The Effect of OMT on Functional Outcomes and Anti-inflammatory Biomarkers in Mild to Moderate Traumatic Brain Injury
NCT ID: NCT03163901
Last Updated: 2020-06-24
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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COMPLETED
NA
29 participants
INTERVENTIONAL
2017-09-18
2020-02-29
Brief Summary
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Detailed Description
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A unique and trail blazing aspect of our proposed work is to screen for biochemical alterations in the plasma and urine of these patients following administration of OMT and to correlate these changes with vestibular function tests and other clinical parameters that may shed light on the biological mechanism(s) underlying the OMT. The impact of our proposed research lies in our attempt to establish a foundation for the basis of using OMT procedures to accelerate recovery of patients following mild to moderate brain injury and to find correlations between cognitive functions, biochemical markers, and self-reported assessments of quality of life.
The successful achievement of positive outcomes in this project will serve as the basis for our future efforts to seek funding from the National Institutes of Health for recruitment of larger numbers of subjects in a multi-center research effort.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Treatment groups
To recruit and organize patients with TBI enrolled in a standard rehabilitation program into three groups ((a) treatment group receiving OMT; (b) control group A receiving sham treatment; and (c) control group B receiving neither OMT nor sham treatment) in order to assess the feasibility and adherence to the protocol and determine participation and attrition rates in preparation for a larger study.
Osteopathic Manipulative Treatment
OMT techniques applied in the thoracic spine soft tissue, cervical spine soft tissue, suboccipital release, occipital condyle condylar decompression, and cranial venous sinus release.
Effect of OMT on clinical outcome measures
Clinical outcome measures including Neurocom Balance Manager assessments (Modified Clinical Test of Sensory Interaction and Balance; Stability Evaluation Test; Rhythmic Weight Shift; Limits of Stability), Vestibular Oculomotor Screen, Motion Sensitivity Test, as well as questionnaires such as the Headache Impact Test (HIT-6), Dizziness Handicap Inventory, and the more general quality of life measures (dressing; bathing; medication management, etc. as assessed by the SF 36 QOL questionnaire).
Osteopathic Manipulative Treatment
OMT techniques applied in the thoracic spine soft tissue, cervical spine soft tissue, suboccipital release, occipital condyle condylar decompression, and cranial venous sinus release.
Anti-inflammatory Biomarkers
to analyze urine and plasma samples collected from the three groups of participants: urine and plasma samples one hour before, plasma samples one hour after and 48 hours after treatment for alterations in the levels of low molecular weight compounds or protein components to identify potential biomarkers that may correlate with the TBI condition and/or the OMT.
No interventions assigned to this group
Infrastructure development
to establish the infrastructure for the recording, management, and extraction of clinical data and to estimate effect sizes and variability in key outcome measures so that a larger, longer term study can be planned with sufficient statistical power to identify significant results.
No interventions assigned to this group
Interventions
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Osteopathic Manipulative Treatment
OMT techniques applied in the thoracic spine soft tissue, cervical spine soft tissue, suboccipital release, occipital condyle condylar decompression, and cranial venous sinus release.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Chief complaint of headache and/or dizziness
* 18 years or older
* Medically stable/free from acute infection or fever
* Not a danger to self or others
* Not actively engaged in substance abuse
* Minimum Ranchos Los Amigos Level of 4 (http://www.traumaticbraininjury.com/symptoms-of-tbi/).
Exclusion Criteria
* Any acute fracture or bleeding
* Head, neck or back wounds that would prevent OMT treatment
18 Years
ALL
Yes
Sponsors
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American Osteopathic Association
OTHER
Michigan State University
OTHER
Responsible Party
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Rebecca Wyatt
Assistant Professor
Principal Investigators
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Rebecca Wyatt, DO
Role: PRINCIPAL_INVESTIGATOR
Assistant Professor at Michigan State University
Locations
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Origami Brain Injury Rehabilitation Center
Mason, Michigan, United States
Countries
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Other Identifiers
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i053814
Identifier Type: -
Identifier Source: org_study_id
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