Analogue Scale Pain Intensity Research Articles

Nasal packing in posterior epistaxis. Comparison of two methods

ObjectiveTo evaluate tolerance and efficiency of two nasal blocking systems for posterior refractory epistaxis. Patients and methodsA five year comparative and longitudinal prospective study was developed in patients with epistaxis who attended our Emergency Unit and who required posterior nasal packing. Two groups were considered: one group was treated with a bi-chamber pneumatic inflation system (n=105). In the other one, posterior occlusion was carried out with gauze, accessing through the mouth and using nasal reinforcement (n=47). The tolerance was measured by means of an analogue scale of pain intensity during the placement and maintenance of the packing, as well as for the need of analgesia. The efficiency was evaluated by episodes of rebleeding, need for other concomitant measures, blood transfusion and side effects. ResultsIn patients with inflatable nasal packing, its placement was significantly faster (36±19 s vs 228±102 s; P<.001) and less painful (6.7±1.7 vs 8.3±1.5; P<.001), requiring less analgesia until its removal. Patients with gauze packs showed a lower average incidence of rebleeding (17% vs 26%; P<.001), fewer cases of blood transfusion (15% vs 18%; P<.001) or of other procedures (4% vs 11%; P<.001). The health cost of the latter was also lower (€1,327±€202 vs €1,648±€318; P<.001) and it generated fewer short and long-term complications. ConclusionsThe classic posterior packing with gauze is less rapid and comfortable to adapt, but it ensures a higher success rate in the control of epistaxis, produces fewer local injuries and reduces health costs in comparison with inflatable balloon packing.

Randomized Controlled Trial for Efficacy of Intra-Articular Injection for Adhesive Capsulitis: Ultrasonography-Guided Versus Blind Technique

Lee H-J, Lim K-B, Kim D-Y, Lee K-T. Randomized controlled trial for efficacy of intra-articular injection for adhesive capsulitis: ultrasonography-guided versus blind technique. Objective To evaluate the clinical effect of ultrasonography (US)-guided intra-articular injections compared with a blind (unguided) technique for the treatment of adhesive capsulitis. Design Randomized controlled trial. Setting Outpatient rehabilitation clinic. Participants Patients (N=43) diagnosed as having adhesive capsulitis after clinical examinations and radiologic and ultrasonographic study. Intervention Under either US-guided or a blind technique, patients received a 20-mg intra-articular injection of triamcinolone mixed with 1.5mL 2% lidocaine and 4mL normal saline in the first week followed by 5 weekly injections of sodium hyaluronate. Main Outcome Measures A visual analog scale for pain intensity, range of motion (ROM) of the shoulder (flexion, abduction, external rotation, and internal rotation), and general shoulder function during daily activities at preinjection as a baseline and then every week after injection for 6 weeks for each patient. Results Twenty patients out of 22 in the blind injection group and 20 out of 21 in the US-guided group finished the entire 6-week study period. The improvement in pain intensity, ROM, and shoulder function score was significantly greater in the US-guided injection group than in the blind injection group by the second week postinjection ( P<.05). However, there were no further significant differences in the improvement between the 2 groups beyond the third week. Conclusions US-guided intra-articular injections may offer advantages over a blind technique for the treatment of adhesive capsulitis and may deliver clinical benefits during the first few weeks of treatment. This finding suggests that the improved targeting to the intra-articular space by using US can result in better treatment of adhesive capsulitis.

Cost-effectiveness of ziconotide in intrathecal pain management for severe chronic pain patients in the UK

ABSTRACTObjective: To examine the cost-effectiveness of using intrathecal ziconotide in the treatment of severe chronic pain compared to best supportive care for patients with intractable chronic pain in the United Kingdom.Methods: Using a simulation model, the analysis evaluated the cost and health economic consequences of using ziconotide as a treatment for severe chronic pain. The modelled population and clinical data were based on a randomised controlled trial in which the main outcome was reduction in pain as measured by the visual analogue scale of pain intensity (VASPI). Resource use data were elicited using a modified Delphi panel and costed using published sources. Utility values were derived from a separate research study. The main outcome measure was the cost per quality-adjusted life-year (QALY). Extensive scenario analysis was conducted to evaluate parameter uncertainty.Results: Overall, findings were robust to most assumptions. The cost-effectiveness of ziconotide compared to best supportive care (BSC) was £27 443 per QALY (95% CI £18 304–38 504). Scenarios were investigated in which discount rates, the time horizon, the threshold for qualifying as a responder, pump-related assumptions, utilities, ziconotide drug dose, and the patient discontinuation rate with ziconotide were varied. The most sensitive parameter was the dosage of ziconotide: using the lower and upper bounds of the average ziconotide dosage observed in the long-term open-label study changed the incremental cost-effectiveness ratio (ICER) to £15 500 [£8206–25 405] and £44 700 [£30 541–62 670].Conclusions: Ziconotide may offer an economically feasible alternative solution for patients for whom current treatment is inappropriate or ineffective. The main study limitation is that some model inputs, mainly related to resource use, are based on assumptions or expert interviews.

Pilot Randomized Controlled Trial of Hatha Yoga for Chronic Low Back Pain in a Predominant Minority Population

The effect of spa therapy, a non-pharmacological treatment for chronic low back pain (CLBP) has been evaluated by several randomized clinical trials. This randomized controlled trial was conducted to compare the effect of balneotherapy alone versus balneotherapy with physical exercise.Participants (n = 60) with low back pain for more than 6 months and attending a musculoskeletal clinic were recruited into this study. They were randomized to either the balneotherapy group (immersion in thermo-mineral water) or to a balneotherapy + exercise group (group exercises delivered in addition to balneotherapy).Before intervention and 3 and 6 months after intervention, statistically significant decreases were observed according to a visual analog scale of pain intensity (p < 0.05). Improvements recorded on a health assessment questionnaire lasted up to 6 months in both groups; however, values were not statistically significant. Fingertips-to-floor distance and Schober’s Index measurements showed significant decreases in the balneotherapy + exercise group after treatment and at 3 months and only after treatment in the balneotherapy alone group. The Waddell Disability Index showed better recovery for the balneotherapy group at the end of the treatment and at the 3rd month. When the two groups were compared using the Waddell evaluation, the balneotherapy group was found to be superior (p < 0.047).Although two weeks of spa therapy was beneficial in improving pain and physical function in patients with CLBP, there was no difference between balneotherapy combined with physical exercise therapy and balneotherapy alone. However, this therapeutic approach seemed advantageous in improving mobility and flexibility in these patients.

Poster 225: Assessment of Pain Intensity Using a Set of Pain Emoticons: Preliminary Normative Data

Objective: To obtain preliminary normative data to determine the order of a set of 6 pain emoticons as a scale of pain intensity, and to evaluate its reproducibility. Design: Participants were asked to place the 6 emoticons in order to reflect increasing pain intensity. They then selected the emoticon that best described the worst pain they had experienced over the previous month, and rated its intensity also on a visual analogue Scale of Pain Intensity (range, 0–5). Where possible, emoticons were placed in order independently for a second time at least 24 hours later.

Effect of pine bark extract (Pycnogenol®) on symptoms of knee osteoarthritis

The safe and efficacious use of Pycnogenol (French maritime pine bark extract) in other inflammatory diseases prompted this study of its antiinflammatory effects in patients with osteoarthritis (OA). The aim of the study was to evaluate whether Pycnogenol reduces the symptoms of OA in a double-blind, placebo-controlled, randomly allocated trial with patients suffering from knee osteoarthritis stages I and II. 100 patients were treated for 3 months either by 150 mg Pycnogenol per day at meals or by placebo. Patients had to report any change of use of previously prescribed antiinflammatory medication during the study period. Patients filled the Western Ontario and Mc Masters University (WOMAC) questionnaire for osteoarthritis every 2 weeks and evaluated weekly pain symptoms using a visual analogue scale for pain intensity. Following treatment with Pycnogenol patients reported an improvement of WOMAC index (p < 0.05), and a significant alleviation of pain by visual analogue scale (p < 0.04), the placebo had no effect. The use of analgesics diminished in the verum group but increased under the placebo. Treatment with Pycnogenol was well tolerated. Results show that Pycnogenol in patients with mild to moderate OA improves symptoms and is able to spare NSAIDs.

Preemptive combined preventive delivery of flurbiprofen axetil produced effective analgesia after lumpectomy

Summary Background Preoperative and intraoperative administration of analgesics was considered an effective way to suppress postoperative pain. The aim of this study was to investigate the analgesic efficacy of flurbiprofen axetil administered preemptively plus preventively in the earlier period of lumpectomy. Methods Four hundred ASA I–II patients, undergoing lumpectomy, were screened and 236 were randomly assigned into one of two groups ( n = 118). In the flurbiprofen group, patients received an i.v. injection of flurbiprofen 50 mg 15 min before the start and the end of the operation, separately. The placebo group received the same volumes of saline before the start and the end of the operation. The Visual Analog Scale (VAS) pain intensity at rest, overall satisfaction score, additional morphine consumption and side effects were recorded. Results A total of 196 patients completed the study. Subjects received flurbiprofen experienced significant pain relief and improvement of the feeling of satisfaction at the first 24 h after surger. The additional morphine was consumed [8.5 mg (95% CI 4.2–12.4) in the saline group vs. 1.1 mg (95% CI 0.7–2.5) in the flurbiprofen group, p = 0.046]. No intergroup difference was observed in the incidence of side effects. Conclusion Preemptive combined preventive administration of flurbiprofen axetil showed effective analgesia significantly up to 24 h after lumpectomy and suggested it is a reliable analgesic for acute postoperative pain therapy.

Tension neck syndrome treated by acupuncture combined with physiotherapy: A comparative clinical trial (pilot study)

To evaluate the effect of acupuncture combined with physiotherapy in comparison with acupuncture and physiotherapy performed alone in different parameters; pain intensity, muscle tension, functional disability and muscle strength in the treatment of tension neck syndrome (TNS). A prospective, comparative clinical trial. Acupuncture and Rehabilitation Department. TNS can occur in computer users. Acupuncture has been one alternative treatment in physiotherapeutic rehabilitation of musculoskeletal disorders. Forty-six patients with TNS. Patients were allocated into three groups: Group-1 received physiotherapy (therapeutic exercises) combined with acupuncture; Group-2, acupuncture alone, and Group-3, physiotherapy alone; over a period of 10 weeks, with one or two sessions weekly. All patients had completed the protocols and were assessed using a visual analogue scale for pain intensity (VASpain) and muscle tension (VASmt), the Neck Disability Index: Brazilian Portuguese version for functional disability, and the cranio-cervical Flexion Test for isometric neck muscle strength (INMS); in the periods before treatment (baseline), after 10 weeks of treatment, and after 6 months of follow-up. All groups showed significant improvement (p < 0.001) in these parameters after 10 weeks of treatment and after 6 months of follow-up. Group-1 was superior to Group-3 in pain and functional disability improvements (p<0.05); and Group-1 was superior to both Group-2 (p < 0.01) and Group-3 (p < 0.05) in INMS. After 6 months of follow-up, the improvements of all groups were maintained (p < 0.05). The data suggested that acupuncture effect may facilitate and/or enhance physiotherapy performance in musculoskeletal rehabilitation for tension neck syndrome.

Phase II, Open-Label, Multicenter Study of Combined Intrathecal Morphine and Ziconotide: Addition of Ziconotide in Patients Receiving Intrathecal Morphine for Severe Chronic Pain

To assess the safety and efficacy of adding intrathecal ziconotide to intrathecal morphine in patients being treated with a stable intrathecal morphine dose. Phase II, multicenter, open-label study with a 5-week titration phase and an extension phase. Outpatient clinics. Patients with suboptimal pain relief receiving stable intrathecal morphine doses (2-20 mg/day). Intrathecal morphine dosing remained constant during the titration phase. Ziconotide therapy began at 0.60 microg/day and was titrated to a maximum of 7.2 microg/day. During the extension phase, ziconotide and intrathecal morphine dosing were adjusted at the investigator's discretion. Safety was assessed primarily via adverse event reports. Efficacy was analyzed via percentage change on the visual analog scale of pain intensity and in weekly systemic opioid consumption. Twenty-six patients were enrolled. Treatment-emergent adverse events were generally mild or moderate; the most common (> or = 15% of patients in either study phase) study drug-related (i.e., ziconotide/morphine combination [or ziconotide monotherapy in the extension phase only]) events were confusion, dizziness, abnormal gait, hallucinations, and anxiety. The mean percentage improvement in visual analog scale of pain intensity scores was 14.5% (95% confidence interval: -9.4% to 38.5%) from baseline to week 5 and varied during the extension phase (range: -0.4% to 42.8%). Mean percentage change from baseline in systemic opioid consumption was -14.3% at week 5 and varied considerably during the extension phase. Ziconotide, combined with stable intrathecal morphine, may reduce pain and decrease systemic opioid use in patients with pain inadequately controlled by intrathecal morphine alone.

Open-Label, Multicenter Study of Combined Intrathecal Morphine and Ziconotide: Addition of Morphine in Patients Receiving Ziconotide for Severe Chronic Pain

To assess the safety and efficacy of adding intrathecal morphine to intrathecal ziconotide in patients treated with stable ziconotide doses. Multicenter, open-label study with a 4-week morphine titration phase during which ziconotide was held constant and an extension phase during which dosing of either drug could vary. Outpatient clinics. Patients with suboptimal pain relief receiving stable ziconotide doses (> or = 4.8 microg/day) in one of two ongoing ziconotide trials. Ziconotide dosing remained constant during the titration phase; intrathecal morphine titration was based on each patient's daily systemic opioid dose at the study's start. During the extension phase, intrathecal ziconotide and morphine dosing were adjusted per investigator discretion. Safety was assessed primarily via adverse events. Efficacy was analyzed via percentage change on the visual analog scale of pain intensity and in weekly systemic opioid consumption. Twenty-five patients enrolled. The most common (> or = 10% of patients in either study phase) study drug-related (i.e., ziconotide/morphine combination [or ziconotide monotherapy in the extension phase only]) treatment-emergent adverse events included dizziness, peripheral edema, pruritus, and nausea. From the initial visit to week 4, visual analog scale of pain intensity scores improved by a mean of 26.3% (95% confidence interval: 15.6%-37.1%) but varied during the extension phase (mean percentage change from the initial visit ranged from -0.4% at week 16 to -35.0% at week 72). Mean percentage decrease in systemic opioid consumption from the initial visit was 49.1% at week 4 and 51.2% at week 56 of the extension phase. Intrathecal morphine, combined with stable intrathecal ziconotide doses, reduced pain in patients with previously suboptimal pain relief on ziconotide monotherapy.

An Open-Label, Multicenter Study of the Safety and Efficacy of Intrathecal Ziconotide for Severe Chronic Pain When Delivered via an External Pump

Objectives. The study aims to assess the safety and efficacy of intrathecal (IT) ziconotide when delivered via an external infusion system. Materials and Methods. Patients with severe chronic pain were implanted with an external infusion system, and IT ziconotide was titrated over one to four weeks. Safety was evaluated via adverse event (AE) reports, and efficacy measures included the visual analog scale of pain intensity (VASPI), categorical pain relief scale (CPRS), and clinical global impression (CGI). Results. Sixty-four of the 71 patients (90.1%) experienced an AE during titration; five patients developed meningitis after completing at least two weeks of therapy. A significant (p≤0.005) median percentage improvement in VASPI scores was seen at week 1 and maintained through week 4 (range: 11.0-32.6%); 53.6% of patients reported good to excellent pain control on the CGI and 52.2% of patients reported moderate to complete pain relief on the CPRS. Conclusions. The study results suggest that a short-term trial of IT ziconotide using an external infusion system may be sufficient to assess patient response. High rates of AEs were noted; however, ziconotide-related AEs were consistent with those reported in previous trials.

Intrathecal Ziconotide for Severe Chronic Pain: Safety and Tolerability Results of an Open-Label, Long-Term Trial

Ziconotide is a non-opioid drug indicated for management of severe chronic pain in patients for whom intrathecal (IT) therapy is warranted and who are intolerant of or refractory to other treatments. Six-hundred and forty-four patients with severe chronic pain participated in this open-label, multicenter study. Ziconotide titration was followed by long-term infusion. Efficacy assessments included the Visual Analog Scale of Pain Intensity. Safety was assessed via adverse events (AEs), vital signs, and routine laboratory values. One-hundred and nineteen patients received ziconotide for > or = 360 days; total exposure was 350.9 patient years. Median duration of ziconotide therapy was 67.5 days (range, 1.2-1215.5 days); mean dose at last infusion was 8.4 microg/d (range, 0.048-240.0 microg/d). Median Visual Analog Scale of Pain Intensity scores at baseline, month 1, and the last available observation up to month 2 were 76 mm (range, 4-100 mm), 68 mm (range, 0-100 mm), and 73 mm (range, 0-100 mm), respectively. Most patients (99.7%) experienced > or = 1 AE. Most AEs were of mild (43.5%) or moderate (42.3%) severity; 58.6% of AEs were considered unrelated to ziconotide. The most commonly reported AEs (> or = 25% of patients) included nausea, dizziness, headache, confusion, pain, somnolence, and memory impairment. Clinically significant abnormalities (> 3 times the upper limit of normal) in creatine kinase levels were reported in 0.9% of patients at baseline, 5.7% at month 1, and 3.4% at ziconotide discontinuation. No drug-related deaths, IT granulomas, or permanent adverse sequelae occurred with ziconotide therapy. We conclude that long-term IT ziconotide is an option for patients with severe, refractory chronic pain.

Tubeless Percutaneous Nephrolithotomy: What about Replacing the Double-J Stent with a Ureteral Catheter?

To evaluate the feasibility and safety of replacing the Double-J stent with a ureteral catheter in tubeless percutaneous nephrolithotomy (PCNL). From August 1998 to February 2007, 33 patients underwent tubeless PCNL for renal calculi by the same surgeon. A retrograde 7F ureteral catheter was placed at the beginning of the surgery in all patients. A nephrostomy tube was not used in any patient. At the end of the procedure, the working tract was electrocauterized using a 26F resectoscope with a rollerball electrode; no hemostatic sealant was used. The ureteral catheter was the sole means of drainage left in place. The incidence and type of complications, the operative time, the length of hospitalization, the rate of transfusion, and the degree of pain were obtained by chart review. In this group of patients, the mean stone burden was 17.25 mm. The mean operative time was 71.5 min. The mean length of hospitalization was 1.9 day (range 1 to 7 days). The mean hemoglobin decrease was 0.8 g/dL. No blood transfusions were needed. The mean visual analog pain intensity scale was 1.87. Complications developed in five (15%) patients, of whom one needed a Double-J stent placement. The complications were pyelonephritis, urinary extravasation, sustained hematuria, and renal colic. The ureteral catheter was removed by postoperative day 1 in 91% of patients. Replacing the Double-J stent with a ureteral catheter in tubeless PCNL is an effective procedure and can be performed in patients with a moderate stone burden. The electrocauterization of the bleeding points at the end of percutaneous renal surgery with a rollerball resectoscope is safe.

Relationship between Chronic Pain and Cognition in Cognitively Intact Older Persons and in Patients with Alzheimer’s Disease

Background: Brain areas that are involved in cognition and mood also play a role in pain processing. Objective: The goal of the present study was to examine the relationship between chronic pain and cognition [executive functions (EF) and memory], while controlling for mood, in cognitively intact older persons and in patients with Alzheimer’s disease (AD). Methods: Two groups of subjects participated: 20 older persons without dementia and 19 patients in an early stage of probable AD who suffered from arthrosis/arthritis. Pain intensity and pain affect were assessed by the Colored Analogue Scale for Pain Intensity and for Pain Affect, the Faces Pain Scale (FPS) and the Number of Words Chosen-Affective (NWC-A). Level of depression and anxiety were evaluated by questionnaires. EF and memory were assessed by neuropsychological tests. Results: The results show that significant correlations between specific cognitive functions, pain intensity and pain affect were lacking in the cognitively intact older persons. Cognition, in particular memory, appeared to be related to depressive symptoms. In contrast, a significant positive correlation was observed between EF, pain intensity and pain affect measured by the FPS in the AD group. Conclusions: Although older persons with depression were excluded, in studies on pain and cognition one should control for the presence of depressive symptoms in older persons with and without dementia.

Continuous Intrathecal Infusion of Ziconotide for Treatment of Chronic Malignant and Nonmalignant Pain Over 12 Months: A Prospective, Open-label Study

Objectives. This study aims to assess the safety and efficacy of long-term intrathecal (IT) ziconotide infusion. Materials and Methods. In this prospective study, 155 patients with severe chronic pain (48 with malignant pain, 107 with nonmalignant pain) who had been responsive to short-term IT ziconotide in a double-blind, placebo-controlled study received long-term, open-label IT ziconotide monotherapy. Efficacy assessments included the mean percentage change on the visual analog scale of pain intensity from baseline in the study of origin; safety was monitored by adverse event (AE) reports, periodic laboratory tests, and vital sign measurements. Results. At the last available observation, the visual analog scale of pain intensity scores had decreased by a mean of 36.9% from baseline in the short-term trial (N=144; 95% CI: 30.1-43.7%; p<0.0001). The mean IT ziconotide dose remained stable over 12months in the 31 patients who participated in the study for≥oneyear. Ziconotide-related AEs were reported in 147 out of 155 patients (94.8%); 39.4% of patients discontinued treatment because of AEs, the majority of which were considered ziconotide related. Conclusions. Ziconotide IT monotherapy provided patients with analgesia for 12months in this open-label study, with an acceptable benefit/risk profile and no evidence of tolerance.

Effectiveness of intrathecal ziconotide in malignant pain: A combined analysis of two controlled trials

8552 Background: Ziconotide is a nonopioid, N-type calcium channel blocker that inhibits neuronal calcium influx, thereby reducing neurotransmitter release at primary pain afferents. Clinical trials have shown ziconotide is useful in managing severe chronic pain, including nociceptive and neuropathic pain of malignant etiology. We reviewed the effectiveness of ziconotide using the Visual Analog Scale of Pain Intensity (VASPI: 100 mm=worst possible pain, 0 mm=no pain). Methods: Cancer patients from two double-blind, placebo-controlled trials (Studies 95–001 and 301) were analyzed. Study 95–001 used a fast titration scheme over 5 to 6 days, enrolling only patients with malignant pain due to cancer or AIDS. In Study 95–001, the initial dosing regimen was based on a pilot trial and was later modified due to the frequency of adverse events (AEs). The final slower titration, lower dosing regimen resulted in a reduced AE rate. Only patients from the final dosing regimen of Study 95–001 were included in this analysis. Study 301 used a slower titration scheme over 21 days, enrolling patients with malignant or nonmalignant pain. A two-sided, two-sample t-test was used to evaluate the null hypothesis that the mean percent change in VASPI score from baseline to end of titration for the ziconotide group was not significantly different from that of the placebo group (intent-to-treat population). Results: A total of 67 patients with malignant pain were treated in the trials; 51 (35 ziconotide, 16 placebo) had both baseline and end of titration VASPI scores. The ziconotide and placebo groups had similar mean baseline VASPI scores (75.5 and 75.8 mm, respectively). The mean percent improvement in VASPI score was 36.5% in the ziconotide group and 8.6% in the placebo group (p=0.0230). Conclusions: These results indicated that ziconotide was effective in relieving malignant pain. [Table: see text]

A Randomized, Double-Blind, Placebo-Controlled Study of Intrathecal Ziconotide in Adults with Severe Chronic Pain

Safety and efficacy data from a study of slow intrathecal (IT) ziconotide titration for the management of severe chronic pain are presented. Patients randomized to ziconotide ( n = 112) or placebo ( n = 108) started IT infusion at 0.1 μg/hour (2.4 μg/day), increasing gradually (0.05–0.1 μg/hour increments) over 3 weeks. The ziconotide mean dose at termination was 0.29 μg/hour (6.96 μg/day). Patients' baseline Visual Analogue Scale of Pain Intensity (VASPI) score was 80.7 (SD 15). Statistical significance was noted for VASPI mean percentage improvement, baseline to Week 3 (ziconotide [14.7%] vs. placebo [7.2%; P = 0.036]) and many of the secondary efficacy outcomes measures. Significant adverse events (AEs) reported in the ziconotide group were dizziness, confusion, ataxia, abnormal gait, and memory impairment. Discontinuation rates for AEs and serious AEs were comparable for both groups. Slow titration of ziconotide, a nonopioid analgesic, to a low maximum dose resulted in significant improvement in pain and was better tolerated than in two previous controlled trials that used a faster titration to a higher mean dose.

Post-discectomy syndrome treated with lumbar interbody fusion

We studied 27 patients with post-discectomy syndrome. All patients had Lumbar Interbody Fusion with titanium cages and pedicle screw fixation either as Anterior (ALIF, n=18) or as Transforaminal Lumbar Interbody Fusion (TLIF, n=9). Follow-up ranged from 24 to 94 months. The clinical and radiological data were compared. The outcome was evaluated using the Oswestry low back pain disability score and the visual analogue pain intensity scale. Outcomes were similar for all patients regardless of surgical technique and showed a significant improvement at final follow-up.

Intrathecal Ziconotide in the Treatment of Chronic Nonmalignant Pain: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Objective. The safety and efficacy of intrathecal (IT) ziconotide was studied in a randomized, double-blind, placebo-controlled trial. Materials and Methods. Patients (169 ziconotide, 86 placebo) with severe chronic nonmalignant pain unresponsive to conventional therapy and a visual analog scale of pain intensity (VASPI score)≥50mm were treated over a 6-day period in an inpatient hospital setting. Initial starting dose was 0.4µg/hour and was titrated to analgesia or intolerance (maximum dose 7.0µg/hour). The starting and maximum doses were reduced to 0.1µg/hour and 2.4µg/hour, respectively, due to adverse events (AEs). Results. The mean percent reduction in VASPI score from baseline was 31.2% and 6.0% for ziconotide- and placebo-treated patients, respectively (p≤0.001). During the initial titration phase, a significantly greater percentage of patients in the ziconotide group compared to the placebo group reported AEs, including abnormal gait, amblyopia, dizziness, nausea, nystagmus, pain, urinary retention, and vomiting. Conclusion. Ziconotide provided significant analgesia in patients for whom conventional therapy failed. However, there was a considerable incidence of ziconotide-associated AEs due to the rapid titration and high doses administered.

Alcohol Delamination of the Corneal Epithelium: An Alternative in the Management of Recurrent Corneal Erosions

To investigate the efficacy of alcohol delamination in the management of recurrent corneal erosions (RCEs). Prospective single-center consecutive descriptive case series. Twelve patients with RCEs who did not respond to conservative management were treated with alcohol delamination. A consecutive case series of 12 patients with RCEs who did not respond to conservative management were treated by alcohol delamination. A pain score was generated based on a visual analog scale of pain intensity. The duration of pain and frequency were also recorded. Patients were followed up at 1 week, 4 weeks, 3 months, 6 months, and 1 year and then at yearly intervals and monitored for recurrence of symptoms and corneal morphology. The removed epithelial sheet was examined by electron microscopy in 4 patients. The affected area of epithelium was peeled off after an application of 20% alcohol for 40 seconds under topical anesthesia. Eyes of patients were treated with an antibiotic and preservative-free artificial tear medication, and a bandage contact lens was inserted until epithelial healing was complete. Frequency of recurrence of erosions and duration and intensity of symptoms after alcohol delamination were studied. Eleven of the 12 eyes of patients had dramatic relief of symptoms over the follow-up period, ranging from 6 to 40 months. Eight patients were symptom free, and 1 patient had 2 mild symptom episodes in the first posttreatment month before becoming symptom free. The average follow-up period was 23.5 months. There were no residual effects from the application of alcohol noted in any patient. Electron microscopy of removed epithelium showed features of the underlying pathology. The separation of the epithelium occurred at the interface of the subepithelial abnormal deposit and the surface of Bowman's zone. Alcohol delamination appears to be a novel, simple, inexpensive treatment for RCEs. Unlike other methods, the removed epithelium is available as a sheet that may be subjected to further examination, though some of the changes observed may reflect the effect of alcohol on the epithelium.