Showing papers on "Visual analogue scale published in 2019"

Recommendations for selection of self-report pain intensity measures in children and adolescents: a systematic review and quality assessment of measurement properties.

Abstract: In 2006, PAIN published a systematic review of the measurement properties of self-report pain intensity measures in children and adolescents (Stinson JN, Kavanagh T, Yamada J, Gill N, Stevens B. Systematic review of the psychometric properties, interpretability and feasibility of self-report pain intensity measures for use in clinical trials in children and adolescents. PAIN 2006;125:143-57). Key developments in pediatric pain necessitate an update of this work, most notably growing use of the 11-point numeric rating scale (NRS-11). Our aim was to review the measurement properties of single-item self-report pain intensity measures in children 3 to 18 years old. A secondary aim was to develop evidence-based recommendations for measurement of child and adolescent self-report of acute, postoperative, and chronic pain. Methodological quality and sufficiency of measurement properties for reliability, validity, responsiveness, and interpretability was assessed by at least 2 investigators using COnsensus based Standards for the selection of health Measurement INstruments (COSMIN). Searches identified 60 unique self-report measures, of which 8 (reported in 80 papers) met inclusion criteria. Well-established measures included the NRS-11, Color Analogue Scale (CAS), Faces Pain Scale-Revised (FPS-R; and original FPS), Pieces of Hurt, Oucher-Photographic and Numeric scales, Visual Analogue Scale, and Wong-Baker FACES Pain Rating Scale (FACES). Quality of studies ranged from poor to excellent and generally reported sufficient criterion and construct validity, and responsiveness, with variable reliability. Content and cross-cultural validity were minimally assessed. Based on available evidence, the NRS-11, FPS-R, and CAS were strongly recommended for self-report of acute pain. Only weak recommendations could be made for self-report measures for postoperative and chronic pain. No measures were recommended for children younger than 6 years, identifying a need for further measurement refinement in this age range. Clinical practice and future research implications are discussed.

Intra-articular injections of platelet-rich plasma, hyaluronic acid or corticosteroids for knee osteoarthritis : A prospective randomized controlled study.

Abstract: Knee osteoarthritis (KOA) is a degenerative joint disease leading to pain and disability for which no curative treatment exists. Intra-articular (IA) therapies are part of this multimodal approach and are approved by the Food and Drug Administration (FDA) and European Medicines Agency (EMA). Platelet-rich plasma (PRP), hyaluronic acid (HA), and corticosteroids (CS) have been increasingly used in recent years to treat KOA. To determine whether IA-PRP was superior to IA-HA or IA-CS administration routes in these patients. In this trial the patients were randomized to IA-HA (2 ml/week, for 3 weeks), IA-CS (1 ml) or IA-PRP (3 times, 4 ml, every 3 weeks) groups. The outcome was assessed using the Western Ontario and McMaster Universities (WOMAC) score prior to the first injection and then at 3, 6, 9 and 12 months. Pain was evaluated by a visual analogue scale (VAS) prior to treatment and after 12 months. In this study 120 patients were randomized into 3 groups. There was a significant improvement in all scores (WOMAC, VAS) in each group compared to the pretreatment values (P 0.05) but IA-PRP showed significantly lower scores 6, 9 and 12 months after treatment (P < 0.05). Intra-articular PRP injections into the knee for symptomatic early stages of KOA are a valid treatment option. The clinical efficacy of IA-PRP is comparable to that of the IA-HA and IA-CS forms after 3 months and the long-term efficacy of IA PRP is superior to IA-HA and IA-CS.

Role of Virtual Reality in Pain Perception of Patients Following the Administration of Local Anesthesia.

Abstract: Background: Dental anxiety and anxiety-related avoidance of dental care creates significant problems for the patients and dental practitioners. Administration of local anesthesia is one of the procedures which results in increased anxiety level among patients. Aim: The aim of this study was to study the effectiveness of virtual reality (VR) as a distraction tool during the administration of local anesthesia in patients undergoing a dental procedure. Materials and Methods: Fifty patients were randomized into two groups, namely, control group (n = 25) and study group (n = 25). Preoperative, intra-operative, and postoperative pulse rate and oxygen saturation were measured using pulse oximeter for all the patients. Local anesthesia was administered without the use of VR for the control group and with the VR for the study group. Statistical Analysis: The data were evaluated using the Statistical Package for the Social Sciences 20. Student's t-test was used to compare the variables. Results: Statistically significant results were obtained for preoperative and postoperative oxygen saturation, intraoperative pulse rate, and postoperative visual analog scale pain scale. Conclusion: The findings of the current study indicate that immersive VR is an effective distraction tool to alleviate the anxiety of the patient.

Efficacy of low-level laser therapy on pain and disability in knee osteoarthritis: systematic review and meta-analysis of randomised placebo-controlled trials

Abstract: Objectives Low-level laser therapy (LLLT) is not recommended in major knee osteoarthritis (KOA) treatment guidelines. We investigated whether a LLLT dose–response relationship exists in KOA. Design Systematic review and meta-analysis. Data sources Eligible articles were identified through PubMed, Embase, Cumulative Index to Nursing and Allied Health Literature, Physiotherapy Evidence Database and Cochrane Central Register of Controlled Trials on 18 February 2019, reference lists, a book, citations and experts in the field. Eligibility criteria for selecting studies We solely included randomised placebo-controlled trials involving participants with KOA according to the American College of Rheumatology and/or Kellgren/Lawrence criteria, in which LLLT was applied to participants’ knee(s). There were no language restrictions. Data extraction and synthesis The included trials were synthesised with random effects meta-analyses and subgrouped by dose using the World Association for Laser Therapy treatment recommendations. Cochrane’s risk-of-bias tool was used. Results 22 trials (n=1063) were meta-analysed. Risk of bias was insignificant. Overall, pain was significantly reduced by LLLT compared with placebo at the end of therapy (14.23 mm Visual Analogue Scale (VAS; 95% CI 7.31 to 21.14)) and during follow-ups 1–12 weeks later (15.92 mm VAS (95% CI 6.47 to 25.37)). The subgroup analysis revealed that pain was significantly reduced by the recommended LLLT doses compared with placebo at the end of therapy (18.71 mm (95% CI 9.42 to 27.99)) and during follow-ups 2–12 weeks after the end of therapy (23.23 mm VAS (95% CI 10.60 to 35.86)). The pain reduction from the recommended LLLT doses peaked during follow-ups 2–4 weeks after the end of therapy (31.87 mm VAS significantly beyond placebo (95% CI 18.18 to 45.56)). Disability was also statistically significantly reduced by LLLT. No adverse events were reported. Conclusion LLLT reduces pain and disability in KOA at 4–8 J with 785–860 nm wavelength and at 1–3 J with 904 nm wavelength per treatment spot. PROSPERO registration number CRD42016035587.

A Randomized Controlled Trial on the Use of Virtual Reality for Needle-Related Procedures in Children and Adolescents in the Emergency Department

Abstract: Objective: A large number of children report fear and distress when undergoing blood work and intravenous placement. In pediatric departments, Child Life interventions are considered to be the gold standard in nonmedical pain management techniques. Virtual reality (VR) has also been identified as an effective tool for pain distraction in children undergoing painful medical procedures. The aim of this study was to document the efficacy of VR as a mode of distraction during a medical procedure compared with two comparison conditions: watching television (TV, minimal control condition) and distraction provided by the Child Life (CL, gold standard control condition) program. Materials and Methods: A total of 59 children aged 8-17 years (35% female) were recruited through the emergency department (ED) of the Children's Hospital of Eastern Ontario and randomly assigned to one of the three conditions. The key outcome measures were visual analog scale ratings of pain intensity and fear of pain, administrated before and right after the procedure. Patient satisfaction was also measured after the intervention. Results: A significant reduction in fear of pain and pain intensity was reported in all three conditions. A larger and statistically significant reduction in fear of pain was observed among children who used VR distraction compared with the CL and TV conditions, but this effect was not observed for pain intensity. The children's satisfaction with the VR procedure was significantly higher than for TV and comparable to CL. Discussion: The advantages of using VR in the ED to manage pain in children are discussed.

Serlopitant reduced pruritus in patients with prurigo nodularis in a phase 2, randomized, placebo-controlled trial.

Abstract: Background Anecdotal evidence suggests that neurokinin 1 receptor antagonism reduces pruritus intensity in chronic pruritic conditions such as prurigo nodularis (PN). Objective This study assessed safety and efficacy of the neurokinin 1 receptor antagonist serlopitant for treatment of pruritus in PN. Methods In this randomized, double-blind, placebo-controlled study, 128 patients with chronic, treatment-refractory PN for more than 6 weeks received serlopitant, 5 mg, or placebo orally once daily for 8 weeks. The primary end point was change in average itch visual analog scale score at weeks 4 and 8. Results Average itch visual analog scale scores significantly improved with serlopitant versus with placebo at weeks 4 and 8: the least squares mean difference (serlopitant minus placebo) was −1.0 at week 4 (P = .02) and −1.7 at week 8 (P Limitations The 8-week duration may be insufficient to assess clinically relevant resolution of PN lesions. Conclusions Serlopitant reduced pruritus in patients with treatment-refractory PN and was well tolerated.

Efficacy of a drug composed of herbal extracts on postoperative discomfort after surgical removal of impacted mandibular third molar: a randomized, triple-blind, controlled clinical trial

Abstract: This study investigated and compared the effectiveness of a phytotherapeutic drug composed of herbal extracts on postsurgical discomfort after mandibular third molar surgery. Eighty-two patients requiring the surgical removal of a mandibular third molar were randomly assigned to receive placebo (group 1), ibuprofen (group 2), and a phytotherapeutic drug (composed of baicalin, 190 mg; bromelain, 50 mg; escin, 30 mg) (group 3). Drugs were administered after tooth extraction twice a day for 5 days. The primary outcome, pain, was evaluated using a visual analogue scale at 2 h, 6 h, 12 h, 24 h, 48 h, and 7 and 10 days after surgery. The secondary outcomes were the changes in maximum mouth opening and facial contours (mm) between baseline and at 24 h, 72 h, and 7 and 10 days after surgery. Compared to the baseline, all treatments demonstrated an improvement in the primary and secondary outcomes. Moreover, compared to groups 1 and 2, patients in group 3 yielded a significant reduction of the postoperative pain score at 12 h (p < 0.001), 24 h (p = 0.010), and 48 h (p = 0.048) after surgery. The mean reduction of the swelling and trismus was similar between groups. The results of this study suggest that a postoperative administration of a phytotherapeutic drug was found to be effective in postoperative pain management after the surgical removal of impacted mandibular third molars. The phytotherapeutic drug composed of herbal extract determined a decrease in the severity of postoperative pain compared to ibuprofen and placebo.

Clinical Outcomes of Transcatheter Arterial Embolisation for Chronic Knee Pain: Mild-to-Moderate Versus Severe Knee Osteoarthritis.

Abstract: This retrospective study was conducted to compare the clinical outcomes of transcatheter arterial embolisation for chronic knee pain in patients with mild-to-moderate versus severe knee osteoarthritis. This study included patients (n = 41) who were refractory to conservative treatments and who underwent transcatheter arterial embolisation using imipenem/cilastatin sodium between June 2017 and July 2018. A total of 71 knees, including 30 bilateral cases, were treated and categorised into two groups according to the Kellgren–Lawrence grade: mild-to-moderate osteoarthritis (n = 59, Kellgren–Lawrence grade 1–3) and severe osteoarthritis (n = 12, Kellgren–Lawrence grade 4). The clinical outcomes were measured by the visual analogue scale score. There were no significant differences in age, body mass index or baseline visual analogue scale scores between the two groups. The mean visual analogue scale scores in the mild-to-moderate osteoarthritis group were significantly decreased at 1 day, 1 week, 1 month, 3 months, and 6-months (5.5 at baseline vs. 3.2, 3.1, 2.9, 2.2, and 1.9, after treatment; all P = .00). These improvements were maintained at a mean of 10 ± 3 months (range 6–19 months) post-treatment. The visual analogue scale scores were significantly decreased in the severe osteoarthritis group for 1 month post-treatment (6.3 at baseline vs. 4.1, 4.1, and 4.4 at 1 day, 1 week, and 1 month; all P < .01). However, a decrease in pain was not statistically significant from 3 to 6 months (5.4 and 5.9 at 3 months and 6 months, respectively). Transcatheter arterial embolisation effectively relieved pain in patients with mild-to-moderate osteoarthritis. In patients with severe osteoarthritis, pain severity decreased for 1 month but gradually increased to the initial severity score within 3 months. 4, Case series.

The Impact of Dysmenorrhea on Quality of Life Among Spanish Female University Students

Abstract: (1) Background: Primary dysmenorrhea, which is characterized by menstrual pain in the absence of a pelvic pathology, is one of the main reasons for gynecological consultation. This study aimed to assess the prevalence of dysmenorrhea in a sample of university students, as well as their quality of life, and to examine the most common methods used for alleviating symptoms. (2) Methods: The participants comprised 305 female university students with a mean age of 20.32 ± 3.19 years who completed a self-report survey comprising sociodemographic, gynecological and lifestyle questions. EuroQol-5 dimensions-5 levels (EQ-5D-5L) was used to measure quality of life. (3) Results: In total, 76% of the sample suffered from dysmenorrhea. Among the students who did not suffer from dysmenorrhea, a significantly greater proportion participated in activities such as jogging or Pilates on a regular basis (several times per week). Concerning quality of life, patients with dysmenorrhea showed significant differences on the pain/discomfort scale and on the total score for perceived quality of life. However, this perception showed no correlation with the VAS (visual analogue scale) pain scale. Additionally, 90.5% of students with dysmenorrhea used pharmacological treatment, and 80% self-medicated. (4) Conclusions: Dysmenorrhea represents a major problem among youth today and the impact on the quality of life (QoL) of patients is evident. Physical activity may alleviate symptoms of dysmenorrhea and this and other complementary treatments should be promoted within health services.

Spinal manipulation plus laser therapy versus laser therapy alone in the treatment of chronic non-specific low back pain: a randomized controlled study.

Abstract: BACKGROUND Low back pain (LBP) is a common musculoskeletal disorder causing pain and disability in most of the countries. In recent years, new approaches such as Spinal manipulation and laser therapy have been considered as an alternative to conventional exercise and also found contradicting results in terms of its effectiveness. AIM A study to compare the combined effects of spinal manipulation, Laser and exercise versus Laser and exercise alone in chronic non-specific low back pain (cnLBP). DESIGN Randomized control study. SETTING Subjects with cnLBP were treated with spinal manipulation, Laser and exercise in outpatient department for four weeks. POPULATION Three hundred and thirty subjects who fulfilled the selection criteria were randomized (1:1:1 ratio) into SM-LT-CE (N.=110), LT-CE (N.=110) and control group (N.=110). METHODS The outcome measurements were Visual Analog Scale (VAS), Modified Modified Schober Test (MMST) Roland and Morris Disability Questionnaire (RMDQ), Physical Health Questionnaire-9 (PHQ-9) and Health Related Quality of Life-4 (HRQOL-4). Baseline and follow-up measurements were measured at 4 weeks, 6 and 12 months by a blinded investigator. RESULTS Three hundred and twenty-six subjects completed the intervention and 304 completed the 12-month follow-up. Demographic variables show homogeneity between the groups and ANOVA analyses showed significant improvement (P<0.001) in pain reduction (VAS), flexion range of motion (MMST), functional disability (RMDQ), depression status (PHQ-9), and quality of life (HRQOL-4) in SM-LT-CE group compared to the other two groups at one-year follow-up. CONCLUSIONS Spinal manipulation combined with laser therapy and conventional exercise is more effective than laser therapy and conventional exercise alone in chronic non-specific low back pain. CLINICAL REHABILITATION IMPACT Spinal manipulation is an adjuvant intervention and it can be applied in every day clinical practice.

Ultrasound-guided serratus anterior plane block for analgesia after thoracic surgery

Abstract: Background Patients who undergo surgical procedures that impair the integrity of the chest wall frequently experience extremely severe postoperative pain. Opiates and weaker analgesics, such as nonsteroidal anti-inflammatory drugs (NSAIDs), are not sufficiently effective in achieving control of severe pain and might cause respiratory and gastrointestinal complications. In the past decade, there has been an increased interest in the use of regional nerve blocks for post-thoracoscopy and post-thoracotomy analgesia. Methods This is a prospective, randomized, double-blind and single-center study. We recruited 104 patients who underwent elective thoracoscopy. Prior to surgery, the participating patients were randomized into one of two study groups: Group 1- the "standard control group" that received standard postoperative pain control with intravenous opioids, NSAIDs and acetaminophen (paracetamol) and Group 2- the "block group" that was treated by ultrasound-guided serratus anterior plane (SAP) block (a single injection of 0.25% bupivacaine hydrochloride 2 mg/kg plus dexamethasone 8 mg) with standard postoperative pain control regimen. We compared the clinical, laboratory, and postoperative pain assessment data of both groups. Results Patients in the SAP block Group 2 reported significantly lower levels of pain after thoracic surgery as assessed by their visual analog scale scores, as compared to the patients in the standard pain control Group 1 (P<0.001). The total dosage of morphine and tramadol required for pain relief during the first hours after surgery was significantly lower in the patients who received SAP block. Also, the incidence of vomiting after surgery was significantly lower among the patients who received SAP block than among the patients who received standard pain control. Conclusion The results of the present study suggest that SAP block is an effective adjuvant treatment option for post-thoracic surgery analgesia. Compared to the current methods used for post-thoracic surgery pain relief, SAP block has some significant merits, particularly its ease of use and its low potential for side effects.

Peripheral nerve blocks for postoperative pain after major knee surgery

Abstract: Background Major knee surgery is a common operative procedure to help people with end-stage knee disease or trauma to regain mobility and have improved quality of life. Poorly controlled pain immediately after surgery is still a key issue for this procedure. Peripheral nerve blocks are localized and site-specific analgesic options for major knee surgery. The increasing use of peripheral nerve blocks following major knee surgery requires the synthesis of evidence to evaluate its effectiveness and safety, when compared with systemic, local infiltration, epidural and spinal analgesia. Objectives To examine the efficacy and safety of peripheral nerve blocks for postoperative pain control following major knee surgery using methods that permit comparison with systemic, local infiltration, epidural and spinal analgesia. Search methods We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (Issue 1, 2014), MEDLINE and EMBASE, from their inception to February 2014. We identified ongoing studies by searching trial registries, including the metaRegister of controlled trials (mRCT), clinicaltrials.gov and the WHO International Clinical Trials Registry Platform (ICTRP). Selection criteria We included participant-blind, randomized controlled trials of adult participants (15 years or older) undergoing major knee surgery, in which peripheral nerve blocks were compared to systemic, local infiltration, epidural and spinal analgesia for postoperative pain relief. Data collection and analysis Two review authors independently assessed study eligibility and extracted data. We recorded information on participants, methods, interventions, outcomes (pain intensity, additional analgesic consumption, adverse events, knee range of motion, length of hospital stay, hospital costs, and participant satisfaction). We used the 5-point Oxford quality and validity scale to assess methodological quality, as well as criteria outlined in the Cochrane Handbook for Systematic Reviews of Interventions. We conducted meta-analysis of two or more studies with sufficient data to investigate the same outcome. We used the I² statistic to explore the heterogeneity. If there was no significant heterogeneity (I² value 0% to 40%), we used a fixed-effect model for meta-analysis, but otherwise we used a random-effects model. For dichotomous data, we present results as a summary risk ratio (RR) and a 95% confidence interval (95% CI). Where possible, we calculated the number needed to treat for an additional beneficial outcome (NNTB) or for an additional harmful outcome (NNTH), together with 95% CIs. For continuous data, we used the mean difference (MD) and 95% CI for similar outcome measures. We describe the findings of individual studies where pooling of data was not possible. Main results According to the eligibility criteria, we include 23 studies with 1571 participants, with high methodological quality overall. The studies compared peripheral nerve blocks adjunctive to systemic analgesia with systemic analgesia alone (19 studies), peripheral nerve blocks with local infiltration (three studies), and peripheral nerve blocks with epidural analgesia (one study). No study compared peripheral nerve blocks with spinal analgesia.Compared with systemic analgesia alone, peripheral nerve blocks adjunctive to systemic analgesia resulted in a significantly lower pain intensity score at rest, using a 100 mm visual analogue scale, at all time periods within 72 hours postoperatively, including the zero to 23 hours interval (MD -11.85, 95% CI -20.45 to -3.25, seven studies, 390 participants), the 24 to 47 hours interval (MD -12.92, 95% CI -19.82 to -6.02, six studies, 320 participants) and the 48 to 72 hours interval (MD -9.72, 95% CI -16.75 to -2.70, four studies, 210 participants). Subgroup analyses suggested that the high levels of statistical variation in our analyses could be explained by larger effects in people undergoing total knee arthroplasty compared with other types of surgery. Pain intensity was also significantly reduced on movement in the 48 to 72 hours interval postoperatively (MD -6.19, 95% CI -11.76 to -0.62, two studies, 112 participants). There was no significant difference on movement between these two groups in the time period of zero to 23 hours (MD -6.95, 95% CI -15.92 to 2.01, five studies, 304 participants) and 24 to 47 hours (MD -8.87, 95% CI -27.77 to 10.03, three studies, 182 participants). The included studies reported diverse types of adverse events, and we did not conduct a meta-analysis on specific types of adverse event. The numbers of studies and participants were also too few to draw conclusions on the other prespecified outcomes of: additional analgesic consumption; median time to remedication; knee range of motion; median time to ambulation; length of hospital stay; hospital costs; and participant satisfaction. There were insufficient data to compare peripheral nerve blocks and local infiltration or between peripheral nerve blocks and epidural analgesia. Authors' conclusions All of the included studies reported the main outcome of pain intensity but did not cover all the secondary outcomes of interest. The current review provides evidence that the use of peripheral nerve blocks as adjunctive techniques to systemic analgesia reduced pain intensity when compared with systemic analgesia alone after major knee surgery. There were too few data to draw conclusions on other outcomes of interest. More trials are needed to demonstrate a significant difference when compared with local infiltration, epidural analgesia and spinal analgesia.

Platelet rich plasma injection for acute Achilles tendon rupture: PATH-2 randomised, placebo controlled, superiority trial

Abstract: Objective To determine whether an injection of platelet rich plasma improves outcomes after acute Achilles tendon rupture. Design Randomised, placebo controlled, two arm, parallel group, participant and assessor masked, superiority trial. Setting Secondary care trauma units across 19 hospitals in the United Kingdom’s health service. Participants Recruitment commenced in July 2015 and follow-up was completed in March 2018. 230 adults aged 18 years and over were included, with acute Achilles tendon rupture presenting within 12 days of injury and managed with non-surgical treatment. Exclusions were injury at the insertion or musculotendinous junction, major leg injury or deformity, diabetes mellitus, platelet or haematological disorder, systemic corticosteroids, anticoagulation treatment, and other contraindicating conditions. Interventions Participants were randomised 1:1 to platelet rich plasma (n=114) or placebo (dry needle; n=116) injection. All participants received standard rehabilitation care (ankle immobilisation followed by physiotherapy). Main outcomes and measures Primary outcome was muscle tendon function at 24 weeks, measured objectively with the limb symmetry index (injured/uninjured×100) in maximal work done during the heel rise endurance test (an instrumented measure of repeated single leg heel rises until fatigue). Secondary outcomes included patient reported function (Achilles tendon rupture score), quality of life (short form 12 version 2®), pain (visual analogue scale), goal attainment (patient specific functional scale), and adverse events. A central laboratory analysed the quality and content of platelet rich plasma. Analyses were by modified intention to treat. Results Participants were 46 years old on average, and 57 (25%) of 230 were female. At 24 weeks, 202 (88%) participants completed the heel rise endurance test and 216 (94%) the patient reported outcomes. The platelet rich plasma was of good quality, with expected growth factor content. No difference was detected in muscle tendon function between participants receiving platelet rich plasma injections and those receiving placebo injections (limb symmetry index, mean 34.7% (standard deviation 17.7%) v 38.5% (22.8%); adjusted mean difference −3.9% (95% confidence interval −10.5% to 2.7%)) or in any secondary outcomes or adverse event rates. Complier average causal effect analyses gave similar findings. Conclusions There is no evidence to indicate that injections of platelet rich plasma can improve objective muscle tendon function, patient reported function, or quality of life after acute Achilles tendon rupture compared with placebo, or that they offer any patient benefit. Trial registration ISRCTN54992179.

Patient-reported quality of life after tisagenlecleucel infusion in children and young adults with relapsed or refractory B-cell acute lymphoblastic leukaemia: a global, single-arm, phase 2 trial

Abstract: Summary Background The ELIANA trial showed that 61 (81%) of 75 paediatric and young adult patients with relapsed or refractory B-cell acute lymphoblastic leukaemia achieved overall remission after treatment with tisagenlecleucel, a chimeric antigen receptor targeted against the CD19 antigen. We aimed to evaluate patient-reported quality of life in these patients before and after tisagenlecleucel infusion. Methods ELIANA, a global, single-arm, open-label, phase 2 trial, was done in 25 hospitals across Australia, Austria, Belgium, Canada, France, Germany, Italy, Japan, Norway, Spain, and the USA. Patients with B-cell acute lymphoblastic leukaemia aged at least 3 years at the time of screening and 21 years or younger at the time of initial diagnosis who were in second or greater bone marrow relapse, chemorefractory, relapsed after allogeneic stem-cell transplantation, or were otherwise ineligible for allogeneic stem-cell transplantation were enrolled. Patients received a single intravenous administration of a target dose of 0·2–5 × 106 transduced viable T cells per kg for patients weighing 50 kg or less or 0·1–2·5 × 108 transduced viable T cells for patients weighing more than 50 kg. The primary outcome, reported previously, was the proportion of patients who achieved remission. A prespecified secondary endpoint, reported here, was patient-reported quality of life measured with the Pediatric Quality of Life Inventory (PedsQL) and European Quality of Life-5 Dimensions questionnaire (EQ-5D). Patients completed the questionnaires at baseline, day 28, and months 3, 6, 9, and 12 after treatment. The data collected were summarised using descriptive statistics and post-hoc mixed models for repeated measures. Change from baseline response profiles were illustrated with cumulative distribution function plots. The proportion of patients achieving the minimal clinically important difference and normative mean value were reported. Analysis was per protocol. This study is registered with ClinicalTrials.gov , NCT02435849 . Findings Between April 8, 2015, and April 25, 2017, 107 patients were screened, 92 were enrolled, and 75 received tisagenlecleucel. 58 patients aged 8–23 years were included in the analysis of quality of life. At baseline, 50 (86%) patients had completed the PedsQL questionnaire and 48 (83%) had completed the EQ-5D VAS. Improvements in patient-reported quality-of-life scores were observed for all measures at month 3 after tisagenlecleucel infusion (mean change from baseline to month 3 was 13·3 [95% CI 8·9–17·6] for the PedsQL total score and 16·8 [9·4–24·3] for the EQ-5D visual analogue scale). 30 (81%) of 37 patients achieved the minimal clinically important difference at month 3 for the PedsQL total score and 24 (67%) of 36 patients achieved this for the EQ-5D visual analogue scale. Interpretation These findings, along with the activity and safety results of ELIANA, suggest a favourable benefit–risk profile of tisagenlecleucel in the treatment of paediatric and young adult patients with relapsed or refractory B-cell acute lymphoblastic leukaemia. Funding Novartis.

Treatment of Soft Tissue and Bony Spinal Stenosis by a Visualized Endoscopic Transforaminal Technique Under Local Anesthesia

Abstract: OBJECTIVE To analyze long-term clinical outcomes of endoscopic transforaminal foraminoplasty for foraminal stenosis. METHODS Long-term 5-year MacNab outcomes, visual analogue scale (VAS) scores, complications, and unintended aftercare were analyzed in a series of 86 patients who underwent endoscopic transforaminal foraminoplasty for foraminal stenosis. RESULTS At minimum 5-year follow-up, excellent results according to the MacNab criteria were obtained in 32 patients (37.2%), Good in 40 (46.5%), fair in 11 (12.8%), and poor in 3 (3.5%), respectively. The mean preoperative VAS was 6.15. The mean postoperative and last follow-up VAS was 3.44. Both postoperative VAS and last follow-up VAS were statistically reduced at a significance level of p<0.0001. Postoperative dysesthesia occurred in 9 patients. Another 9 patients had recurrent disc herniations (10.5%). Failure to cure with persistent pain occurred in 3 patients. Two patients developed pain postoperatively stemming from a different level. One patient experienced a postoperative hematoma which ultimately was inconsequential and did not require any additional surgery. Only 3 patients opted for revision endoscopic discectomy and another 2 for revision fusion surgery. CONCLUSION Patients with symptomatic foraminal stenosis may be treated successfully with early transforaminal endoscopic decompression while maintaining favorable long-term outcomes without the need for fusion in the vast majority of patients.

How Can We Define Clinically Important Improvement in Pain Scores After Hip Arthroscopy for Femoroacetabular Impingement Syndrome? Minimum 2-Year Follow-up Study:

Abstract: Background:Patient postoperative pain is being increasingly reported in the field of hip preservation surgery. The visual analog scale (VAS) for pain is one of the most commonly utilized measures f...

Adductor Canal Block or Local Infiltrate Analgesia for Pain Control After Total Knee Arthroplasty? A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

Abstract: Background Total knee arthroplasty is a treatment option for debilitating arthritis. In the postoperative period, patients experience moderate to severe pain affecting the rehabilitation, hospital stay, and patient satisfaction. This study aims at utilizing current best evidence to determine whether adductor canal block (ACB) or periarticular injection (PAI) is a better modality for managing short-term postoperative pain and opioid consumption. Methods Embase, MEDLINE, HealthStar, Emcare, and PubMed were searched for randomized controlled trials from 1946 to August 2018, for literature addressing the comparison of ACB and PAI for pain management in the setting of total knee arthroplasty. A systematic review and meta-analysis were performed. Results Six studies were included in our meta-analysis. When examining the combined visual analog scale (VAS) pain values for each group, analysis demonstrated greater reduction in scores for the PAI group, and the difference was statistically significant (P = .001). When comparing the VAS scores of subgroups analyzed at specific periods in time, there was a trend toward lower VAS scores in subgroups analyzed at 24 hours and 48 hours postoperatively (at rest and at movement) in the PAI group. Overall opioid consumption was lower in the PAI group, with demonstrated statistical significance (P = .03). When comparing the postoperative subgroups, there was a trend toward decreased opioid use in the PAI group, with 13.25% less opioid use at 48 hours and 9.5% less opioid use at 24 hours. Conclusion PAI could significantly improve postoperative pain and opioid consumption when compared with ACB. Additional, high-quality studies are required to further address this topic.

Preoperative sleep quality affects postoperative pain and function after total joint arthroplasty: a prospective cohort study

Abstract: The relationship between preoperative sleep quality and postoperative clinical outcomes after total joint arthroplasty (TJA) is unclear. We performed a prospective cohort study to determine whether preoperative sleep quality was correlated with postoperative outcomes after TJA. In this prospective cohort study, 994 patients underwent TJA. Preoperative sleep measures included scores on the Pittsburgh Sleep Quality Index (PSQI), the Epworth Sleepiness Scale (ESS), and a ten-point sleep quality scale. The primary study outcome measured was the visual analog scale (VAS) pain score to 12 weeks postoperation. The consumption of analgesic rescue drugs (oxycodone and parecoxib) and postoperative length of stay (LOS) were recorded. We also measured functional parameters, including range of motion (ROM), Knee Society Score (KSS), and Harris hip score (HHS). The mean age for total knee and hip arthroplasties was 64.28 and 54.85 years, respectively. The PSQI scores were significantly correlated with nocturnal and active pain scores and ROM and functional scores from postoperative day 1 (POD1) to POD3. In addition, significant correlation was noted between the correlation between the active pain scores and ESS scores in the TKA group at postoperative 3 months. The consumption of analgesics after joint arthroplasty was significantly correlated with the PSQI scores. Moreover, significant correlations were noted between the sleep parameters and postoperative length of hospital stay (LOS). Preoperative sleep parameters were correlated with clinical outcomes (i.e., pain, ROM, function, and LOS) after TJA. Clinicians should assess the sleep quality and improve it before TJA.

Test-Retest Reliability of a Modified Visual Analog Scale Assessment Tool for Determining Incidence and Severity of Gastrointestinal Symptoms in Response to Exercise Stress.

Abstract: Considering the recent growth of exercise gastroenterology research focusing on exercise-induced gastrointestinal syndrome mechanisms, response magnitude, prevention and management strategies, the ...