AsthmaNCT05316363
Efficacy and Safety of OMT on Asthmatics
A study testing OMT in people with Asthma, run by Western University of Health Sciences.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Asthma
- What is being tested?
- OMT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 11 Dec 2012to 8 Jan 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- pneumonia
- COPD as a primary diagnosis
- pulmonary fibrosis
- smoking history
- inability to perform pulmonary function tests
- history of recent myocardial infarction or heart disease
Show all 11Show fewer
- 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
About this study
Official title: Efficacy and Safety of Osteopathic Manipulative Treatment on Asthmatics
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.
Read the 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.
- Conditions
- Asthma
- Being tested
- OMT
- Keywords
- OMT
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OMTOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: OMT |
| Control | No intervention | Patients lie supine on the treatment table and rested quietly for a total of 8 minutes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Between baseline and 5 weeks
Secondary outcomes (4)
Morphological Measurements of Chest and Diaphragm Excursion
Chest wall and diaphragm excursion measurements were obtained to assess wall and diaphragm motion during respiration at three different levels: The anterior landmarks were the third intercostal space, xiphoid process and superior aspect of umbilicus which corresponded with the posterior landmarks of the transverse processes of T5, T10 and T12 vertebrae, respectively for participants with and without OMT.
Measured: Between baseline and 5 weeks
Pulse Oximetry (Pulse Rate)
Pulse rate in beats per minute (BPM) was compared between subjects who received OMT as compared to subjects who only received standard care.
Measured: Between baseline and 5 weeks
Pulse Oximetry (Blood O2 Saturation Levels)
Blood O2 Saturation levels as measured by a pulse oximeter as a percentage was compared between subjects that received OMT versus those treated with only standard care.
Measured: Between baseline and 5 weeks
Spirometry Readings: Forced Expiratory Volume in One Second (FEV1)
Forced expiratory volume in one second was reported as volume of air expired in one second in subjects who received OMT as compared to subjects who only received standard care.
Measured: Between baseline and 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start11 Dec 2012
- Primary completion8 Jan 2015
- Study completion8 Jan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized into two groups: Standard asthmatic care with OMT intervention and standard asthmatic care with no OMT.
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jesus Sanchez, Western University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05316363
- Sponsor's protocol ID
- 11/IRB/090
- Status last verified
- Mar 2022
- First submitted
- 18 Mar 2022
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Osteopathic Manipulative Treatment on Asthmatics
- ClinicalTrials.gov ID
- NCT05316363
- Acronym / sponsor ID
- 11/IRB/090
- Conditions
- Asthma
- Keywords
- OMT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Western University of Health SciencesUniversity, hospital or other
- Study start
- 11 Dec 2012 (actual)
- Primary completion
- 8 Jan 2015 (actual)
- Study completion
- 8 Jan 2015 (actual)
- First posted
- 7 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
- Model description
- Randomized into two groups: Standard asthmatic care with OMT intervention and standard asthmatic care with no OMT.
| Arm | Type | Receives |
|---|---|---|
| OMT Intervention Arm | Experimental | Other: OMTPatients 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. |
| Control | No intervention | –Patients lie supine on the treatment table and rested quietly for a total of 8 minutes. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (11 listed)
- pneumonia
- COPD as a primary diagnosis
- pulmonary fibrosis
- smoking history
- inability to perform pulmonary function tests
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OMTSuboccipital 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. | Other | OMT Intervention Arm |
Primary outcome
Asthma Control Test (ACT) Score
Time frame: Between baseline and 5 weeks
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.
4 secondary outcomes
Morphological Measurements of Chest and Diaphragm Excursion
Time frame: Between baseline and 5 weeks
Pulse Oximetry (Pulse Rate)
Time frame: Between baseline and 5 weeks
Pulse Oximetry (Blood O2 Saturation Levels)
Time frame: Between baseline and 5 weeks
Spirometry Readings: Forced Expiratory Volume in One Second (FEV1)
Time frame: Between baseline and 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing OMT in people with Asthma, run by Western University of Health Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asthma Control Test (ACT) Score (time frame: Between baseline and 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2022.