Numeric Rating Scale Scores Research Articles

Efficacy and Safety of Ruxolitinib Cream for the Treatment of Moderate to Severe Chronic Hand Eczema: Top-Line Results From a 16-Week, Multicenter, Randomized, Double-Blind Study

Hand eczema is a common inflammatory disorder involving skin of the hands. Chronic hand eczema (CHE) is defined as hand eczema that persists for >3 months or recurs ≥2 times within a 12-month period. The efficacy and safety of ruxolitinib (selective Janus kinase [JAK] 1/JAK2 inhibitor) cream was investigated in adults with moderate to severe CHE in a phase 2, randomized, double-blind, vehicle-controlled study (NCT05906628). Patients aged ≥18 years with a diagnosis of CHE for ≥6 months, an Investigator’s Global Assessment (IGA)-CHE score of 3 or 4, and no current or history (≤5 y) of atopic dermatitis were randomized 1:1 to apply twice-daily 1.5% ruxolitinib cream or vehicle cream for 16 weeks of double-blind treatment. Patients (N=186) had a median (range) age of 50.0 (18–80) years, and 59.7% were female. The median (range) Itch numerical rating scale (NRS) score was 6.6 (2.1–10), and 72.6% of patients had an IGA-CHE score of 3. At Week 16, significantly more patients who applied ruxolitinib cream versus vehicle achieved IGA-CHE treatment success (primary endpoint; 53.2% vs 10.9%; P<0.0001), defined as an IGA-CHE score of 0 (clear) or 1 (almost clear) with a ≥2-grade improvement from baseline. Significantly more patients who applied ruxolitinib cream versus vehicle achieved a ≥4-point improvement from baseline in Itch NRS score (Itch NRS4) at Week 4 (46.7% vs 17.6%; P<0.0001; key secondary endpoint) and Week 16 (52.2% vs 23.1%; P<0.0001; key secondary endpoint). Numerical improvements in Itch NRS4 with ruxolitinib cream versus vehicle were observed at Day 2 with statistically significant improvement observed on Day 7 (27.4% vs 9.0%; P=0.0024; key secondary endpoint). Substantially more patients who applied ruxolitinib cream versus vehicle achieved a ≥75% or ≥90% improvement from baseline in Hand Eczema Severity Index (HECSI) score at Week 16 (80.2% vs 26.9% and 64.0% vs 11.5%, respectively). Ruxolitinib cream was generally well tolerated through Week 16 with no new safety signals; no serious infections, major adverse cardiovascular events, malignancies, or thromboses were observed. Application site reactions were infrequent. No treatment-related grade ≥3 treatment-emergent adverse events (TEAEs) were reported, and no patients discontinued owing to a TEAE. In conclusion, ruxolitinib cream demonstrated significant reductions of CHE signs and symptoms versus vehicle through Week 16 and was generally well tolerated, consistent with the known safety profile. (Funding, Incyte Corporation)

Deucravacitinib, an Oral, Selective, Allosteric Tyrosine Kinase 2 (TYK2) Inhibitor, in Patients With Moderate to Severe Scalp Psoriasis: Improvement in Scalp-Related Quality of Life and Symptoms in the Phase 3b/4 Multicenter, Randomized, Double-Blinded, Placebo-Controlled PSORIATYK SCALP Trial

Introduction: PSORIATYK SCALP (NCT05478499)—an ongoing 52-week, phase 3b/4, multicenter, randomized, double-blinded, placebo-controlled trial—assesses the efficacy and safety of deucravacitinib in patients aged ≥18 years with moderate to severe scalp psoriasis (Psoriasis Scalp Severity Index ≥12, scalp-specific Physician Global Assessment ≥3, scalp surface area involvement ≥20%, and body surface area [BSA] involvement ≥3%). We assessed Week 16 patient-reported outcomes using Scalpdex, a validated, scalp-specific quality-of-life instrument, and numeric rating scales (NRSs) for scalp-specific symptoms. Methods: Patients were randomized 1:2 to placebo or deucravacitinib 6 mg for 16 weeks, stratified by previous biologic use (yes or no) and body weight (<90 or ≥90 kg). Changes from baseline in Scalpdex total score and NRS scores for scalp-specific itch, pain, and flaking were assessed with an analysis of covariance (ANCOVA) model with treatment and randomization stratification factors as fixed effects and the baseline value as a covariate. Scalpdex total score change from baseline was further assessed in BSA subgroups (BSA 3–10%, BSA >10%), using an ANCOVA model with treatment as a fixed effect and the baseline value as a covariate. P values are nominal. Results: Mean baseline scores (placebo: n=51; deucravacitinib: n=103) indicated severe impact on quality of life (Scalpdex total score >44.0) and moderate to severe symptoms (NRS ≥4.0). At Week 16, adjusted mean change from baseline (95% CI) in Scalpdex total score was greater in patients receiving deucravacitinib versus placebo (−22.3 [−26.1, −18.6] vs −10.5 [−15.7, −5.2]; P=0.0003). Changes from baseline (95% CI) in scalp-specific NRS measures were greater in patients receiving deucravacitinib versus placebo (itch: −3.2 [−3.7, −2.7] vs −0.7 [−1.4, 0.0]; pain: −2.1 [−2.6, −1.6] vs −0.1 [−0.8, 0.5]; flaking: −3.9 [−4.5, −3.4] vs −1.0 [−1.8, −0.2]; all P<0.0001). In each BSA subgroup, patients receiving deucravacitinib versus placebo reported greater Week 16 change from baseline in Scalpdex total score (BSA 3–10%: −19.8 [−23.9, −15.6] vs −10.5 [−16.1, −4.9]; P=0.0096; BSA >10%: −26.2 [−33.2, −19.3] vs −11.2 [−22.3, 0.0]; P=0.0263). Conclusion: Deucravacitinib was efficacious in improving scalp-specific psoriasis symptoms and quality of life. Furthermore, scalp-related quality of life was improved in patients receiving deucravacitinib in both BSA subgroups.

Dupilumab Demonstrates a Higher Likelihood of Achieving Improvements in Signs, Symptoms, and Quality of Life vs. Tralokinumab at Week 16: Results from a Bucher Indirect Treatment Comparison

Background: Dupilumab and tralokinumab are biologics approved by the US Food and Drug Administration (FDA) for the treatment of patients with moderate-to-severe atopic dermatitis (AD), aged ≥6 months and ≥12 years, respectively. Dupilumab and tralokinumab have demonstrated efficacy and safety in clinical trials. However, no direct head-to-head trials have been performed to compare the efficacy of dupilumab vs tralokinumab. The Bucher indirect treatment comparison (ITC) is a robust, placebo-adjusted, and accepted method to evaluate the relative efficacy of drugs in the absence of direct comparisons. The objective of this analysis was to report results from a Bucher ITC comparing the efficacy of dupilumab+topical corticosteroid (TCS) vs tralokinumab+TCS at Week 16. Methods: The placebo-adjusted Bucher ITC included published data from the two similarly designed phase 3 trials, LIBERTY AD CHRONOS (NCT02260986) and ECZTRA 3 (NCT03363854). For both studies, data from the 16-week period were used, employing non-responder imputation, with the following doses: 300mg dupilumab every 2 weeks (q2w)+TCS or placebo+TCS, and 300mg tralokinumab q2w+TCS or placebo+TCS. The evaluated endpoints included the proportions of patients achieving an Investigator’s Global Assessment score 0/1 (IGA 0/1; clear/almost clear), 75% and 90% improvements from baseline in Eczema Area and Severity Index (EASI-75 and EASI-90), ≥4-point improvement from baseline in the Peak Pruritus Numerical Rating Scale score (PP-NRS >4), and ≥4-point improvement from baseline in the Dermatology Life Quality Index (DLQI >4). The Bucher ITC with the frequentist approach was performed using R software (v 4.20; netmeta package) with a fixed-effect model. Results were reported as odds ratio (OR) with 95% confidence interval (CI). Results: A total of 801 patients (LIBERTY AD CHRONOS: placebo+TCS: 315; dupilumab+TCS: 106; ECZTRA 3: placebo+TCS: 127; tralokinumab+TCS: 253) were included in the Bucher ITC. Baseline disease characteristics indicated comparable severity between the two trial populations based on IGA and PP-NRS. However, CHRONOS showed slightly higher baseline EASI scores (median [Q1, Q3] score 30.9 [22.3, 41.6] vs. ECZTRA 3: 24.7 [18.4, 35.9]), while ECZTRA 3 showed slightly higher DLQI scores (median [Q1, Q3] score 18.0 [12.0, 23.0] vs. CHRONOS: 13.5 [8.0, 20.0]). Patients treated with dupilumab+TCS had a significantly higher likelihood of achieving IGA 0/1 (OR=2.49, 95%CI 1.24–5.00), EASI-75 (OR=3.21, 95%CI 1.66–6.19), EASI-90 (OR=2.92, 95%CI 1.41–6.02), PP-NRS ≥4 (OR=3.62, 95%CI 1.87–7.00), and DLQI ≥4 (OR=2.16, 95%CI 1.03–4.54) at Week 16 vs those treated with tralokinumab+TCS. Conclusions: A placebo-adjusted Bucher ITC showed that the likelihood of achieving improvements in signs, symptom, and quality of life is significantly higher for patients treated with dupilumab+TCS vs tralokinumab+TCS at Week 16.

Shear wave elastography based analysis of changes in fascial and muscle stiffness in patients with chronic non-specific low back pain

BackgroundThe quantitative assessment of individual muscle and fascial stiffness in patients with low back pain remains a challenge. This study aimed to compare the stiffness of the thoracolumbar fascia (TLF), erector spinae (ES), and multifidus (MF) in patients with and without chronic non-specific low back pain (CNLBP) using shear wave elastography (SWE). It also sought to explore the relationship between muscle and fascial stiffness and the levels of pain and dysfunction in patients with CNLBP.MethodsIn this cross-sectional study, 30 patients with CNLBP (age 27.40 ± 4.57 years, 19 males, 11 females, BMI 22.96 ± 2.55 kg/m2) and 32 healthy controls (age 27.94 ± 4.94 years, 15 males, 17 females, BMI 22.52 ± 2.26 kg/m2) were enrolled. Stiffness of the TLF, ES, and MF was measured using SWE, and Young’s modulus values were recorded. The numeric rating scale (NRS) for quantifying pain intensity and the Oswestry Disability Index (ODI) scores were recorded for the case group to examine their correlations with the resilience index.ResultsThe CNLBP group exhibited significantly higher shear modulus values at the L4-5 bilateral TLF (left: p = 0.014, d = 0.64; right: p = 0.002, d = 0.86), ES (left: p = 0.013, d = 0.66; right: p = 0.027, d = 0.58), and MF (left: p = 0.009, d = 0.69; right: p = 0.002, d = 0.85) compared to the control group. Comparable findings were observed for the right ES (p = 0.026, d = 0.59) and left MF (p = 0.020, η2 = 0.09) at L1-2. Strong correlations were observed between the shear modulus of the bilateral TLF (left: r = 0.57, p = 0.001; right: r = 0.65, p < 0.001) at L4-5 and the NRS scores. Moderate correlations were noted between the shear modulus of the ES (left: r = 0.42, p = 0.022; right: r = 0.48, p = 0.007) and MF (left: r = 0.50, p = 0.005; right: r = 0.42, p = 0.023) at L4-5 and the NRS scores. Additionally, the shear modulus of the MF (r = 0.50, p = 0.005) on the left side of L1-2 showed similar correlations. Strong correlations were observed between the shear modulus of the bilateral TLF (left: r = 0.60, p < 0.001; right: r = 0.58, p < 0.001) at L4-5 and the ODI scores. Moderate correlations were observed between the shear modulus of the right TLF (r = 0.43, p = 0.017), ES (r = 0.38, p = 0.037), and MF (r = 0.44, p = 0.015) at L1-2, as well as the bilateral MF (left: r = 0.46, p = 0.011; right: r = 0.45, p = 0.012) at L4-5, and the ODI scores. No significant correlations were found at other measurement sites.ConclusionIn patients with CNLBP, the stiffness of the lumbar fascia and muscles is generally higher than in individuals without LBP. However, this increase is not uniform across all lumbar regions, with the most significant changes observed in the L4-5 segments. In addition, higher stiffness may be associated with pain and dysfunction, primarily manifested in the TLF.

Real-world efficacy and safety of dupilumab for paediatric atopic dermatitis: a multicentre retrospective study.

Real-world data regarding the use of dupilumab in children with atopic dermatitis (AD) are limited. To evaluate the real-world efficacy of dupilumab in children with moderate-to-severe AD over an extended follow-up period. This was a retrospective study of patients (≤ 18 years) with moderate-to-severe AD treated with dupilumab in four Israeli tertiary centres. Efficacy and safety were assessed using descriptive statistics. In total, 230 patients were included in the analysis [age 9.9 years (SD 4.3), male/female 1 : 1 ratio)]. Of them, 59.6% (137/230) had ≥ 1 atopic comorbidity. The follow-up duration ranged from 2 to 248 weeks, with a median of 52 weeks (interquartile range 24-96). Within 12 weeks of treatment, 41.7% (68/163) of patients had reached Investigator Global Assessment 0-1. The mean body surface area was reduced from 58.0% (SD 20.5%) at baseline to 27.8% (SD 20.2%) at 12 weeks. The average Pruritus Numeric Rating Scale score was reduced from 7.9 (SD 2.2) at baseline to 2.3 (SD 2.8) at 12 weeks. Adverse events, in 210 patients, included conjunctivitis in 34 patients (16.2%), injection-site reactions in 11 patients (5.2%) and dupilumab-associated head and neck dermatitis in 6 patients (2.9%). Overall, 26 of 210 patients (12.3%) discontinued the treatment: 9 of the 26 patients (35%) because of adverse events and 15 patients (58%) because of inadequate efficacy. The overall probability of dupilumab survival at 52 weeks was 94.0%. Real-world data presented here for 230 paediatric and adolescents with moderate-to-severe AD reinforce dupilumab's efficacy and safety and highlight dupilumab's high survival rate after 1 year of treatment in the paediatric population.

Intra-articular corticosteroid injections versus platelet-rich plasma as a treatment for cervical facetogenic pain: a randomized clinical trial

ObjectiveThe study’s primary objective was to compare the effectiveness of intra-articular platelet-rich plasma injections versus corticosteroid injections for the treatment of cervical facetogenic pain. Secondary aims were to compare self-rated...

Efficacy and Safety Analysis in Chinese Patients with Moderate-to-Severe Psoriasis from a Phase 3 Trial: Impact of Treatment Withdrawal and Retreatment of Ixekizumab.

In China, approximately 2.3 million people have psoriasis. Continuous treatment is recommended for moderate-to-severe psoriasis. This study aimed to evaluate the outcomes of continuous versus interrupted ixekizumab (IXE) treatment and retreatment with IXE after disease worsening in Chinese patients. In this Phase 3, multicenter, randomized, double-blind, placebo-controlled study, patients were randomized to IXE or placebo at Week 0. At Week 12, IXE responders (static Physician's Global Assessment [sPGA] score, 0 or 1 [0,1]) were re-randomized (2:1) to IXE (IXE/IXE, continuous treatment) or placebo (IXE/PBO, interrupted treatment). After re-randomization, treatment in IXE/PBO patients with disease worsening (relapse, sPGA ≥ 3) was switched to IXE every 4weeks (IXE/PBO + IXEQ4W, retreatment). Efficacy was assessed by evaluating the response rates of Psoriasis Area and Severity Index (PASI) 75/90/100, sPGA (0,1), Dermatology Life Quality Index (DLQI) (0,1), mean PASI, and Itch Numerical Rating Scale (NRS) scores and improvements of special body areas. Safety was evaluated by assessing treatment-emergent adverse events (AEs) and serious AEs. At Week 12, 289 IXE responders were re-randomized to the IXE/IXE group (192 patients) and IXE/PBO group (97 patients). High rates of PASI 75 and sPGA (0, 1) responses were maintained in the IXE/IXE group until Week 60. At Week 60, 88 (90.7%) patients in the IXE/PBO group had disease relapse; the median time to relapse was approximately 20weeks. After 24weeks of retreatment, PASI 75 and sPGA (0, 1) were recaptured (97.2% and 74.6%, respectively, in the IXE/PBO + IXEQ4W group). AEs were comparable in patients who received continuous treatment and retreatment. In Chinese patients who received continuous IXE treatment, high response rates were maintained through 60weeks. Most patients had disease relapse after treatment withdrawal. After retreatment, most of these patients had regained and maintained response since Week 12. NCT03364309.

Rocatinlimab Improves Patient-Reported Outcomes in Adults with Moderate-to-Severe Atopic Dermatitis: Results from a Double-Blind Placebo-Controlled Phase2b Study.

In adults with moderate-to-severe atopic dermatitis (AD), rocatinlimab demonstrated significant and progressive improvement in clinical measures of disease severity compared with placebo. This post hoc analysis of a phase2b study was undertaken to understand the disease burden and to assess the impact of rocatinlimab on patient-reported outcomes (PROs). This analysis used baseline data from a multicenter, randomized, double-blind study of adults with moderate-to-severe AD, who completed a Worst Pruritus numerical rating scale (NRS), Sleep Disturbance NRS, and the Dermatology Life Quality Index (DLQI). A mixed model for repeated measures was used to estimate changes in PRO scores from baseline; scores were also compared with clinically meaningful change benchmarks. The analysis included 267 subjects, mean (SD) age 37.9 (14.7) years, 40.8% female; 55.1% grade3 and 44.9% grade4 Investigator Global Assessment for AD. Mean (SD) scores were: Worst Pruritus NRS 7.5 (1.9), Sleep Disturbance NRS 5.5 (2.9), DLQI total score 12.6 (7.1). Worst Pruritus and Sleep NRS scores had low positive correlations with SCORing AD (SCORAD) score (r = 0.44, r = 0.45 respectively) and negligible correlations with Eczema Area and Severity Index (EASI) score and area affected (r < 0.30). DLQI score varied by sex, study country, race, age, longer disease duration, disease severity (EASI and SCORAD), presence of asthma, and Worst Pruritus NRS, Sleep disturbance NRS, and DLQI scores. Rocatinlimab showed benefit on all three PROs, with significant improvements from baseline at the end of the double-blind period (week18) and active treatment extension (week36). Benefits were maintained over 20weeks' post-treatment follow-up. The benefit of rocatinlimab treatment on PROs is rapid and maintained for at least 20weeks following treatment completion. This analysis demonstrates the importance of characterizing the burden of moderate-to-severe AD from the patient's perspective, alongside clinical disease measures, to develop a fuller picture of treatment benefit. ClinicalTrials.gov identifier, NCT03703102.

Improving Pain Assessment After Inpatient Orthopedic Surgery: A Comparison of Two Scales.

In pain assessment, the commonly used Numeric Rating Scale (NRS) offers an incremental 0-to-10 range of response options. But this broad range often leads to discordant evaluations between nurses and their patients. This study aimed to compare the NRS to the three-category Interventional Pain Assessment (IPA) scale, validate the IPA scale in an inpatient setting, and determine RN and patient scale preferences. This prospective study enrolled 122 postoperative orthopedic patients and their designated 104 RNs at a level 1 trauma center in the midwestern United States. Patients were asked to verbally rate their pain from 0 to 10 using the NRS and from 0 to 2 on the IPA scale. Patients were also asked which scale best conveyed their pain. The RNs were asked which scale best informed them of their patient's pain situation and which scale they preferred. To establish a correlation between the two scales, we considered NRS values of 0 to 7 (signifying no pain to moderate pain) to correspond to IPA scale values of 0 to 1 (signifying no pain to tolerable pain). NRS values of 8 to 10 (signifying severe pain) were considered to correspond to IPA scale values of 2 (signifying intolerable pain). Responses in which patients reported IPA scores indicating no pain to tolerable pain but NRS scores above 7 or IPA scale scores indicating intolerable pain but NRS scores of 7 or below were defined as discordant answers. Data analysis revealed a strong significant correlation between the NRS and IPA scale (τ = 0.597), with an 82.7% concordance rate. Once an NRS score rose above 7, more discordance between the two scales became increasingly prevalent, as evidenced by the 45% of patients who also reported tolerable pain on the IPA scale. Significantly more patients (89.3%) preferred the IPA scale to communicate their pain level than the NRS (10.7%). Significantly more RNs (76%) felt the IPA scale best informed them of their patient's pain and was a better guide for treatment than felt the NRS did so (24%). The IPA scale asks about pain tolerability and thus has a direct role in the management of pain medications. Both patients and nurses felt they were better able to convey and understand pain when using the IPA scale than when using the NRS. There was consensus regarding pain scale preference among patients and their RNs, with both groups preferring the IPA scale due to its simplicity and, among the RNs, its usefulness in guiding treatment. The IPA scale may be a much better tool for accurately assessing a patient's pain experience and needs, with the potential to change practice and improve pain management.

Collagenase Chemonucleolysis for Treating Cervical Disc Herniation: An Exploratory, Single-Arm, Open-Label, Multicenter Clinical Trial.

Cervical disc herniation (CDH) is the most common cause of cervical radiculopathy and causes persistent neck pain and neurological deficits. Collagenase chemonucleolysis has been successfully applied to treat lumbar disc herniation, which has a similar pathological mechanism to CDH. However, its application for CDH remains under-researched, and there is an even greater lack of high-quality clinical evidence. This study aims to evaluate the efficacy and safety of collagenase chemonucleolysis for treating CDH. Eligible patients with CDH underwent collagenase chemonucleolysis via anterior cervical intradiscal injection or epidural injection. The primary efficacy endpoint showed an excellent and good rate regarding the Odom criteria, which was not lower than the reference value (≥ 78%) at 6 months postoperatively. The secondary efficacy endpoints were the percentage reduction in Numeric Rating Scale (NRS) and Neck Disability Index (NDI) scores from baseline, which were not lower than the reference values (≥ 40%, ≥ 30%), and improvement in the 36-Item Short Form Health Survey (SF-36) score compared to the preoperative value. The pre- and postoperative CDH index of patients were also compared. Safety endpoints included the incidence of adverse events (AEs) and serious adverse events (SAEs). An excellent and good rate regarding the Odom criteria 6 months postoperatively was 90.5% (133/147), which was significantly higher than 78% (P < 0.004, 95% confidence interval 85.7-95.2%). The reduction in NRS and NDI scores exceeded 40% (P < 0.001) and 30% (P < 0.001), respectively. The SF-36 scores at 3 months and 6 months postoperatively were significantly higher than those preoperatively (P < 0.001). A significant difference was observed in the pre- and postoperative CDH index (109.6 ± 119.1 vs. 70.8 ± 74.8, P < 0.001). The incidence of AEs was 22.5% (33/147), of which 97.8% were grade 1-2. No collagenase-related AEs and SAEs occurred. Collagenase chemonucleolysis treatment for CDH exhibited favorable efficacy and safety and may be a better choice for patients in whom conservative treatment is ineffective. The trial was registered on www.Chictr.org.cn (ChiCTR2200063043).

Correlation between self-reported low back pain and morphological changes in abdominal wall muscles.

Morphological changes in the abdominal wall muscle in diastasis recti abdominis (DRA) patients with low back pain (LBP) symptoms and whether there is a wider interrectus distance (IRD) remain unclear. The aim of this study was to determine the correlation between DRA severity and LBP and the morphological differences in abdominal wall muscles between patients who presented with symptoms of LBP and those who were asymptomatic. A total of 57 postpartum DRA patients were enrolled, including 21 without LBP, 36 with LBP, and 30 healthy nulliparous women. The numerical rating scale (NRS) was used to evaluate the degree of LBP. The IRD and muscle thickness of the abdominal muscles were measured via an ultrasonography device at the end of a natural breathing cycle. The abdominal muscles of the rectus abdominis (RA), external oblique muscle (EO), and transversus abdominis (TrA) in the DRA patients were significantly thinner than those in the control group (p< 0.05), whereas the difference in the internal oblique muscle (IO) was not significant (p> 0.05). There were no statistically significant differences in abdominal muscle thickness or the IRD regardless of whether the patients with DRA had LBP symptoms, with similar findings between the NRS score and DRA severity (P> 0.05). In DRA patients within one year postpartum, no significant difference was found in the severity of DRA or abdominal muscles, regardless of whether they were complicated by LBP symptoms. Shortening the IRD alone may not be beneficial for improving LBP symptoms in DRA patients. The relationship between DRA and LBP and the role of the abdominal muscles in postpartum LBP should be interpreted with caution.

The Impact of Changes in Paraspinal Muscle Tissue on Lumbar Percutaneous Intradiscal Radiofrequency Therapy

Background/Objectives: This study aimed to assess whether fatty changes in paraspinal muscle tissue negatively affect pain relief and functional outcomes, measured by the Oswestry Disability Index (ODI), in patients undergoing intradiscal bipolar radiofrequency thermocoagulation for lumbar degenerative disc (LDD) disease. Fatty changes in paraspinal muscles, often associated with sarcopenia, are known to negatively influence treatment outcomes. However, there is limited research on how these changes affect pain and functional capacity following intradiscal procedures. Methods: In this study, data from 59 patients treated for LDD were analyzed. Pain severity was measured using the Numerical Rating Scale (NRS), and the ODI was recorded before the procedure and at 1, 3, and 6 months post-procedure. Fatty changes in the paraspinal muscle tissue were evaluated using the Goutallier classification based on pre-procedure T2-weighted MRI scans, while disc degeneration was assessed using the Pfirrmann classification. Results: The results showed significant positive correlations between the Goutallier and Pfirrmann classifications and pain levels at all time points post-procedure (p &lt; 0.05). Notably, the relationship between NRS scores and Goutallier classification was stronger than that with Pfirrmann classification (p &lt; 0.05). ODI scores were also significantly correlated with both Goutallier and Pfirrmann classifications at each time point, with a stronger association observed between ODI and Goutallier classification than with NRS (p &lt; 0.05). Conclusions: These findings suggest that fatty changes in the paraspinal muscle tissue may significantly influence treatment outcomes and should be considered during pre-treatment evaluations. Further research is needed to explore this relationship more comprehensively.

COMPARISON OF ULTRASOUND-GUIDED LUMBAR ERECTOR SPINAE PLANE BLOCK AND TRANSMUSCULAR QUADRATUS LUMBORUM BLOCK FOR POST-OPERATIVE ANALGESIA IN TOTAL HIP REPLACEMENT SURGERIES: A PROSPECTIVE RANDOMIZED STUDY

Objectives: The objective of the study is to compare the efficacy of ultrasound-guided lumbar erector spinae plane block (ESPB) and transmuscular quadratus lumborum block (QLB) in providing post-operative analgesia for patients undergoing total hip replacement (THR) surgeries. Methods: This prospective, randomized, double-blind study compared the efficacy of ultrasound-guided lumbar ESPB and transmuscular QLB (QLB-t) for post-operative analgesia in THR surgeries. Ninety patients were randomized into three groups: ESPB, QLB, and a control group. Primary outcomes included the duration of analgesia, measured by numeric rating scale scores, and secondary outcomes assessed total analgesic consumption and the incidence of post-operative nausea and vomiting (PONV) within 24 h. For statistical purposes, p&lt;0.05 was taken as statistically significant. Results: This study compared lumbar ESPB and QLB for post-operative analgesia in THR surgeries. At the 1st h, pain scores were significantly lower in the ESPB (1.30) and QLB (1.05) groups compared to the control group (2.15) (p&lt;0.001). Tramadol consumption in the first 12 h was significantly lower in the ESPB (52.3 mg) and QLB (50.1 mg) groups compared to the control group (135.20 mg) (p&lt;0.001). PONV was absent in 60% of ESPB and 63% of QLB patients, compared to only 33% in the control group (p=0.038). Conclusion: Lumbar-ESPB and QLB-t blocks effectively reduce post-operative pain and analgesic requirements in THR surgeries, showing comparable benefits. Both techniques also lower the incidence of PONV.

Correlation between severity of preoperative low back pain and postoperative outcomes in lumbar disc herniation surgery: A retrospective cohort study.

BACKGROUND CONTEXTLow back pain (LBP) frequently occurs in patients with lumbar disc herniation (LDH), however the extent to which discectomy ameliorates it and how preoperative LBP influences postoperative outcomes remains unclear. PURPOSETo evaluate the improvement in LBP and its impact on postoperative patient-reported outcome measures (PROMs). STUDY DESIGN/SETTINGMulticenter retrospective observational study. PATIENT SAMPLEPatients undergoing discectomy for LDH at eight hospitals from April 2017 to March 2021. OUTCOME MEASURESData were collected on patients’ backgrounds, operative factors, and PROMs, including the Numeric Rating Scale (NRS) for pain in the low back, buttock, or leg, EuroQol 5 Dimension (EQ-5D), Oswestry Disability Index (ODI) scores, and postoperative satisfaction. METHODSPatients were categorized into mild (NRS 0–3), moderate (NRS 4–7), or severe (NRS 8–10) LBP groups. Inverse probability weighting with propensity scores was used to adjust for demographic and clinical differences between groups. Chi-square tests and one-way analysis of variance were conducted to compare background data and clinical characteristics. Additionally, multivariate logistic regression was performed to identify risk factors for less than 50% improvement in LBP. RESULTSThis study included 928 patients: 270 mild, 343 moderate, and 315 severe. After adjustment, preoperative NRS scores were significantly different across groups, with scores of 1.6 (SD 1.3), 5.6 (SD 1.0), and 8.8 (SD 0.9), respectively. Postoperative NRS scores also varied significantly, with worse outcomes observed in the severe group compared to the mild group, yet similar to the moderate group. A total of 46.8% of the mild group, 86.6% of the moderate group, and 72.9% of the severe group achieved a 50% decrease in NRS scores of LBP. Preoperative EQ-5D and ODI scores were significantly worse in the severe group compared to the mild or moderate groups, but postoperative scores were not significantly different between the severe and moderate groups. No significant differences in postoperative satisfaction were observed among the groups. Being female was a significant risk factor for less than 50% improvement in LBP (odds ratio = 1.56, p = 0.022). CONCLUSIONSDiscectomy significantly improved LBP in patients with LDH, including those with moderate or severe LBP. Patients with severe LBP showed similar improvements in PROMs as those with moderate LBP. Female gender emerged as a significant risk factor for less than optimal improvement in LBP.

Effectiveness of Virtual Yoga for Chronic Low Back Pain

Chronic low back pain (CLBP) is a common condition with substantial impact on patients, in the form of physical and emotional suffering; health care costs; productivity; and health care professional burden. Although clinical guidelines recommend use of nonpharmacologic treatments first, such as yoga, there is a gap between guidelines and implementation in clinical practice. To compare the effects of virtual yoga classes vs a wait-list control on CLBP intensity, back-related function, sleep quality, and pain medication use. Single-blinded, 24-week, 2-arm, randomized clinical trial conducted from May 3, 2022, through May 23, 2023, comparing live streamed yoga classes (the yoga now group) with a wait-list control (the yoga later group, in which participants were offered the virtual intervention after the study but without assessments) among adults with CLBP. Adults 18 to 64 years of age with CLBP were recruited from the Cleveland Clinic Employee Health Plan, a large health system self-insured health plan. Inclusion criteria included a mean LBP intensity score of at least 4 on an 11-point numerical rating scale (scores ranged from 0 to 10, with higher scores indicating worse pain) and daily back pain interference about half or more of the days. Twelve consecutive weekly, 60-minute, virtual, live streamed hatha yoga group classes. Coprimary outcomes were mean pain intensity in the previous week on the 11-point numerical rating scale and back-related function as assessed using the 23-point modified Roland Morris Disability Questionnaire ([RMDQ], with higher scores reflecting poorer function) at 12 weeks. Secondary and exploratory outcomes included these measures at 24 weeks, pain medication use, and PROMIS sleep quality assessed using the Sleep Disturbance Short Form 8a, item 1 (scores ranged from 0 to 4, with higher scores reflecting better sleep quality). Analyses followed the intention-to-treat principle. Among 140 participants enrolled (yoga now = 71; yoga later = 69), the mean (SD) age was 47.8 (11.7) years and most were female (113 [80.7%]) and college-educated (103 [73.5%]). Mean (SD) baseline pain intensity (5.7 [1.5]) and RMDQ ([12.1 [4.4]) scores reflected moderate back pain and impairment. At week 12, yoga now compared with yoga later had greater reductions in mean pain intensity (-1.5 [95% CI, -2.2 to -0.7] points; P < .001) and mean RMDQ (-2.8 [95% CI, -4.3 to -1.3] points; P < .001) scores. At 24 weeks, the improvements in pain (mean change, -2.3 [95% CI, -3.1 to -1.6] points; P < .001) and RMDQ (mean change, -4.6 [95% CI, -6.1 to -3.1] points; P < .001) scores were sustained. At 12 weeks, yoga now participants reported 21.4 (95% CI, 5.2-37.6) absolute percentage points less use of any analgesic medication during the past week than yoga later participants and at 24 weeks, 21.2 absolute percentage points (95% CI, 5.2%-37.3%). Improvements in sleep quality were greater for participants in yoga now than among participants in yoga later at 12 weeks (mean change, 0.4 [95% CI, 0.1-0.7] points; P = .008) and 24 weeks (mean change, 0.4 [95% CI, 0.1-0.7] points; P = .005). Results of this randomized clinical trial of 140 adults with CLBP who were members of a large health system self-insured health plan suggest that virtual yoga classes may be a feasible, safe, and effective treatment option. ClinicalTrials.gov Identifier: NCT05319691.

Effect of pericapsular nerve block on the quality of recovery after shoulder arthroscopy.

Shoulder arthroscopy, a standard orthopedic procedure, often results in severe postoperative pain, leading to high opioid consumption and delayed recovery. Various analgesic methods, including peripheral nerve blocks, manage this pain. The pericapsular nerve group block is a relatively new technique whose efficacy in shoulder surgeries has yet to be extensively studied. This study aimed to assess the impact of the pericapsular nerve group block on postoperative recovery quality following shoulder arthroscopy, as measured by the Quality of Recovery-15 score. A randomized, prospective, controlled, multicenter study was conducted with 60 patients undergoing unilateral shoulder arthroscopy. Participants were allocated to either Group P (patients receiving the pericapsular nerve group block and multimodal analgesia) or Group C (patients receiving only multimodal analgesia). The primary outcome measured was the Quality of Recovery-15 score 24 hours post-surgery. Secondary outcomes included postoperative numeric rating scale scores, the requirement for rescue analgesia, time to first rescue analgesia, postoperative complications, the necessity for antiemetics, and patient satisfaction. The median Quality of Recovery-15 score was significantly higher in Group P compared to Group C (120±10 vs. 89±11; P<0.001). Additionally, Group P exhibited lower pain scores at rest and during movement, a decreased need for rescue analgesia, and an extended duration before the first rescue analgesia was required. Postoperative nausea and vomiting were less common in Group P, and patient satisfaction scores were notably higher in this group. The pericapsular nerve group block significantly enhances postoperative recovery quality, reduces pain and opioid consumption, and improves patient satisfaction without significant complications.

Clinical course of psoriatic arthritis treated with biologics delineated with ultrasonography.

Psoriatic arthritis (PsA) is a chronic, inflammatory articular disease regarded as a specific subtype of psoriasis. Long-term assessment for PsA using ultrasonography has not yet been investigated. The present study was conducted to delineate the changes in articular lesions after the initiation of biologics using ultrasonography, and to provide the evidence of the utility of ultrasonography in long-term follow-up of PsA patients. We retrospectively recruited 17 Japanese PsA patients treated with biologics who met the classification criteria for psoriatic arthritis. Ultrasonographic images were recorded using a high-frequency linear 18 MHz probe through Doppler- and B-modes. Before the treatment with biologics, all examined patients (100%) had enthesitis and extensor tendinitis, while only six patients (35.3%) had loss of the fibrillar pattern of the tendon (LFP). There were significant changes over time in the numerical rating scale score for pain, and in the degree of ultrasonographic findings, including enthesitis, extensor tendinitis, and LFP. Also, there were significant changes over time between these ultrasonographic findings. The study identified the improvement course for a specific PsA lesion after the initiation of biologics. The improvement courses in enthesitis, extensor tendinitis, and LFP were found to differ from each other. These results may contribute to deeper understanding of the pathogenesis of PsA.

The effect of sacral erector spinae plane block on the quality of recovery after total hip arthroplasty: a prospective, randomized, controlled, multicenter study.

Total hip arthroplasty, commonly performed to alleviate hip pain and enhance functionality in elderly patients, requires effective postoperative pain management to reduce opioid consumption and its associated side effects. A novel regional anaesthesia technique, the sacral erector spinae plane block, has the potential to enhance the quality of postoperative recovery significantly. This prospective, randomized, controlled multicenter study investigated the effects of the sacral erector spinae plane block on recovery quality in patients undergoing total hip arthroplasty. The study comprised 50 patients, divided into Group S (patients receiving patients receiving sacral erector spinae plane block [S-ESPB]) and Group C (patients getting just multimodal analgesia). The primary outcome measured was the Quality of Recovery-15 score 24 hours post-surgery. Secondary outcomes included postoperative numerical rating scale scores (A score of 0 indicates no pain, while 10 indicates the most severe pain), total consumption of rescue analgesics, time to first rescue analgesic administration, patient satisfaction, time to first ambulation, the occurrence of complications, and the need for antiemetics. Group S had markedly higher quality of recovery-15 scores compared to Group C (Group S: median 117 percentiles [97-121]; Group C: median 89 percentiles [75-96]; P<0.001). Group S scored higher in postoperative pain, physical comfort, support, emotional state, and general quality of recovery-15 (P<0.001). Nevertheless, the physical independence category ratings were comparable across both groups (P=0.286). Sacral erector spinae plane block is a promising analgesic technique that enhances postoperative recovery and patient comfort in total hip arthroplasty.

Evaluation of postoperative pain on Transversus Abdominis Plane block and Erector Spinae Plane block in patients undergoing gynecological surgery: a prospective, comparative study

INTRODUCTION: Moderate to severe pain after gynecological surgery has an impact on postoperative recovery and mobilization. Transversus Abdominis Plane (TAP) block and Erector Spinae Plane (ESP) block have been used as multimodal analgesia for abdominal surgery. OBJECTIVES: This study aims to compare postoperative pain in patients undergoing either ESP blocks or TAP blocks, and the need for postoperative morphine in patients undergoing gynecological surgery.MATERIALS AND METHODS: This was a single-center, prospective, double-arm, comparative study. Forty subjects were enrolled in this study, and classified into two groups. One group of 20 subjects underwent ESP block, and the remaining 20 subjects underwent TAP block following a gynecologic surgical procedure. Patients were then assessed using with the Numeric Rating Scale (NRS) pain score which will be observed at intervals of 0–1 hour, 1–6 hours, 6–12 hours, and 12–24 hours. Numerical data analysis was done using an unpaired T-test on normally distributed data and the Mann-Whitney test on non-normally distributed data. Categorical data analysis was done using Fisher's Exact Test. RESULTS: NRS score at rest was higher in the TAP block group at 1–6 hours and 6–12 hours (pain scale 3) than in the ESP block group (pain scale 1). Movement-evoked pain NRS score was higher in the TAP block groups significantly. CONCLUSION: ESP block results in a lower postoperative pain score NRS value and reduces the need for morphine in post-gynecological surgery patients with a median incision compared to the TAP block.

Comparison of Ultrasound-Guided Single-Injection Erector Spinae Plane Block, Retrolaminar Block and Paravertebral Block for Postoperative Analgesia in Single-Incision Video-Assisted Thoracoscopic Surgery: A Three-Arm, Double-Blind, Randomized Controlled Non-Inferiority Trial.

Effective postoperative analgesia is critical for thoracic surgery. This study compares the analgesic efficacy of the erector spinae plane block (ESPB), retrolaminar block (RLB), and paravertebral block (TPVB) in single-incision video-assisted thoracoscopic surgery (SITS). Seventy-six patients underwent general anesthesia followed by ultrasound-guided nerve blocks with 20mL of 0.5% ropivacaine. Primary outcomes included the area under the curve (AUC) of Numeric Rating Scale (NRS) scores during rest and coughing over 24 hours. Secondary outcomes included perioperative opioid use, plasma biomarkers, and postoperative recovery measures. The AUC for NRS was 107.8±10.53 in the ESPB group, 104.8±8.05 in the RLB group, and 103.6±10.42 in the TPVB group, demonstrating non-inferiority for ESPB (difference: 4.2±3.0, 95% CI -1.82 to 10.22) and RLB (difference: 1.2±2.6, 95% CI -3.97 to 6.37) compared to TPVB. No significant differences were observed in opioid use, plasma biomarkers, QoR-15 scores, or adverse events. ESPB and RLB provide non-inferior analgesia compared to TPVB in SITS patients and are effective alternatives that enhance safety.