Faster Improvement in Migraine Pain Intensity and Migraine-Related Disability at Early Time Points with AVP-825 (Sumatriptan Nasal Powder Delivery System) versus Oral Sumatriptan: A Comparative Randomized Clinical Trial Across Multiple Attacks from the CO

2017 ◽  
Vol 57 (10) ◽  
pp. 1570-1582 ◽  
Author(s):  
Richard B. Lipton ◽  
James S. McGinley ◽  
Kenneth J. Shulman ◽  
R.J. Wirth ◽  
Dawn C. Buse
Keyword(s):  
Clinical Trial ◽  
Pain Intensity ◽  
Randomized Clinical Trial ◽  
Delivery System ◽  
Early Time ◽  
Time Points ◽  
Migraine Pain ◽  
System Versus

scholarly journals NurOwn, phase 2, randomized, clinical trial in patients with ALS

Neurology ◽  
2019 ◽  
Vol 93 (24) ◽  
pp. e2294-e2305 ◽  
Author(s):  
James D. Berry ◽  
Merit E. Cudkowicz ◽  
Anthony J. Windebank ◽  
Nathan P. Staff ◽  
Margaret Owegi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Disease Progression ◽  
Randomized Clinical Trial ◽  
Rating Scale ◽  
Controlled Trial ◽  
Early Time ◽  
Phase 2 ◽  
Post Transplantation ◽  
Monocyte Chemoattractant Protein 1 ◽  
Time Points

ObjectiveTo determine the safety and efficacy of mesenchymal stem cell (MSC)-neurotrophic factor (NTF) cells (NurOwn®, autologous bone marrow-derived MSCs, induced to secrete NTFs) delivered by combined intrathecal and intramuscular administration to participants with amyotrophic lateral sclerosis (ALS) in a phase 2 randomized controlled trial.MethodsThe study enrolled 48 participants randomized 3:1 (treatment: placebo). After a 3-month pretransplant period, participants received 1 dose of MSC-NTF cells (n = 36) or placebo (n = 12) and were followed for 6 months. CSF was collected before and 2 weeks after transplantation.ResultsThe study met its primary safety endpoint. The rate of disease progression (Revised ALS Functional Rating Scale [ALSFRS-R] slope change) in the overall study population was similar in treated and placebo participants. In a prespecified rapid progressor subgroup (n = 21), rate of disease progression was improved at early time points (p < 0.05). To address heterogeneity, a responder analysis showed that a higher proportion of treated participants experienced ≥1.5 points/month ALSFRS-R slope improvement compared to placebo at all time points, and was significant in rapid progressors at 4 and 12 weeks (p = 0.004 and 0.046, respectively). CSF neurotrophic factors increased and CSF inflammatory biomarkers decreased in treated participants (p < 0.05) post-transplantation. CSF monocyte chemoattractant protein-1 levels correlated with ALSFRS-R slope improvement up to 24 weeks (p < 0.05).ConclusionA single-dose transplantation of MSC-NTF cells is safe and demonstrated early promising signs of efficacy. This establishes a clear path forward for a multidose randomized clinical trial of intrathecal autologous MSC-NTF cell transplantation in ALS.Classification of evidenceThis phase II study provides Class I evidence.

scholarly journals Evaluation of Methods to Minimize Pain in Newborns during Capillary Blood Sampling for Screening: A Randomized Clinical Trial

2022 ◽  
Vol 19 (2) ◽  
pp. 870
Author(s):  
Magdalena Napiórkowska-Orkisz ◽  
Aleksandra Gutysz-Wojnicka ◽  
Mariola Tanajewska ◽  
Iwona Sadowska-Krawczenko
Keyword(s):  
Clinical Trial ◽  
Heart Rate ◽  
Heart Rate Variability ◽  
Pain Management ◽  
Pain Relief ◽  
Pain Intensity ◽  
Randomized Clinical Trial ◽  
Capillary Blood ◽  
Pain Outcome ◽  
Capillary Blood Sampling

Aim: The aim of the study was to assess the severity of pain experienced by a newborn during a heel puncture for screening using the Newborn Pain Scale (NIPS), measure the heart rate and compare the effectiveness of non-pharmacological methods of pain control. Design: Randomized clinical trial. No experimental factors. The test was performed during routine screening. Surroundings: Provincial Specialist Hospital in Olsztyn. Patients/Participants: Pain was assessed in 90 full-term newborns. The newborns were rooming in with their mothers in the hospital. Interventions: Newborns were divided into three groups. Three different methods of pain relief were used: breastfeeding, 20% glucose administered orally and non-nutritional sucking. Main Outcome Measures: The primary pain outcome was measured using the NIPS and the secondary pain outcome measures (heart rate, oxygen saturation) were measured using a pulse oximeter. Results: During capillary blood sampling from the heel, most newborns, n = 56 (62.2%), experienced no pain or mild discomfort, severe pain occurred in n = 23 (25.6%) and moderate pain occurred in n = 11 (12.2%). No significant statistical differences were found between the degree of pain intensity and the intervention used to minimize the pain p = 0.24. Statistically significant relationships were demonstrated between heart rate variability and the degree of pain intensity (p = 0. 01). There were no statistically significant differences between the newborn’s pain intensity and the mother’s opinion on the effectiveness of breastfeeding in minimizing pain. Conclusions: This study did not answer the question of which pain management method used during the heel prick was statistically more effective in reducing pain. However, the results indicate that each of the non-pharmacological interventions (breastfeeding, oral glucose dosing and non-nutritive sucking) applied during heel puncture resulted in effective pain management in most of the newborns enrolled in the study. The relationship between heart rate variability and the severity of pain was confirmed. Mothers of newborns in the breastfeeding group were satisfied with the pain relief methods used in the child and the opportunity to console their newborn during painful procedures in a technologically invasive environment.

scholarly journals The Effect of Subcutaneous and Intraperitoneal Instillation of Local Anesthetics on Postoperative Pain after Laparoscopic Varicocelectomy: A Randomized Controlled Trial

Children ◽  
2021 ◽  
Vol 8 (11) ◽  
pp. 1051
Author(s):  
Zenon Pogorelić ◽  
Tea Gaberc ◽  
Miro Jukić ◽  
Goran Tintor ◽  
Ana Nevešćanin Biliškov ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Postoperative Pain ◽  
Pain Intensity ◽  
Randomized Clinical Trial ◽  
Local Anesthetic ◽  
Local Anesthetics ◽  
Control Group ◽  
Number Of Patients ◽  
Intraperitoneal Instillation ◽  
Time Point

Background: The main goal of the present randomized clinical trial was to investigate the effects of subcutaneous administration of two different local anesthetics at trocar incision sites at the abdominal wall in combination with intraoperative intraperitoneal instillation of local anesthetics, on the character of postoperative pain, in adolescents who underwent laparoscopic varicocelectomy. Methods: A total of 60 patients with a median age of 16 years, who received laparoscopic varicocele repair, were included in this randomized clinical trial. The patients were randomly assigned to three study groups receiving 2% lidocaine, 0.5% levobupivacaine, or the control group. The Visual Analogue Scale (VAS) was used by a blinded nurse at four different time points (2, 6, 12 and 24 h after the surgery) to measure pain intensity. Results: The significant effect of time on the pain intensity (p = 0.001) was found. Additionally, the interaction between time and different local analgesics (p < 0.001) was observed. In patients in whom 0.5% levobupivacaine has been used, significantly lower VAS pain scores were recorded at each time point assessed, in comparison with the patients who received 2% lidocaine or the patients from the control group in whom no local anesthetic was applied (p < 0.001). Furthermore, in patients in whom 2% lidocaine was administrated, significantly lower pain levels according to VAS were reported than in those from the control group, except for the time point at 24 h after surgery when pain levels were comparable. Concerning the postoperative pain control, the number of patients who requested oral analgesics postoperatively was significantly lower in the group of patients in whom local anesthetic was administrated intraoperatively (2% lidocaine – n = 4, 20%; 0.5% levobupivacaine – n = 1, 5%) compared to the patients who did not receive any local anesthetic during the surgery (n = 13; 65%) (p < 0.001). Conclusion: A significant reduction in postoperative pain intensity and analgesics consumption in patients undergoing laparoscopic varicocelectomy who received intraoperative local anesthetic was observed. The best effect on postoperative pain intensity, according to the VAS score, was achieved by 0.5% levobupivacaine.

Six-month Follow-up of the Effect of Nonvital Bleaching on IL-1β and RANK-L: A Randomized Clinical Trial

2019 ◽  
Vol 44 (6) ◽  
pp. 581-588 ◽  
Author(s):  
C Bersezio ◽  
J Estay ◽  
M Sáez ◽  
F Sánchez ◽  
R Vernal ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Hydrogen Peroxide ◽  
Randomized Clinical Trial ◽  
Gingival Crevicular Fluid ◽  
Color Change ◽  
Double Blind ◽  
Time Points ◽  
Periodontal Tissues ◽  
Significant Difference ◽  
Spearman Test

SUMMARY Objectives: It has been reported that bleaching generates an increase in the activity of osteoclasts in vitro. We quantified the RANK-L and IL-1β biomarkers in a double-blind, randomized clinical trial evaluating the in vivo effect of hydrogen peroxide (35%) and peroxide carbamide (37%) six months after whitening. Methods and Materials: Fifty volunteers participated, each with color change in a nonvital tooth. Fifty teeth were randomly divided into two groups (n=25), and the teeth were bleached using either 35% hydrogen peroxide (G1) or 37% carbamide peroxide (G2). Intracoronal bleaching was carried out by a technical “walking bleach” over four sessions. Gingival crevicular fluid samples were collected and used to quantify the IL-1β and RANK-L secreted levels. Samples of six periodontal sites (three vestibular and three palatal) were collected for up to six months (at the beginning of the study [baseline] and at one week, one month, and six months posttreatment). The color change was visually monitored using the Vita Bleached Guide (ΔSGU). Results: Comparing each time to baseline assessment, a significant increase in the levels of IL-1β and RANK-L across time points was detected (p&lt;0.05). The color change was 4 in G1 and G2, and a statistically significant difference (p&lt;0.05) was found at the month time point between the groups. Using the Spearman test, a strong correlation (&gt;0.8) between the IL-1β and RANK-L levels in both groups at all time points was detected. Conclusions: Nonvital bleaching using a technical walking bleach induces an increase in the IL-1β and RANKL production in periodontal tissues, which persists for six months after treatment. Both biomarkers were highly correlated in both groups and at all time points.

scholarly journals A Randomized Clinical Trial of Auricular Point Acupressure for Chronic Low Back Pain: A Feasibility Study

2013 ◽  
Vol 2013 ◽  
pp. 1-9 ◽  
Author(s):  
Chao Hsing Yeh ◽  
Lung Chang Chien ◽  
Devora Balaban ◽  
Rebecca Sponberg ◽  
Jaclyn Primavera ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Low Back Pain ◽  
Back Pain ◽  
Pain Intensity ◽  
Randomized Clinical Trial ◽  
Feasibility Study ◽  
Chronic Low Back Pain ◽  
Low Back ◽  
Duration Of Treatment ◽  
Auricular Point

Objectives. This prospective, randomized clinical trial (RCT) was designed to investigate the feasibility and effects of a 4-week auricular point acupressure (APA) for chronic low back pain (CLBP).Methods. Participants were randomized to either true APA (true acupoints with taped seeds on the designated ear points for CLBP) or sham APA (sham acupoints with taped seeds but on different locations than those designated for CLBP). The duration of treatment was four weeks. Participants were assessed before treatment, weekly during treatment, and 1 month following treatment.Results. Participants in the true APA group who completed the 4-week APA treatment had a 70% reduction in worst pain intensity, a 75% reduction in overall pain intensity, and a 42% improvement in disability due to back pain from baseline assessment. The reductions of worst pain and overall pain intensity in the true APA group were statistically greater than participants in the sham group(P<0.01)at the completion of a 4-week APA and 1 month followup.Discussion. The preliminary findings of this feasibility study showed a reduction in pain intensity and improvement in physical function suggesting that APA may be a promising treatment for patients with CLBP.

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