thorax. 1999 Dec;54(12):1055-60. doi: 10.1136/thx.54.12.1055.
citation: Guiney PA, Chou R, Vianna A, Lovenheim J. Effects of osteopathic manipulative treatment on pediatric patients with asthma: a randomized controlled trial. J Am Osteopath Assoc. 2005 Jan;105(1):7-12.
citation: Noll DR, Degenhardt BF, Johnson JC, Burt SA. Immediate effects of osteopathic manipulative treatment in elderly patients with chronic obstructive pulmonary disease. J Am Osteopath Assoc. 2008 May;108(5):251-9.
citation: Henderson AT, Fisher JF, Blair J, Shea C, Li TS, Bridges KG. Effects of rib raising on the autonomic nervous system: a pilot study using noninvasive biomarkers. J Am Osteopath Assoc. 2010 Jun;110(6):324-30.
citation: Juniper EF, Guyatt GH, Willan A, Griffith LE. Determining a minimal important change in a disease-specific Quality of Life Questionnaire. J Clin Epidemiol. 1994 Jan;47(1):81-7. doi: 10.1016/0895-4356(94)90036-1.