Post Concussion SyndromePCSNCT01962883
Effects of Osteopathic Treatment on Vestibular Disturbed Active Post Concussed Individual
A study testing Osteopathic treatment in people with Post Concussion Syndrome, run by Collège d'Études Ostéopathiques at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Post Concussion Syndrome
- What is being tested?
- Osteopathic treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2013to Jan 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Osteopathic Treatment on Balance and Dizziness of the Vestibular Disturbed Active Post Concussed Individual.
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
Read the 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
- Post Concussion Syndrome
- Being tested
- Osteopathic treatment
- Keywords
- Post Concussion Syndrome, Vestibular disturbance, Balance, Dizziness, Dizziness handicap inventory, Balance Error Scoring System
- Medical subject headings
- Post-Concussion Syndrome, Dizziness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic treatmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Osteopathic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2013 (estimated)
- Study startAug 2013
- Primary completionDec 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Post Concussion SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Collège d'Études Ostéopathiques
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christal Geier, Collège d'Études Ostéopathiques
- Investigators
- Bonnie Sutter, DOMP, CAT(C), Study director, College d'Etudes Osteopathiques (Vancouver Campus)Christal Geier, CAT(C), Principal investigator, College d'Etudes Osteopathiques (Vancouver Campus)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01962883
- Sponsor's protocol ID
- CEOVtPCS
- Acronym
- PCS
- Status last verified
- Feb 2015
- First submitted
- 5 Oct 2013
- Last updated
- 4 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23473405Guskiewicz 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.
PubMed 11495323Jacobson 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.
PubMed 2317323Riemann 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.
PubMed 16558603Treleaven J. Dizziness Handicap Inventory (DHI). Aust J Physiother. 2006;52(1):67. doi: 10.1016/s0004-9514(06)70070-8. No abstract available.
PubMed 16555410
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Osteopathic Treatment on Balance and Dizziness of the Vestibular Disturbed Active Post Concussed Individual.
- ClinicalTrials.gov ID
- NCT01962883
- Acronym / sponsor ID
- PCS / CEOVtPCS
- Conditions
- Post Concussion Syndrome
- Keywords
- Post Concussion Syndrome, Vestibular disturbance, Balance, Dizziness, Dizziness handicap inventory, Balance Error Scoring System
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Collège d'Études OstéopathiquesUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 14 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Osteopathic evaluation Cognitive and Physical Rest |
| Osteopathic Treatment Group | Experimental | Other: Osteopathic treatment4 osteopathic treatments following a set protocol to which only the osteopathic lesions found within the subjects assessment will be treated. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osteopathic 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. | Other | Osteopathic Treatment Group |
Primary outcome
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).
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.
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2015.
- Background: PubMed 23473405Iverson 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.
- Background: PubMed 11495323Guskiewicz 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.
- Background: PubMed 2317323Jacobson 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.
- Background: PubMed 16558603Riemann 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.
- Background: PubMed 16555410Treleaven J. Dizziness Handicap Inventory (DHI). Aust J Physiother. 2006;52(1):67. doi: 10.1016/s0004-9514(06)70070-8. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bonnie Sutter, DOMP, CAT(C) study director
College d'Etudes Osteopathiques (Vancouver Campus)
Christal Geier, CAT(C) principal investigator
College d'Etudes Osteopathiques (Vancouver Campus)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteopathic treatment in people with Post Concussion Syndrome, run by Collège d'Études Ostéopathiques at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01962883, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2015.