Clinical trial NCT01962883: Effects of Osteopathic Treatment on Vestibular Disturbed Active Post Concussed Individual
Official title: The Effects of Osteopathic Treatment on Balance and Dizziness of the Vestibular Disturbed Active Post Concussed Individual.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Concussion Syndrome
Keywords: Post Concussion Syndrome
Vestibular disturbance
Balance
Dizziness
Dizziness handicap inventory
Balance Error Scoring System
Lead sponsor: Collège d'Études Ostéopathiques
Sponsor class: OTHER
First posted: 2013-10-14
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Dizziness Handicap Inventory (DHI)
timeFrame: Subject to complete DHI form daily for 9 weeks. Change in DHI scores over time periods: baseline (day 3), time 1-4 (day 5 post treatment or equivalent in control group) and time 5 (19 days post final treatment/equivalent in control group).
measure: Balance Error Scoring System (BESS)
timeFrame: Subject to complete BESS once a week for the first 5 weeks and again week 8. Change in BESS scores over time periods: baseline, week 1, week 2, week 3, week 4 and week 8.
Secondary outcomes:
Other outcomes:
Locations:
city: Carstairs
country: Canada
facility: Take Flight Athletic Therapy Clinic
state: Alberta
Study officials:
affiliation: College d'Etudes Osteopathiques (Vancouver Campus)
name: Bonnie Sutter, DOMP, CAT(C)
role: STUDY_DIRECTOR
affiliation: College d'Etudes Osteopathiques (Vancouver Campus)
name: Christal Geier, CAT(C)
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Guskiewicz KM. Postural stability assessment following concussion: one piece of the puzzle. Clin J Sport Med. 2001 Jul;11(3):182-9. doi: 10.1097/00042752-200107000-00009.
citation: Jacobson GP, Newman CW. The development of the Dizziness Handicap Inventory. Arch Otolaryngol Head Neck Surg. 1990 Apr;116(4):424-7. doi: 10.1001/archotol.1990.01870040046011.
citation: Riemann BL, Guskiewicz KM. Effects of mild head injury on postural stability as measured through clinical balance testing. J Athl Train. 2000 Jan;35(1):19-25.
citation: Treleaven J. Dizziness Handicap Inventory (DHI). Aust J Physiother. 2006;52(1):67. doi: 10.1016/s0004-9514(06)70070-8. No abstract available.