ClinicalTrials.Veeva

Menu

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

C

Collège d'Études Ostéopathiques

Status

Completed

Conditions

Post Concussion Syndrome

Treatments

Other: Osteopathic treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT01962883
CEOVtPCS

Details and patient eligibility

About

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

Full 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.

Enrollment

6 patients

Sex

All

Ages

18 to 45 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

6 participants in 2 patient groups

Control group
No Intervention group
Description:
Osteopathic evaluation Cognitive and Physical Rest
Osteopathic Treatment Group
Experimental group
Description:
4 osteopathic treatments following a set protocol to which only the osteopathic lesions found within the subjects assessment will be treated.
Treatment:
Other: Osteopathic treatment

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems