Effects of Osteopathic Treatment on Vestibular Disturbed Post Concussed Athlete (PCS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Collège d'Études Ostéopathiques
Sponsor:
Information provided by (Responsible Party):
Christal Geier, Collège d'Études Ostéopathiques
ClinicalTrials.gov Identifier:
NCT01962883
First received: October 5, 2013
Last updated: October 9, 2013
Last verified: October 2013
  Purpose

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

Condition Intervention
Post Concussion Syndrome
Other: Osteopathic treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Osteopathic Treatment on Balance and Dizziness of the Vestibular Disturbed Post Concussed Athlete.

Resource links provided by NLM:


Further study details as provided by Collège d'Études Ostéopathiques:

Primary Outcome Measures:
  • 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). ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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 & Iverson et al, 2008). The stance is held for 20 seconds to which error points are given based on changes to the stance such as opening the eyes; a maximum of 10 points is utilized for this study (Iverson et al, 2008). Normative values have been established for the BESS (Iverson et al, 2008) and significant correlations have been established between BESS and force-platform sway measures (Riemann et al, 2000).


Estimated Enrollment: 30
Study Start Date: August 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control group
Osteopathic evaluation Cognitive and Physical Rest
Experimental: Osteopathic Treatment Group
4 osteopathic treatments following a set protocol to which only the osteopathic lesions found within the subjects assessment will be treated.
Other: 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.


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

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or Female Athletes between the ages of 18-40
  • Participate in athletic endeavours at least 4 times/week prior to injury
  • Post Concussive symptoms with associated vestibular disturbance (balance and dizziness) greater than one month in duration and no longer than 12 months
  • Concussion was secondary to athletic participation only (i.e. no motor vehicle accident (MVA) mechanisms)

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01962883

Contacts
Contact: Christal Geier, CAT(C) 1.403.837.1521 take.flight.AT@gmail.com
Contact: Momoko Okomoto, CAT(C) 1.403.948.6533 momokomomo@gmail.com

Locations
Canada, Alberta
Take Flight Athletic Therapy Clinic Recruiting
Carstairs, Alberta, Canada, T0M 0N0
Contact: Christal Geier, CAT(C)    1.403.837.1521    Take.Flight.AT@gmail.com   
Contact: Momoko Okomoto, CAT(C)    1.403.948.6533    momokomomo@gmail.com   
Sponsors and Collaborators
Collège d'Études Ostéopathiques
Investigators
Study Director: Bonnie Sutter, DOMP, CAT(C) College d'Etudes Osteopathiques (Vancouver Campus)
Principal Investigator: Christal Geier, CAT(C) College d'Etudes Osteopathiques (Vancouver Campus)
  More Information

Publications:
Responsible Party: Christal Geier, Osteopathic Manual Practitioner Thesis Candidate, Collège d'Études Ostéopathiques
ClinicalTrials.gov Identifier: NCT01962883     History of Changes
Other Study ID Numbers: CEOVtPCS
Study First Received: October 5, 2013
Last Updated: October 9, 2013
Health Authority: Canada: College d'Etudes Osteopathiques (Vancouver)

Keywords provided by Collège d'Études Ostéopathiques:
Post Concussion Syndrome
Vestibular disturbance
Balance
Dizziness
Dizziness handicap inventory
Balance Error Scoring System

Additional relevant MeSH terms:
Post-Concussion Syndrome
Brain Concussion
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Head Injuries, Closed
Wounds and Injuries
Wounds, Nonpenetrating

ClinicalTrials.gov processed this record on July 22, 2014