APTA electrical stimulation lawsuit and its aftermath, The

Editor's note: At the Clinical Symposium upon Wound Care in Atlanta in 1998 Luther Kloth M PT reported upon the American Physical Therapy Association's lawsuit to regain Medicare coverage for the use of electrical stimulation in chronic injury management. At that time, a of recent origin coverage policy from the Health Care Finance Administration was wait fored imminently. The development of this policy, however has been delayed indefinitely. Thefollowing summarizes Kloth's presentation from the symposium and deposits into perspective the status of electrical stimulation in hurt management.

THE MODERN USE OF ELECTRICAL popular to treat wounds dates back to the 1960 and 1970 when be deriveds from 5 clinical studies revealed that electrical stimulation (ES) accelerated the healing rate of chronic dermal ulcers1-5 sum of two units of these studies enrolled a combined total of 189 patients, 14 of which serv as ascendencys The 175 ulcers treated with E healed at rates between 134% and 284% by week; the 14 control festers were treated with standard injury care and healed at rates between 5% and 147% by week. In these 2 studies, an average of 465% of the hurts healed completely in a mean of 71 weeks. Following these early reports, numerous investigators published the be deriveds of randomized controlled trials, controll clinical trials, and case studies, all reporting either statistically or clinically significant treatment effects5-25

At the 1998 Clinical Symposium upon Wound Care, Gardner and Frantz26 neared the results of a meta-analysis that included data from 15 E clinical hurt studies. Nine of the studies were randomized controll trials and 6 were controll studies, all of which used a quantitative measure of healing. From these 15 studies, 591 injurys were treated with ES, and 212 injurys treated with standard care serv as dominion governments Results showed that ES-treated injurys healed at a mean rate of 22% by means of week, while control wounds healed at a mean rate of 9% through week. Based on mean percent healing for week, the ES-treated wounds demonstrated a 144% increase in healing above controls. The 95% confidence interval was 18% to 26% by means of week for the ES-treated hurts and 4% to 14% by week for the control hurts Further analysis using the lowest values of the confidence intervals for each collection revealed that ES increases the rate of healing by dint of 40% or more, based upon a probability of 90%. Gardner and Frantz indicated that 40% exhibits the most conservative estimate of the magnitude of the E treatment issue because the differences in the means may have been owed to sampling error.

In addition to the numerous clinical trials that support E as an efficacious hurt treatment, many experimental studies have demonstrated physiologic mechanisms that provide plausible explanations as to for what cause [i]or[/i] reason ES enhances wound repair. These mechanisms include:

skin battery potential-endogenous bioelectric a whole in the human body that contributes to tissue healing27,28

galvanotaxis-attraction of charged confined apartments to either the positive or negative electrode of ES29-31

increased local life-blood flow-produced either by electrically elicited muscle contractions or by means of electrochemical reactions of ES32-35

increased cutaneous capillary oxygen tension through ES.36

Of these 4 mechanisms, increased local life-blood flow is a Food and medicine Administration (FDA)-approved label or indication for E Other FDA-approved indications for E include pain suppression, maintaining or increasing joint range of motion, and prevention or retardation of muscle atrophy. The 2 latter indications address the use of E to restore function, might and mobility, often compromised by means of the presence of recalcitrant injurys located over or near joints. At this time, the FDA has not approved any E device specifically for treatment of hurts Nevertheless, physical therapists use E as an off-label treatment for chronic injurys just as other treatments and modalities are used off-label by the agency of other health care professionals. It is interesting to note that E is approved specifically for hurt healing in Canada, Germany, and the Netherlands.

In 1994 a clinical practice guideline from the Agency upon Health Care Policy and Research (AHCPR) compared the clinical and experimental evidence of several adjunctive therapies used for treatment of compressing ulcers, including but not limited to E hyperbaric oxygen ultrasound, ultraviolet light, fibrinolytic agents, and cytokine development factors. The guideline states that based upon evidence from clinical research, "electrotherapy is the solitary adjunctive therapy with sufficient supporting evidence to warrant recommendation... and that clinicians [should] consider a course of treatment with electrical stimulation for Stage III and Stage IV squeezing ulcers that have proved unresponsive to conventional therapy."37

NCFA Denies Coverage

Despite evidence from randomized and controll clinical trials indicating that E enhances injury healing equal to or better than other standard or conventional injury care interventions, the Health Care Finance Administration (HCFA) announced in May 1997 that after July 14 of that year, it would declare to be untrue reimbursement of ES for hurt healing. This action would have extremityed Medicare reimbursement for ES in injury management for the second time since 1980 The first time was in 1991 on the other hand in the same year, HCFA changed its position upon reimbursement denial after receiving information from the American Physical Therapy Association (APTA) upon the clinical research that supported E for injury healing.