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

NCT03163901 | Completed

• 1 other identifier: i053814
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Vestibular Disorder; Headache; Traumatic Brain Injury

Keywords

traumatic brain injury

Outcome Measures

Primary Outcomes (2)

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

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

  12 weeks

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

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

  12 weeks

Secondary Outcomes (1)

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

  12 weeks

Study Arms (4)

Treatment groups

ACTIVE COMPARATOR

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

Effect of OMT on clinical outcome measures

OTHER

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

Anti-inflammatory Biomarkers

NO INTERVENTION

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

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.

Interventions

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.

Also known as: OMT

Effect of OMT on clinical outcome measures; Treatment groups

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of mild to moderate traumatic brain injury
• Chief complaint of headache and/or dizziness
• 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/).

You may not qualify if:

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

Sponsors & Collaborators

• Michigan State University: lead
• American Osteopathic Association: collaborator

Study Sites (1)

Origami Brain Injury Rehabilitation Center

Mason, Michigan, 48854, United States

Location

MeSH Terms

Conditions

Vestibular Diseases; Headache; Brain Injuries, Traumatic

Interventions

Manipulation, Osteopathic

Condition Hierarchy (Ancestors)

Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Rebecca Wyatt, DO

  Assistant Professor at Michigan State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 15, 2017
• First Posted: May 23, 2017
• Study Start: September 18, 2017
• Primary Completion: February 29, 2020
• Study Completion: February 29, 2020
• Last Updated: June 24, 2020

Record last verified: 2020-06

Locations

US (1)