The Effect of OMT on Functional Outcomes and Anti-inflammatory Biomarkers in Mild to Moderate Traumatic Brain Injury

Michigan State University

Status: Completed

Conditions: Traumatic Brain Injury; Headache; Vestibular Disorder

Treatments: Other: Osteopathic Manipulative Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT03163901

i053814

Details and patient eligibility

About

Test the hypothesis that a certain set of osteopathic manipulation procedures preformed on patients with mild to moderate traumatic brain injury will result in accelerated rates of recovery assessed using vestibular function tests, quality of life questionnaires and measurements of the levels of anti-inflammatory metabolite and protein biomarkers in the blood and urine.

Full description

This project proposes to test the hypothesis that a certain set of osteopathic manipulative treatment (OMT) procedures performed on patients with mild to moderate traumatic brain injury (TBI) will result in accelerated rates of recovery as assessed using vestibular function tests, patient response on quality of life questionnaires, and measurements of the levels of anti-inflammatory metabolite and protein biomarkers in urine and blood. The OMT techniques, performed ensemble (as a set) and in sequence, will encompass: (a) soft tissue to the upper-mid thoracic spine; (b) soft tissue to the cervical spine; (c) suboccipital release; (d) condylar decompression; and (e) cranial venous sinus release. The key clinical outcome measures will include 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 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).

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.

Enrollment: 29 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Diagnosis of mild to moderate traumatic brain injury
• 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

• Minors below age of 18
• Any acute fracture or bleeding
• Head, neck or back wounds that would prevent OMT treatment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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29 participants in 4 patient groups

Treatment groups

Active Comparator group

Description:

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.

Treatment:

Other: Osteopathic Manipulative Treatment

Effect of OMT on clinical outcome measures

Other group

Description:

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).

Treatment:

Other: Osteopathic Manipulative Treatment

Anti-inflammatory Biomarkers

No Intervention group

Description:

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.

Infrastructure development

No Intervention group

Description:

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.