The Effects of OMT on the Expression Patterns of Immune Cell Biomarkers
NCT ID: NCT03250312
Last Updated: 2020-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
40 participants
INTERVENTIONAL
2017-09-13
2019-08-31
Brief Summary
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Detailed Description
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Participants will be randomly assigned into two groups, control or OMT using a random number generator. Males and females will be randomized separately to ensure equal distribution into the two study groups. Demographics including sex, age, and body mass index (BMI) will be collected on all participants. All participants will receive two blood draws,with 8 ml each draw: first blood draw immediately prior to intervention and second blood draw following the intervention.
The OMT treatment will begin with a brief physical examination to identify somatic dysfunction that the treating physician judges to be relevant to the individual participant's low back pain. OMT will be performed to improve the somatic dysfunctions that the treating physicians finds most relevant. The types of OMT techniques used will include muscle energy, articular, or high velocity-low amplitude (HVLA) as indicated by the physical findings and will be at the discretion of the treating physician. Additional techniques such as still, counter strain, facilitated positional release, balanced ligamentous tension, and cranial techniques may also be used at the discretion of the treating physician. The treatment will conclude with 2 minutes of pedal lymphatic pumping technique. The total treatment time will not to exceed 20 minutes.
The control group will wait in another room for approximately 30 minutes. To encourage participation in the proposed study, participants who are assigned to the control group will have an opportunity to receive OMT after the second blood draw.
The investigators shall determine the expression patterns of 60 immune cell biomarkers in human peripheral blood mononuclear cells (PBMC) of the study participants, and determine the ratio change of those 60 biomarkers, after the OMT treatment. The investigators shall compare the effects of OMT treatment on the ratio change of those 60 biomarkers, with those in the control group.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
SINGLE
Study Groups
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The OMT group
This group will be treated by the osteopathic manipulation techniques (OMT). The types of OMT techniques used will include muscle energy, articular, or high velocity-low amplitude (HVLA) as indicated by the physical findings and will be at the discretion of the treating physician. Additional techniques such as still, counter strain, facilitated positional release, balanced ligamentous tension, and cranial techniques may also be used at the discretion of the treating physician. The treatment will conclude with 2 minutes of pedal lymphatic pumping. The total treatment time will not to exceed 20 minutes.
The Osteopathic Manipulation
The types of OMT techniques used will include muscle energy, articular, or high velocity-low amplitude (HVLA) as indicated by the physical findings and will be at the discretion of the treating physician. Additional techniques such as still, counter strain, facilitated positional release, balanced ligamentous tension, and cranial techniques may also be used at the discretion of the treating physician. The treatment will conclude with 2 minutes of pedal lymphatic pumping
The control group
The control group will wait in another room for approximately 30 minutes.
To encourage participation in the proposed study, participants who are assigned to the control group will have an opportunity to receive OMT after the second blood draw
No interventions assigned to this group
Interventions
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The Osteopathic Manipulation
The types of OMT techniques used will include muscle energy, articular, or high velocity-low amplitude (HVLA) as indicated by the physical findings and will be at the discretion of the treating physician. Additional techniques such as still, counter strain, facilitated positional release, balanced ligamentous tension, and cranial techniques may also be used at the discretion of the treating physician. The treatment will conclude with 2 minutes of pedal lymphatic pumping
Eligibility Criteria
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Inclusion Criteria
* BMI (body mass index) \< 30 kg/m2
* be able to lie on my back for 30 minutes
* be able to tolerate OMT
Exclusion Criteria
* Have corticosteroids in the 2 weeks prior to the study date
* Have nonsteroidal anti-inflammatory medication in the 48 hours prior to the study data
* Have spinal surgery in the lumbar or low thoracic spine
* Have congenital deformities of the lumbar spine such as spina bifida
20 Years
55 Years
ALL
Yes
Sponsors
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A.T. Still University of Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Karen Snider, D. O.
Role: PRINCIPAL_INVESTIGATOR
A.T. Still University of Health Sciences
Locations
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A. T. Still University of Health Sciences
Kirksville, Missouri, United States
Countries
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References
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Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Other Identifiers
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IRB #170804-001
Identifier Type: -
Identifier Source: org_study_id
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