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

This study is currently recruiting participants.
See Contacts and Locations
Verified September 2017 by Rebecca Wyatt, Michigan State University
Sponsor:
Collaborator:
American Osteopathic Association
Information provided by (Responsible Party):
Rebecca Wyatt, Michigan State University
ClinicalTrials.gov Identifier:
NCT03163901
First received: May 15, 2017
Last updated: September 17, 2017
Last verified: September 2017
  Purpose
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.

Condition Intervention
Vestibular Disorder Headache Traumatic Brain Injury Other: Osteopathic Manipulative Treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Effect of OMT on Functional Outcomes and Anti-inflammatory Biomarkers in Mild to Moderate Traumatic Brain Injury

Resource links provided by NLM:


Further study details as provided by Rebecca Wyatt, Michigan State University:

Primary Outcome Measures:
  • 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.

  • 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 Outcome Measures:
  • 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


Estimated Enrollment: 180
Actual Study Start Date: September 18, 2017
Estimated Study Completion Date: August 31, 2019
Estimated Primary Completion Date: August 31, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Other: 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 Name: OMT
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).
Other: 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 Name: OMT
No Intervention: 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 Intervention: 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.

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03163901

Contacts
Contact: Amanda Origami Brain Injury Rehabilitation Center, OT (517) 455-0274 amanda.carr@origamirehab.org
Contact: Anne Origami Brain Injury Rehabilitation (517) 3366060 annevankirk@origamirehab.org

Locations
United States, Michigan
Origami Brain Injury Rehabilitation Center Recruiting
Mason, Michigan, United States, 48854
Contact: Amanda Carr, OT    517-336-6060    amanda.carr@origamirehab.org   
Contact: Rebecca Wyatt, DO    51733666060    Rebecca.Wyatt@hc.msu.edu   
Sponsors and Collaborators
Michigan State University
American Osteopathic Association
Investigators
Principal Investigator: Rebecca Wyatt, DO Assistant Professor at Michigan State University
  More Information

Responsible Party: Rebecca Wyatt, Assistant Professor, Michigan State University
ClinicalTrials.gov Identifier: NCT03163901     History of Changes
Other Study ID Numbers: i053814
Study First Received: May 15, 2017
Last Updated: September 17, 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Rebecca Wyatt, Michigan State University:
traumatic brain injury

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Headache
Vestibular Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Pain
Neurologic Manifestations
Signs and Symptoms
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on September 19, 2017