Informed Consent for Intravenous Tissue Plasminogen Activator in New York State Designated Stroke Centers.

OBJECTIVE: Our objective was to assess informed consent procedures for intravenous tissue plasminogen activator in acute stroke among New York State (NYS) Department of Health (DOH) designated stroke centers. METHODS: A 13-question survey stratified by 0- to 3-hour and 3.0- to 4.5-hour treatment windows was used to determine the type of consent or if no consent was required. RESULTS: Of the 117 hospitals, 111 responded (95%). All 111 hospitals provided treatment within the 3-hour window, whereas 97 (87%) provided treatment beyond the 3-hour window (P < .001). For hospitals that did provide treatment, there was a difference between the percentages of hospitals requiring consent (verbal or written) within 3 hours (82%) and beyond 3 hours (92%) (P = .04). Of the hospitals requiring consent, there was a difference in the type of consent: 31 of 91 (34%) required written consent within the 3-hour window, whereas 57 of 89 (64%) required written consent beyond the 3-hour window (P < .001). Within both treatment windows, 98% accepted a health-care proxy or surrogate in lieu of the patient. Of the hospitals with less than 500 beds, 11 of 81 (14%) did not require consent within the 3-hour treatment window, compared to hospitals with 500 or more beds where 9 of 30 (30%) did not require consent within the 3-hour treatment window (P < .05). Beyond the 3-hour treatment window, hospitals with more than 500 beds required written consent-2-fold increase "compared to less than 3 hour window" (P < .05). Fifty-five percent of the hospitals were academic, whereas 45% were nonacademic. Academic status was not related to the type of consent in either window. CONCLUSIONS: Significant variability exists in the types of informed consent based on hospital bed size and treatment windows across NYS DOH designated stroke centers.

Pulsed electromagnetic fields to reduce diabetic neuropathic pain and stimulate neuronal repair: a randomized controlled trial.

OBJECTIVE: To determine whether repetitive and cumulative exposure to low-frequency pulsed electromagnetic fields (PEMF) targeting painful feet can reduce neuropathic pain (NP), influence sleep in symptomatic diabetic peripheral neuropathy (DPN), and influence nerve regeneration. DESIGN: Randomized, double-blind, placebo-controlled parallel study. SETTING: Sixteen academic and clinical sites in 13 states. PARTICIPANTS: Subjects (N=225) with DPN stage II or III were randomly assigned to use identical devices generating PEMF or sham (placebo) 2 h/d to feet for 3 months. INTERVENTIONS: Nerve conduction testing was performed serially. MAIN OUTCOME MEASURES: Pain reduction scores using a visual analog scale (VAS), the Neuropathy Pain Scale (NPS), and the Patient's Global Impression of Change (PGIC). A subset of subjects underwent serial 3-mm punch skin biopsies from 3 standard lower limb sites for epidermal nerve fiber density (ENFD) quantification. RESULTS: Subjects (N=225) were randomized with a dropout rate of 13.8%. There was a trend toward reductions in DPN symptoms on the PGIC, favoring the PEMF group (44% vs 31%; P=.04). There were no significant differences between PEMF and sham groups in the NP intensity on NPS or VAS. Twenty-seven subjects completed serial biopsies. Twenty-nine percent of PEMF subjects had an increase in distal leg ENFD of at least 0.5 SDs, while none did in the sham group (P=.04). Increases in distal thigh ENFD were significantly correlated with decreases in pain scores. CONCLUSIONS: PEMF at this dosimetry was noneffective in reducing NP. However neurobiological effects on ENFD, PGIC and reduced itching scores suggest future studies are indicated with higher dosimetry (3000-5000 G), longer duration of exposure, and larger biopsy cohort.

A randomized controlled trial of the effects of a combination of static and dynamic magnetic fields on carpal tunnel syndrome.

OBJECTIVE: To determine if a physics-based combination of simultaneous static and time-varying dynamic magnetic field stimulation to the wrist 4 hours/day for 2 months can reduce subjective neuropathic pain and influence objective electrophysiologic parameters of patients with carpal tunnel syndrome (CTS). METHODS: Randomized, double-blinded, placebo-controlled trial of 36 symptomatic hands. Primary endpoints were visual analog scale (VAS) and neuropathic pain scale (NPS) scores at baseline and 2 months and a Patient's Global Impression of Change (PGIC) questionnaire at the end of 2 months. Secondary endpoints were neurologic examination, median nerve distal latencies (compound muscle action potential [CMAP]/sensory nerve action potential [SNAP]), dynamometry, pinch gauge readings, and current perception threshold (CPT) scores. An "active" device was provided gratis at the end of the study, with 15 subjects voluntarily remaining within the open protocol an additional 2-10 months and using the preselected primary and secondary parameters. RESULTS: (two months). Of the 31 hands, 25 (13 magnet, 12 sham) had moderate to severe pain (VAS > 4). The VAS and PGIC revealed a nonsignificant pain reduction. NPS analyses (anova) demonstrated a statistically significant reduction of "deep" pain (35% downward arrow vs 12% upward arrow, P = 0.018), NPS Total Composite (decreases of 42% vs 24%, P = 0.042), NPS Total Descriptor Score (NPS 8; 43% vs 24%), and NPS 4 (42% vs 11%). Motor strength, CMAP/SNAP, and CPT scores were not significantly changed. Of the 15 hands with up to 10 months of active PEMF (pulsed electromagnetic fields) exposure, there was objective improvement in nerve conduction (CMAP = 53%, SNAP = 40%, >1 SD), and subjective improvement on examination (40%), pain scores (50%), and PGIC (70%). No detectable changes in motor strength and CPT. CONCLUSIONS: PEMF exposure in refractory CTS provides statistically significant short- and longterm pain reduction and mild improvement in objective neuronal functions. Neuromodulation appears to influence nociceptive-C and large A-fiber functions, probably through ion/ligand binding.

Biologic effects of 3 Tesla (T) MR imaging comparing traditional 1.5 T and 0.6 T in 1023 consecutive outpatients.

BACKGROUND: The recent use of high and ultra-high magnetic field (MF) systems (3.0 T and above) have raised concerns about biologic effects and safety. Sensory symptoms (magnetophosphenes, dizziness/vertigo, headaches, metallic taste, pain changes, and cognitive effects) have been reported. We monitored 1023 consecutive outpatients undergoing MRI after recent introduction of a 3 T MR unit in our community. METHODS/DESIGN: Observational study utilizing a pretest and posttest symptom rating scale (0-10) questionnaire presented to subjects undergoing MRI at three different facilities with five MRI machines, specifically a 3 T (Philips), three units with 1.5 T (GE, GE, Philips), and one 0.6 T (Fonar) unit to record symptoms before and after study. RESULTS: 147 subjects (14%) experienced either new (N= 69; 6.7%) or changes (N= 78; 8%) in symptoms. New onset symptoms occurred predominantly with 3 T and female preponderance (75%) [P= .002]. Vertigo/dizziness (N= 28, 5.6%) [P= .001], headache (N= 8), spine pain (N= 11) occurred more frequently on 3 T, whereas magnetophosphenes (N= 8) and metallic mouth symptoms (N= 4) occurred principally in 1.5 T. Seventy-eight subjects (8%) experienced pain symptoms upward arrow downward arrow with 75% occurring with 1.5 T. Females were 60%. Forty-three percent of individuals had brain MRIs. Symptoms of vertigo/dizziness, headaches, and magnetophosphenes were more commonly seen in individuals undergoing brain MRIs but other body sites were also represented. CONCLUSIONS: Although no harmful effects were reported in 1023 cases, an unexpected high rate of 14% of individuals experienced sensory stimulation in both 3 T and 1.5 T units. Females appear to be more magnetically sensitive.

Thrombolysis (tissue plasminogen activator) in stroke: a medicolegal quagmire.

BACKGROUND AND PURPOSE: Despite the success of the 1995 National Institutes of Neurological Disorders and Stroke (NINDS) study using IV recombinant tissue plasminogen activator (tPA) within 3 hours in acute stroke and its subsequent FDA approval, there has been a reluctance to use tPA because of safety and efficacy issues with high incidence of intracerebral hemorrhage, and protocol violations. SUMMARY OF REVIEW: The following cases will illustrate the increased number of malpractice lawsuits generated by the controversy of "standard of care" and illustrate and educate clinicians regarding specific issues and how to avoid: (A) Failure to use tPA (loss of chance) or to transfer, Reed versus Granbury Hospital (Texas): acute stroke victim taken to local hospital with tPA available only for cardiology. Wife subsequently transferred patient to nearby stroke center but no tPA given. Defendant verdict; (B) Stroke misdiagnosis (failure to diagnose, loss of chance), Mei versus Kaiser Permanente South (San Francisco, CA): acute stroke while driving with ambulance taking to local hospital. Symptoms were misdiagnosed and neurologist did not see her for 6 hours. Plaintiff verdict; (C) Bleeding complications of therapy/failure of informed consent, Harris versus Oak Valley Hospital (California): acute stroke and hypertension treated with tPA with subsequent development of intracerebral hemorrhage. Patient alleged that tPA should not have been given. Defense verdict; (D) Expert witness testimony, Wojcicki versus Caragher (Massachusetts): a prominent neurologist gave "false and misleading testimony" and the Court found that the neurologist perpetrated a "fraud on the Court" intentionally and deliberately misleading the Court and jury. Court sanctioned the neurologist 88,685 dollars; Ensink versus Mecosta County General Hospital (Michigan): neurological testimony (plaintiff expert) regarding potential benefit of using tPA during last available 1 hour of window was felt to be "speculative". Defendant verdict. CONCLUSIONS: Neurologists, emergency room physicians and hospitals are at increased liability risk if they use or do not use tPA. Detailed documentation, informed consent or timely transfer should reduce threat of legal action.

Pulsed magnetic field therapy in refractory neuropathic pain secondary to peripheral neuropathy: electrodiagnostic parameters--pilot study.

CONTEXT: Neuropathic pain (NP) from peripheral neuropathy (PN) arises from ectopic firing of unmyelinated C-fibers with accumulation of sodium and calcium channels. Because pulsed electromagnetic fields (PEMF) safely induce extremely low frequency (ELF) quasirectangular currents that can depolarize, repolarize, and hyperpolarize neurons, it was hypothesized that directing this energy into the sole of one foot could potentially modulate neuropathic pain. OBJECTIVE: To determine if 9 consecutive 1-h treatments in physician's office (excluding weekends) of a pulsed signal therapy can reduce NP scores in refractory feet with PN. DESIGN/SETTING/PATIENTS: 24 consecutive patients with refractory and symptomatic PN from diabetes, chronic inflammatory demyelinating polyneuropathy (CIDP), pernicious anemia, mercury poisoning, paraneoplastic syndrome, tarsal tunnel, and idiopathic sensory neuropathy were enrolled in this nonplacebo pilot study. The most symptomatic foot received therapy. Primary endpoints were comparison of VAS scores at the end of 9 days and the end of 30 days follow-up compared to baseline pain scores. Additionally, Patients' Global Impression of Change (PGIC) questionnaire was tabulated describing response to treatment. Subgroup analysis of nerve conduction scores, quantified sensory testing (QST), and serial examination changes were also tabulated. Subgroup classification of pain (Serlin) was utilized to determine if there were disproportionate responses. INTERVENTION: Noninvasive pulsed signal therapy generates a unidirectional quasirectangular waveform with strength about 20 gauss and a frequency about 30 Hz into the soles of the feet for 9 consecutive 1-h treatments (excluding weekends). The most symptomatic foot of each patient was treated. RESULTS: All 24 feet completed 9 days of treatment. 15/24 completed follow-up (62%) with mean pain scores decreasing 21% from baseline to end of treatment (P=0.19) but with 49% reduction of pain scores from baseline to end of follow-up (P<0.01). Of this group, self-reported PGIC was improved 67% (n=10) and no change was 33% (n=5). An intent-to-treat analysis based on all 24 feet demonstrated a 19% reduction in pain scores from baseline to end of treatment (P=0.10) and a 37% decrease from baseline to end of follow-up (P<0.01). Subgroup analysis revealed 5 patients with mild pain with nonsignificant reduction at end of follow-up. Of the 19 feet with moderate to severe pain, there was a 28% reduction from baseline to end of treatment (P<0.05) and a 39% decrease from baseline to end of follow-up (P<0.01). Benefit was better in those patients with axonal changes and advanced CPT baseline scores. The clinical examination did not change. There were no adverse events or safety issues. CONCLUSIONS: These pilot data demonstrate that directing PEMF to refractory feet can provide unexpected shortterm analgesic effects in more than 50% of individuals. The role of placebo is not known and was not tested. The precise mechanism is unclear yet suggests that severe and advanced cases are more magnetically sensitive. Future studies are needed with randomized placebo-controlled design and longer treatment periods.

Complementary and alternative methods of treatment of neck pain.

The enthusiasm for complementary and alternative medicine (CAM) is worldwide and is based on the public perception that these approaches are safe and effective. In reality, however, this attitude is based more on cultural and anecdotal experiences than on stringent scientific trials. Because neck pain is a common and disabling symptom that frustrates both patients and physicians, this article reviews the applicability of several CAM therapies for the treatment of neck pain. Despite the long history of CAM, more systematic and better designed, randomized, placebo-controlled trials are needed to determine which approaches have merit. This article recognizes the shortcomings of conventional therapies and encourages clinicians to explore additional treatment options. It is hoped that in the future greater acceptance and integration of CAM can be based on sound scientific results.

Static magnetic field therapy for symptomatic diabetic neuropathy: a randomized, double-blind, placebo-controlled trial.

OBJECTIVE: To determine if constant wearing of multipolar, static magnetic (450G) shoe insoles can reduce neuropathic pain and quality of life (QOL) scores in symptomatic diabetic peripheral neuropathy (DPN). DESIGN: Randomized, placebo-control, parallel study. SETTING: Forty-eight centers in 27 states. PARTICIPANTS: Three hundred seventy-five subjects with DPN stage II or III were randomly assigned to wear constantly magnetized insoles for 4 months; the placebo group wore similar, unmagnetized device. INTERVENTION: Nerve conduction and/or quantified sensory testing were performed serially. MAIN OUTCOME MEASURES: Daily visual analog scale scores for numbness or tingling and burning and QOL issues were tabulated over 4 months. Secondary measures included nerve conduction changes, role of placebo, and safety issues. Analysis of variance (ANOVA), analysis of covariance (ANCOVA), and chi-square analysis were performed. RESULTS: There were statistically significant reductions during the third and fourth months in burning (mean change for magnet treatment, -12%; for sham, -3%; P<.05, ANCOVA), numbness and tingling (magnet, -10%; sham, +1%; P<.05, ANCOVA), and exercise-induced foot pain (magnet, -12%; sham, -4%; P<.05, ANCOVA). For a subset of patients with baseline severe pain, statistically significant reductions occurred from baseline through the fourth month in numbness and tingling (magnet, -32%; sham, -14%; P<.01, ANOVA) and foot pain (magnet, -41%; sham, -21%; P<.01, ANOVA). CONCLUSIONS: Static magnetic fields can penetrate up to 20mm and appear to target the ectopic firing nociceptors in the epidermis and dermis. Analgesic benefits were achieved over time.