Clinical Trial: Effects of Osteopathic Treatment on Vestibular Disturbed Active Post Concussed Individual

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: The Effects of Osteopathic Treatment on Balance and Dizziness of the Vestibular Disturbed Active Post Concussed Individual.

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 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.

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.


Sponsor: Collège d'Études Ostéopathiques

Current Primary Outcome:

  • Dizziness Handicap Inventory (DHI) [ Time Frame: 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). ]
    The DHI is a subjective self or clinician administered paper test consisting of 25 questions measuring the self-perceived handicap related to dizziness (Treleaven, 2006). The DHI represents 3 subdomains associated with dizziness or unsteadiness: functional, emotional and physical (Jacobson & Newman, 1990). Each Yes answer is marked as a 4, each Sometimes answer is marked a 2 and each No answer is marked 0 to which the sum of the scores demonstrates the perceived handicap (Treleaven, 2006). Scores 0-30 is indicative of a mild handicap; 31-60 indicates a moderate handicap; 61-100 indicates a severe handicap (Treleaven, 2006). Jacobson & Newman (1990) found a difference of at least 18 points from pre-treatment to post-treatment findings to suggest significant change in a patient's subjective perception on dizziness handicap. The DHI has shown significant correlation between specific objective measures of balance (Treleaven, 2006).
  • Balance Error Scoring System (BESS) [ Time Frame: 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. ]
    The BESS test is a short and easily administered objective clinical balance test often used in assessing and tracking recovery from athletic concussion (Iverson et al, 2008). It tests balance in a variety of stances either on solid ground or medium density foam (Guskiewicz, 2001 & Ive

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    Original Secondary Outcome:

    Information By: Collège d'Études Ostéopathiques

    Dates:
    Date Received: October 5, 2013
    Date Started: August 2013
    Date Completion:
    Last Updated: February 2, 2015
    Last Verified: February 2015