Effects of Osteopathic Treatment on Vestibular Disturbed Active Post Concussed Individual

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2015-01-31

Brief Summary

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The proposed study is a randomized clinical trial with the purpose of determining the efficacy of osteopathic treatment on vestibular symptoms of the post concussed vestibular disturbed athlete as determined by the Dizziness Handicap Inventory (DHI) and the Balance Error Scoring System (BESS). Of secondary interest, this study will evaluate the osteopathic assessment findings of this population and side effects, positive and negative, associated with the osteopathic treatment provided.

Primary Hypothesis

1. Osteopathic treatment will have no effect on the symptoms of dizziness of the vestibular disturbed post concussed athlete using the Dizziness Handicap Inventory
2. Osteopathic treatment will have no effect on the balance recovery of the vestibular disturbed post concussed athlete using Balance Error Scoring System (BESS)

Secondary Hypothesis
3. To determine the side effects of osteopathic treatment of the vestibular disturbed post concussed athlete

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Detailed Description

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The proposed study is a randomized clinical trial with the purpose of determining the efficacy of osteopathic treatment on vestibular symptoms of the post concussed vestibular disturbed athlete as determined by the Dizziness Handicap Inventory (DHI) and the Balance Error Scoring System (BESS). Of secondary interest, this study will evaluate the osteopathic assessment findings of this population and side effects, positive and negative, associated with the osteopathic treatment provided.

The study will focus on Athletes between the ages of 18-40 who have received a concussion and continue to suffer the sequela of symptoms, including vestibular disturbances, a minimum of 1-month and maximum of 1-year post concussion. A sports medicine physician will screen potential participants for inclusion and exclusion criteria and referred to the project as appropriate.

All subjects will receive an initial osteopathic evaluation and baseline BESS and DHI. There will be a total of 7 balance tests performed each week for the first 5 weeks and then the final at the 8-week mark. Dizziness inventories will be completed daily for the duration of the 8-week project. The control group will receive the standard of care, rest, whereas the experimental group will receive four osteopathic treatments in addition to rest. The experimental group, in addition to completing BESS testing and DHI forms will also account for any side effects associated with osteopathic treatments daily following treatments.

Conditions

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Post Concussion Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Control group

Osteopathic evaluation Cognitive and Physical Rest

Group Type NO_INTERVENTION

No interventions assigned to this group

Osteopathic Treatment Group

4 osteopathic treatments following a set protocol to which only the osteopathic lesions found within the subjects assessment will be treated.

Group Type EXPERIMENTAL

Osteopathic treatment

Intervention Type OTHER

The following treatment protocol is an outline only; structures will be treated only if the dysfunction was present during the evaluation.

Week 1: Venous Sinuses, diaphragms, major cranial compactions, sphenobasilar symphysis normalization and dural release

Week 2 Non-Physiological without respect of axis dysfunction in cranium, spine, pelvis, ankle. Non-physiological with respect of axis dysfunctions in the cranium. Temporal and orbital sutures.

Week 3 Non-Physiological with respect of axis dysfunction lesions within the spine, pelvis and ankle. Visceral tissues: kidneys, liver, spleen, heart. Cerebral hemisphere and lateral ventricles.

Week 4 Physiological dysfunctions within the cranium, spine, pelvis, and ankle. Myofascial restrictions and muscles of the jaw and eye.

Interventions

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Osteopathic treatment

The following treatment protocol is an outline only; structures will be treated only if the dysfunction was present during the evaluation.

Week 1: Venous Sinuses, diaphragms, major cranial compactions, sphenobasilar symphysis normalization and dural release

Week 2 Non-Physiological without respect of axis dysfunction in cranium, spine, pelvis, ankle. Non-physiological with respect of axis dysfunctions in the cranium. Temporal and orbital sutures.

Week 3 Non-Physiological with respect of axis dysfunction lesions within the spine, pelvis and ankle. Visceral tissues: kidneys, liver, spleen, heart. Cerebral hemisphere and lateral ventricles.

Week 4 Physiological dysfunctions within the cranium, spine, pelvis, and ankle. Myofascial restrictions and muscles of the jaw and eye.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Active Male or Female Individuals between the ages of 18-45
* Active defined as a minimum of 30 minutes of activity 3 times a week (prior to concussion)
* Post Concussive symptoms with associated vestibular disturbance (balance and dizziness) greater than one month in duration and no longer than 18 months

Exclusion Criteria

* Known vestibular disease (ex. Menieres Disease, Benign Paroxysmal Positional Vertigo (BPPV), ear infection)
* Positive Dix-Hallpike Maneuver
* Current participating in any treatment program including vestibular rehabilitation, vestibular depressant medication or anti-depressants for the treatment of post concussed syndrome or associated conditions such as post traumatic stress disorder (PTSD) or depression
* Braces or fixed dental retainer
* Temporal Mandibular Joint dysfunction (TMJ) in the past year
* Recent (within past 6 months) osteo-articular injury within the lower extremity
* Surgery in the past year
* Prior dental surgery or surgery to the face/head
* Prior fractures to the cranial or facial bones
* Disease such as cancer, liver disease, kidney disease, heart disease, epilepsy, spinal cord disease, multiple sclerosis, rheumatoid arthritis
* History of hypertension or hypotension, high blood pressure, myocardial infarction, angina, stroke, brain tumor, migraines not associated with current concussion and diabetes
* Females that are currently pregnant

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No