Effects of Osteopathic Treatment on Vestibular Disturbed Active Post Concussed Individual

NCT01962883 | Completed

• 1 other identifier: CEOVtPCS
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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. 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. 2.Osteopathic treatment will have no effect on the balance recovery of the vestibular disturbed post concussed athlete using Balance Error Scoring System (BESS)
3. 3.To determine the side effects of osteopathic treatment of the vestibular disturbed post concussed athlete

Conditions

Post Concussion Syndrome

Keywords

Post Concussion Syndrome; Vestibular disturbance; Balance; Dizziness; Dizziness handicap inventory; Balance Error Scoring System

Outcome Measures

Primary Outcomes (2)

• 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).

  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).

• 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).

  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.

Study Arms (2)

Control group

NO INTERVENTION

Osteopathic evaluation Cognitive and Physical Rest

Osteopathic Treatment Group

EXPERIMENTAL

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

Other: Osteopathic treatment

Interventions

Osteopathic treatment OTHER

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.

Osteopathic Treatment Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Collège d'Études Ostéopathiques: lead

Study Sites (1)

Take Flight Athletic Therapy Clinic

Carstairs, Alberta, T0M 0N0, Canada

Location

Related Publications (5)

• 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.

  PMID: 23473405 BACKGROUND

• 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.

  PMID: 11495323 BACKGROUND

• 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.

  PMID: 2317323 BACKGROUND

• 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.

  PMID: 16558603 BACKGROUND

• Treleaven J. Dizziness Handicap Inventory (DHI). Aust J Physiother. 2006;52(1):67. doi: 10.1016/s0004-9514(06)70070-8. No abstract available.

  PMID: 16555410 BACKGROUND

MeSH Terms

Conditions

Post-Concussion Syndrome; Dizziness

Interventions

Manipulation, Osteopathic

Condition Hierarchy (Ancestors)

Brain Concussion; Head Injuries, Closed; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries; Wounds, Nonpenetrating; Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Bonnie Sutter, DOMP, CAT(C)

  College d'Etudes Osteopathiques (Vancouver Campus)

  STUDY DIRECTOR

• Christal Geier, CAT(C)

  College d'Etudes Osteopathiques (Vancouver Campus)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Osteopathic Manual Practitioner Thesis Candidate

Study Record Dates

• First Submitted: October 5, 2013
• First Posted: October 14, 2013
• Study Start: August 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: January 1, 2015
• Last Updated: February 4, 2015

Record last verified: 2015-02

Locations

CA (1)