Efficacy and Safety of OMT on Asthmatics

NCT05316363 | Completed

• 1 other identifier: 11/IRB/090
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Asthma

Keywords

OMT

Outcome Measures

Primary Outcomes (1)

• Asthma Control Test (ACT) Score

  Determine the efficacy of adjunctive OMT treatment when compared to standard care in the reduction of symptomatology of dyspnea, wheezing and bronchoconstriction and decrease medication use as measured by the Expert Panel Report 3 and Global Initiative for Asthma Monitoring Asthma Control Test (ACT) questionnaire which is scored on a range from 5 to 25 with higher scores indicating better control of asthma symptoms.

  Between baseline and 5 weeks

Secondary Outcomes (4)

• Morphological Measurements of Chest and Diaphragm Excursion

  Between baseline and 5 weeks

• Pulse Oximetry (Pulse Rate)

  Between baseline and 5 weeks

• Pulse Oximetry (Blood O2 Saturation Levels)

  Between baseline and 5 weeks

• Spirometry Readings: Forced Expiratory Volume in One Second (FEV1)

  Between baseline and 5 weeks

Study Arms (2)

OMT Intervention Arm

EXPERIMENTAL

Patients treated with 4 techniques for 8 minutes in the supine position. OMT systematically administered to address the 4 body regions - cervical spine, thoracic spine, ribs and diaphragm. The techniques utilized for this study include: suboccipital release, diaphragmatic release, rib raising and paraspinal inhibition of the thoracic spine. Each technique administered for approximately 2 minutes.

Other: OMT

Control

NO INTERVENTION

Patients lie supine on the treatment table and rested quietly for a total of 8 minutes.

Interventions

OMT OTHER

Suboccipital Release - Finger pads are placed onto suboccipital musculature and a smooth, gentle, and rhythmic laterocephalad traction is applied to reduce muscle tension. Paraspinal Inhibition - Hands are placed under the patient's thoracolumbar spine and contract the erector spinae tissue to draw the thoracolumbar spine into extension and hold until relaxation is felt. Rib Raising - Hands are placed under the subject's thorax and contact the rib angles with finger pads. Fingers are flexed while adding an anteriolateral traction directed at the rib angle while maintaining neutral wrists. Arms are used as a lever by leaning forward thus creating a fulcrum with the treatment table with a smooth, rhythmic motion. This motion is repeated several times throughout the entire thoracic region, unilaterally and then switch sides. Diaphragm Release - Hands apply a gentle pressure until a barrier or point of ease of the fascia is felt and hold that position until tissue response is felt.

OMT Intervention Arm

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Western University of Health Sciences: lead

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: Care providers were not involved in any data analysis and the investigator was also blind to the assignment and outcomes assessment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Dean of Academic Affairs, Professor of NMM/OMM & Family Medicine

Model Details: Randomized into two groups: Standard asthmatic care with OMT intervention and standard asthmatic care with no OMT.

Study Record Dates

• First Submitted: March 18, 2022
• First Posted: April 7, 2022
• Study Start: December 11, 2012
• Primary Completion: January 8, 2015
• Study Completion: January 8, 2015
• Last Updated: April 7, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share