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Scientific Research into Dysphagia Treatment Modality ReachesUnprecedented...



An updated summary of extensive independent clinical trials and research initiatives on the treatment of dysphagia with electrical stimulation was released by Empi Recovery Sciences, a leading distributor of electrical stimulation products used in rehabilitation.



Dysphagia, or difficulty with swallowing, is a sorely neglected medical disorder that impacts as many as 15 million Americans, with hundreds of thousands annually receiving a new diagnosis of the condition.



The paper, Neuromuscular Electrical Stimulation in the Treatment of Dysphagia: A Summary of the Evidence, shows that the scientific data has proliferated over the past two years at an unprecedented rate.



Neuromuscular Electrical Stimulation (NMES) used as an adjunct modality in the treatment of dysphagia has gained increasing adoption by medical professionals since the clearance by the Food and Drug Administration of VitalStim's174; Therapy, the only device on the market with such clearance. (FDA 2002)



According to Yorick Wijting, director of clinical research for VitalStim, The need for clinical data to support the efficacy of electrical stimulation in the continuing treatment of dysphagia is being satisfied by independent medical researchers around the world.



Research activity in this area is unparalleled in the history of dysphagia research. Available data now provide substantial scientific and clinical support for the addition of



electrotherapy in the treatment of dysphagia to enhance treatment outcomes. In actual fact, available evidence supporting the use of NMES for dysphagia at present exceeds the evidence supporting other reimbursable interventions used in the treatment of dysphagia.



Use of NMES in the treatment of dysphagia involves the administration of small electrical impulses to swallowing muscles in the throat through electrodes attached to the skin overlying the musculature.



The therapist determines which musculature would benefit from this intervention though the standard evaluation procedure which typically includes some form of instrumental assessment. The data gathered from the assessment permits the therapist to recommend the appropriate electrode placement in order to facilitate the target musculature. Once the current intensity reaches the appropriate therapeutic level, traditional swallowing therapy is initiated. The patient exercises the swallowing muscles during a treatment session that may last up to one hour, all the while receiving concurrent electrical stimulation. The electrical stimulation when applied in this manner accelerates muscle strengthening and increases the effectiveness of the exercise therapy.



To date, over 30 studies have been conducted among a diverse patient population, with numerous others in progress. The published and/or presented research contained in the summary was evaluated in terms of safety, efficacy, user and patient satisfaction, diagnosis-specific application of NMES for dysphagia, and VitalStim's174; Therapy protocol and reimbursement. Some highlights of the summary follow:



Safety - The use of NMES in the treatment of dysphagia has been demonstrated to be safe. The studies reviewed all tracked for the occurrence of adverse events and none were reported, across all patient ages and diagnoses.



Efficacy - A meta-analysis of the available treatment research published in the past 30 years. (Carnaby-Mann and Crary 2007) confirmed that no adverse events were identified and attributed a statistically significant positive treatment effect favoring the use of NMES on the throat in the rehabilitation of dysphagia.



User and Patient Satisfaction - Therapists in the U.S. are rapidly adopting the use of NMES in the treatment of dysphagia. Besides the growing empirical evidence base, this adoption is primarily as a result of widespread reports of good patient outcomes and good patient satisfaction. An independent user survey of 2,000 therapists (Crary et al. 2007) confirmed that the majority of users are reporting good outcomes, good therapist and patient satisfaction and no adverse events.



Diagnosis-Specific Application of NMES for Dysphagia - The summary of evidence evaluates the use of NMES in treating Head 's38; Neck Cancer, Stroke and other conditions. (See complete paper for details)



VitalStim Therapy Protocol and Reimbursement - In most available studies the VitalStim Therapy device and electrodes were used to deliver the therapy. The VitalStim Therapy device is the only device specifically cleared by the FDA for the treatment of dysphagia with electrode placements on the anterior portion of the neck. (FDA 2002) The equipment, the accompanying supplies and the mandatory competency training for treating therapists were specifically designed to satisfy safety and efficacy concerns of the FDA. The use of VitalStim Therapy, when applied as instructed and as intended, is


therefore consistent with the FDA cleared protocol and backed up by evidence. This is an important consideration from a reimbursement perspective since Medicare will not reimburse for therapy delivered using off-label (not cleared by the FDA) equipment


and supplies; CMS considers these to be experimental and investigational and therefore not covered.



Copies of the report Neuromuscular Electrical Stimulation in the Treatment of Dysphagia: A Summary of the Evidence are available from Empi and its authorized dealers or at www.vitalstim.com.



About VitalStim's174; Therapy:


VitalStim's174; Therapy is a patented therapy process and equipment system developed specifically to treat dysphagia. It is the only NMES therapy and equipment system to have received clearance from the Food 's38; Drug Administration for the treatment of dysphagia: muscle re-education by application of external stimulation to the muscles necessary for pharyngeal contraction. To date, VitalStim's174; Therapy has been administered with no reported adverse effects to over 100,000 patients by over 11,000 VitalStim-trained and certified therapists around the country. VitalStim is an Empi product.



CONTACT:


LEE LAINO


212-879-1814






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