Comparing the Effect of Osteopathic Manipulative Medicine (OMM) Versus Counseling in the Treatment of Concussion

Purpose:

The purpose of this study is to investigate the effectiveness of osteopathic manipulative
treatment (OMT) in improving concussion-related symptoms.

Previous studies and case reports have found a positive effect of OMT on resolving
concussion-like symptoms such as vertigo, imbalance, and tinnitus. It is hypothesized that
OMT improves proprioceptive input from the cervical spine and joints and sensory input from
the internal auditory meatus. The investigators propose to further investigate this
relationship in order to quantify the effect of OMT through the SMART Balance Master and
return to play/work time. As this is a pilot study, the investigators intend to determine if
a correlation exists between OMT and return to work/play and SMART Balance Master scores.

Specifically, the investigators have three main aims for this study:

Specific Aim #1: OMT will show a statistically significant improvement balance as measured by
the SMART Balance Master scores pre- and post-OMT

Specific Aim #2: OMT will decrease concussion symptom as measured by surveys

Specific Aim #3: OMT will decrease return to play/work time in concussed subjects compared to
standard.

Background/Rationale:

Concussion or mild traumatic brain injury (TBI) is a challenging injury for physicians to
manage. It is undetectable by traditional imaging techniques, and there are limited treatment
options. A concussion results from a biomechanical force directed towards the head that
precedes and contributes to neurologic dysfunction, including impairment in the level of
consciousness. However, a loss of consciousness is not a requirement for the diagnosis.

The CDC estimates the annual burden of concussion in the United States to be roughly 1.4-3.8
million. Over the past decade, the CDC also reports a 70% increase in TBI emergency
department visits, as well as an increase in TBI-related hospitalizations. Other studies have
determined the prevalence of individuals with chronic concussion problems in the US is 5.3
million. Importantly, these figures should be considered an underestimate as patients with
milder injuries often do not seek treatment.

The mechanism of concussion involves a primary and secondary phase of tissue injury. A
primary injury is immediate and irreversible, resulting from acceleration/deceleration
mechanical damage. Secondary injuries result from non-mechanical damage derived from neuronal
cell membrane disruption and axonal stretch. The membrane defects result from secondary
injury and lead to ionic influx and accumulation of toxic substances such as glutamate within
the nervous system. Individuals with mild concussion recover within a few days; however, 15%
of patients with mild concussion suffer from long-term complications largely due to the
secondary phase of injury.

Recent literature has studied the role of restricted cerebral blood flow and inflammation on
perpetuating the symptoms of a concussion. Meier et al. discovered an inverse relationship
between cerebral blood flow in the dorsal midinsular cortex and the time to return to play.
Other studies have investigated the role of inflammation, through the production of reactive
oxygen species, that not only contribute to the initial injury but also potentiate its own
pathological course. These studies highlight potential mechanisms that could be targeted to
decrease symptoms and improve outcomes.

Treatment for mild concussion in the past has been limited to bed rest. Previous studies have
noted that bed rest following a concussion does not improve recovery time and, if continued
for too long, can negatively impact recovery. Some pilot projects have reported promising
findings such as decreased 30-day mortality with progesterone. Through a meta-analysis of
non-surgical interventions following a mild TBI, Nygren-de Boussard et al. found that there
are poor randomized controlled trials or comparison groups to indicate any intervention can
provide therapeutic benefit. Furthermore, evidence supports a more individualized approach
when treating post-concussive symptoms.

Alternative or complementary treatments encompass a variety of individual approaches for
different patients including herbal supplements, homeopathy, hyperbaric oxygen, arts and
recreational therapies, meditation practice, and Tai Chi Chuan. Empirical literature on
alternative treatments for mild concussion is sparse, with many studies either insufficiently
powered or poorly controlled. The widespread use and popularity of these treatment options
and their potential to help treat concussions demands further scientific investigation.

Osteopathic manipulative treatment (OMT) is defined in the Glossary of Osteopathic
Terminology as "the therapeutic application of manually guided forces by an osteopathic
physician to improve physiologic function and/or support homeostasis that has been altered by
somatic dysfunction." Somatic dysfunctions, or restrictions of skeletal or myofascial
structures, disrupt the normal function of vascular, lymphatic and neural components related
to or that pass through these structures. By treating somatic dysfunctions, OMT aims to
remove musculoskeletal (MSK) restrictions which allow for increased blood flow and lymphatic
drainage and decreased nerve impingements. Somatic dysfunctions in the cranium and spine can
contribute to patient's concussion symptoms including dizziness and tinnitus. Treatment of
somatic dysfunctions with OMT, targeting structures involved with concussion-related
symptoms, may be another treatment option that can be offered to these patients.

Evidence has supported the use of the SMART Balance Master as a validated tool to measure
balance. Fraix et al. used the SMART Balance Master by NeuroCom® to quantify the beneficial
effect of OMT on improving patients' balance and dizziness. The SMART Balance Master® can be
used to quantify changes in balance before and after OMT. The Sensory Organization Test (SOT)
is one assessment tool that can measure three different aspects of balance and posture:
somatosensory, visual, and vestibular. The complete protocol for SOT can be found on the
NeuroCom® website.

The ImPACT test is a widely used tool to help detect and assess the severity of concussion in
athletes. This computerized test is administered to athletes routinely to establish a
baseline of memory and cognitive function, and administered again in the suspicion of a
concussion in order to evaluate the difference in cognitive function. The test is widely used
and has been shown to be an effect adjunct test for evaluation of concussion as part of a
comprehensive medical diagnosis involving other testing methods.

The SCAT-3 (sport concussion assessment tool - 3rd edition) is an improved version of a
widely used aid for physicians for evaluating concussion severity and progress. The test is a
combination of patient-reported symptom evaluation as well as an objective cognitive and
physical exam.

The King-Devick Test objectively measures visual tracking and saccadic eye movements (rapid
movement of the eye between fixation points). The test was originally developed in 1976 by
eye care specialists to help evaluate reading disabilities as they related to oculomotor
movement. Since 2011, the test has been used as a rapid sideline screening tool for
concussion in a variety of sports, based on the findings that concussion is associated with
many neuro-ophthalmologic signs. Many studies have shown the King-Devick Test to be a valid
aid in detecting and evaluating concussions.

It is with these tools, the investigators aim to measure the effects of OMT on
post-concussion symptoms.

Inclusion Criteria:

- Subject is at least 18 years age

- Subject has suffered from non-life threatening head trauma head trauma resulting in
current concussion-related symptoms

- Subject is evaluated and diagnosed with a concussion

- Subject has been cleared to participate in the study by the physician/neurologist
having excluded any potential emergent conditions

Exclusion Criteria:

- The subject has no absolute contraindications to osteopathic manipulative treatment,
such as skull fracture, cervical fracture, signs of intracranial bleeding, cervical
dissection, or stroke

- The subject suffered from any of the following at the time of event leading to
concussion:

- Loss of consciousness >2 minutes in the field

- Seizures

- Intractable vomiting

- Paralysis

- The subject has been diagnosed with an underlying neurodegenerative condition that may
confound test results (e.g.. Parkinson's Disease, Alzheimer's Disease)

- The subject has a current or previous spinal cord injury

- The subject is unable to complete the assessment tools

- The subject is pregnant