Mean Change In Visual Analog Scale Score Research Articles

Trial of Nemolizumab and Topical Agents for Atopic Dermatitis With Pruritus

To evaluate the effect of nemolizumab, a subcutaneously administered humanized monoclonal antibody against interleukin 31 receptor A and concomitant topical medications and oral antihistamines versus placebo on atopic dermatitis (AD)-induced pruritus.A double-blind, placebo-controlled, parallel group, multicenter phase 3 study population of Japanese adolescents and adults aged ≥13 years (n = 215; median ages: 39 years [nemolizumab] and 40.5 years [placebo]) with a confirmed diagnosis of AD, weight of 30 to 120 kg, inadequate response to medium-potency topical corticosteroids or topical calcineurin inhibitors and oral antihistamines, and elevated visual analog scale (VAS) for pruritus and Eczema Area and Severity Index (EASI) scores.Patients were randomly assigned in a 2:1 ratio to receive nemolizumab 60 mg subcutaneously (n = 143) versus placebo (n = 72) every 4 weeks, for 16 weeks total. Patients in both groups were allowed to continue the use of topical corticosteroids, calcineurin inhibitors, oral antihistamines, and topical moisturizers. Patients were excluded if they were on other biological therapy, phototherapy, hyposensitization therapies, or other systemic treatments. The primary end point was the percentage change in weekly mean VAS score for pruritus from the baseline, whereas secondary end points included the change in VAS score to week 4 and changes in EASI score, Dermatology Life Quality Index score and Insomnia Severity Index. Intention-to-treat models were used for analysis of all end points with patients who received at least 1 dose of nemolizumab or placebo. A mixed-effects model for repeated measures was used to analyze weekly scores. The mixed-effects model for repeated measures, analysis of covariance, and intention-to treat analysis were applied to other end points.After 16 weeks of therapy, the mean change in VAS score from the baseline to week 16 was −42.8% ± 2.6 in the nemolizumab group versus −21.4% ± 3.6 in the placebo group, resulting in a −21.5% difference in the 2 groups (P < .001). The initial 4 week change in VAS score was −34.4% in the nemolizumab group versus −15.3% in the placebo group, resulting in a −19.3% difference between the groups. The change in EASI score >16 weeks was −45.9% (nemolizumab) versus −33.2% (placebo). In the nemolizumab group, 67% of patients had a change in Dermatology Life Quality Index score of ≥4 points, and 55% of patients had a change in an ISI score of ≤7 at week 16 versus 50% and 21%, respectively, in the placebo group. The most commonly reported adverse event was worsening AD in 24% of patients in the nemolizumab group and 21% of patients in the placebo group.Patients with moderate to severe pruritus associated with AD, uncontrolled by topical agents and oral antihistamines, who received nemolizumab saw a reduction in pruritus based on several scoring systems, compared with those who received the placebo >16 weeks.Currently, the only Food and Drug Administration–approved biological therapy available for moderate to severe AD is dupilumab, approved for those aged ≥6 years. Although this study included mostly adults, adolescents were included and did show some efficacy for reducing pruritus in AD. However, it is concerning that >20% of patients in the intervention group had worsening AD symptoms. Thus, further controlled trials, including the pediatric population, are needed to be able to assess overall effect on AD control.

Diazepam and Meclizine Are Equally Effective in the Treatment of Vertigo: An Emergency Department Randomized Double-Blind Placebo-Controlled Trial

BackgroundVertigo is a debilitating disease that is commonly encountered in the emergency department (ED). Diazepam and meclizine are oral medications that are commonly used to alleviate symptoms. ObjectivesWe sought to determine whether meclizine or diazepam is superior in the treatment of patients with peripheral vertigo in the ED. MethodsWe performed a double-blind clinical trial at a suburban, teaching ED. We randomized a convenience sample of adult patients with acute peripheral vertigo (APV) to diazepam 5 mg or meclizine 25 mg orally. Demographic and historical features were recorded on a standardized data form. Patients recorded their initial level (t0) of vertigo on a 100-mm visual analog scale (VAS) and after 30 min (t30) and 60 min (t60). The primary outcome parameter was the mean change in VAS score from t0 to t60. Differences between groups and 95% confidence intervals were calculated. Our a priori power calculation estimated that a sample size of 20 patients in each group was required to have an 80% power to detect a difference of 20 mm between treatment groups. ResultsThere were 20 patients in the diazepam group and 20 in the meclizine group. The two groups were similar with respect to patient demographics and presenting signs and symptoms. At t60, the mean improvements in the diazepam and meclizine groups were 36 and 40, respectively (difference −4; 95% confidence interval −20 to 12; p = 0.60). ConclusionWe found no difference between oral diazepam and oral meclizine for the treatment of ED patients with acute peripheral vertigo.

Abdominal pain endpoints currently recommended by the FDA and EMA for adult patients with irritable bowel syndrome may not be reliable in children.

The Food and Drug Administration (FDA) recommended ≥30% decrease on patient-reported outcomes for pain be considered clinically significant in clinical trials for adults with irritable bowel syndrome. This percent change approach may not be appropriate for children. We compared three alternate approaches to determining clinically significant reductions in pain among children. 80 children with functional abdominal pain participated in a study of the efficacy of amitriptyline. Endpoints included patient-reported estimates of feeling better, and pain Visual Analog Scale (VAS). The minimum clinically important difference in pain report was calculated as (i) mean change in VAS score for children reporting being 'better'; (ii) percent changes in pain (≥30% and ≥50%) on the VAS; and (iii) statistically reliable changes on the VAS for 68% and 95% confidence intervals. There was poor agreement between the three approaches. 43.6% of the children who met the FDA ≥30% criterion for clinically significant change did not achieve a reliable level of improvement (95% confidence interval). Children's self-reported ratings of being better may not be statistically reliable. A combined approach in which children must report improvement as better and achieve a statistically significant change may be more appropriate for outcomes in clinical trials.

Patient selection for lumbar arthroplasty and arthrodesis: the effect of revision surgery in a controlled, multicenter, randomized study

Patient selection is perhaps the most important factor in successful lumbar surgery. In this study, the authors analyzed the clinical outcomes of patients enrolled in the CHARITE investigational device exemption (IDE) trial who underwent revision surgery after primary total disc replacement with CHARITE or an anterior lumbar interbody fusion (ALIF) with placement of a BAK cage and iliac crest autograft. This revision surgery was either a supplemental posterior lumbar fixation or a 360 degrees fusion. Statistical analysis was conducted to compare clinical success in patients who underwent revision surgery with those who did not. The patients enrolled in the CHARITE IDE study were divided into 6 groups according to treatment and repeated operation status, and their Oswestry Disability Index (ODI) and visual analog scale (VAS) scores at the 2-year follow-up and at baseline were compared. The patients had received the following treatments by group: A) ALIF without reoperation; B) ALIF with conversion to 360 degrees fusion; C) arthroplasty (randomized) without repeated operation; D) arthroplasty with supplemental posterior lumbar fixation; E) arthroplasty (nonrandomized) without repeated operation; and F) arthroplasty (nonrandomized) with supplemental posterior lumbar fixation. Outcome scores in the groups of patients who required revision surgeries (Groups B, D, and F; 23 patients) were compared with the groups that did not require revision surgery (Groups A, C, and E; 299 patients). Patients who required revision surgery had a significantly lower level of clinical improvement than those who did not. The mean change in ODI score was -53.0% in Groups A, C, and E, but just -12.7% in Groups B, D, and F (p < 0.0001). The mean change in VAS score was -59.1% in Groups A, C, and E, compared to -23.4% in Groups B, D, and F (p < 0.0001). No significant differences were identified in analyzing absolute change in scores and the percentage change. A comparison of outcomes in patients who had undergone arthroplasty without reoperation (Groups C and E) with all patients who had undergone revision surgery (Groups B, D, and F) demonstrated similar results (p < 0.0001). The 7.1% of patients who underwent a secondary stabilization procedure had poor clinical improvement. This finding may indicate that if the alternative treatment had been the initial treatment, these patients would not have benefited, and further implies a 7.1% rate of imprecision in preoperative evaluation.

Treatment of chronic lumbar diskogenic pain with intradiskal electrothermal therapy: A prospective outcome study

Lutz C, Lutz GE, Cooke PM. Treatment of chronic lumbar diskogenic pain with intradiskal electrothermal therapy: a prospective outcome study. Arch Phys Med Rehabil 2003;84:23-8. Objective: To determine the clinical efficacy of intradiskal electrothermal annuloplasty in treating patients with chronic constant lumbar diskogenic pain who have not responded to at least 6 months of aggressive nonoperative care. Design: Prospective case series. Setting: Academic-affiliated private physiatry practice. Participants: Thirty-three patients with chronic constant lumbar diskogenic pain of more than 6 months in duration diagnosed with history and physical examination, with concordant pain on provocative pressure-controlled lumbar diskography, and with symptomatic annular tears and/or protrusions less than 5mm, who did not respond to aggressive nonoperative care. Intervention: Intradiskal electrothermal annuloplasty. Main Outcome Measures: Visual analog scale (VAS) pain scores for the back and for the lower extremity, the Roland-Morris Disability Questionnaire (RMDQ), and the North American Spine Society Patient Satisfaction Index. Results: A total of 33 patients, with mean age of 40 years and a mean duration of symptoms of 46 months, were observed with a mean follow-up of 15 months. Relief of pain and improvement in physical function were associated with a mean change in the VAS score of 3.9 ( P[lt ].001), a mean change in the lower-extremity VAS score of 3.7 ( P[lt ].001), and a mean change in the RMDQ of 7.3 ( P[lt ].001). For patient satisfaction, 75.7% reported that they would undergo the same procedure for the same outcome. Complete pain relief was achieved in 24% of the patients, and partial pain relief in 46% of the patients. Conclusions: Intradiskal electrothermal annuloplasty offers a safe, minimally invasive treatment option for carefully selected patients with chronic lumbar diskogenic pain who have not responded to aggressive nonoperative care. [copy ] 2003 by the American Congress of Rehabilitation Medicine and the American Academy of Physical Medicine and Rehabilitation

Intramuscular Droperidol versus Intramuscular Dimenhydrinate for the Treatment of Acute Peripheral Vertigo in the Emergency Department: A Randomized Clinical Trial

Objective: The emergency department (ED) treatment of acute peripheral vertigo (APV) has not been well studied. The purpose of this study was to determine the efficacy of intramuscular (IM) droperidol vs IM dimenhydrinate, in the treatment of ED patients with APV. Methods: The study was a randomized, double‐blinded clinical trial, performed at a suburban, teaching ED. A convenience sample of adult patients with symptoms and signs consistent with rigid diagnostic criteria for APV were randomized to one of two treatment groups. Patients more than 65 years of age were excluded to reduce the likelihood of diagnostic misclassification. Demographic and historical features were recorded on a standardized data form. Patients recorded their initial level (t0) of discomfort on a 10‐centimeter (cm) visual analog scale (VAS). Treatment group 1 received 2.5 mg droperidol IM, while treatment group 2 received 50 mg dimenhydrinate IM. After 30 minutes (t30), patients again recorded the severity of their symptoms on the VAS. Chi‐square, t‐tests, and Mann‐Whitney were used for statistical comparison as appropriate. All tests were two‐tailed, with alpha set at 0.05. Primary outcome parameters were the mean change in VAS score from t0 to t30, and the percentage of patients in each treatment group who felt well enough to go home after t30 without further ED intervention. Results: There were 20 patients in the droperidol group and 20 in the dimenhydrinate group. The two groups were similar with respect to mean age (40 ± 13 years droperidol vs. 42 ± 13 years dimenhydrinate; p = 0.6), female sex (60% vs. 50%; p = 0.7), and mean median duration of symptoms [3 (interquartile range 2‐12) vs 9 (interquartile range 2‐30) hours; p = 0.2]. Mean initial t0 VAS scores were 7.2 ± 2.3 and 7.8 ± 1.9 (p = 0.47). Both treatment groups had mean reductions in VAS scores at t30 of 3.3 [95% confidence interval (95% CI) = 2.3 to 4.3]. At t30, 42% of patients in the droperidol group and 45% of patients in the dimenhydrinate group felt well enough to go home without further ED intervention. Conclusions: The authors found no difference between the therapeutic efficacies of IM droperidol and dimenhydrinate for the treatment of acute peripheral vertigo.

A randomized clinical trial to assess the efficacy of intramuscular droperidol for the treatment of acute migraine headache

In a recent case series, we reported that intramuscular droperidol appeared to be an effective therapy for the treatment of acute migraine headache. The objective of the study was to further assess the efficacy of intramuscular droperidol for the treatment of acute migraine headache. The study design was a randomized, clinical trial set in a community-based ED. The population was a convenience sample of ED patients who met International Headache Society acute migraine criteria. Exclusions included pregnancy, use of narcotic or phenothiazine medications within 24 hours. For the protocol, patients were randomized to 1 of 2 treatment groups. Patients and physicians were blinded as to the treatment provided. Patients recorded their initial pain on a 100mm Visual Analog Scale (VAS) Patients were randomized to receive either 2.5 mg droperidol intramuscularly; the other group received 1.5 mg/kg meperidine intramuscularly. After 30 minutes patients recorded their pain on the VAS and recorded their preference for the medication on a Likert Scale. Physicians recorded the incidence of any side effects and the need for rescue medication. Statistical analysis consisted of categorical variables that were analyzed by chi-square, continuous interval data by t-tests and ordinal data by Mann-Whitney U test. The primary outcome parameters were mean VAS score change and the percentage of patients who wanted to go home without rescue medication. The study had an 80% power to detect a 26 mm difference in the mean change in VAS between groups. Of the 29 patients who were enrolled, 15 received droperidol. Both groups were similar with respect to age (30.7 ± 8.9 years droperdol v 32.7 ± 9.9 years meperidine; P =.59), female sex (73% v 71%; P =.91), mean headache duration (24.7 ± 28.3 v 18.3 ± 25.8 hours; P =.55). The droperidol group had a higher mean initial VAS score (88 v 76 mm; P =.03). The 2 groups were similar with regard to outcome, including: mean change in VAS score (47 v 37 mm; P =.33), average Likert score (1.1 v 1.9; P =.85), and the percentage of patients who did not want rescue medication (67% v 57%; P =.61). The incidence of sedation was 6.7 v 14.3%. Akathisia occurred in 13.3% of pts who received droperidol. We found that intramuscular droperidol was similar in efficacy to meperidine with a low incidence of side effects. (Am J Emerg Med 2002;20:39-42. Copyright © 2002 by W.B. Saunders Company)

Intradiscal electrothermal treatment for chronic discogenic low back pain: a prospective outcome study with minimum 1‐year follow‐up. (SOAR, Physiatry Medical Group, Menlo Park, CA) Spine 2000;25:2622–2627.

Intradiscal electrothermal treatment for chronic discogenic low back pain: a prospective outcome study with minimum 1‐year follow‐up. (SOAR, Physiatry Medical Group, Menlo Park, CA) <i>Spine</i> 2000;25:2622–2627.

Intradiscal electrothermal treatment for chronic discogenic low back pain: a prospective outcome study with minimum 1-year follow-up.

Prospective case series. To determine the outcome of patients with chronic low back pain whose symptoms did not improve with aggressive nonoperative care and who chose (intradiscal electrothermal anuloplasty) IDET as an alternative to chronic pain management or interbody fusion surgery. Patients with unremitting chronic discogenic low back pain are faced with the choice of long-term pain management or fusion surgery. Intradiscal electrothermal anuloplasty (IDET) was developed as an alternative minimally invasive treatment. Sixty-two patients from the author's practice who had chronic low back pain unresponsive to nonoperative care, no evidence of compressive radiculopathy, and concordant pain reproduction at one or more disc levels on provocative discography were enrolled in the study. Visual analog scale (VAS) pain scores and Short Form (SF)-36 Health Status Questionnaire Physical Function subscale and SF-36 Bodily Pain subscale scores were assessed at baseline and at least 1 year later. Mean follow-up was 16 months, and mean preoperative duration of symptoms was 60 months. Baseline and follow-up outcome measures demonstrated a mean change in VAS score of 3.0 (P < 0.001), mean change in SF-36 physical function of 20 (P < 0.001), and mean change in SF-36 bodily pain of 17 (P < 0.001). Symptoms improved in 44 (71%) of 62 of the study group on the SF-36 physical function subscale, in 46 (74%) of 62 on the SF-36 Bodily Pain subscale, and in 44 (71%) of 62 on the VAS scores. Twelve (19%) of 62 of the patients did not show improvement on any scale. A cohort of patients with chronic unremitting low back pain of discogenic origin whose symptoms had failed to improve with aggressive nonoperative care demonstrated a statistically significant and clinically meaningful improvement on the SF-36 and the VAS scores at a minimum follow-up of 1 year after IDET. The positive results should be validated with placebo-controlled randomized trials and studies that compare IDET with alternative treatments.-