VitalStim Therapy
"VitalStim Therapy is an
innovative therapy for patients suffering from a swallowing disorder called
dysphagia. This non-invasive, painless treatment uses controlled neuromuscular
electrical stimulation to strengthen the muscles used in swallowing" (Moore,n.d.).
http://www.vitalstimtherapy.com/inthenews.html
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VitalStim Therapy-A Brief Overview
VitalStim Therapy is utilized to treat dysphagia (swallowing disorders). "It is an active rehabilitation program" (www.vitalstimtherapy.com/hope.html). It is non-invasive and is utilized to strengthen the muscles utilized during swallowing.
What are the Mechanics of VitalStim Therapy?
VitalStim Therapy utilizes a special
type of neuromuscular electri
cal
stimulation and electrodes that are specially designed to stimulate the muscles
involved in swallowing.
It utilizes less voltage than external stimulators.
For use with dysphagia treatment, it utilizes ¼ the amount of voltage utilized for physical and occupational therapy or athletic training (Waldowski, 2002).
The VitalStim device produces consistent levels of stimulation when treating dysphagia.
What does VitalStim Research Show?
Research shows that individuals with chronic swallowing difficulties that received
outpatient therapy where VitalStim was utilized did show success.
Research also shows that success appears to be higher in individuals who exhibit dysphagia "without cricopharyngeal involvement" (www.vitalstimtherapy.com/hope.html).
Improvement of swallowing difficulties can be expected to be seen anywhere from 6 to 20 daily sessions, with some individuals noticing improvement with as few as 3 daily sessions (www.vitalstimtherapy.com/hope.html).
VitalStim therapy has a 97% success rate in improving an individual’s swallow (Waldowski, 2002).
How Does it Work?
The VitalStim device is pre-set and gives continual stimulation, with a small break every 60 seconds. The VitalStim transmitter differs from those typically used for electrical stimulation of other muscles because it delivers only one quarter of electrical current used in other applications. (FDA) During the session, the patient is encouraged to take small sips or chews, to swallow hard, and to remember to clear the throat, if needed. The electrical stimulation allows the patient to take tiny swallows, such as with juice, slowly re-educating throat muscles how to handle thin liquids. Throughout the session the patient’s health is also monitored using a pulsoximeter to measure the patient’s blood oxygen saturation levels and heart rate.
The treatment is non-invasive and painless and claims to offer dramatic improvement in the patient’s swallowing, as well as significant cost savings compared to traditional treatments. According to the manufacturer, Chattanooga Group (2003), cost savings through the use of VitalStim Therapy are dramatic when compared to the costs associated in the management of a patient on a feeding tube. Feeding tube costs average over $31,000 per patient per year. In comparison, VitalStim Therapy units cost $1,595 per year and supplies are approximately $20 per treatment. Fees for the therapy vary based on clinician charges. There is also the cost of electrodes which are approximately $20 per pack for one hour of e-stim. Training to be certified in the technique is currently $895 (Career Improvement and Advancement Opportunities, 2004).
Is it Safe?
The FDA approved the VitalStim device for sale in the United States. FDA approval means that the device assures the public you that the product has been tested safety and seemed to be effective the clinical trial. The FDA outlines indications for use and includes information about the agent’s side effects. FDA approval does not assure that a given treatment agent will be effective in individual cases. The FDA has approved this device as Regulatory Class II. Class II devices are those for which general controls alone are insufficient to assure safety and effectiveness, and existing methods are available to provide such assurances. In the case of VitalStim, this means that the device must be prescribed by a physician and used by a licensed medical professional.
There are some contradictions and warnings associated with this device (Center for Devices and Radiological Health, 2002.) These warnings include caution to be used when delivering the therapy to those with cardiac pacemakers. Additional warnings include:
Is it Effective?
The manufacturers say that reviews and studies indicate this form of therapy has shown marked success with patients with chronic dysphagia . In these studies, 71 percent of patients, diagnosed with dysphagia and experiencing cricopharyngeal dysfunction, progressed to swallow all consistencies of food with a combination of VitalStim Therapy and esophageal sphincter dilation (VitalStim Therapy, 2004).
They also claim even higher success rates in cases of patients diagnosed with dysphagia without cricopharyngeal involvement with some patients seeing dramatic improvement in six to 20 daily sessions, sometimes in as little as three days.
Many feel research on the technique is inconclusive and insufficient. Large scale studies have not been done and existing marketing of the therapy is based primarily on findings from its inventor.
In one study (Freed, Freed, Chatburn, & Christian, 2001), the authors compared the effectiveness of the electric stimulation treatment to thermal-tactile stimulation treatment in patients with dysphagia caused by stroke and to assess the safety of the VitalStim technique. In this study, stroke patients with swallowing disorders were assigned a electrical stimulation therapy group or to a thermal-tactile stimulation group. The thermal-tactile stimulation group received therapy consisting touching the base of the anterior faucial arch with a metal probe chilled by immersion in ice. The electrical stimulation group was administered therapy with a modified hand-held battery-powered electrical stimulator connected to a pair of electrodes positioned on the neck. Each group received daily treatments lasting 1 hour. Both treatment groups showed improvement in swallowing, but the final swallow scores were higher in the electrical stimulation. In addition, the authors noted that 98% of the electrical stimulation group showed some improvement, while 27% of the thermal-tactile simulated patients remained at initial swallow score and 11% got worse.
In another study (Leelamanit, Limsakul, & Geater, 2002), the authors tested the claim that synchronous contraction of the thyrohyoid muscle by electrical stimulation during swallowing would improve dysphagia. In this study, 23 patients with a moderate to severe degree of dysphagia resulting from reduced laryngeal elevation who did not respond to medical treatment were treated by stimulating synchronous contraction of the thyrohyoid muscle during swallowing with the synchronous electrical stimulator. Treatment was given daily for 4 hours until criteria for improved swallow were fulfilled or other intervention was deemed necessary. Twenty of the patients showed marked improvement at the first course of treatment. The duration of the therapy varied from 2 to 4 days in patients with moderate dysphagia and from 3 to 30 days in patients with severe dysphagia. Two patients failed synchronous electrical stimulator treatment and subsequently required tube insertion for feeding. Six patients who achieved improved swallow criteria relapsed at 2 to 9 months after the first treatment course and were successfully treated with an additional course of synchronous electrical stimulation. From the study the authors concluded that stimulating synchronous contraction of the thyrohyoid muscle by the electrical stimulator during swallowing improves dysphagia (resulting from reduced laryngeal elevation.)
Validity has been questioned in both of these studies. According to Clark (2003), studies of this therapy, where electrical stimulation is applied to the swallowing mechanism, have been few and limited information is available regarding the appropriate practice of this therapy. Further, differences exist between muscles stimulated through electrical current and those strengthened by active exercise. This author adds that there is limited evidence on the benefit of electrical stimulation therapy for improved swallowing. Clark also noted that Freed’s article may show investigator bias as she is the person marketing this device. Clark feels Freed may not have had similar enough participants for the trial or may have selected which participants went to each group which would make replicating the trial difficult. In the Leelamanit, Limsakul, & Geater (2003) study, Clark feels the subjects may not have been different enough and the authors may have overgeneralized the results. With the lack of different studies which all find the therapy effective (or ineffective) the jury is may still be out of the issue of efficacy.
It could be noted that the fact this therapy claims a very high success rate and does not explain the process of how it exactly improves the swallow may be red flags for a money-making scheme. Additionally, the fact that one cannot perform the therapy unless you are certified by the sellers of the device also may add to this opinion.
However, it must be noted that there are often few good studies in the area of swallowing treatments. If only strategies and techniques that were proven to be effective by repeated double-blind studies were used, there would be little that a therapist could do. Added to this is the fact that many research studies are conducted using a highly homogenous group (e.g., dysphagia from stroke, Parkinson's, spasticity, etc.)and actual use of therapies address a more wide range of patients. Positive or negative results from a homogeneous study would technically apply only to individuals with a similar diagnosis. While good research is invaluable to clinicians, new methods are often devised by those with experience who have an idea, explore that idea with clients and begin to see patterns of change in the client group. Ideally, that clinician will would have access to qualified researchers and funds to do an initial pilot study to test the hypothesis, and eventually the resources to do a full-scale study that can be published in a peer-reviewed journal.
Marcy Freed's work is very interesting and as a stimulus for learning more about how the swallowing system functions. Because she is doing both electrical stimulation and dilatation of the esophageal junction, we don't really know what part of the combined strategy is making the difference for some patients. Further, we don't know how much of the total approach simply becomes a stimulus for patients to do their own self-healing. We do, however, know that with the FDA approval that there is an initial level of approval of the equipment and procedure. Of course, the FDA has been wrong in the past in some of it's statements of safety or effectiveness of drugs or treatments, but right now, it's the best safeguard we have. It is not completely understood why and how it works, but one could say that about a lot of things that are used effectively in science and medicine (e.g., aspirin, acupuncture, etc.). And we certainly don't know which groups of clients are likely to benefit from the procedure and which are not. With the greater availability of VitalStim to the general public will help answer some of these clinical questions that can lead to more meaningful research.