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Completed

NCT Number: NCT03163901

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Osteopathic manipulative treatment

Other

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 names: OMT

Primary outcomes

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

    Time frame: 12 weeks

    Participants will be evaluated prior to treatment on the Neurocom Balance Manager. Reassessment done at 12 week. The balance score will be recorded.

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

    Time frame: 12 weeks

    Participants will be given the HIT-6 questionnaire at 0 and12 weeks. The scores will be recorded.

Secondary outcomes

  1. Change in Anti-inflammatory Biomarker after 12 weeks of OMT or sham treatment

    Time frame: 12 weeks

    Urine sample will be taken one hour prior to initial OMT or sham treatment and again at12 weeks. Plasma samples will be taken one hour prior to OMT/sham treatment and 48 hours after treatment this will be done at week 0, 6 and 12. The anti-inflammatory biomarkers will be recorded and compared (before/after treatment) to see if they levels decrease after OMT treatments

Sponsors and collaborators

Lead sponsor

Michigan State University

Other

Collaborators

  • American Osteopathic Association

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
May 23, 2017
Registry last updated
Jun 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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