Clinical Trials Directory

Trials / Completed

CompletedNCT01962883

Effects of Osteopathic Treatment on Vestibular Disturbed Active Post Concussed Individual

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
6 (actual)
Sponsor
Collège d'Études Ostéopathiques · Academic / Other
Sex
All
Age
18 Years – 45 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHEROsteopathic treatmentThe 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.

Timeline

Start date
2013-08-01
Primary completion
2014-12-01
Completion
2015-01-01
First posted
2013-10-14
Last updated
2015-02-04

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT01962883. Inclusion in this directory is not an endorsement.