Clinical trial NCT03163901: The Effect of OMT on Functional Outcomes and Anti-inflammatory Biomarkers in Mild to Moderate Traumatic Brain Injury
Official title: The Effect of OMT on Functional Outcomes and Anti-inflammatory Biomarkers in Mild to Moderate Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vestibular Disorder
Headache
Traumatic Brain Injury
Keywords: traumatic brain injury
Lead sponsor: Michigan State University
Sponsor class: OTHER
Collaborators: name: American Osteopathic Association
First posted: 2017-05-23
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline Neurocom Balance Manager assessment in 12 weeks after OMT
timeFrame: 12 weeks
measure: Change of baseline Headache Impact Test (HIT-6) scores after 12 weeks of OMT
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in Anti-inflammatory Biomarker after 12 weeks of OMT or sham treatment
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Mason
country: United States
facility: Origami Brain Injury Rehabilitation Center
state: Michigan
Study officials:
affiliation: Assistant Professor at Michigan State University
name: Rebecca Wyatt, DO
role: PRINCIPAL_INVESTIGATOR
References: