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Post Concussion Syndrome | Effects of Osteopathic Treatment on Vestibular Disturbed Active Post Concussed Individual

Post Concussion Syndrome research study

What is the primary objective of this study?

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

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Post Concussion Syndrome

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Other:Osteopathic treatmentThe 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.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Control groupOsteopathic evaluation Cognitive and Physical Rest

Osteopathic Treatment Group4 osteopathic treatments following a set protocol to which only the osteopathic lesions found within the subjects assessment will be treated.

Study Status

Completed

Start Date: August 2013

Completed Date: January 2015

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Dizziness Handicap Inventory (DHI)

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Bonnie Sutter, DOMP, CAT(C)

Lead Sponsor: Collège d'Études Ostéopathiques

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01962883

Iverson GL, Koehle MS. Normative data for the modified balance error scoring system in adults. Brain Inj. 2013;27(5):596-9. doi: 10.3109/02699052.2013.772237. Epub 2013 Mar 8.

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