Vertigo Clinical Trial
Official title:
Efficacy of a Mechanical Chair for Treatment of Benign Paroxysmal Positional Vertigo (BPPV)
Benign paroxysmal positional vertigo (BPPV) is the most common inner ear cause of dizziness. It has been reported that up to 900 of every 10,000 people in the United States experience this problem with an estimated annual healthcare cost approaching $2 Billion. This problem occurs when calcium carbonate "crystals" which are present and needed in one part of the balance area of the inner ear become displaced to a different part of the balance area. This is very disruptive to the function of the inner ear and results primarily in intense vertigo. Nausea,imbalance, and falls can also occur. The accepted course of management for BPPV is the use of "repositioning maneuvers" which are completed by moving patients through specific head/body positions that literally reposition the displaced crystals out of the wrong area. These treatment methods are reported to be effective for about 80% of patients after one-to-three treatments. For the remaining 20% of patients, more treatments may be necessary and for a small percentage of patients surgical options may be the only cure. Additionally, some patients with BPPV are not able to physically move into the needed positions because of hip and neck problems, spinal problems, obesity, other mobility limitations, etc. Within the past decade, a motorized chair was developed to help reposition any patient with BPPV. There have been no reported adverse incidents with the motorized chair but the device was quite expensive so it was only available at a handful of clinical sites. At this time the motorized chair is no longer being manufactured. More recently, a mechanical chair was developed and has been in use in Europe and China. The mechanical chair has all the advantages of the motorized chair but with a lesser cost. The inventor of the mechanical chair has also developed some slight variations on treatment technique that may have the potential to improve treatment efficacy. We are privileged to have the only mechanical chair of this type in the United States. The primary purpose of the current project is to systematically investigate the treatment efficacy of this mechanical chair for patients with BPPV. We will compare treatment outcomes for patients diagnosed with BPPV using standard methods, the mechanical chair, and a sham condition also using the mechanical chair. A secondary purpose is to determine treatment efficacy for patients with covert BPPV. We will simply measure if treatment with the mechanical chair has any effect on patient symptoms. If we determine treatment is improved with the mechanical chair then it may be possible to help a greater number of patients with BPPV with fewer treatments.
Benign paroxysmal positional vertigo (BPPV) is the most common cause of vertigo
(Bhattacharyya et al., 2017). BPPV is estimated to affect 900 out of 10,000 people annually
(Kerrigan et al., 2013) with healthcare costs approaching $2 Billion (Bhattacharyya et al.,
2017). We have shown that patients with BPPV rate the impact on their quality of life similar
to patients with macular degeneration, hepatitis B, and HIV/AIDS (Roberts et al., 2009). BPPV
occurs when calcium carbonate crystals from one part of the inner ear balance system
(utricle) become displaced into other parts of the inner ear balance system (semicircular
canal). Normal head and body movements cause movement of the crystal debris within the
semicircular canals. This movement causes changes in stimulation of the sensory structures of
the semicircular canals that result in vertigo, nausea, imbalance, and even falls. It is well
established that BPPV affects the posterior semicircular canal 80% of the time, the
horizontal canal 15% of the time and the anterior canal 5% of the time.
There are established methods that have been proven to be effective in treatment of BPPV with
randomized controlled trials (Hilton & Pinder, 2014). Each of these methods involves moving a
patient's head and body through specific positions to remove the debris from the involved
canal. However, many of these patients require multiple treatments and there is a group of
patients with BPPV that do not respond to these treatments and for whom surgical options are
ultimately considered. Further, patients with hip or neck problems, spinal issues, and even
obesity are often unable to be placed in or move through the required positions.
A motorized chair was developed to improve treatment consistency and efficacy and broaden the
group of patients who could receive appropriate treatment (Nakayama & Epley, 2005). Although
the motorized chair was effective and there are no known reports of adverse events, it was
also very expensive. Few facilities were able to purchase the motorized chair so the
anticipated impact on helping patients with BPPV was never realized. The motorized chair is
no longer being manufactured. A mechanical chair for assessment and treatment of BPPV was
also described around the same time as the motorized chair (Richard-Vitton et al., 2005).
This is referred to as the TRV chair which are the initials of the inventor.
This mechanical chair has been used in several countries including across Europe and in
China. Wang et al. (2014) reported they were able to clear various types of BPPV in 202 of
208 (97.1%) cases. The remaining six cases reported significant improvement. There was no
control group in this study and the inventor is listed as an author. No adverse events were
reported. West et al. (2016) completed a retrospective chart review of patients treated for
BPPV in their clinic.Interestingly, they had both the TRV chair and the motorized chair. Some
of their patients also underwent treatment with traditional methods which do not incorporate
a specialized chair to help position patients. The authors concluded that specialized chairs
(motorized or mechanical) are useful for treatment of BPPV, especially for more difficult
cases. There are also some limitations with this report in that no control group was used and
participants were not randomly assigned to a treatment type. Patients with a typical history
of BPPV, and identified with the most common type affecting the posterior canal, were treated
with the traditional methods first and then perhaps with a specialized chair. Other patients
were treated with both types of chair. No adverse events were reported.
Specialized chairs do appear to offer some advantages over traditional methods of BPPV
treatment. Reports in the literature suggest the specialized chairs are able to treat more
difficult cases of BPPV. This should allow improved cure rates for the approximately 20% of
patients that require multiple treatments using the traditional methods. Use of specialized
chairs would also increase the number of patients who can be treated because there are no
contraindications related to hip, spine, and mobility issues as there are for traditional
methods of BPPV treatment. The mechanical chair (TRV chair) appears to offer all of the
advantages of the motorized chair but at a lessor cost anticipated to be $65,000 compared to
$100,000 for the motorized chair. One may speculate there is less maintenance required for a
mechanical versus a motorized system and there is the fact that the currently described
motorized version is no longer available for purchase.
The primary purpose of this project is to determine treatment efficacy of the motorized TRV
chair for patients with BPPV. This information has not been published using a randomized
controlled design. A secondary purpose of the project is to determine if the TRV chair is
helpful in patients experiencing chronic symptoms of dizziness and unsteadiness who may have
complaints suggesting positional vertigo but who fail to generate nystagmus (i.e. covert
BPPV). If the TRV chair is more efficacious than traditional methods, our hope is that nearly
all patients with BPPV will be able to be managed in a more efficient manner. This will
decrease the impact of BPPV on health-related quality of life, could decrease falls related
to BPPV, and should also decrease the burden of healthcare costs.
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