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

Primary Purpose

Post Concussion Syndrome

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Osteopathic treatment
Sponsored by
Collège d'Études Ostéopathiques
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Concussion Syndrome focused on measuring Post Concussion Syndrome, Vestibular disturbance, Balance, Dizziness, Dizziness handicap inventory, Balance Error Scoring System

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Take Flight Athletic Therapy Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group

Osteopathic Treatment Group

Arm Description

Osteopathic evaluation Cognitive and Physical Rest

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

Outcomes

Primary Outcome Measures

Dizziness Handicap Inventory (DHI)
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)
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).

Secondary Outcome Measures

Full Information

First Posted
October 5, 2013
Last Updated
February 2, 2015
Sponsor
Collège d'Études Ostéopathiques
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1. Study Identification

Unique Protocol Identification Number
NCT01962883
Brief Title
Effects of Osteopathic Treatment on Vestibular Disturbed Active Post Concussed Individual
Acronym
PCS
Official Title
The Effects of Osteopathic Treatment on Balance and Dizziness of the Vestibular Disturbed Active Post Concussed Individual.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Collège d'Études Ostéopathiques

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 Osteopathic treatment will have no effect on the symptoms of dizziness of the vestibular disturbed post concussed athlete using the Dizziness Handicap Inventory 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Concussion Syndrome
Keywords
Post Concussion Syndrome, Vestibular disturbance, Balance, Dizziness, Dizziness handicap inventory, Balance Error Scoring System

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
Osteopathic evaluation Cognitive and Physical Rest
Arm Title
Osteopathic Treatment Group
Arm Type
Experimental
Arm Description
4 osteopathic treatments following a set protocol to which only the osteopathic lesions found within the subjects assessment will be treated.
Intervention Type
Other
Intervention Name(s)
Osteopathic treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Dizziness Handicap Inventory (DHI)
Description
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).
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).
Title
Balance Error Scoring System (BESS)
Description
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).
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bonnie Sutter, DOMP, CAT(C)
Organizational Affiliation
College d'Etudes Osteopathiques (Vancouver Campus)
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Christal Geier, CAT(C)
Organizational Affiliation
College d'Etudes Osteopathiques (Vancouver Campus)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Take Flight Athletic Therapy Clinic
City
Carstairs
State/Province
Alberta
ZIP/Postal Code
T0M 0N0
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
23473405
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.
Results Reference
background
PubMed Identifier
11495323
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.
Results Reference
background
PubMed Identifier
2317323
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.
Results Reference
background
PubMed Identifier
16558603
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.
Results Reference
background
PubMed Identifier
16555410
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.
Results Reference
background

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Effects of Osteopathic Treatment on Vestibular Disturbed Active Post Concussed Individual

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