Search Results (135)

Fibromyalgia (FM) causes widespread pain, poor sleep, fatigue, and reduced quality of life. Exercise is the best supported non-pharmacological treatment, yet many patients report that it is insufficient on its own. Somatic tracking is a component of pain reprocessing therapy. It is promising in chronic back pain but untested as a stand-alone intervention in FM. The Fibromyalgia Somatic Tracking and Exercise Program Study (FIBROSTEPS) is a single-center 2 × 2 factorial randomized controlled superiority trial estimating the separate and combined effects of group exercise and somatic tracking on the impact of FM. Two hundred adults aged 18–65 years, of either sex, with FM diagnosed by the 2016 criteria, are randomized 1:1:1:1 after an 8-week baseline period to general activity recommendations plus usual care (control), supervised group exercise, somatic tracking, or both. Both interventions run for 16 weeks with one session per week (45 min physiotherapist-led group exercise; 40 min guided somatic tracking with a certified therapist). The primary outcome is change in total original Fibromyalgia Impact Questionnaire score (0–100) from week 8 to week 24, analyzed by intention-to-treat. Secondary outcomes include insomnia severity, daily pain intensity, and Fitbit-measured activity and sleep. The trial has 80% power for the two main effects; the exercise × somatic-tracking interaction is prespecified as exploratory. No results are reported; the trial will provide randomized evidence on somatic tracking in FM, alone and combined with exercise, informing multi-component FM rehabilitation. Trial Registration: ClinicalTrials.gov (NCT06922747). Ethics Approval: Regional Committee for Medical and Health Research Ethics (REK), reference 2025/853403. Full article

Low back pain (LBP) is associated with altered motor control that may be reflected in sensor-derived features. This exploratory development study analysed 3567 gait-analysis variables from 36 participants using a 15-feature pipeline and leave-one-subject-out evaluation. The primary outcome contrasted pain-free with high pain intensity after 11 participants in the intermediate mild-pain stratum were excluded by design (25 participants; 50 trials). Stacking achieved an accuracy of 0.780 (95% CI 0.620–0.920) and balanced accuracy of 0.731 (95% CI 0.573–0.893). Recurrent features involved the feet, left thigh and multifidus-specific EMG asymmetry. An exploratory two-cluster analysis showed clinical associations but weak separation (silhouette 0.172). As model configuration and comparison were developed within the available cohort, the estimates represent internal exploratory performance rather than validation of a clinical prediction model. The findings are hypothesis-generating and require independent external validation. Full article

Background and Objectives: Movement representation techniques (MRTs), including motor imagery and mirror therapy, have been investigated in several chronic pain conditions; however, their effectiveness in chronic non-specific spinal pain (CNSP) has not been specifically synthesized using meta-analytic methods. This systematic review and meta-analysis aimed to evaluate the effects of MRTs on pain intensity, disability, and kinesiophobia in adults with CNSP. Materials and Methods: A systematic search was conducted in PubMed, CINAHL, Scopus, Cochrane Library, and PEDro, supplemented by grey literature sources. Randomized and non-randomized controlled trials investigating MRTs as a standalone or adjunct intervention in adults with CNSP were eligible. Methodological quality was assessed using the PEDro scale, risk of bias was evaluated using the RoB 2 tool, and certainty of evidence was evaluated using the GRADE approach. Effect sizes were calculated as Hedges’ g using a random-effects model. The review was registered in PROSPERO (CRD42023488671). Results: Nine studies involving 411 participants were included in the systematic review, of which eight randomized trials (337 participants) contributed to the meta-analyses. MRTs showed a large and statistically significant effect on pain intensity (Hedges’ g = −1.63; 95% CI: −2.56 to −0.70; p = 0.001) and a moderate statistically significant effect on disability (Hedges’ g = −0.64; 95% CI: −1.03 to −0.26; p = 0.001). The effect on kinesiophobia was large but not statistically significant (Hedges’ g = −1.55; 95% CI: −3.25 to 0.16; p = 0.075). In analyses restricted to motor imagery, significant effects were observed for pain intensity (Hedges’ g = −1.87; 95% CI: −2.95 to −0.79) and disability (Hedges’ g = −0.75; 95% CI: −1.15 to −0.35), consistent in direction with the primary analyses. Heterogeneity was substantial for pain intensity and kinesiophobia; all pooled trials were judged to be at high risk of bias or to raise some concerns, and the certainty of evidence was very low for all three outcomes. Conclusions: Very low-certainty evidence suggests that MRTs may reduce pain intensity and improve disability in adults with CNSP. Given the high risk of bias and substantial heterogeneity, these estimates are exploratory and do not support firm clinical recommendations. Further well-designed randomized controlled trials with standardized MRT protocols and long-term follow-up are needed. Full article

Vaccine-associated anterior uveitis (VAAU) is an uncommon ocular inflammatory phenotype reported after several vaccine platforms. It describes anterior segment inflammation occurring after vaccination when infectious, autoimmune, idiopathic, medication-related, and other possible causes have been reasonably excluded. The current literature indicates that post-vaccination uveitis is rare relative to the scale of immunization, although anterior uveitis is frequently reported among post-vaccination ocular inflammatory events. Evidence remains limited by reliance on case reports, case series, retrospective cohorts, and passive surveillance data, which restricts precise incidence estimation and causal interpretation. Accordingly, the available evidence primarily supports a temporal association rather than a confirmed causal relationship. Proposed mechanisms include innate immune activation, molecular mimicry, adjuvant- or formulation-related immune stimulation, bystander activation, delayed-type hypersensitivity, and host susceptibility related to prior uveitis, autoimmune disease, immune dysregulation, or genetic predisposition. Clinically, VAAU may present with redness, pain, photophobia, blurred vision, anterior chamber cells and flare, keratic precipitates, posterior synechiae, elevated intraocular pressure, vitritis, or cystoid macular edema. Most cases described in the literature are mild to moderate and improve with topical corticosteroids and cycloplegic therapy, whereas recurrent, severe, or treatment-intensive courses have been reported mainly in predisposed individuals. Future work should emphasize active surveillance, standardized phenotype-specific reporting, harmonized case definitions, and mechanistic studies to better define risk, recurrence patterns, and causality. Careful interpretation of suspected cases can support accurate diagnosis, patient counseling, and vaccine-safety monitoring without undermining clinically indicated immunization. Full article

Background: Bone Marrow Edema Syndrome (BMEs) encompasses primary clinical conditions characterized by pain and high-intensity signals on fluid-sensitive magnetic resonance imaging at the subchondral bone level. This study aimed to evaluate bone mineral density (BMD) and turnover markers in BMEs patients compared to a healthy control group. Methods: We selected from the records 165 patients—comprising Complex Regional Pain Syndrome type 1 (CRPS-1, n = 61), hip BMEs (n = 42), and knee BMEs (n = 62)—alongside 150 age- and sex-matched healthy controls. Assessments included bone turnover markers, vitamin D levels, and BMD at the lumbar spine and femur by Dual-Energy X-ray Absorptiometry. Trabecular Bone Score (TBS) was calculated to estimate bone microarchitecture. Results: BMEs patients demonstrated significantly lower BMD across all skeletal sites and reduced TBS values compared to controls. Osteoporosis prevalence was significantly higher in all BMEs subgroups, with CRPS-1 and hip BMES patients showing higher rates than those with knee BMEs. No significant differences were observed in vitamin D or bone turnover markers between groups. Conclusions: Patients with CRPS-1 and BMEs of the hip or knee exhibit a higher prevalence of osteoporosis and compromised bone microarchitecture. These findings highlight a significant association between BME-related conditions and altered BMD/TBS parameters, suggesting a potential shared pathophysiological link. Full article

Background/Objectives: Pain intensity and depressive symptoms are closely associated in adults with chronic pain (CP), contributing to greater disability, poorer treatment outcomes, and increased healthcare costs. However, the mechanisms underlying this symptom-level relationship remain incompletely understood. This systematic review and meta-analysis aimed to (i) identify all candidate factors mediating the effect of pain intensity on depressive symptoms, or vice versa, in adults with CP and (ii) estimate the magnitude of indirect, direct and total effects reported across eligible studies. Methods: Seven databases were searched in May–July 2023 and updated in May–June 2024. Observational studies and randomized controlled trials evaluating mediators of the relationship between pain intensity and depressive symptoms, or vice versa, in adults with CP were eligible. Data extraction and methodological appraisal were performed independently by three reviewers. Findings were synthesized narratively using vote counting and displayed using harvest plots. When appropriate, meta-analyses were conducted using regression coefficients, standard errors and sample sizes to estimate pooled indirect, direct and total effects. Results: The search identified 6826 studies, of which 34 (47 mediation models) met the inclusion criteria. Twenty-nine studies (combined n = 13,587) examined the effect of pain intensity on depressive symptoms, identifying 24 candidate mediators. Exploratory meta-analyses were feasible only for pain catastrophizing (indirect effect [IE]: β = 0.150; 95% confidence interval [CI]: 0.066, 0.233) and helplessness (IE: β = 0.101; CI: 0.066, 0.137). The pooled estimate for pain catastrophizing showed substantial heterogeneity and was highly influenced by a single study. Sleep quality, pain self-efficacy and pain interference showed preliminary evidence of mediation in narrative synthesis. Nine studies (combined n = 1359) investigated the effect of depressive symptoms on pain intensity, identifying 12 candidate mediators. Pain catastrophizing was the most consistently supported mediator, although quantitative synthesis was not feasible. Conclusions: Several potentially modifiable mediators of the pain–depression relationship were identified and may represent targets for multidisciplinary interventions. However, quantitative findings remain preliminary because of the limited number of studies, substantial heterogeneity for some mediators, and the predominance of cross-sectional evidence. Robust three-wave longitudinal mediation studies with adequate statistical power, standardized measures and reporting, and theory-driven models are needed to establish the temporal validity of candidate mediators and strengthen causal inferences. Full article

Background/Objectives: Trigeminal neuralgia (TN) is a relapsing-remitting condition predominantly managed in primary care, where carbamazepine remains the sole recommended first-line therapy. Prior meta-analyses report end-of-treatment pain reductions with acupuncture but have not stratified results by risk of bias, audited pain outcome reporting quality, or examined whether analgesic effects persist beyond the treatment period. This updated systematic review addressed these gaps. Methods: Seven databases were searched from inception to February 2026 for randomized controlled trials comparing acupuncture against non-acupuncture controls in adults with TN (PROSPERO: CRD420251271469). End-of-treatment VAS, follow-up VAS, attack frequency, recurrence rate, and adverse events were analyzed using random-effects models with Hartung–Knapp–Sidik–Jonkman adjustment. Risk of bias was assessed with Cochrane RoB 2. Recall period specification was audited for all pain outcomes. Results: Twenty-three trials (1774 participants) were included, all from China, with one sham-controlled comparator. Fewer than 15% of VAS outcomes specified a recall period. End-of-treatment pain intensity favored acupuncture (MD = −1.49; 95% CI −1.81 to −1.16; I² = 93.1%), but the prediction interval crossed zero and significance was confined to high-risk studies (k = 16; p < 0.001). At three-month follow-up, the pooled estimate was comparable in magnitude (k = 3; MD = −1.50; I² = 47.0%) but was not robust to single-study removal. Recurrence rate favored acupuncture in both reporting studies. Acupuncture was associated with fewer adverse events than carbamazepine (RR = 0.31; I² = 0%). Conclusions: End-of-treatment estimates are compromised by risk-of-bias dependence and pervasive recall period omission. Follow-up data showed a directionally consistent but statistically fragile signal of analgesic persistence. Sham-controlled trials with prospective pain diaries and follow-up as a co-primary endpoint are needed. Full article

Remote tele-rehabilitation requires objective pain assessment, but existing approaches fail in two distinct ways. Self-report scales such as the Visual Analog Scale and the Numeric Pain Rating Scale are easy to falsify, opening a special case of the Oracle problem in blockchain-based insurance. Cloud-based computer vision handles falsification but transmits raw biometric video off the patient’s device, violating privacy requirements. A decentralized Edge AI-Oracle architecture is proposed that combines MediaPipe Face Mesh landmark extraction with a recurrent classifier mapping Action-Unit feature sequences to a learned pain score aligned with the Prkachin and Solomon Pain Intensity scale. The recurrent cell is selected empirically across short-context (T = 2) and long-context (T = 120 frames at 24 fps) regimes, with a two-layer Long Short-Term Memory (LSTM) network adopted for deployment. Inference and Elliptic Curve Digital Signature Algorithm (ECDSA) signing run inside an ARM TrustZone Trusted Execution Environment (TEE). Biometric logs are stored off-chain on the InterPlanetary File System (IPFS). Smart contracts anchor results on-chain and open a 24 h optimistic verification window for an off-chain Watchtower auditor. On SynPAIN the LSTM reaches F1 = 0.683 on T = 120 video (leave-one-stratum-out), with a directional but non-significant advantage over Gated Recurrent Unit (GRU) (Wilcoxon p = 0.167). Cross-dataset validation on BioVid Heat Pain Database Part A (87 subjects, 174 paired observations, leave-one-subject-out) yields F1 = 0.519 for LSTM and 0.499 for GRU (Wilcoxon p = 0.549). A processor-only TEE surrogate benchmark estimates 1.96 ms (FP32) and 0.45 ms (INT8) inference latency at T = 120 with a 0.34 MB footprint and 707 µs ECDSA signing latency, leaving the INT8 inference latency more than an order of magnitude below the 33 ms per-frame budget. The dual-layer storage reduces gas costs by a factor of 23.4 (160,261 vs. 3,744,872 gas), corresponding to an illustrative mainnet cost of approximately 0.53 USD per submission at 1 gwei, rising to roughly 16 USD at a busier 30 gwei, and falling to approximately 0.005 USD on Arbitrum One (April 2026 reference parameters), so that continuous monitoring is economically practical on Layer-2. An adaptive-adversary analysis of the Watchtower shows that gross score tampering is detected at every usable operating threshold, whereas a rational adversary who inflates by less than the dispute threshold, or who shapes the injected score to fall just inside it, evades detection. Because the false-positive rate reaches zero only for $\mathsf{\delta }\gtrsim 0.15$, the protocol bounds rather than eliminates patient-side fraud and motivates a zero-knowledge proof-of-inference successor. The framework is architecturally and economically feasible as a cryptographically verifiable, privacy-preserving tele-rehabilitation substrate aligned with General Data Protection Regulation (GDPR) and Health Insurance Portability and Accountability Act (HIPAA) requirements through the Zero-Video Transmission principle, while remaining economically viable under post-Dencun mainnet and Layer-2 conditions. Recognition accuracy on real-world data and robustness to small-magnitude tampering remain limitations that the interchangeable recognition and audit components must improve before clinical deployment. Full article

Background: Non-specific neck pain is associated with altered muscle mechanical properties, including increased stiffness. Radial extracorporeal shockwave therapy (rESWT) and orthopedic manual therapy (OMT) are commonly used interventions, although their combined effects on cervical muscle stiffness remain unclear. This study aimed to evaluate the short-term and within-session effects of adding rESWT to OMT on cervical muscle stiffness measured by means of shear wave elastography (SWE) in individuals with non-specific neck pain. Methods: A randomized controlled trial was conducted including 24 participants (mean age 34.36 years) allocated to an intervention group (IG, n = 12) or a control group (CG, n = 12). The IG received a combined protocol of rESWT (1500 impulses per point at 10 Hz, 2–4 bar) and OMT based on the Maitland concept, while the CG received OMT alone. Primary outcomes included cervical muscle stiffness assessed via SWE expressed in meters per second (m/s) and kilopascals (kPa). Secondary outcomes were pain intensity (VAS), pressure pain threshold (PPT), cervical range of motion (ROM), and shoulder elevation strength (SES). Treatment effects were estimated using ANCOVA adjusted for baseline values. Results: The combined intervention was associated with greater reductions in cervical muscle stiffness compared with the control group, with significant decreases in SWE values (m/s: β = −1.27, p < 0.001; kPa: β = −27.97, p < 0.001). Pain intensity was also reduced (β = −2.12, p = 0.012), while PPT increased (β = 18.84, p = 0.024). Improvements were observed in cervical extension ROM (β = 10.30, p = 0.014) and right SES (β = 3.85, p = 0.044). No significant differences were found for other ROM variables or left SES. Conclusions: The addition of rESWT to OMT was associated with greater short-term improvements in cervical muscle stiffness, pain intensity, and mechanical sensitivity compared with OMT alone in individuals with non-specific neck pain. However, these findings should be interpreted with caution due to the study limitations. Full article

Background and Objectives: Anxiety can influence the intensity of postoperative pain, anesthesia and the need for analgesia. Likewise, proper anxiety management can reduce hospital stays. Therefore, it is important to review the actions of nursing professionals and estimate the effect size of nursing interventions to reduce anxiety in pre- and postsurgical processes. Therefore, the objective of this study was to analyze the effectiveness of preoperative motivational interviews by nursing to reduce pre- and postoperative anxiety and postoperative pain after surgery. Materials and Methods: A systematic review was carried out according to the PRISMA guidelines, with a record in PROSPERO using DeCS and Boolean operators OR and AND to increase the specificity of the search. In the EBSCOhost, Pubmed, Cochrane Library and Scopus databases, 104 studies were obtained. Patients ≥ 18 years of age with scheduled surgeries, communication skills, clinical trials or quasi-experimental studies were included. The risk of bias 2 (RoB2) tool was used to assess the risk of bias in the studies. A random effects meta-analysis was performed to analyze pre- and postoperative anxiety and postoperative pain. Results: A total of 6 studies were included (4 clinical trials and 2 quasi-experimental studies). All the studies analyzed preoperative anxiety, which was significantly lower (SMD = −1.53; 95% CI: −4.01 to −0.95; I² = 40%). Postoperative pain (SMD = −0.74; 95% CI: −0.94 to −0.54; I² = 35%) and postoperative anxiety (SMD = −0.48; 95% CI: −0.78 to −0.19; I² = 0%) also decreased. Conclusions: Motivational interviews by nurses may help provide clearer information and emotional support and allow patients to express doubts, reducing their fear of anesthesia, pain and the recovery process. Emotional control improved adaptation to the surgical environment, reducing postoperative pain. With respect to implications for clinical practice, it is necessary to use the same scales to measure anxiety to better compare the studies. Full article

Background and Objectives: Muscle symptoms are the most visible adverse event attributed to statins, but terminology is often imprecise. Most patients report myalgia or nonspecific aches, whereas objective myopathy, inflammatory or necrotizing myositis, rhabdomyolysis, and anti-HMGCR immune-mediated necrotizing myopathy are uncommon and clinically distinct entities. To provide a clinically oriented narrative synthesis of statin-associated muscle symptoms (SAMS) and severe statin-associated myotoxicity, and to propose a practical prevention, evaluation, and management algorithm. The classification of muscle events is used to standardize terminology and avoid diagnostic confusion, not to create a new formal taxonomy. Materials and Methods: A clinically oriented narrative review was performed using PubMed, Google Scholar, and major society documents published from January 2021 to April 2026. Eligible sources addressed SAMS, statin myopathy/myositis, rhabdomyolysis, anti-HMGCR immune-mediated necrotizing myopathy, nocebo/drucebo effects, pharmacogenetics, drug interactions, diagnosis, or management. The final evidence set comprised 55 verifiable sources, including blinded randomized or n-of-1/crossover evidence; meta-analyses; clinical statements and reviews; pharmacovigilance analyses; pharmacogenetic guidance; mechanism-focused reviews; anti-HMGCR series; and lipid-lowering guideline/treatment studies. Because the review was narrative, no pooled estimate or formal PRISMA screening log was generated. Results: Blinded evidence indicates only a small absolute excess of muscle pain with statins, concentrated mainly in the first year of therapy, and that most muscle symptoms reported during statin therapy are not pharmacologically caused by the statin. N-of-1 and crossover trials show that symptom intensity is often similar during statin and placebo periods, consistent with an important nocebo/drucebo contribution. Severe muscle toxicity can nevertheless occur, especially when systemic statin exposure is increased by a high dose, interacting drugs, frailty, renal or hepatic impairment, hypothyroidism, transporter or metabolic genotypes, or intense unaccustomed exercise. Statin choice matters chiefly through dose, pharmacokinetics, and interaction burden. Conclusions: SAMS are common as reported clinical problems, but confirmed statin-caused muscle injury is substantially less frequent than routine clinical attribution suggests. Permanent discontinuation should be reserved for carefully assessed cases. A structured approach—baseline risk assessment, selective CK measurement, exclusion of alternative causes, correction of modifiable risks, dechallenge/rechallenge, statin switching, dose reduction, and combination with non-statin therapy—preserves cardiovascular benefit while protecting the rare patient with genuine toxicity. Full article

Background: Boswellia serrata has traditionally been used in Ayurvedic medicine for its anti-inflammatory and antioxidant properties. Although several studies support clinical analgesic efficacy, the underlying mechanisms have not been investigated in human experimental pain models. This randomized, double-blind, placebo-controlled, crossover pilot trial aimed to examine the mode of action of Boswellia serrata to differentiate between its peripheral and central effects. This exploratory pilot study was designed to generate preliminary effect size estimates and assess functional pain-processing outcomes, rather than to provide definitive evidence of clinical efficacy. Methods: Twelve healthy volunteers were recruited and received either 300 mg of Boswellia serrata extract or a visually identical placebo twice daily for 28 days, separated by a 4-week washout period. Pain and sensitization were induced using a topical capsaicin model. Outcomes included spontaneous pain intensity, mechanical allodynia, pinprick hyperalgesia, thermal thresholds, and conditioned pain modulation, alongside psychological assessments of mood, anxiety, sleep, and structured adverse-event monitoring. Results: Results showed no significant difference in the primary endpoint of spontaneous pain intensity between Boswellia and placebo (VAS 43 ± 21 vs. 47 ± 17; d = 0.18; p = 0.539). Conclusions: While Boswellia serrata did not significantly reduce acute peak pain in this model, the observed trends suggest a potential multi-level modulatory influence on nociceptive processing and endogenous pain inhibition. These findings warrant larger clinical trials to further elucidate its therapeutic potential, particularly in populations with impaired pain modulation. Full article

Background/Objectives: Arthroscopic shoulder surgery is associated with postoperative pain and loss of function. Percutaneous electrical nerve stimulation (PENS) may serve as an effective adjunct to postoperative rehabilitation. This randomized clinical trial examined whether adding ultrasound-guided PENS to a multimodal rehabilitation program improves pain, disability, pressure pain sensitivity, shoulder range of motion, and muscle strength in individuals with postoperative pain following shoulder arthroscopy. Methods: A randomized, parallel-group clinical trial (registry: NCT06331871) was conducted. Seventy patients who had undergone shoulder arthroscopy were randomized to receive manual therapy/exercise alone (n = 35) or manual therapy/exercise/PENS (n = 35). All participants received the multimodal program including manual therapy and exercises four weeks after surgery for a duration of 12 weeks (five sessions/week). Those allocated to the PENS group also received two sessions (once per week) of ultrasound-guided PENS targeting the suprascapular and axillary nerves. Pain intensity (Numeric Pain Rating Scale (NPRS)) and disability (Disabilities of the Arm, Shoulder and Hand (DASH)) were the primary outcomes, whereas function (Shoulder Pain and Disability Index (SPADI)), pressure pain threshold (PPT), isometric strength, and shoulder range of motion (ROM) were secondary outcomes. Pain, PPT, strength, and ROM were assessed before and after treatment, and at 1 and 3 months. Disability and function were assessed at baseline and 3 months after treatment. Results: Patients receiving PENS showed greater improvements in shoulder pain (F_{2.72, 182.32} = 7.76, p = 0.007, η²p = 0.10), disability (F_{1, 68} = 5.63, p = 0.020, η²p = 0.08), function (F_{1, 68} = 4.15, p = 0.046, η²p = 0.02) and PPT over the infraspinatus muscle (F_{3.20, 217.28} = 2.93, p = 0.032, η²p = 0.04) than those receiving manual therapy/exercise alone. No between-group differences were observed for PPT at the deltoid or tibialis anterior muscles. The PENS group also showed greater improvements in some, but not all, measures of shoulder strength and range of motion; however, the effect sizes were small and the clinical relevance of these differences remains uncertain. Conclusions: Adding ultrasound-guided PENS targeting the suprascapular and axillary nerves to a multimodal physical therapy program resulted in greater improvements in pain, disability, and shoulder-specific function, with limited additional benefits for some measures of strength and range of motion, compared with physical therapy alone, in individuals with postoperative shoulder pain. However, many of the lower-bound estimates of the 95% confidence interval did not surpass the minimal clinically important difference. Therefore, the clinical relevance of the results should be considered with caution. Full article

Background: Pain assessment in critically ill, mechanically ventilated pediatric patients is highly complex owing to communication barriers and the frequent use of sedation. A standardized, rapid, and objective tool such as the Behavioral Pain Scale (BPS) is urgently needed in Japanese pediatric intensive care units (PICUs), particularly in mixed adult–pediatric settings, to ensure consistent, multidisciplinary assessment. This study aimed to evaluate the clinical applicability, validity, and reliability of the Japanese version of the BPS in critically ill mechanically ventilated pediatric patients. Methods: This single-center, prospective cross-sectional observational study was conducted between October 2021 and March 2023. The final analysis included 70 observations from 37 pediatric patients who needed mechanical ventilation (MV). Concurrent and convergent validity were assessed using Spearman’s rank correlation coefficients (ρ) between the BPS; the Face, Legs, Activity, Cry, Consolability (FLACC) scale; and the COMFORT-Behavior (COMFORT-B) scale. Interrater reliability was evaluated using intraclass correlation coefficients (ICCs) and weighted kappa values among the three independent observers. The sample size (52 observations) was calculated based on the kappa coefficient estimation. The impact of sedation depth (assessed using the Richmond Agitation–Sedation Scale [RASS]) and the observers’ prior clinical experience with the evaluations were also analyzed. Results: Concurrent and convergent validity were high, showing strong correlations with the FLACC (ρ = 0.49–0.91) and COMFORT-B (ρ = 0.69–0.87) scales. The total BPS score showed moderate interrater reliability (ICC = 0.66, 95% CI = 0.55–0.76; weighted κ = 0.63–0.71). However, deep sedation (defined as a median RASS score ≤ −4 across observers), present in 68.6% of the observations, caused a pronounced floor effect that suppressed behavioral responses, even during painful procedures. Consequently, the reliability of fine motor subscales like “upper limb movement” (κ = 0.08) was slight and for “facial expression” (κ = 0.38), it was fair. Furthermore, the correlation strength with the FLACC scale varied significantly with observer experience, with the strongest correlation (ρ = 0.91) achieved by the observer with extensive adult ICU experience. Conclusions: As an initial validation, the Japanese version of the BPS has demonstrated acceptable validity and moderate reliability in mechanically ventilated pediatric patients. However, its clinical application requires careful interpretation because of the pronounced floor effect under deep sedation. Furthermore, accurate assessment depends heavily on specific training and familiarity with the adult-derived scale. With adequate training, the BPS has the potential to serve as an alternative tool and a valuable common multidisciplinary language in mixed intensive care settings. Future research should investigate whether implementing this tool improves multidisciplinary communication and clinical outcomes. Full article

Objective: Peripheral arterial occlusive disease (PAOD) is characterized by impaired tissue perfusion, chronic ischemia, and increased platelet reactivity. Hyperbaric oxygen therapy (HBOT) is used as adjunctive treatment in advanced PAOD, but its effect on platelet function remains insufficiently studied. This study examined the association between HBOT and platelet aggregation. Methods: This prospective observational study included 90 patients with Fontaine stage IV PAOD and chronic ulceration, assigned to an HBOT group (n = 60) or waiting-list control group (n = 30). Patients were predominantly male; mean age was 66.82 ± 9.42 years in the study group and 63.00 ± 8.31 years in controls, and diabetes mellitus was present in 55.0% and 63.3%, respectively. Prior revascularization included open surgery in 33.3% and 30.0%, endovascular treatment in 36.7% and 43.3%, and no option for revascularization in 30.0% and 26.7%, respectively. HBOT was administered over 4 weeks (20 sessions, 2.0–2.5 ATA). Platelet aggregation was measured by impedance aggregometry using arachidonic-acid-induced aggregation (ASPI), adenosine-diphosphate-induced aggregation (ADP), and thrombin-receptor-activating peptide-induced aggregation (TRAP) agonists. Changes were analyzed using generalized estimating equation models adjusted for antiplatelet therapy, diabetes mellitus, smoking, and C-reactive protein (CRP). Results: Significant group × time interactions were observed for all platelet activation pathways, indicating greater reductions in the HBOT group than controls: ASPI (β = −290.5; p < 0.001), ADP (β = −243.6; p < 0.001), and TRAP (β = −330.9; p < 0.001). No significant change was observed in controls. HBOT was associated with reduced pain intensity, while CRP and platelet-to-lymphocyte ratio (PLR) remained stable. Ulcer size showed no significant change after 4 weeks. Conclusions: In patients with PAOD, HBOT was associated with reduced platelet reactivity independent of antiplatelet therapy. Further randomized studies are needed to determine its clinical significance. Full article