Clinical trial NCT05316363: Efficacy and Safety of OMT on Asthmatics
Official title: Efficacy and Safety of Osteopathic Manipulative Treatment on Asthmatics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: OMT
Lead sponsor: Western University of Health Sciences
Sponsor class: OTHER
First posted: 2022-04-07
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized into two groups: Standard asthmatic care with OMT intervention and standard asthmatic care with no OMT.
Primary purpose: TREATMENT

Brief summary: This is a pilot study in which the objective is to determine the feasibility of a randomized clinical trial investigating the safety and efficacy of OMT as an adjunctive treatment for patients with mild to moderate asthma compared to the same patient population without the use of OMT. OMT may be able to correct anatomical dysfunctions that contribute to increased symptoms in asthmatic patients. OMT's effect on asthma will be demonstrated by symptomatology reporting, frequency of medication use, and pulmonary function tests.

Detailed description: Asthma is a leading cause of activity limitation and healthcare burden in the United States of America. The asthmatic population is in need of treatments that target reducing asthma symptoms, reduce the need for medication, and improve lung functionality. As of today, there are not many studies investigating the efficacy and safety of osteopathic manipulative treatment (OMT) on asthmatic patients. This is a pilot study in which the objective is to determine the feasibility of a randomized clinical trial investigating the safety and efficacy of OMT as an adjunctive treatment for patients with mild to moderate asthma compared to the same patient population without the use of OMT. Subjects will be randomized into either a control group or an intervention group where OMT will be used in conjunction with standard asthmatic treatment. Subjective and objective measurements will be taken including the Asthma Control Test (ACT) questionnaire, peak flow, spirometry, pulse oximetry, and chest/diaphragmatic excursion measurements. Measurements will be compared from baseline, before the first treatment and at the follow-up visit after the final treatment.

Eligibility criteria: Inclusion Criteria:

* Clinically diagnosed with mild to moderate asthma (Episodic symptoms included were airflow obstruction or airway hyper-responsiveness, and airflow obstruction that was at least partially reversible (based upon an increase in FEV1 or greater than or equal to 12% from baseline or by an increase of at least 10% of predicted FEV1 after inhalation of a short-acting bronchodilator)

Exclusion Criteria:

* pneumonia
* COPD as a primary diagnosis
* pulmonary fibrosis
* smoking history
* inability to perform pulmonary function tests
* history of recent myocardial infarction or heart disease
* unable to respond to the questionnaire
* unable to provide informed consent
* pregnant
* using muscle relaxants
* Any contraindications to OMT such as: known bone metastases, severe osteoporosis, osteomyelitis, or fracture

Primary outcomes:
measure: Asthma Control Test (ACT) Score
timeFrame: Between baseline and 5 weeks
Secondary outcomes:
measure: Morphological Measurements of Chest and Diaphragm Excursion
timeFrame: Between baseline and 5 weeks
measure: Pulse Oximetry (Pulse Rate)
timeFrame: Between baseline and 5 weeks
measure: Pulse Oximetry (Blood O2 Saturation Levels)
timeFrame: Between baseline and 5 weeks
measure: Spirometry Readings: Forced Expiratory Volume in One Second (FEV1)
timeFrame: Between baseline and 5 weeks
Other outcomes:
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