100-mm Visual Analog Scale Research Articles

Effects of the maize-derived protein zein, and the milk proteins casein, whey, and α-lactalbumin, on subjective measures of satiety and food intake in normal-weight young men

Protein is considered to be the most satiating food macronutrient and the satiating effect may be dependent on the source of the protein. The maize-derived protein zein and milk protein casein have been shown previously to lower stomach emptying rate more than dairy whey protein, but the effect of zein on satiety has not been evaluated. The objective was to compare the satiating effects of zein and casein, with whey protein and its protein component α-lactalbumin. The study was a randomised crossover design with thirteen normal-weight men (mean age 27.8 years and mean BMI 24.4 kg/m2) consuming isoenergetic (∼4000 kJ, ∼990 kcal) preload mixed meals enriched with Zein, Casein, whey protein isolate (Whey), α-lactalbumin (ALac), or maltodextrin carbohydrate (Carb). Consumption of an ad libitum standardised test meal of chicken fried rice and water provided 360 min following ingestion of the preload meal was measured, and subjective feelings of appetite (hunger, fullness, desire to eat, and prospective food consumption) were assessed using 100-mm visual analogue scales (VAS). There were no differences among the five preload mixed meals in the amount of chicken fried rice consumed at the ad libitum test meal (mean ± sem: 531.6 ± 35.0 g, p = 0.47) or total (preload + test meal) energy intakes (mean ± sem: 5780.5 ± 146.0 kJ, p = 0.29). The subjective VAS appetite ratings and total area under the curve responses for hunger, fullness, desire to eat, and prospective food consumption, were not different following consumption of all five preload mixed meals (p > 0.05). The findings indicate that the effects of zein and casein on satiety were not different from the satiating effects of whey protein and α-lactalbumin.

S515 App-Delivered Gut-Directed Hypnotherapy Program Nerva Improves Symptoms in Patients With Irritable Bowel Syndrome but How Can We Ensure Users Are Compliant?

Introduction: App-delivered gut-directed hypnotherapy (GDH) is an efficacious treatment for irritable bowel syndrome (IBS), reducing overall and individual gastrointestinal symptoms at similar rates to face-to-face delivery.1 However, program adherence is poor. This study aimed to retrospectively assess symptoms of patients with IBS undergoing the app-delivered GDH program Nerva and to assess whether healthcare provider (HCP) referral aids program adherence. Methods: 15,552 patients with self-reported IBS downloaded a 42-session mobile app-delivered GDH program ‘Nerva’. The first 7 sessions were free. Overall and individual gastrointestinal symptoms were assessed at baseline and 6 weeks after starting the program, using a 100-mm visual analogue scale (VAS). Psychological outcomes were measured using the PHQ4, which is validated to categorise likelihood psychological distress into normal (0-2), mild (3-5), moderate (6-8) and severe (9-12). Data were parametric and presented per protocol. Results: Out of 15,552 users, 3101 completed the program. Of those who completed the program, overall gastrointestinal symptoms improved by 28 mm, to a level that would be considered meaningful clinically (mean 67 mm to 39 mm; p< 0.001 t-test). In the those who did not complete the program, overall gastrointestinal symptoms still significantly improved, but to a smaller magnitude (68 mm to 58 mm). Similar results were seen with individual symptoms. Linear regression analysis indicated that users who completed the program were more likely to respond (p< 0.001). Total adherence rate was generally low, with only 20% of users completing the program. However, users who were referred to Nerva by a HCP were statistically more likely to complete the program (24%) compared with those self-referred (19%) (OR 1.3; p< 0.001 logistic regression). HCP referral did not alter gastrointestinal symptom response (p=0.024). Users who completed the program were more likely to improve psychologically (mean ∆3, shifting from moderate to mild distress, vs 1, p< .001). Conclusion: App-delivered GDH improves overall and individual gastrointestinal symptoms. Users who complete the program report greater improvement in psychological outcomes. HCP referral is a positive predictor of program completion, but does not alter rates of efficacy.

Thread Embedding Acupuncture for Temporomandibular Disorder: Protocol for a Pilot Randomized Controlled Trial.

BackgroundTemporomandibular disorder (TMD) affects multiple tissues of the temporomandibular joint complex and manifests as orofacial pain and functional disturbance. While thread embedding acupuncture (TEA) is used for the treatment of TMD in clinical practice, sufficient clinical evidence is lacking. This pilot trial will explore the feasibility of a confirmatory randomized controlled trial (RCT) by considering the efficacy, safety, and cost-effectiveness of TEA to address pain, function, and quality of life in patients with TMD.MethodsThis randomized, assessor-blinded, controlled trial will include two parallel arms. Thirty patients with TMD and temporomandibular joint pain more severe than 40 mm on the 100-mm visual analog scale (VAS) and aged 19–70 years will be recruited and randomly allocated to either TEA or usual care groups. The TEA group will receive treatment at 14 predefined acupoints once weekly for 4 weeks. The usual care group will receive physical therapy consisting of transcutaneous electrical nerve stimulation and infrared therapy. The average VAS score over the last week for temporomandibular pain after four sessions will be assessed as the primary outcome. Furthermore, maximum pain VAS, vertical opening movement, Graded Chronic Pain version 2, Jaw Functional Limitation Scale 20, Patient Global Impression of Change, Korean version of Beck’s Depression Index, Short Form-12 Health Survey, EuroQol 5-Dimension 5-level, treatment expectation, rescue medication consumption, adverse events, and medical costs for economic evaluation will be measured and analyzed as secondary outcomes during four follow-up visits and after the termination of all sessions.ConclusionThe results of this trial will help evaluate the feasibility of a confirmatory RCT considering efficacy, safety, and cost-effectiveness and verify the effect size required to determine an appropriate sample size.Trial Registration NumberKCT0007421.

Arthrocentesis versus non-surgical intervention as initial treatment for temporomandibular joint arthralgia: a randomized controlled trial with long-term follow-up

Arthrocentesis for arthralgia of the temporomandibular joint (TMJ) is often only indicated when conservative, non-surgical interventions have failed. However, performing arthrocentesis as initial therapy may facilitate earlier and better recuperation of the joint. The aim of this study was to assess the efficacy of this therapy with a long-term follow-up. Eighty-four patients were randomly allocated to receive either arthrocentesis as initial treatment (n = 41) or non-surgical intervention (n = 43). Pain (100-mm visual analogue scale, VAS) and mandibular function impairment questionnaire scores (MFIQ, 0–100) were recorded at 3, 12, and 26 weeks, and ≥ 5 years (median 6.2, interquartile range 5.6–7.4 years). Univariable analyses were performed and linear mixed-effect models were constructed. Patients in the arthrocentesis group experienced significantly lower TMJ arthralgia compared to those treated non-surgically (pain during movement: −10.23 mm (95% confidence interval −17.86; −2.60); pain at rest: − 8.39 mm (95% confidence interval −13.70; −3.08)), while mandibular function remained similar in the two groups (MFIQ −2.41 (95% confidence interval −8.61; 3.78)). Of the final sample, 10 patients (10/39, 26%) in the non-surgical intervention group and two patients (2/34, 6%) in the arthrocentesis group received additional treatment during follow-up. Thus, initial treatment with arthrocentesis reduced TMJ arthralgia more efficaciously than non-surgical intervention in the long term, while maintaining similar mandibular function.

Study protocol for a randomised controlled trial of diacerein versus placebo to treat knee osteoarthritis with effusion-synovitis (DICKENS)

BackgroundThere is an unmet need for treatments for knee osteoarthritis (OA). Effusion-synovitis is a common inflammatory phenotype of knee OA and predicts knee pain and structural degradation. Anti-inflammatory therapies, such as diacerein, may be effective for this phenotype. While diacerein is recommended for alleviating pain in OA patients, evidence for its effectiveness is inconsistent, possibly because studies have not targeted patients with an inflammatory phenotype. Therefore, we will conduct a multi-centre, randomised, placebo-controlled double-blind trial to determine the effect of diacerein on changes in knee pain and effusion-synovitis over 24 weeks in patients with knee OA and magnetic resonance imaging (MRI)-defined effusion-synovitis.MethodsWe will recruit 260 patients with clinical knee OA, significant knee pain, and MRI-detected effusion-synovitis in Hobart, Melbourne, Adelaide, and Perth, Australia. They will be randomly allocated to receive either diacerein (50mg twice daily) or identical placebo for 24 weeks. MRI of the study knee will be performed at screening and after 24 weeks of intervention. The primary outcome is improvement in knee pain at 24 weeks as assessed by a 100-mm visual analogue scale (VAS). Secondary outcomes include improvement in volumetric (ml) and semi-quantitative (Whole-Organ Magnetic Resonance Imaging Score, 0–3) measurements of effusion-synovitis using MRI over 24 weeks, and improvement in knee pain (VAS) at 4, 8, 12, 16, and 20 weeks. Intention-to-treat analyses of primary and secondary outcomes will be performed as the primary analyses. Per protocol analyses will be performed as the secondary analyses.DiscussionThis study will provide high-quality evidence to determine whether diacerein improves pain, changes disease trajectory, and slows disease progression in OA patients with effusion-synovitis. If diacerein proves effective, this has the potential to significantly benefit the substantial proportion (up to 60%) of knee OA patients with an inflammatory phenotype.Trial registrationAustralian and New Zealand Clinical Trial Registry ACTRN12618001656224. Registered on 08 October 2018.

Clinical efficacy of mandibular complete dentures with a resilient liner: study protocol for a multicenter randomized controlled trial

BackgroundDuring restoration of poorly fitting complete dentures (CDs) in edentulous patients, liners are used to reconstruct the concave surfaces of CDs with a new base material. These relining materials are classified into resilient liners (RLs) and non-resilient liners (NRLs), but the clinical effects of these liners and their selection criteria remain unclear. The purpose of this study is to evaluate the clinical efficacy of relining mandibular CDs using RL and NRL and to conduct a follow-up study.MethodsThe study is currently being conducted at eight centers, and a parallel-group randomized controlled trial (RCT) is underway. One hundred thirty-two edentulous patients with poorly fitting mandibular CDs will be assigned to two groups based on whether they will receive RL or NRL. Participants will have an RL or NRL applied for relining their CDs using an indirect method of dynamic impressions. Data will be recorded at 1 week and 3, 6, and 12 months after denture delivery. The primary outcome will be assessment of the patients’ general satisfaction by using a 100-mm visual analog scale (VAS). Secondary outcomes will be measured as patient-reported outcomes, including food intake status and oral hygiene-related quality of life. Masticatory performance and the number of sore spots on the oral mucosa will also be recorded. Comparisons between the two groups and within-subject comparisons of pre- and post-intervention measurements will be conducted.DiscussionFor dentists and prosthetic researchers in Japan, this RCT will provide information on the clinical efficacy of RL materials in comparison to RNL in CD wearers. The new evidence regarding the use of RL materials in an aging population will also be useful to dentists in other countries in their routine clinical practice.Trial registrationThis clinical trial has been registered at the University Hospital Medical Information Network (UMIN) Center (UMIN000041950).

Effects of raltegravir formulation change on medication adherence and medication errors.

This study was aimed at assessing the adherence and incorrect drug intake associated with changes in the dosing schedule of raltegravir, the first integrase strand transfer inhibitor, from 400 mg twice a day (BID) to 600 mg × 2 tablets once a day (QD) in human immunodeficiency virus (HIV)-infected patients. Medication adherence over 1 month was evaluated in 25 male patients using the 100-mm visual analog scale (VAS) at the 3-day recall pill count and during pharmacist counseling after the first post-change visit. VAS scores before and after the raltegravir formulation change were compared. Medication adherence increased from 96 ± 4.3 mm (BID) to 100 ± 0.3 mm (QD) (P < 0.05). The patients exhibited improved medication adherence; however, three patients incorrectly took the drug when the formulation changed. This discovery can be used to facilitate the treatment of HIV-infected patients to increase treatment suitability and safety.

A two-year comparative assessment of retention of arch width increases between modified vacuum-formed and Hawley retainers: a multi-center randomized clinical trial

ObjectivesTo compare the clinical effectiveness of Hawley retainers (HRs) and modified vacuum-formed retainers (mVFRs) with palatal coverage in maintaining transverse expansion throughout a 24-month retention period and to assess the subjects’ perception toward the retainers.Materials and methodsThe trial accomplished blinding only by the outcome assessor and data analyst. Data were collected from post-orthodontic treatment patients who met the inclusion criteria. Thirty-five subjects were randomly allocated using a centralized randomization technique into either mVFR (n = 18) or HR group (n = 17). Dental casts of subjects were evaluated at debond (T0), 3-month (T1), 6-month (T2), 12-month (T3), and 24-month retention (T4). The intercanine width (ICW), interpremolar width (IPMW), interfirst molar mesiobuccal cusp width (IFMW1), and interfirst molar distobuccal cusp width (IFMW2) were compared between groups over time using Mixed ANOVA. A pilot-tested and validated questionnaire consisting of six items were given at T4. Subjects were instructed to rate their retainer in terms of fitting, speech, appearance, oral hygiene, durability, and comfort on a 100-mm Visual Analogue Scale (VAS).ResultsNo statistically significant differences in arch width were found between the two groups at ICW (P = .83), IPMW (P = 0.63), IFMW1 (P = .22), and IFMW2 (P = .46) during the 24-month retention period. Also, no statistically significant differences were found between perception of both retainers in terms of fitting, speech, oral hygiene, durability, and comfort (P > .05) after 24-month wear. The appearance of mVFRs was rated significantly higher compared to HRs (P < .05).ConclusionsHR and mVFR have similar clinical effectiveness for retention of transverse expansion cases in a 24-month retention period. Both retainers were perceived to be equal in terms of fitting, speech, oral hygiene, durability, and comfort. Subjects in the mVFRs group found their retainers to be significantly more esthetic than those in HRs group.

Thermal grill illusion of pain in patients with chronic pain: a clinical marker of central sensitization?

The thermal grill illusion of pain (TGIP) is a paradoxical burning pain sensation elicited by the simultaneous application of innocuous cutaneous warm and cold stimuli with a thermode ("thermal grill") consisting of interlaced heated and cooled bars. Its neurophysiological mechanisms are unclear, but TGIP may have some mechanisms in common with pathological pain, including central sensitization in particular, through the involvement of N-methyl- d -aspartate receptors. However, few studies have investigated TGIP in patients with chronic pain and its clinical relevance is uncertain. We hypothesized that the TGIP would be increased in comparison with controls in patients with fibromyalgia or irritable bowel syndrome, which are regarded as typical "nociplastic" primary pain syndromes related to changes in central pain processing. We compared the sensations elicited by a large range of combinations of temperature differentials between the warm and cold bars of a thermal grill applied to the hand between patients with fibromyalgia (n = 30) or irritable bowel syndrome (n= 30) and controls (n = 30). The percentage of TGIP responses and the intensity and unpleasantness of TGIP were significantly greater in patients than controls. Furthermore, positive correlations were found between TGIP intensity and clinical pain intensity and between TGIP intensity and the cold pain threshold measured on the hand. These results are consistent with our working hypothesis of shared mechanisms between TGIP and clinical pain mechanisms in patients with nociplastic chronic pain syndromes and suggest that TGIP might represent a clinical marker of central sensitization in these patients.

Evaluating the baseline auscultation abilities of second-year chiropractic students using simulated patients and high-fidelity manikin simulators: A pilot study.

To assess the ability of 2nd-year students to identify normal and abnormal findings during cardiac and lung auscultation using high-fidelity manikin simulators and standardized patients. A secondary objective was to assess students' perceived competence and confidence in their abilities. This was a descriptive pilot study of randomly selected 2nd-year students at 1 chiropractic training program. Participants were asked to perform cardiac and lung auscultation on high-fidelity manikins (2 stations) and standardized human patients (2 stations) with normal and abnormal auscultation sounds. Participants described the auscultated sound as "abnormal" or "normal" and were also asked to score their confidence in describing the sound and competence in performing auscultation on a 100-mm visual analog scale. Descriptive statistics were calculated for all study variables. Thirty-two students (23 women and 9 men) were included. For lung auscultation, 15.6% were incorrect on the human subject and 6.2% were incorrect on the manikin. For cardiac auscultation, 62.5% were incorrect on the human subject and 40.6% were incorrect on the manikin. Confidence mean scores ranged from 34.8 to 60. Competence mean scores ranged from 34.8 to 50. Results identified that 2nd-year students from 1 institution were correct in identifying an abnormal sound during lung auscultation but reported low levels of perceived competence or confidence in their responses. They performed poorly on cardiac auscultation and reported low perceived confidence and competence in their abilities to perform cardiac auscultation and identify sounds.

Periosteal block versus intravenous regional anesthesia for reduction of distal radius fractures: A randomized controlled trial.

We compare periosteal block and intravenous regional anesthesia (IVRA) as anesthetic techniques for reduction of distal radius fractures when performed by emergency department (ED) clinicians following brief training. This was a single-center, nonblinded randomized controlled trial of a convenience sample of patients presenting with distal radius fractures requiring closed reduction. Primary outcome measure was patient reported fracture reduction pain score, rated on a 100-mm visual analog scale. Secondary outcomes included adjunct pain medication use, ED length of stay, remanipulation rates, participant satisfaction, clinician assessed efficacy, and clinician-assessed ease of the procedure. Eighty-one patients were randomized to receive IVRA (n= 41) or periosteal block (N= 40). Reduction pain scores were not normally distributed. Median (25th-75th percentile) pain scores in participants assigned to IVRA and periosteal block were 5 (1-27.5) and 26 (8.5-63)mm, respectively, (p= 0.007). Use of adjunct medications during reduction was higher for the periosteal block group compared with IVRA (57.5% vs. 22.5%, p= 0.003). Remanipulation rates were 17.5% for periosteal block versus 7.5% for IVRA (p= 0.31). There was no difference in length of stay, patient satisfaction, or clinician's assessed ease of the anesthetic technique. There was a difference in clinician's assessment of efficacy between groups, with IVRA described as "extremely effective" by 65% and periosteal block described as "extremely effective" by 25% (p= 0.003). When performed by a diverse group of ED clinicians periosteal block provided inferior analgesia to IVRA but may provide an alternative when IVRA cannot be performed.

A prospective, single-arm, open-label, multicenter study to determine the safety and effectiveness of a fixed-dose combination of camylofin dihydrochloride and paracetamol in Indian children with acute colicky abdominal pain

Background: The aim of this prospective, single-arm, open-label, multicenter study was to determine the safety and effectiveness of a fixed dose combination of paracetamol and the antispasmodic camylofin dihydrochloride in Indian children with acute colicky abdominal pain.Methods: A total of 197 children with acute colicky abdominal pain were enrolled to receive 2 teaspoons (10 mL) of the syrup thrice daily orally for 5 days per local label. Primary objective was to assess safety as incidence of adverse events (AEs) and change in the severity and frequency of AEs from baseline to end of treatment (EOT). Secondary objectives were effectiveness as evaluated by change in mean (standard deviation [SD]) pain intensity (based on the 100-mm visual analog scale [VAS]) and mean change in the frequency of daily pain episodes from baseline to EOT.Results: In all, 182 (92.4%) patients completed the study. Twenty AEs were reported in 17 patients (8.7%). All AEs were treatment-emergent and of non-serious type. Common AEs included anemia, vomiting, and constipation. At EOT, mean pain intensity significantly (p&lt;0.0001) reduced to 3.3 (8.50) with a mean change of -61.5 (19.56) from baseline. Percentage change in mean intensity of pain from baseline to EOT visit was 94.9%. At EOT, the frequency of daily pain intensity significantly (p&lt;0.0001) reduced to 1.7 (1.01) with a mean change of -3.5 (2.14) from baseline.Conclusions: A fixed-dose combination of camylofin dihydrochloride and paracetamol was effective and well tolerated and had a good safety profile in Indian children with acute colicky abdominal pain.

Atelocollagen-Induced Chondrogenesis Versus Microfracture Alone for Osteochondral Lesions of the Talus: Surgical Technique and a 1-Year Clinical Outcome Study.

Osteochondral lesions of the talus (OLTs) are a common cause of post-traumatic ankle pain and disability. Atelocollagen-induced chondrogenesis (ACIC) aims to encourage the development of hyaline cartilage, which is biomechanically superior to fibrocartilage. This single-center, retrospective database study assessed patients who underwent arthroscopic microfracture with or without atelocollagen scaffold augmentation for OLT. Between 2010 and 2019, 87 patients underwent microfracture only and 31 patients underwent ACIC. Propensity score matching was used to match the ACIC group in a 1:2 ratio to a corresponding microfracture-only group using logistic regression. American Orthopaedic Foot & Ankle Society (AOFAS) scores, 100-mm Visual Analog Scale (VAS), Short Form-36 (SF-36), and satisfaction were assessed at preoperative, 3-, 6-, and 12-month intervals. There were no differences in baseline characteristics between groups after matching (P > .05). Both groups had similar improvements to VAS, AOFAS, and SF-36 scores up to 12 months (P > .05). Both groups had significant 1-year improvements to physical functioning, physical limitations in usual role activities, pain, and social functioning domains, but the ACIC group additionally had significant improvements to general health, vitality, and mental health. Patients in the ACIC group were also more satisfied than the microfracture group at all time points. Patients with OLTs who underwent ACIC reported superior satisfaction and improvements to quality of life, although clinical outcomes were similar to those who underwent microfracture alone at 1 year.Level of Evidence: Level III: Cohort study.

Effect of Ultrasonography-Guided Corticosteroid Injection vs Placebo Added to Exercise Therapy for Achilles Tendinopathy

Corticosteroid injections and exercise therapy are commonly used to treat chronic midportion Achilles tendinopathy, but the evidence for this combination is limited. To investigate the effect of corticosteroid injection and exercise therapy compared with placebo injection and exercise therapy for patients with Achilles tendinopathy. This was a participant-blinded, physician-blinded, and assessor-blinded randomized clinical trial of patients with Achilles tendinopathy verified by ultrasonography. Assessment of pain and function were conducted at baseline and at 1, 2, 3, 6, 12, and 24 months. Patients were recruited from a university medical clinic and a private rheumatology clinic in Denmark between April 2016 and September 2018. Data analysis was performed from June to September 2021. Corticosteroid injection and placebo injection were performed with ultrasonography guidance. Exercise therapy was based on previous trials and consisted of 3 exercises done every second day. The primary outcome was the Victorian Institute of Sports Assessment-Achilles (VISA-A) score (range, 1-100, with 100 representing no symptoms) at 6 months. Secondary outcomes included pain measured using a 100-mm Visual Analog Scale for morning pain and pain during exercise (with higher scores indicating worse pain), global assessment (Likert scale), and tendon thickness. A total of 100 patients were included, with 52 randomized to placebo (mean age, 46 years [95% CI, 44-48 years]; 32 men [62%]) and 48 randomized to corticosteroid injection (mean age, 47 years [95% CI, 45-49 years]; 28 men [58%]). Patients in the 2 groups had similar height (mean [SD], 177 [8] cm), weight (mean [SD], 79 [12] kg), and VISA-A score (mean [SD], 46 [18]) at baseline. The group receiving exercise therapy combined with corticosteroid injections had a 17.7-point (95% CI, 8.4-27.0 points; P < .001) larger improvement in VISA-A score compared with patients receiving exercise therapy combined with placebo injections at 6 months. No severe adverse events were observed in either group, and there was no deterioration in the long term (2-year follow-up). Corticosteroid injections combined with exercise therapy were associated with better outcomes in the treatment of Achilles tendinopathy compared with placebo injections and exercise therapy. A combination of exercise therapy and corticosteroid injection should be considered in the management of long-standing Achilles tendinopathy. ClinicalTrials.gov Identifier: NCT02580630.

Effect of Paracervical Block Volume on Pain Control for Dilation and Aspiration: A Randomized Controlled Trial.

To compare pain scores during office dilation and aspiration between low-volume and high-volume paracervical block of the same dose. We conducted a multi-site, randomized, single-blind, placebo-controlled trial from October 2018 to December 2020. We randomized participants presenting for office dilation and aspiration under minimal sedation stratified by procedural indication (induced abortion vs early pregnancy loss) to a 20-mL buffered 1% lidocaine paracervical block or a 40-mL buffered 0.5% lidocaine paracervical block, both with two units of vasopressin in a standardized technique. To detect a 15-mm or greater difference in pain at the time of cervical dilation with 80% power and a two-sided alpha of 0.05, a total of 104 participants was required. The study was also powered to detect a 20-mm or greater difference in pain at the time of cervical dilation within each stratum (induced abortion and early pregnancy loss). The primary outcome was pain with cervical dilation on a 100-mm visual analog scale in the overall cohort. Secondary outcomes included pain with cervical dilation within each stratum. We used a Wilcoxon rank-sum test to compare median pain scores between groups. We enrolled 114 participants. There was no difference in median pain scores between low-volume and high-volume groups during dilation (62 mm vs 59 mm, P=.94), aspiration (69.5 mm vs 70 mm, P=.47), postprocedure (25 mm vs 25 mm, P=.76), or overall (60 mm vs 60 mm, P=.23). Stratified by indication, there were no significant differences in scores at any time point between the low-volume and high-volume paracervical block groups. There was decreased overall pain in patients with induced abortion who received the higher volume paracervical block, though this did not reach statistical significance (67.5 mm vs 60.5 mm, P=.08). Pain during paracervical block administration was similar between groups (55 mm vs 45 mm, P=.24) and there was no difference in occurrence of side effects (P=.63). We found no difference in pain with cervical dilation among participants who received the low-volume compared with high-volume paracervical block when studied alone. ClinicalTrials.gov, NCT03636451.

Virtual Reality as Anxiolysis During Laceration Repair in the Pediatric Emergency Department

BackgroundAlthough procedural pain is effectively treated with analgesics, managing anxiety during laceration repair is more challenging. ObjectivesWe examined the feasibility of using immersive virtual reality (VR) as anxiolysis during laceration repair in the pediatric emergency department (ED). MethodsWe conducted a non-blinded, observational, pilot study in an urban pediatric ED that enrolled a convenience sample of children aged 5–13 years undergoing sutured repair of non-facial lacerations. Subjects played an immersive VR game while undergoing laceration repair. Parents assessed their child's anxiety on a 100-mm visual analogue scale at enrollment and during laceration repair. The primary outcome measure was the percentage of children whose anxiety score did not increase by ≥ 20 mm from enrollment to the first stitch. ResultsForty patients completed the study. Mean initial anxiety score was 54 mm (standard deviation 33 mm). Thirty-seven of forty patients (93%; 95% confidence interval [CI] 83–99%) had anxiety scores that did not increase by 20 mm or more from enrollment to the first stitch. Eighty percent (95% CI 64–91%) of patients’ anxiety scores decreased between enrollment and first stitch. The mean change in anxiety score at first stitch was −39 mm (95% CI −51 mm to −27 mm; p < 0.001). Similar downward trends in anxiety scores were noted throughout the procedure. All laceration repairs were successfully completed without sedation or restraints. There were no adverse events noted, and the main barriers identified with VR use involved easily correctable technical difficulties with the equipment. ConclusionImmersive VR is a safe and effective distractive technique to reduce procedural anxiety during laceration repair in the pediatric ED.

Therapeutic Potential of the 4 Strategies to SUlfide-REduction (4-SURE) Diet in Adults with Mild to Moderately Active Ulcerative Colitis: An Open-Label Feasibility Study

Diet therapy may bridge the therapeutic gap in ulcerative colitis (UC). The novel 4-SURE diet (4-strategies-to-SUlfide-REduction), designed to modulate colonic fermentation and influence production of excess hydrogen sulfide, was examined in a feasibility study for tolerability, clinical efficacy, and effects on microbial endpoints. Adults aged ≥18 y old with mild to moderately active UC were advised to increase intake of fermentable fibers, restrict total and sulfur-containing proteins, and avoid specific food additives for 8 wk. The primary outcome was tolerability of diet [100-mm visual analogue scale (VAS) with 100-mm being intolerable]. Secondary exploratory outcomes were self-reported adherence (always adherent ≥76-100%), clinical and endoscopic response (reduction in partial Mayo ≥2 and Mayo endoscopic subscore ≥1), modulation of fecal characteristics including markers of protein and carbohydrate fermentation, and food-related quality of life (IBD-FRQoL-29). Primary analysis was by intention to treat, performed using paired t and Wilcoxon signed-rank statistical tests. Twenty-eight adults with UC [mean (range) age: 42 (22-72) y, 15 females, 3 proctitis, 14 left-sided, and 11 extensive] were studied. Prescribed dietary targets were achieved overall. The diet was well tolerated (VAS: 19mm; 95% CI: 7, 31mm) with 95% frequently or always adherent. Clinical response occurred in 13 of 28 (46%) and endoscopic improvement in 10 of 28 participants (36%). Two participants (7%) worsened. Fecal excretion of SCFAs increased by 69% (P<0.0001), whereas the proportion of branched-chain fatty acids to SCFAs was suppressed by 27% (-1.34%; 95% CI: -2.28%, -0.40%; P=0.007). The FRQoL improved by 10 points (95% CI: 4, 16; P<0.001). The 4-SURE dietary strategy is considered tolerable and an acceptable diet by adults with mild to moderately active UC. The dietary teachings achieved the prescribed dietary and fecal targets. Given signals of therapeutic efficacy, further evaluation of this diet is warranted in a placebo-controlled trial. This trial was registered at https://www.anzctr.org.au (Australian New Zealand Clinical Trials Registry) as ACTRN12619000063112.

Analgesic and Anxiolytic Effects of Virtual Reality During Minor Procedures in an Emergency Department: A Randomized Controlled Study

We aimed to assess the analgesic and anxiolytic efficacy of distraction, a nonpharmacologic intervention provided by 3-dimensional (3D) virtual reality (VR) compared with that provided by 2-dimensional (2D) VR during minor emergency department (ED) procedures. This randomized controlled study conducted in the ED of a teaching hospital included patients aged more than or equal to 18 years undergoing minor procedures. The patients watched the same computer-generated VR world either in 3D in a head-mounted display (intervention) or in 2D on a laptop screen (control). Our main outcomes were pain and anxiety during the procedure, assessed on a 100-mm visual analog scale. Secondary outcomes included the impression of telepresence in the computer-generated world assessed using the Igroup Presence Questionnaire, and the prevalence and intensity of cybersickness measured on a 100-mm visual analog scale. The final analysis included 117 patients. The differences in median procedural pain and anxiety levels between the 2D and 3D VR groups were not significant:-3 mm (95% confidence interval [CI]-14 to 8) and-4 mm (95% CI-15 to 3), respectively; the difference in telepresence was 2.0 point (95% CI 0 to 2.0), and the proportion difference of cybersickness was-4% (95% CI-22 to 14), with an intensity difference of-5 mm (95% CI-9 to 3). During minor procedures in adult patients in the ED, distraction by viewing a 3D virtual world in a head-mounted VR display did not result in lower average levels of procedural pain and anxiety than that by 2D viewing on a screen despite a higher sense of telepresence. There were no significant differences in the prevalence and intensity of cybersickness between the 2 groups.

Compression following treatment of superficial venous incompetence: systematic review.

International guidelines recommend postprocedural compression when treating symptomatic superficial venous incompetence (SVI). This updated review of RCTs investigated the requirement for postprocedural compression and how it can be applied optimally. The National Institute for Health and Care Excellence's Healthcare Databases Advanced Search engine was used to identify all English-language RCTs of compression following treatment for SVI. Outcomes of interest included postprocedural pain, venous thromboembolism, health-related quality of life (HRQoL), and anatomical occlusion. A total of 18 studies were included comprising some 2584 treated limbs. Compression was compared with no compression in four studies, nine studies compared different durations of compression, and a further five compared different types of compression. A 1-2-week period of compression was associated with a mean reduction of 11 (95 per cent c.i. 8 to 13) points in pain score on a 100-mm visual analogue scale compared with a shorter duration (P < 0.001). This was associated with improved HRQoL and patient satisfaction. Longer durations of compression did not add further benefit. There was low-quality evidence suggesting that 35-mmHg compression with eccentric thigh compression achieved lower pain scores than lower interface pressures. There were no significant differences in venous thromboembolism rates or technical success in any group, including no compression. Postprocedural compression of 1-2 weeks after SVI treatment is associated with reduced pain compared with a shorter duration. The optimal interface pressure and type of compression, and the impact on venous thromboembolism risk, remain to be determined.

Oral phenazopyridine vs intravesical lidocaine for bladder onabotulinumtoxinA analgesia: a randomized controlled trial

The efficacy of intradetrusor onabotulinumtoxinA injections for the management of idiopathic overactive bladder has been well-established. The injections are typically performed in the office setting using local analgesia, most commonly a 20 to 30-minute intravesical instillation of lidocaine. There are limited data evaluating alternative bladder analgesics. To compare pain scores with preprocedure oral phenazopyridine vs intravesical lidocaine in women undergoing intradetrusor onabotulinumtoxinA injections for idiopathic overactive bladder. Nonpregnant adult females with idiopathic overactive bladder, scheduled for office injection of 100 units of intradetrusor onabotulinumtoxinA were randomized to either 200 mg of oral phenazopyridine taken 1 to 2 hours preprocedure or a 20-minute preprocedure intravesical instillation of 50 mL of 2% lidocaine. We excluded participants with neurogenic bladders, and those who had received intradetrusor onabotulinumtoxinA injections in the previous 12 months. The primary outcome was pain measured by a 100-mm visual analog scale. Demographic characteristics and overall satisfaction with the procedure were also recorded. Providers answered questions about cystoscopic visualization, ease of procedure, and perception of participant comfort. Prespecified noninferiority margin was set to equal the anticipated minimum clinically important difference of 14 mm. A planned sample of 100 participants, 50 in each treatment arm, provided 80% power to detect noninferiority at a significance level of.05. We performed a modified intention-to-treat analysis and compared variables with the t test or the Fisher exact test. A total of 111 participants were enrolled, and complete data were obtained for 100 participants; 47 participants were randomized to phenazopyridine and 53 to lidocaine. Baseline characteristics did not differ between groups. There were 19.6% and 20.8% of participants in the phenazopyridine and lidocaine groups, respectively, who previously underwent intradetrusor onabotulinumtoxinA injections. The mean postprocedure pain was 2.7 mm lower in the phenazopyridine group than in the lidocaine group (95% confidence interval,-11.3 to 10.7), demonstrating noninferiority. More than 90% of participants in both groups stated that the pain was tolerable. Slightly more participants reported being "very satisfied" in the lidocaine group, although this was not statistically significant (50.0% vs 40.4%; P=.34). Providers reported clear visualization in 89.4% of participants in the phenazopyridine group and in 100% of participants in the lidocaine group (P=.02). Provider perception of participant comfort and overall ease of procedure were not different between groups. Length of time in the exam room was significantly shorter in the phenazopyridine than in the lidocaine group (44.4 vs 57.5 minutes; P=.0003). In women receiving intradetrusor onabotulinumtoxinA injections for idiopathic overactive bladder, oral phenazopyridine was noninferior to intravesical lidocaine for procedural pain control. Phenazopyridine is well-tolerated by participants, allows for the procedure to be performed with similar ease, and is associated with shorter appointment times.