CompletedNot Applicable

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

United States29 participantsStarted 2017-09-18

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change from baseline Neurocom Balance Manager assessment in 12 weeks after OMT

Timeframe: 12 weeks

Change of baseline Headache Impact Test (HIT-6) scores after 12 weeks of OMT

Timeframe: 12 weeks

Trial details

NCT IDNCT03163901

SponsorMichigan State University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-02-29

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