Numeric Rating Scale Research Articles

Dupilumab is Efficacious in Young Children with Atopic Dermatitis Regardless of Type2 Comorbidities.

Patients with atopic dermatitis (AD) often have other comorbid type2 inflammatory conditions. The aim of this study was to evaluate the impact of type2 comorbidities on the response to and safety of dupilumab in young children with AD. LIBERTY AD PRESCHOOL partB was a randomized, placebo-controlled trial in children aged 6months to 5years with moderate-to-severe AD. In this posthoc analysis, patients were stratified by the presence or absence of caregiver-reported selected type2 comorbidities at baseline: asthma, allergic rhinitis (AR), and food allergies (FAs). At week16, significantly more patients receiving dupilumab versus placebo, with or without asthma and AR, achieved an Investigator's Global Assessment (IGA) score of 0/1 and a ≥ 75% improvement in Eczema Area and Severity Index (all p < 0.05). Significantly more patients receiving dupilumab versus placebo with FAs and numerically more patients without FAs achieved an IGA score of 0/1 (p = 0.0007 and p = 0.06). Numerically more patients receiving dupilumab versus placebo with asthma and significantly more patients without asthma achieved a ≥ 4-point reduction in the weekly average of daily score on the Worst Scratch/Itch Numeric Rating Scale (WSI-NRS) (p = 0.6 and p < 0.0001). Additionally, significantly more patients receiving dupilumab versus placebo with or without AR (p = 0.008 and p < 0.0001) and with or without FAs (p = 0.0002 and p = 0.004) achieved a ≥ 4-point reduction in the weekly average of daily score on the WSI-NRS. Overall safety was consistent with the known dupilumab safety profile. Dupilumab treatment improves AD signs and symptoms in children aged 6months to 5years with and without type2 comorbidities such as asthma, AR, and FAs. ClinicalTrials.gov registration number NCT03346434. Do type 2 comorbidities impact the response to dupilumab in children with atopic dermatitis? (MP4 103,451 KB).

Combined Oxygen-Ozone and Porcine Injectable Collagen Therapies Boosting Efficacy in Low Back Pain and Disability.

Background/Objectives: Intervertebral disc degeneration is the most common cause of low back pain (LBP), and lumbosciatica is a major challenge to healthcare systems worldwide. For years, ozone therapy has been used with excellent results in intervertebral disc disease and in patients with LBP. In vitro studies have demonstrated the positive action of porcine collagen in extracellular matrix remodeling and homeostasis. These tissue changes, associated with LBP, may suggest an indication for combined ozone/collagen treatment in patients with LBP. However, no studies have been reported regarding this combination of treatments. Methods: The present work compared retrospective data of two treatment groups (each of 10 LBP patients): (A) oxygen-ozone therapy (OOT) vs. (B) OOT plus porcine collagen type 1 injections (COL I). Pain intensity and physiological function were assessed by the numerical rating scale (NSR) method. The Roland-Morris questionnaire was used to assess disability. Patient data were acquired before, during, and at the six-month follow-up. Significant differences were assessed by ANOVA and Student's t-test. Results: The analyses revealed significant statistical differences comparing the two arms, where the (OOT+COL I) treatment demonstrated a booster efficacy in pain (a reduction of 62% vs. 35%), while the questionnaire revealed a reduction in disability (70% vs. 31%). Conclusions: Therefore, this combination therapy (oxygen-ozone plus porcine injectable collagen) might be a promising approach for the management of patients with LBP.

Nociception level index-directed superficial parasternal intercostal plane block vs erector spinae plane block in open-heart surgery: a propensity matched non-inferiority clinical trial.

This single-center study explored the efficacy of superficial parasternal intercostal plane block (SPIPB) versus erector spinae plane block (ESPB) in opioid-sparing within Nociception Level (NOL) index-directed anesthesia for elective open-heart surgery. After targeted propensity matching, 19 adult patients given general anesthesia with preincisional SPIPB were compared to 33 with preincisional ESPB. We hypothesized that SPIPB is non-inferior to ESPB in reducing total intraoperative fentanyl consumption, with a non-inferiority margin (δ) set at 0.1mg. Intraoperative fentanyl dosing targeted a NOL index ≤ 25. Postoperatively, paracetamol 1g 6-hourly and morphine for numeric rating scale (NRS) ≥ 4 were administered. This study could not demonstrate that SPIPB was inferior to ESPB for total intraoperative fentanyl consumption, as the confidence interval for the median difference of 0.1mg (95% CI 0.05-0.15) crossed the predefined δ, with the lower bound falling below and the upper bound exceeding δ, p = 0.558. SPIPB led to higher postoperative morphine use at 24 and 48h: 0 (0-40.6) vs. 59.5 (28.5-96.1) µg kg-1, p < 0.001 and 22.2 (0-42.6) vs. 63.5 (28.5-96.1) µg kg-1, p = 0.001. Four times fewer SPIPB patients remained morphine-free at 48h, p < 0.001, and their time to first morphine dose was three times shorter compared to ESPB patients, p = 0.001. SPIPB led to higher time-weighted average NRS scores at rest, 1 (0-1) vs. 1 (1-2), p = 0.004, and with movement, 2 (1-2) vs. 3 (2-3), p = 0.002, calculated over the 48-h period post-extubation. The SPIPB group had a significantly higher average NOL index, p = 0.003, and greater NOL index variability, p = 0.027. This study could not demonstrate that SPIPB was inferior to ESPB for intraoperative fentanyl consumption. Significant differences were observed in secondary outcomes, with SPIPB leading to higher postoperative morphine use, higher pain scores, and reduced nociception control.

CULTURAL adaptation and validation of the Indonesian version of the Roland-Morris disability questionnaire: A psychometric analysis

BACKGROUND: Epidemiological evidence underscores low back pain (LBP) as a prevalent and consequential musculoskeletal disorder, posing a significant public health challenge. Patient-reported outcome measures (PROMs) play a crucial role in the diagnostic process for LBP, with the Roland-Morris Disability Questionnaire (RMDQ) being a commonly utilized tool in evaluating LBP. OBJECTIVE: This cross-sectional study aimed to cross-culturally adapt and validate the Indonesian version of the 24-item-RMDQ among nonspecific LBP (NSLBP) patients. METHODS: The RMDQ scales underwent forward-backwards translation, readability, and content validity assessments with NSLBP patients (n = 137), with a mean age of 38.6±11.8 years (59% female). Psychometric testing included assessments of internal consistency and 1-week test-retest reliability, convergent validity with pain numeric rating scale (PNRS), and the Physical Component Summary (PCS) and Mental Component Summary (MCS) of quality of life (Short Form 12). The construct validity using confirmatory factor analyses (CFA). RESULTS: The findings of this study indicated a good internal consistency (Cronbach α= 0.80) of the translated instrument. Moderate to good repeatability estimates of all RMDQ items were demonstrated with the total ICC of the total RMDQ score of 0.90 [95%CI (0.85–0.94)]. The instrument correlations with PNRS, PCS, and MCS were 0.54, 0.60, and 0.23, respectively. The goodness-of-fit test further affirmed an acceptable fit of the data, although low factor loadings were found in several RMDQ items. CONCLUSION: Although the factor structure of the RMDQ scale warrants further investigation, the overall findings support its suitability for clinical application in Indonesian NSLBP patients.

Focal Vibration Therapy for Motor Deficits and Spasticity Management in Post-Stroke Rehabilitation

Background: Focal mechanical vibration therapy has gained attention as a potential intervention to improve motor function while decreasing spasticity and pain in post-stroke patients. Despite promising results, there remains variability in study designs and outcomes, warranting a review of its clinical efficacy. Methods: A review was conducted to evaluate randomized controlled trials (RCTs) investigating the effects of focal mechanical vibration therapy on post-stroke rehabilitation. Six studies were included, assessing outcomes such as spasticity reduction (using the Modified Ashworth Scale), motor function recovery (Wolf Motor Function Test, Fugl-Meyer Assessment), and pain management (Visual Analog Scale, Numerical Rating Scale). The quality of studies was evaluated using the PEDro scale and RoB-2 tool. An overview review was conducted to provide a comprehensive analysis of the topic. Results: The included studies demonstrated significant reductions in spasticity and improvements in motor function in most patients receiving focal vibration therapy. Notable improvements were observed when focal vibration was combined with other rehabilitation techniques, such as progressive modular rebalancing or robotic rehabilitation. Pain levels were also reduced in several studies. However, differences in vibration parameters (frequency, amplitude), small sample sizes, and short follow-up periods limit the generalizability of the findings. Conclusions: Focal mechanical vibration therapy appears to be an effective adjunct in post-stroke rehabilitation, particularly for reducing spasticity and improving motor function. Although short-term benefits are promising, further research is required to determine long-term efficacy and optimal treatment parameters. This review evaluates the effectiveness of focal vibration therapy in treating motor deficits and spasticity in post-stroke patients. The results suggest its potential to improve these conditions, though further studies with larger sample sizes are needed to confirm its long-term efficacy.

The Impact of Virtual Reality as a Rehabilitation Method Using TRAVEE System on Functional Outcomes and Disability in Stroke Patients: A Pilot Study

Background: Stroke is the third leading cause of disability. Virtual reality (VR) has shown promising results in post-stroke rehabilitation. The VR TRAVEE system was designed for the neuromotor rehabilitation of the upper limb after a stroke and offers the ability to track limb movements by providing auditory feedback and visual augmentation. The World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0), aligned with the International Classification of Functioning, Disability, and Health (ICF) principles, is a valid tool for measuring disability regardless of its cause. This study aimed to investigate the feasibility of the VR TRAVEE system in upper limb rehabilitation for stroke patients. Methods: A total of 14 stroke patients with residual hemiparesis were enrolled in the study. They underwent a 10-day program combining conventional therapy (CnvT) with VR rehabilitation. At baseline (T0), the upper limb was assessed using the Modified Ashworth Scale (MAS), active range of motion (AROM), and the Numeric Rating Scale (NRS) for pain. These assessments were repeated after the 10-day rehabilitation program (T1). Additionally, disability was measured using WHODAS 2.0 at T0 and again 30 days after completing the program. Results: Significant improvements were observed in AROM and MAS scores for the shoulder, elbow, wrist, and metacarpophalangeal joints, as well as in the reduction in shoulder pain (p ˂ 0.001). WHODAS scores decreased across all six domains, with a statistically significant improvement in the Cognition domain (p = 0.011). Conclusions: Combining CnvT with VR as a rehabilitation approach enhances motor function in the upper limb. This method has the potential to reduce disability scores and promote neuroplasticity.

The Effectiveness Of Physical Therapy And Rehabilitation Approaches In Low Back Pain On Pain Severity And Disability; A Systematic Review

Low Back Pain encompasses nociceptive pain, neuropathic pain radiating to the legs, and nociplastic pain, often classified as non-specific due to central nervous system exaggeration. Globally, Low Back Pain is a leading cause of activity restriction and loss of productivity, significantly impacting finances. Objective; This study aimed to review the efficacy of physical therapy and rehabilitation approaches for LBP, focusing on pain intensity and disability. Materials and Methods; A literature review was conducted in PubMed and Web of Science databases up to January 30, 2024. English studies were required, using keywords: “low back pain,” “pain intensity,” “pain severity,” “disability,” and “physical therapy.” Pain intensity was measured using the Visual Analog Scale (VAS) and Numeric Rating Scale (NRS), including the 11-point Pain Intensity Numerical Rating Scale (PI-NRS). Disability was assessed using ADL, IADL scales, Roland Morris Disability Questionnaire (RMDQ), and Oswestry Disability Index (ODI). Results; Seven study met the inclusion criteria from 665 initial records. Interventions included osteopathic manipulative treatment (OMT), core muscle exercise with interferential current (IFC), cognitive functional therapy (CFT), dry cupping therapy, high-intensity machine-based core muscle resistance training (C-IPU), heat therapy, TENS, pelvic traction, Reiki, dynamic muscular stabilization technique (DMST), and McGill Big 3 (MB3). Sample sizes ranged from 30 to 1090 participants. IFC combined with core muscle exercises significantly reduced pain intensity compared to each method alone, though not statistically significant (p &gt; 0.05). The C-IPU group had greater pain relief (P 0.05). Dry cupping did not outperform sham cupping. CFT reduced absenteeism in the first two years but not later. Reiki showed significant improvement in pain and ADL compared to drug therapy, but not to physiotherapy. Conclusions; Physical therapy interventions effectively alleviate symptoms and improve outcomes in LBP. However, variability in interventions and outcome measures necessitates cautious interpretation. Further research with standardized protocols is essential to understand the effectiveness and optimal duration of physical therapy for LBP. Keywords; low back pain; pain intensity; pain severity; disability; physical therapy

Effect of Dural Puncture Epidural Technique on Management of Breakthrough Pain for Parous Women Receiving Labor Analgesia during Induced Labor: A Retrospective Cohort Study.

This study assessed the effectiveness of the dural puncture epidural (DPE) technique in managing breakthrough pain in parous women receiving labor analgesia during induced labor. This single-center retrospective cohort study included term pregnant women with singleton pregnancies who received treatment for breakthrough pain during labor. All participants underwent induced labor, and some parous women among them underwent DPE. The DPE technique consisted of placing an epidural catheter after dural puncture with a 27-gauge spinal needle. Eligible women were allocated into a DPE group and conventional epidural (CE) anesthesia group. Pain was assessed with a numerical rating scale (NRS), and a patient-controlled epidural analgesia (PCEA) bolus was administered when the NRS score was ≥3. Breakthrough pain was defined as an NRS score ≥3 during PCEA management. The primary outcome was the efficacy of rescue interventions in managing breakthrough pain, as determined by a reduction in pain intensity to an NRS score <3 before birth. Among the 55 parous women who received labor analgesia, 44 required additional rescue administration for breakthrough pain. Of the remaining women, 23 received DPE and 19 received CE anesthesia. The DPE group experienced significantly more effective relief of breakthrough pain before birth than did the CE group (DPE: 100%; CE: 68.4%; p=0.005). In parous women, DPE anesthesia was more effective than CE anesthesia in providing analgesia for breakthrough pain immediately before delivery during induced labor.

A preliminary exploration of reduced port laparoscopic proximal gastrectomy with right-sided overlap and single-flap valvuloplasty (ROSF)

Objective: This study aimed to share preliminary experiences of single-incision plus two ports laparoscopic proximal gastrectomy with right-sided overlap and single-flap valvuloplasty (ROSF). Methods: Following the 6th edition of the Japanese Gastric Cancer Treatment Guidelines, proximal gastrectomy with lymphadenectomy was performed. Using a single-port approach, the esophagus was transected at least 2 cm above the tumor's upper margin with linear staplers. The stomach was then extracted through a periumbilical incision, and the proximal stomach was subsequently transected extracorporeally, while ensuring appropriate resection margins on both the greater and lesser curvatures. A single flap was created before returning the remnant stomach to the abdominal cavity and re-establishing pneumoperitoneum. The No.2 clip was used to grasp and elevate the esophageal stump. An incision was made at the right lower edge of the esophageal stump to guarantee that the esophageal lumen was open. The linear stapler was then inserted into the openings of the stomach and esophagus to perform a side overlap anastomosis with a length of 3 cm. Another barbed suture was used to close the common opening of the esophagus and the stomach, and the same barbed suture were used to suture the gastric wall to the lower edge of the muscle flap. The first barbed suture was then used to sequentially suture the proximal brim of the flap to the esophagus and the right brim of the flap to the right brim of the mucosal window. After completion of anastomosis, a drainage tube was inserted through the right upper port. This procedure was employed from November 2023 to March 2024 on five patients diagnosed with adenocarcinoma of the esophagogastric junction and upper stomach. The cohort consisted of three males and two females, with an age range of 62 to 75 years and a body mass index (BMI) of 13.7 to 24.2 kg/m². All cases were preoperatively staged as T1-2N0M0, confirmed by endoscopic biopsy and enhanced CT scans of the chest, abdomen, and pelvis. Results: All five patients successfully underwent the surgery. The median surgery time was 180-325 minutes, with the intraoperative blood loss of 30-50 ml. The number of lymph nodes harvested ranged from 18 to 27. The time to first flatus, and restore liquid diet and was 2.0-5.0 and 1.0-3.0 days, respectively. The postoperative length of stay was 9.0-11.0 days. The pain scores on the Numeric Rating Scale (NRS). On the first day, the pain scores were 3.0 in two cases, 2.0 in two cases, and 1.0 in one case. On the second day, the pain scores were 2.0 in two cases and 1.0 in three cases. On the third day, the pain scores were 1.0 in four cases and 2.0 in one case. No short-term postoperative complications were observed, and there were no perioperative deaths. Conclusion: Single-incision plus two ports laparoscopic proximal gastrectomy with ROSF is safe and feasible.

Long-term efficacy and safety of stapokibart for moderate-to-severe atopic dermatitis: 52-week results from a phase 3 trial.

Management of moderate-to-severe atopic dermatitis (AD) needs long-term therapy. Stapokibart is a humanized monoclonal antibody targeting interleukin-4 receptor α subunit (IL-4Rα), a shared receptor for IL-4 and IL-13 which are key pathogenic drivers of AD. In a pivotal phase 3 trial (NCT05265923), significant higher proportions of adult AD patients receiving stapokibart than placebo achieved ≥75% improvement from baseline in Eczema Area and Severity Index (EASI-75; 66.9% vs. 25.8%) and Investigator's Global Assessment (IGA) score of 0/1 with ≥2-point reduction (44.2% vs. 16.1%) at Week 16. Herein, we report long-term (52 weeks) efficacy and safety of stapokibart from this trial. After 16-week double-blind treatment completed, patients in both stapokibart and placebo groups entered a 36-week maintenance treatment period and received stapokibart 300 mg every 2 weeks. Concomitant use of topical medications for AD was permitted throughout the maintenance period. Of 476 patients entering maintenance period, 430 completed the treatment. At Week 52, EASI-75 was achieved in 92.5% of patients continuing stapokibart and 88.7% of those switching from placebo to stapokibart, respectively; an IGA score of 0 or 1 with a ≥2-point reduction was achieved in 67.3% and 64.2% of patients, respectively; a ≥4-point reduction in weekly average of daily Peak Pruritus Numerical Rating Scale (PP-NRS) was achieved in 67.3% and 60.5% of patients, respectively. Over the 52-week treatment period, 88.1% of patients reported treatment-emergent adverse events, most were mild or moderate. Long-term treatment with stapokibart demonstrated a sustained efficacy and favorable safety profile in adults with moderate-to-severe AD.

Dynamic change and risk factors of intense thirst in patients admitted to neuro-intensive care unit: An observational study.

Thirst is a clinical discomfort symptom reported by most patients admitted to intensive care unit (ICU). Little is known about the dynamic change and risk factors of intense thirst in neuro-intensive care unit (Neuro-ICU). The objective of this study was to explore the dynamic change and determine the risk factors of intense thirst in patients admitted to Neuro-ICU, providing reference for personalized interventions of intense thirst. The study design is a prospective observational study. Demographic and disease-related,treatment, physiological and biochemical data were collected for 230 patients from Neuro-ICU of a hospital from May 2023 to November 2023. We assessed thirst intensity on numeric rating scale (NRS) of 0-10 (10 = worst possible thirst) at eight time points: 7:00, 9:00, 11:00, 13:00, 15:00, 17:00, 19:00 and 21:00 and a self-designed general information questionnaire based on safety protocol for thirst management to analyse the risk factors of intense thirst in Neuro-ICU patients. If thirst scores were more than 7, we defined it as intense thirst. This study followed the STROBE checklist for cross-sectional studies. A total of 230 Neuro-ICU patients were observed. The dynamic analysis results showed an overall downward trend in thirst intensity, with the highest NRS thirst scores at 07:00 (6.13 ± 2.14) and the lowest at 21:00 (4.02 ± 2.72). The investigation of the current situation showedthat the incidence of intense thirst in Neuro-ICU patients was 47.4%. Intense thirst in Neuro-ICU patients was predicted by dysphagia (odds ratio [OR] = 1.436, 95% confidence interval [CI]:1.063-1.941), open mouth breathing (OR = 2.201, 95% CI:1.041-4.656), high glucose (OR = 2.584, 95% CI:1.097-6.087), xerostomia (OR = 3.049, 95% CI:1.950-4.767) (all p < .05). The intensity of thirst was dynamically changing and the incidence of intense thirst in Neuro-ICU patients was relatively high. Timely assessment of Neuro-ICU patients' thirst severity and identification of those at high risk can ensure the implementation of effective interventions based on patients' characteristics. Thirst is a pervasive distressing symptom often reported by critically ill patients. This study revealed that the clinical nurses need to enhance their focus on dynamic change of thirst, which is helpful for improving the efficiency of bundled thirst interventions at the suitable time.

Comparison Between Total Hip and Knee Arthroplasty on Short-Term Performance-Based Outcomes and Factors Associated with the Improvement of Gait Function During Post-Acute Inpatient Rehabilitation.

Background: Data on the differences in functional recovery between inpatient rehabilitation for total hip arthroplasty (THA) and total knee arthroplasty (TKA) are lacking, and the factors influencing the improvement of short-term functional mobility remain unknown. In this study, we compared the short-term functional outcomes of both procedures and identified early postoperative predictors of physical function gain during post-acute rehabilitation. Methods: A total of 435 patients who underwent THA and TKA were included. The main outcomes were knee extension strength, the motor component of the Functional Independence Measure, Numerical Rating Scale, 10 Meter Walk Test, Timed Up and Go (TUG) test, and the Berg Balance Scale. The recovery process and rehabilitation outcomes were compared between patients with THA and TKA. Additionally, predictors related to physical performance improvement were examined for each procedure. Results: Patients with THA and TKA achieved significant short-term functional recovery after multidisciplinary rehabilitation (time; p < 0.001). However, the pain score was higher at discharge in patients with TKA (p < 0.001). Age (β: -0.264, p = 0.009) and TUG test (β: -0.884, p < 0.001) in THA, and non-operated knee extension strength (β: 0.234, p = 0.016) and TUG test (β: -0.783, p < 0.001) in TKA were significant early postoperative predictors of functional mobility. Conclusions: Multidisciplinary rehabilitation was beneficial for functional improvement in patients with THA and TKA despite persistent pain at discharge after TKA. Baseline functional levels in both groups and non-operated knee extension strength in TKA can be useful performance-based predictors of short-term gait function improvement.

Dentin hypersensitivity and quality of life in patients with chronic systemic disease.

To assess the potential impact of dentin hypersensitivity on the quality of life in people with chronic systemic diseases. We included 252 volunteers, 18 years or older, with ≥ 6 teeth, and under outpatient medical follow-up for systemic chronic diseases. Short Form Health Survey 36 (SF-36) was used to assess quality of life (QoL); Oral Health Impact Profile-14 (OHIP-14) and Dentine Hypersensitivity Experience Questionnaire (DHEQ-15) were used for oral health-related quality of life (OHRQoL). Dentin hypersensitivity pain was assessed using an evaporative and tactile test, and pain assessment was performed using a numerical rating scale and a verbal rating scale. Medical information was obtained from anamnesis forms and the hospital digital medical records. Of 252 participants, 60% had dentin hypersensitivity. There was a negative impact on the QoL/OHRQoL of individuals with dentin hypersensitivity regarding the vitality, mental health, physical functioning, and bodily pain dimensions of SF-36, and the functional limitation, physical pain, physical disability, and psychological disability dimensions of OHIP-14. Dentin hypersensitivity appeared to exert an indirect influence on QoL. Dentin hypersensitivity negatively impacts the quality of life in patients with chronic systemic diseases.

Feasibility and safety of flexible ureteroscopy with intelligent control of renal pelvis pressure without urinary catheter: a retrospective study

BackgroundTo explore the feasibility and safety of aflexible ureteroscopy with intelligent control of renal pelvic pressure(FUS-ICP) without a post-operative indwelling urinary catheter .MethodsIn this retrospective study, we assessed patients with upper urinary tract stones who were treated with FUS-ICP at the Ganzhou People’s Hospital from February 2022 to December 2023. Patients were divided into the non-urinary catheter (non-UC) and urinary catheter (UC) groups according to whether an indwelling catheter was used after surgery.ResultsIn total, 142 patients were included in the study. There was no significant difference in the preoperative general data between the two groups. Patients in the non-UC group performed better than those in the UC group in terms of catheter-related bladder irritation (P = 0.001), the Sedation-Agitation Scale score (P = 0.012), and the numerical rating scale (P = 0.003). The incidences of urinary retention (P = 0.620), urinary tract infection (P = 0.529), and replacement of urethral catheter s (P = 0.438) in the UC group were inferior to those in the non-UC group, but there was no statistical significance.ConclusionsIt is feasible and safe to perform FUS-ICP without a post-procedure indwelling urinary catheter.

Does Bone Density Affect Outcomes in Lateral Lumbar Interbody Fusion? A Propensity Score-Matched Analysis of Preoperative Hounsfield Units.

Background: This study aimed to assess whether preoperative Hounsfield unit (HU) values differ in short-term clinical outcomes after lateral lumbar interbody fusion (LLIF) surgery. Methods: In a retrospective analysis, 109 patients undergoing LLIF for lumbar degenerative diseases (LDD) were reviewed. Preoperative Computed Tomography (CT) scans measured HU values at the L1-L4 vertebrae, dividing patients into low and high HU groups. After conducting a cluster analysis of preoperative Hounsfield unit (HU) values, patients were categorized into low and high HU groups using propensity score matching (PSM). The outcomes measured one-year post-surgery included pain intensity (Numeric Rating Scales for Low Back Pain (NRSLBP), Leg Pain (NRSLP), and Leg Numbness (NRSLN)) and quality of life (Japanese Orthopedic Association Back Pain Evaluation Questionnaire: JOABPEQ). Results: After PSM, there were 26 patients in each group. Significant improvements were noted in both low and high HU groups post-surgery, with the low HU group showing a decrease in NRSLBP from 6.2 to 3.7, NRSLP from 7.4 to 2.5, and NRSLN from 6.4 to 3.0. The high HU group exhibited similar improvements (NRSLBP: 6.5 to 3.6, NRSLP: 6.3 to 2.5, NRSLN: 6.2 to 2.4). JOABPEQ scores improved significantly in both groups across all domains, with no significant differences observed. Preoperative HU values have little correlation with the short-term outcomes of pain and quality of life in LLIF surgery. Conclusions: This study suggests reconsidering the role of HU values following indirect decompression via LLIF, particularly in evaluating pain and patient-reported outcome measures in patients with LDD.

Increasing or decreasing load during resistance training is not associated with changes in pain among individuals with patellar tendinopathy: a randomized crossover study

Objectives This study investigated whether exercising with different relative loads would be associated with different experienced pain intensities in individuals with patellar tendinopathy. Materials and Methods We recruited 14 individuals with patellar tendinopathy for this randomized crossover study. In a randomized order, participants performed one set of single-legged leg presses during one session with three relative loads (6 repetition maximum (RM), 10RM, and 14RM). The primary outcome was pain during exercise measured on a 0–10 Numerical Rating Scale (NRS) (0 = no pain, 10 = worst pain), which participants rated after performing the exercise set with each relative load. Results No differences in pain during either of the three relative loads were observed (F(2, 26) = 0.06, p = 0.942). The participants’ experienced pain was 4.5 NRS (SD1.7), 4.5 NRS (SD1.7), and 4.6 NRS (SD2.0) during the 6RM, 10RM, and 14RM loads, respectively. A secondary analysis revealed no statistically significant difference in pain intensity between the performance of the first, second, or third exercise set regardless of the load (F(2, 26) = 1.06, p = 0.367). Conclusions There was no difference in pain intensity during either relative load among individuals with patellar tendinopathy. Therefore, higher loads may be applied, associated with enhanced tendon adaptation.

Exploring Electrophysiological Responses to Hypnosis in Patients with Fibromyalgia

Background/Objectives: Hypnosis shows great potential for managing patients suffering from fibromyalgia and chronic pain. Several studies have highlighted its efficacy in improving pain, quality of life, and reducing psychological distress. Despite its known feasibility and efficacy, the mechanisms of action remain poorly understood. Building on these insights, this innovative study aims to assess neural activity during hypnosis in fibromyalgia patients using high-density electroencephalography (EEG) and self-reported measures. Methods: Thirteen participants with fibromyalgia were included in this study. EEG recordings were done during resting state and hypnosis conditions. After both conditions, levels of pain, comfort, absorption, and dissociation were assessed using a numerical rating scale. Time perception was collected via an open-ended question. The study was prospectively registered in the ClinicalTrials.gov public registry (NCT04263324). Results: Neural oscillations showed increased theta power during hypnosis in the left parietal and occipital electrodes, increased beta power in the frontal and left temporal electrodes, and increased slow-gamma power in the frontal and left parietal electrodes. Functional connectivity using pairwise-phase consistency measures showed decreased connectivity in the frontal electrodes during hypnosis. Graph-based measures, the node strength, and the cluster coefficient were lower in frontal electrodes in the slow-gamma bands during hypnosis compared to resting state. Key findings indicate significant changes in neural oscillations and brain functional connectivity, suggesting potential electrophysiological markers of hypnosis in this patient population.

54 Efficacy of a quality improvement project in paediatric procedural pain management during needle procedures

Abstract Background In paediatric hospital settings, needle procedures significantly contribute to children’s experiences of pain and distress. A structured approach integrating preparation, comfort positions, distraction, relaxation techniques, and topical anesthetics can enhance children’s ability to cope with procedural discomfort. We developed a quality improvement (QI) initiative aiming to alleviate procedural pain and distress through a staggered implementation approach over a 3-year period. Objectives This study aimed to evaluate the impact of the first 2 years of an institutional QI initiative on managing procedural pain and distress in children undergoing needle procedures. The primary objective was to evaluate the use of multimodal strategies to reduce needle-related procedural pain/distress following the QI initiative. The secondary objective was to compare pain scores for needle procedures before and after the QI initiative. Design/Methods This observational study was conducted in a tertiary care university-affiliated paediatric hospital with an ongoing hospital-wide QI initiative aiming to alleviate procedural pain and distress in children undergoing needle procedures. The QI initiative consisted of mandatory sector-by-sector training of healthcare providers (HCP) on procedural pain/distress strategies to increase the use of multimodal pain care. Pain scores were measured during needle procedures (i.e. Numerical Rating Scale (NRS), Faces Pain Scale-R (FPS-R) or the FLACC scales, according to patient age) pre and 3-6 months post implementation of the QI initiative. Scheduled audits were conducted using a standardized questionnaire by a deployment champion nurse during needle procedures to document pain scales and pain/distress strategies used by the HCP during needle procedures in each of the hospital services. Results Throughout the first two implementation years (June 2021-June 2023), 363 audits were conducted on needle procedures for 363 children (Median age 7 yo (0month-18yo□). At this stage, audits took place in 14 different hospital services. The most frequent procedures were IV-line insertions (34%), venous blood draws (27%), and capillary blood sampling (26%). Parental presence and the use of distraction techniques were frequently used (90% and 80% of procedures, respectively). Of the 363 audits, 221 were pre-implementation and 142 post-implementation. Post QI initiative, an increased number of procedures were realized using multimodal strategies (4 or more strategies) to reduce pain/distress (from 60% to 78%). Pain scores were recorded for 203/221 audits pre and 134/142 post with a reduction in severe pain scores (7 or more) from 25% pre to 5% post-implementation. Conclusion The institutional QI initiative demonstrated both an increase in the number of strategies used to prevent pain/distress and a reduction in severe pain scores associated with paediatric needle procedures. This project emphasizes the significance of employing a multifaceted approach to managing procedural pain/distress in children undergoing needle procedures.

Upadacitinib in Adolescents With Moderate to Severe Atopic Dermatitis

The Measure Up 1, Measure Up 2, and AD Up studies demonstrated the efficacy and adverse events of upadacitinib through 52 weeks in adults and adolescents with atopic dermatitis (AD); however, longer-term outcomes (longer than 1 year) in adolescents have not previously been available. To evaluate the efficacy and adverse events of upadacitinib in adolescent patients with moderate to severe AD through 76 weeks. The Measure Up 1, Measure Up 2, and AD Up trials are ongoing double-blind, placebo-controlled phase 3 randomized clinical trials including adolescents (aged 12 to 17 years) with moderate to severe AD. Data were collected from August 2018 to April 2022, and data were analyzed from June 2022 to September 2023. Adolescents were randomized 1:1:1 to receive once-daily oral upadacitinib, 15 mg; upadacitinib, 30 mg; or placebo, either alone (Measure Up 1 and Measure Up 2 trials) or with topical corticosteroids (AD Up). At week 16, placebo-treated patients were rerandomized to receive upadacitinib, 15 mg, or upadacitinib, 30 mg, daily. Coprimary end points assessing efficacy included achievement of 75% reduction or more in the Eczema Area and Severity Index Score (EASI-75) from baseline, Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of clear (0) or almost clear (1) with 2 grades or more of improvement, and Worst Pruritus Numerical Rating Scale (WP-NRS) improvement of 4 points or greater through week 76 for participants with a WP-NRS score of 4 points or higher at baseline. From all studies, 542 adolescents were included; of these, 284 (52.4%) were female. At week 76, among patients in the Measure Up 1, Measure Up 2, and AD Up trials, EASI-75 was achieved by 89.1%, 84.4%, and 87.8% of adolescents taking upadacitinib, 15 mg, respectively, and by 96.1%, 93.6%, and 82.7% of adolescents taking upadacitinib, 30 mg, indicating maintenance or improvement of EASI-75 across 76 weeks with upadacitinib. Efficacy measured by achievement of vIGA-AD score of 0 or 1 and WP-NRS improvement of 4 points or more from baseline was similarly maintained or improved through week 76 for adolescents taking upadacitinib, 15 mg or 30 mg. Long-term outcomes in Measure Up 1, Measure Up 2, and AD Up participants were consistent with the known adverse event profile of upadacitinib (herpetic infection: 4.0, 1.9, and 1.1 events per 100 patient-years, respectively; creatine kinase elevation: 11.6, 11.0, and 7.1 events per 100 patient-years); no new signals were observed with either dose. In this study assessing 3 randomized clinical trials, long-term treatment of adolescents with moderate to severe AD with upadacitinib demonstrated a favorable benefit-risk profile, with sustained efficacy responses through 76 weeks. Measure Up 1 trial: ClinicalTrials.gov Identifier: NCT03569293; Measure Up 2 trial: NCT03607422; AD Up trial: NCT03568318.

Efficacy and Safety of Upadacitinib vs Dupilumab in Adults and Adolescents with Moderate-to-Severe Atopic Dermatitis: Week 16 results of an Open-label, Randomized, Efficacy Assessor-Blinded Head-to-Head Phase 3b/4 Study (Level Up).

Atopic dermatitis (AD) is a chronic skin disease characterized by intense itch and eczematous skin lesions. Some patients continue to experience flares and substantial clinical burden despite ongoing systemic treatment. This study assessed the efficacy and safety of once-daily upadacitinib (UPA), initiated at 15 mg and dose-escalated to 30 mg based on clinical response, compared with dupilumab (DUPI) per its label. Week 16 primary analysis results are presented. Level Up is a phase 3b/4 global, randomized, open-label, efficacy assessor blinded study evaluating UPA vs DUPI in adolescents and adults with moderate-to-severe AD who had inadequate response to systemic therapy or when use was inadvisable. Patients were randomized to UPA or DUPI for 16 weeks of treatment (Period 1). Patients on UPA started on 15 mg and were dose-escalated to 30 mg if they did not achieve an Eczema Area and Severity Index reduction of at least 50% (EASI 50) or a ≥4-point Worst Pruritus Numerical Rating Scale (WP-NRS) improvement on/after Week 4, or EASI 75 on/after Week 8. The primary endpoint was simultaneous achievement of EASI 90 and WP-NRS 0/1 at Week 16. Ranked secondary endpoints included skin and itch responses at varying response levels and timepoints. Safety measures were assessed throughout the study. Superior efficacy in achieving simultaneous EASI 90 and WP-NRS 0/1 response at Week 16 was demonstrated with UPA vs DUPI (19.9% vs 8.9%, respectively; p<0.0001). UPA showed superiority vs DUPI for all ranked secondary endpoints, with post-hoc analyses exhibiting higher itch response rates as early as Day 2. No new safety signals were identified during this period. Treatment of moderate-to-severe AD with UPA, initiated at 15 mg and dose escalated based on clinical response, demonstrated superiority vs DUPI per its label for the primary endpoint of simultaneous achievement of near complete skin clearance (EASI 90) and little to no itch (WP-NRS 0/1) at Week 16, with all ranked secondary endpoints demonstrating superiority at varying skin and itch response levels and timepoints. There were no new safety signals identified compared to the previously reported safety profiles of UPA and DUPI.