Mild Sensation Research Articles

The subjective experience of transcranial electrical stimulation: a within-subject comparison of tolerability and side effects between tDCS, tACS, and otDCS.

Low-intensity transcranial electrical stimulation (tES), including techniques like transcranial direct current stimulation (tDCS), transcranial alternating current stimulation (tACS), and oscillatory transcranial direct current stimulation (otDCS), has been widely explored for its neuromodulatory effects on motor, cognitive, and behavioral processes. Despite well-established safety, these techniques can induce varying degrees of discomfort and side effects, potentially impacting their application. This study presents a within-subject sham-controlled experiment directly comparing the subjective experience and side effects of tDCS, tACS, and otDCS. Participants reported their discomfort levels at multiple time points during 20-min stimulation sessions and completed a side-effects questionnaire before and after each session. Results indicated that the overall discomfort levels were low across all conditions, with ≥95% reporting the absence of discomfort or mild procedure-induced discomfort. Nevertheless, tDCS and otDCS were slightly less comfortable compared to sham, especially at the beginning of stimulation, with tACS-induced discomfort levels being overall comparable to sham. The most common side / adverse effects were mild skin sensations, including itching and tingling, particularly with tDCS and otDCS, while tACS occasionally caused phosphenes and blurred vision. These findings provide a systematic comparison of tES-induced discomfort and side effects between different tES techniques, highlighting the high safety of tES, but also the importance of considering within- and between-person variability and time-course effects in tES applications.

Roflumilast Cream, 0.15%, for Atopic Dermatitis in Adults and Children

Safe, effective, and well-tolerated topical treatment options available for long-term use in patients with atopic dermatitis (AD) are limited and associated with low adherence rates. To evaluate efficacy and safety of once-daily roflumilast cream, 0.15%, vs vehicle cream in patients with AD. Two phase 3, randomized, double-blind, vehicle-controlled trials (Interventional Trial Evaluating Roflumilast Cream for the Treatment of Atopic Dermatitis 1 and 2 [INTEGUMENT-1 and INTEGUMENT-2]), included patients from sites in the US, Canada, and Poland. Participants were 6 years or older with mild to moderate AD based on Validated Global Assessment for Atopic Dermatitis (assessed on a 5-point scale ranging from 0 [clear] to 4 [severe]). Patients were randomized 2:1 to receive roflumilast cream, 0.15%, or vehicle cream once daily for 4 weeks. The primary efficacy end point was Validated Investigator Global Assessment for Atopic Dermatitis success at week 4, defined as a score of 0 or 1 plus at least a 2-grade improvement from baseline. Secondary end points included Eczema Area and Severity Index and Worst Itch Numeric Rating Scale. Safety and local tolerability were also evaluated. Among 1337 patients (654 patients in INTEGUMENT-1 and 683 patients in INTEGUMENT-2), the mean (SD) age was 27.7 (19.2) years, and 761 participants (56.9%) were female. The mean body surface area involved was 13.6% (SD = 11.6%; range, 3.0% to 88.0%). Significantly more patients treated with roflumilast than vehicle achieved the primary end point (INTEGUMENT-1: 32.0% vs 15.2%, respectively; P < .001; INTEGUMENT-2: 28.9% vs 12.0%, respectively; P < .001). At week 4, statistically significant differences favoring roflumilast also occurred for the achievement of at least 75% reduction in the Eczema Area and Severity Index (INTEGUMENT-1: 43.2% vs 22.0%, respectively; P < .001; INTEGUMENT-2: 42.0% vs 19.7%, respectively; P < .001). Roflumilast was well tolerated with low rates of treatment-emergent adverse events. At each time point, investigators noted no signs of irritation at the application site in 885 patients who were treated with roflumilast (≥95%), and 885 patients who were treated with roflumilast (90%) reported no or mild sensation at the application site. In 2 phase 3 trials enrolling adults and children, once-daily roflumilast cream, 0.15%, improved AD relative to vehicle cream, based on multiple efficacy end points, with favorable safety and tolerability. ClinicalTrials.gov Identifiers: NCT04773587, NCT04773600.

Investigation on cognition for insomnia and preference for acupuncture in breast cancer survivors: a in-depth interview study

To understand the cognition for insomnia and preference for acupuncture in breast cancer survivors based on the in-depth interview. Thirty breast cancer survivors with insomnia symptoms were collected for in-depth interview. The interview questions included three aspects, i.e. sleep expectation, cognition for insomnia (discomfort caused by insomnia, and underlying inducing factors of insomnia) and the preference for acupuncture (treatment methods used in the past, the reasons for not choosing acupuncture, and the tendency of acupuncture treatment). Using Colaizzi content analysis method, the data was analyzed. Regarding sleep expectation, most breast cancer survivors with insomnia symptoms were able to maintain normal activity in daytime. Insomnia symptoms often led to fatigue, and the inducing factors of insomnia referred to the treatment with endocrine therapy, anticipatory anxiety and inadequate sleep hygiene. All of the patients had received pharmacotherapy. The use proportion of non-pharmacological therapies was relatively low, and acupuncture was not chosen due to "not familiar with" and "fear of pain". Concerning to the preference for acupuncture, patients preferred the therapeutic methods of acupuncture with mild pain sensation and gentle stimulation; and the treatment should be more acceptable if delivered 2 or 3 times a week. Breast cancer survivors have the expectations for sleep, and are willing to receive the treatment with medication for their sleep disorders. Because of lack of the knowledge for acupuncture effect on insomnia and fear of strong needling sensation, a part of patients are unwilling to be treated with acupuncture therapy, but they are expected to receive the treatment with acupuncture while feeling more comfortable.

Roflumilast Cream 0.15% in Patients with Atopic Dermatitis: Individual Patient Response from the Pooled INTEGUMENT-1 and INTEGUMENT-2 Phase 3 Trials

Introduction: Roflumilast cream 0.15% is a highly selective phosphodiesterase 4 inhibitor under investigation as a once-daily, nonsteroidal treatment for atopic dermatitis (AD). Pooled safety and efficacy results of two Phase 3 clinical trials (INTEGUMENT-1 and INTEGUMENT-2) in patients with AD have been presented previously. Here we present individual patient responses on the Eczema Area and Severity Index (EASI), which is used to assess disease severity in clinical trials. Methods: INTEGUMENT-1 and INTEGUMENT-2 were identical, randomized, double-blind, vehicle-controlled, 4-week trials of once-daily roflumilast cream 0.15% in patients aged ≥6 with AD (body surface area [BSA] affected: ≥3%). Patients were randomly assigned 2:1 to roflumilast cream 0.15% or vehicle cream. The primary efficacy endpoint was Validated Investigator Global Assessment for AD (vIGA-AD) Success (score of 0 [Clear] or 1 [Almost Clear] plus ≥2-point improvement from baseline, assessed on a five-point scale ranging from 0 to 4 [Severe]) at Week 4. EASI was assessed as a secondary endpoint. Safety and tolerability were also evaluated. Results: In total, 884 patients received roflumilast 0.15% cream and 453 patients received vehicle cream. Baseline characteristics and demographics were similar between treatment groups. Significantly more roflumilast- than vehicle-treated patients achieved vIGA-AD Success (31.3% versus 14.1%; P&lt;0.0001) and vIGA-AD of Clear or Almost Clear (41.1% vs. 21.4%; P&lt;0.0001) at Week 4. Roflumilast treatment significantly improved itch by 24 hours after first application (P&lt;0.0001). At the first post-treatment timepoint evaluated (Week 1), 84.9% of roflumilast-treated patients had a measurable improvement in EASI. By Week 4, 91.5% of patients had a measurable improvement in EASI. Differences favoring roflumilast were also observed at Week 4 for percentages of patients achieving a 50% reduction in EASI (69.2% vs. 44.4%; P&lt;0.0001), 75% reduction (44.5% vs. 21.2%, P&lt;0.0001), 90% reduction (22.4% vs 8.6%; P&lt;0.0001), and 100% reduction (9.8% vs 4.8%; P&lt;0.002). Roflumilast cream had low rates of application-site adverse events (AEs), treatment-related AEs, and discontinuations due to AEs, comparable with vehicle. On local tolerability assessments, &gt;95% of investigators reported no evidence of irritation at any time point and &gt;90% of patients reported no or mild sensation after applying roflumilast cream on patient-rated local tolerability assessments. Conclusions: Roflumilast cream 0.15% provided greater improvement in vIGA-AD Success, vIGA-AD of Clear or Almost Clear, itch, and EASI versus vehicle in patients with AD in two Phase 3 trials. Among patients treated with roflumilast cream 0.15%, 91.5% demonstrated an improvement in EASI score by Week 4. Safety and tolerability were favorable, with &gt;90% of roflumilast- and vehicle-treated patients reporting no or mild sensation at the application site at any timepoint. Sponsored by Arcutis Biotherapeutics, Inc. ClinicalTrials.gov Identifiers: INTEGUMENT-1 [NCT04773587]; INTEGUMENT-2 [NCT04773600]

Roflumilast Cream 0.3% in Patients With Chronic Plaque Psoriasis: Individual Patient PASI and PASI-HD Responses: Pooled DERMIS-1 and DERMIS-2 Phase 3 Trials

Background: Roflumilast cream 0.3% is a highly potent phosphodiesterase 4 inhibitor approved as a nonsteroidal, once-daily treatment for patients with plaque psoriasis. Pooled efficacy and safety results from two Phase 3 clinical trials (DERMIS-1 and DERMIS-2) have been presented previously. The Psoriasis Area and Severity Index (PASI) is used to assess the severity of plaque psoriasis in clinical trials; however, PASI is not precise when the area of involvement is &lt;10% of a given anatomic region. A modified version of the PASI, the PASI-high discrimination (PASI-HD), allows more precise assessment of psoriasis in body regions where &lt;10% area is affected. We present individual patient responses using PASI and PASI-HD.&#x0D; Methods: Patients aged ≥2 years with at least mild plaque psoriasis involving 2-20% body surface area were randomized 2:1 to apply roflumilast cream 0.3% or vehicle cream once daily for 8 weeks. The primary efficacy endpoint was Investigator Global Assessment (IGA) Success (score of Clear or Almost Clear plus ≥2-grade improvement from baseline) at Week 8. PASI and PASI-HD were used to measure disease severity; individual patient PASI and PASI-HD responses were plotted graphically. Safety and tolerability were also evaluated and were reported previously.&#x0D; Results: Roflumilast- and vehicle-treated patients had similar baseline demographic and disease characteristics. At Week 8, statistically significantly more roflumilast- than vehicle-treated patients achieved IGA Success (39.9% vs. 6.5%; P&lt;0.0001). Statistically significant differences favoring roflumilast were observed at Week 8 for percentages of patients achieving a 50% reduction in PASI (72.1% vs. 25.5%; P&lt;0.0001), 75% reduction (40.3% vs. 6.5%, P&lt;0.0001), 90% reduction (19.7% vs 2.3%; P&lt;0.0001), and 100% reduction (12.3% vs 0.8%; P&lt;0.001). Likewise, statistically significant differences favoring roflumilast were observed at Week 8 for percentages of patients achieving 50% reduction in PASI-HD (79.4% vs. 33.1%; P&lt;0.0001), 75% reduction (59.9% vs. 17.9%, P&lt;0.0001), 90% reduction (39.9% vs 9.1%; P&lt;0.0001), and 100% reduction (12.3% vs 0.8%; P&lt;0.0001). Roflumilast cream demonstrated low rates of application-site adverse events (AEs), treatment-related AEs, and discontinuations due to AEs, comparable to vehicle. At the first application of roflumilast cream 0.3% (day 1), 96% of patients reported no or mild sensation, increasing to 99% of patients at Weeks 4 and 8.&#x0D; Conclusions: Roflumilast cream 0.3% provided greater improvement in IGA Success, PASI, and PASI-HD versus vehicle with favorable safety and tolerability in patients with psoriasis in two Phase 3 trials. PASI-HD provided higher discrimination of effects of treatment in areas with &lt;10% involvement than the traditional PASI.&#x0D; ClinicalTrials.gov Identifiers: DERMIS-1: NCT04211363; DERMIS-2: NCT04211389&#x0D; Financial Disclosures: Arcutis Biotherapeutics, Inc.

Evaluation of Pain Perception During Orthodontic Debonding of Metallic Brackets with Simultaneous Application of TENS Therapy.

The objective of the present study was to evaluate the effectiveness of transcutaneous electrical nerve stimulation (TENS) therapy on pain during the debonding procedure. A placebo-controlled, randomized split - mouth study was conducted on 30 orthodontic patients. The right and left anterior teeth in the maxilla and mandible were randomly allocated to the control and experimental groups (EG) and were stimulated. TENS application was made through a modified electrode probe that was used from an ammeter. The control group (CG) received the mechanical application of the device with no current, whereas the EG received progressively increasing current from 0.1 mA to the point where the patient experienced a mild tingling sensation for 60 s for each tooth. This was followed by a debonding procedure using an orthodontic debonding plier. Pain perception was recorded on a numerical rating scale after debonding each tooth. The mean pain score was higher in the CG than in the EG, and the difference between the two groups was significant (p=0.001). The pain score was higher in the mandibular teeth than in the maxillary teeth, and the difference between the two groups was also significant (p=0.021). Pain score was higher in female subjects than in male subjects, and the difference between the two groups was significant (p=0.015). The application of TENS therapy results in pain reduction during the debonding procedure. The female subjects experienced more pain. Higher pain scores were recorded for the mandibular anterior teeth than for the maxillary teeth.

505 - Once-daily roflumilast cream 0.15% for atopic dermatitis: pooled results from INTEGUMENT-1/2 phase 3 trials

Abstract Introduction Roflumilast cream 0.15% is a selective, highly potent phosphodiesterase 4 inhibitor under investigation as a non-steroidal, once-daily treatment for atopic dermatitis (AD). Objectives Here, pooled results from two identical Phase 3 randomized controlled trials (INTEGUMENT-1: NCT04773587 and INTEGUMENT-2: NCT04773600) are presented. Methods Patients with AD aged ≥6 years with baseline Eczema Area and Severity Index (EASI) score ≥5 and Validated Investigator Global Assessment-AD (vIGA-AD) score of Mild or Moderate were randomized 2:1 to apply roflumilast (n=884) or vehicle (n=453) once daily for 4 weeks. Results A significantly greater percentage of roflumilast- versus vehicle-treated patients achieved the primary endpoint, vIGA-AD Success (Clear or Almost Clear vIGA-AD plus ≥2-grade improvement from baseline) at Week 4 (31.3% vs. 14.1%; P&amp;lt;0.0001). Significant differences favoring roflumilast were observed for multiple secondary endpoints at Week 4: percentage of patients achieving vIGA-AD of Clear or Almost Clear (41.1% vs. 21.4%; P&amp;lt;0.0001), percentage achieving 75% reduction in EASI (42.7% vs. 20.6%; P&amp;lt;0.0001), and percentage with baseline Worst Itch-Numeric Rating Scale ≥4 achieving a 4-point reduction (31.9% vs. 16.6%; P&amp;lt;0.0001). Improvement in itch was reported as early as 24 hours. Both groups had low incidences of treatment-emergent adverse events (TEAE), serious adverse events, and TEAEs leading to discontinuation. Local tolerability was favorable, with &amp;gt;90% of patients reporting no or mild sensation across both treatment groups at all timepoints. Conclusions Once-daily roflumilast cream 0.15% provided improvement across multiple efficacy endpoints by Week 4 with favorable safety and tolerability in patients aged ≥6 years with AD in two Phase 3 trials.

Roflumilast Cream 0.3% in Patients with Chronic Plaque Psoriasis: Individual Patient Response from the Pooled DERMIS-1 and DERMIS-2 Phase 3 Trials

Roflumilast cream 0.3% in patients with chronic plaque psoriasis: individual patient response from the pooled DERMIS-1 and DERMIS-2 phase 3 trials&#x0D; &#x0D; James Del Rosso1 on behalf of the authors&#x0D; &#x0D; INTRODUCTION: Roflumilast cream 0.3% is a highly potent phosphodiesterase 4 inhibitor approved as a nonsteroidal, once-daily treatment for patients with plaque psoriasis. The efficacy and safety of the pooled results of two Phase 3 clinical trials (DERMIS-1 and DERMIS-2) in patients aged ≥2 years with plaque psoriasis have been previously presented. We present individual patient responses using the Psoriasis Area and Severity Index (PASI).&#x0D; METHODS: Patients aged ≥2 years with at least mild plaque psoriasis involving 2-20% of body surface area were randomized 2:1 to apply roflumilast cream 0.3% or vehicle cream once daily for 8 weeks. The primary efficacy endpoint was Investigator Global Assessment (IGA) Success (score of Clear or Almost Clear plus ≥2-grade improvement from baseline) at Week 8; IGA of Clear or Almost Clear was a secondary endpoint. PASI was used to measure disease severity; individual patient PASI responses were plotted graphically. Safety and tolerability were also evaluated and have been previously reported.&#x0D; RESULTS: Roflumilast- and vehicle-treated patients had similar baseline demographic and disease characteristics. At Week 8, statistically significantly more roflumilast- than vehicle-treated patients achieved IGA Success (39.9% vs. 6.5%; P&lt;0.0001) and IGA of Clear or Almost Clear (48.0% vs. 9.5%; nominal P&lt;0.0001). Statistically significant differences favoring roflumilast were observed at Week 8 for percentages of patients achieving a 50% reduction in PASI (72.1% vs. 25.5%; P&lt;0.0001), 75% reduction (40.3% vs. 6.5%, P&lt;0.0001), 90% reduction (19.7% vs 2.3%; P&lt;0.0001), and 100% reduction (12.3% vs 0.8%; P&lt;0.001). At the first post-treatment timepoint evaluated (Week 2), 85.7% of roflumilast-treated patients had a measurable improvement in PASI, increasing to 95.0% by the last timepoint (Week 8). Roflumilast cream demonstrated low rates of application-site adverse events (AEs), treatment-related AEs, and discontinuations due to AEs, comparable with vehicle. Approximately 96% of patients reported no or mild sensation after the first application of roflumilast cream 0.3%, improving to more than 99% of patients at Week 4 and Week 8, similar to vehicle.&#x0D; CONCLUSIONS: Roflumilast cream 0.3% provided greater improvement in IGA Success, IGA of Clear or Almost Clear, and PASI versus vehicle with favorable safety and tolerability in patients with psoriasis in two Phase 3 trials.&#x0D; Sponsored by Arcutis Biotherapeutics, Inc.&#x0D; ClinicalTrials.gov Identifiers: DERMIS-1: NCT04211363; DERMIS-2: NCT04211389

A Case of Brachial Plexus Schwannoma Presenting as a Cystic Neck Swelling

Schwannomas are benign tumours arising from Schwann cells of the neural sheath. They are rarely seen to arise from the brachial plexus. Brachial plexus schwannomas present as a swelling over lateral neck, supraclavicular region or axilla. Symptoms may include pain, sensory changes, weakness etc. Around 5% of these schwannomas may turn malignant. Although rare, cystic neck swellings can be due to cystic degeneration of a schwannoma. A preoperative evaluation is of utmost importance and in cases of neck swellings which are producing symptoms, a pre-operative MRI should be done to reach the diagnosis before taking the patient in the OT. Presented is a case of lateral neck swelling with mild tingling sensation over arm of the same side.

390 Efficacy and safety of roflumilast cream 0.15% in adults and children aged ≥6 years with mild to moderate atopic dermatitis in two phase 3 trials (INTEGUMENT-1 and INTEGUMENT-2)

Abstract Roflumilast is a selective, highly potent phosphodie­sterase 4 inhibitor under investigation as a nonsteroidal, once-daily cream for treatment of atopic dermatitis (AD). INTEGUMENT-1 (n = 654; NCT04773587) and INTEGUMENT-2 (n = 683; NCT04773600) were identical phase 3 randomized controlled trials conducted in patients with AD aged ≥6 years with baseline Eczema Area and Severity Index (EASI) score ≥5 and Validated Investigator Global Assessment-AD (vIGA-AD) score of mild or moderate. Patients were randomized 2 : 1 to apply once-daily roflumilast cream 0.15% or vehicle for 4 weeks. The primary efficacy endpoint was vIGA-AD Success [defined as score of 0 (clear) or 1 (almost clear) with 2-grade improvement from baseline] at Week 4. Secondary endpoints included 75% improvement in EASI (EASI-75). At Week 4, significantly more roflumilast-treated than vehicle-treated patients achieved vIGA-AD Success (INTEGUMENT-1: 32.2% vs. 15.2%; P &amp;lt; 0.0001; INTEGUMENT-2: 28.9% vs. 12.0%; P &amp;lt; 0.0001) and EASI-75 (INTEGUMENT-1: 43.2% vs. 22.0%; P &amp;lt; 0.0001; INTEGUMENT-2: 42.0% vs. 19.7%; P &amp;lt; 0.0001). Incidence of treatment-emergent adverse events (AEs) was low in both arms, with most assessed as mild to moderate in severity. No AE occurred in more than 3.5% of patients in either arm with low rates of application site pain in both the roflumilast- and vehicle-treated patients (INTEGUMENT-1: 2.1% vs. 0.5%; INTEGUMENT-2: 0.9% vs. 0.9%). Local tolerability was favorable with &amp;gt;90% of roflumilast-treated patients reporting no or mild sensation across arms in both trials at any timepoint. Once-daily roflumilast cream 0.15% improved AD across multiple efficacy endpoints while demonstrating favorable safety and tolerability in two phase 3 trials.

Morphological Features and Clinical Results of C2 Vertebral Body Fractures

Type of study: Retrospective study. Objectives: To classify and analyze the morphological patterns of vertebral body fractures and report the clinical results. Summary of literature review: There have not been many reports on the classification of vertebral body fractures and treatment results, and it remains a matter of debate. Materials and methods: Among 107 patients diagnosed with an axis fracture from 2005 to 2019, 53 patients with fracture involving the vertebral body were selected. After the exclusion of 9 patients with a history of cervical spine surgery or who were lost to follow-up, 44 consecutive patients were enrolled in this retrospective study. Patients were classified into 5 groups (coronal, sagittal, transverse, avulsion, and complex) according to the main fracture line. The demographic data, injury mechanism, discoligamentous injury, combined injury, neurological symptoms, and clinical treatment results were analyzed. Results: Patients’ average age was 61.7 years (range, 25–81 years). 24 patients were male and 20 were female. The average follow-up period was 14.2 months (range, 7–33 months). The coronal, sagittal, transverse, avulsion, and complex groups contained 5, 5,8, 7, and 19 patients, respectively. Six patients were injured by slip-down accidents, 12 patients by falling height, and 26 patients by traffic accidents. Eighteen patients were presented with a discoligamentous injury. Twenty-five patients showed a combination of fractures of cervical vertebrae and bones. Thirteen patients presented neurological symptoms. 16 patients were treated with a neck collar and 28 patients were treated with a halo-vest. Two patients eventually required surgical fusion because union was not achieved with conservative management. In the final follow-up, all neurological symptoms were resolved; however, 4 patients still complained of a mild tingling sensation in the upper extremity. Pin site infection occurred in 3 patients who were treated with a halo-vest, but it was controlled after antibiotic administration. Conclusion: Vertebral body fractures accounted for almost 50% of axis fractures in this study. Vertebral body fractures can be classified into 5 groups (coronal, sagittal, transverse, avulsion, and complex) according to the morphological pattern. Non-operative management can be a reasonable treatment option with good clinical results and bone union.

Prolonged heterogeneous liver enhancement accompanied by abdominal symptoms after sonographic contrast agent injection: a cross-sectional study.

To report the occurrence of abdominal symptoms in patients who presented with prolonged heterogeneous liver enhancement (PHLE) after injecting contrast agent SonoVue®. A total of 105 patients who indicated to have contrast-enhanced ultrasound (CEUS) examinations were consecutively observed. The liver scanning under ultrasound was performed before and after the contrast agent injection. Patients' basic information, clinical manifestations, and ultrasound images under B-mode and CEUS mode were respectively recorded. For patients exhibiting abdominal symptoms, the occurrence and last time of symptoms were recorded in detail. We subsequently compared the difference in clinical characteristics between patients with and without the PHLE phenomenon. In 20 patients with the PHLE phenomenon, 13 showed abdominal symptoms. Eight patients (61.5%) appeared to have mild defecation sensation, and 5 (38.5%) showed apparent abdominal pain. The PHLE phenomenon began to appear within 15 minutes to 1.5 hours after the intravenous injection of SonoVue®. This phenomenon lasted for 30 minutes to 5 hours in ultrasound. Patients with severe abdominal symptoms showed large-area and diffuse PHLE patterns. Only sparse hyperechoic spots in the liver were detected in patients with mild discomfort. Abdominal discomfort resolved spontaneously in all patients. Meanwhile, the PHLE gradually disappeared without any medical treatment. In the PHLE-positive group, the proportion of patients with a history of gastrointestinal disease was significantly higher (P=0.02). Patients with the PHLE phenomenon can exhibit abdominal symptoms. We suggest gastrointestinal disorders may contribute to PHLE, which can be considered a harmless phenomenon that does not affect the safety profile of SonoVue®.

Case Report: Successful Anterior Circulation Thrombectomy After 24 Hours in an Adolescent

BackgroundArterial ischemic stroke in children comes with the potential for morbidity and mortality and can result in high cost of care and decreased quality of life among survivors. Children with arterial ischemic stroke are increasingly being treated with mechanical thrombectomy, but little is known about the risks and benefits 24 hours after a patient’s last known well (LKW) time. MethodsA 16-year-old female presented with acute onset of dysarthria and right hemiparesis with LKW time 22 hours prior. Pediatric National Institutes of Health Stroke Scale score was 12. Magnetic resonance imaging showed diffusion restriction and T2 hyperintensity primarily in the left basal ganglia. Magnetic resonance angiography revealed left M1 occlusion. Arterial spin labeling showed a large apparent perfusion deficit. She underwent thrombectomy with TICI3 recanalization 29.5 hours after LKW time. ResultsAt 2-month follow-up, her examination showed moderate right-hand weakness and mild diminished sensation of the right arm. ConclusionsAdult thrombectomy trials include patients up to 24 hours from their LKW time and suggest that some patients maintain a favorable perfusion profile for over 24 hours. Without intervention many go on to experience infarct expansion. The persistence of a favorable perfusion profile likely reflects robust collateral circulation. We hypothesized our patient was relying on collateral circulation to maintain the noninfarcted areas of her left middle cerebral artery territory. Owing to concern for eventual collateral failure, thrombectomy outside of the 24-hour window was performed. This case serves as a call to action to better understand the impact of collateral circulation on cerebral perfusion in children with large vessel occlusions and delineate which children may benefit from thrombectomy in a delayed time window.

The use of electrodermal activity in pulpal diagnosis and dental pain assessment.

To explore whether electrodermal activity (EDA) can serve as a complementary tool for pulpal diagnosis (Aim 1) and an objective metric to assess dental pain before and after local anaesthesia (Aim 2). A total of 53 subjects (189 teeth) and 14 subjects (14 teeth) were recruited for Aim 1 and Aim 2, respectively. We recorded EDA using commercially available devices, PowerLab and Galvanic Skin Response (GSR) Amplifier, in conjunction with cold and electric pulp testing (EPT). Participants rated their level of sensation on a 0-10 visual analogue scale (VAS) after each test. We recorded EPT-stimulated EDA activity before and after the administration of local anaesthesia for participants who required root canal treatment (RCT) due to painful pulpitis. The raw data were converted to the time-varying index of sympathetic activity (TVSymp), a sensitive and specific parameter of EDA. Statistical analysis was performed using Python 3.6 and its Scikit-post hoc library. Electrodermal activity was upregulated by the stimuli of cold and EPT testing in the normal pulp. TVSymp signals were significantly increased in vital pulp compared to necrotic pulp by both cold test and EPT. Teeth that exhibited intensive sensitivity to cold with or without lingering pain had increased peak numbers of TVSymp than teeth with mild sensation to cold. Pre- and post-anaesthesia EDA activity and VAS scores were recorded in patients with painful pulpitis. Post-anaesthesia EDA signals were significantly lower compared to pre-anaesthesia levels. Approximately 71% of patients (10 of 14 patients) experienced no pain during treatment and reported VAS score of 0 or 1. The majority of patients (10 of 14) showed a reduction of TVSymp after the administration of anaesthesia. Two of three patients who experienced increased pain during RCT (post-treatment VAS > pre-treatment VAS) exhibited increased post-anaesthesia TVSymp. Our data show promising results for using EDA in pulpal diagnosis and for assessing dental pain. Whilst our testing was limited to subjects who had adequate communication skills, our future goal is to be able to use this technology to aid in the endodontic diagnosis of patients who have limited communication ability.

Thresholds for vestibular and cutaneous perception and oculomotor response induced by galvanic vestibular stimulation.

ObjectivesIn this study, the specific threshold intensities and response characteristics of galvanic vestibular stimulation (GVS) on vestibular (conscious) and cutaneous (detrimental) perception as well as oculomotor nystagmus (reflex) were determined.MethodsThe threshold intensities for vestibular and cutaneous perception and oculomotor response induced by GVS were determined in 25 right-handed healthy subjects (32.6 ± 7.2 years of age; 56% female). The subjects were seated upright, and eye movements were recorded while a direct GVS current was applied with paradigms of cathode on the right and anode on the left (CRAL) and also cathode on the left and anode on the right (CLAR).ResultsSubjects experienced dizziness, sense of spinning, or fall tendency, which was more frequently directed to the cathode (76%) than the anode (24%, p < 0.001, chi-square one-variable test) at mean current greater than 0.98 ± 0.29 mA (mean vestibular threshold). The current also triggered a more frequent mild tingling sensation at the cathode (56%) than the anode (30%) or on both sides (14%; p = 0.001, chi-square one-variable test) when above the mean cutaneous threshold of 0.9 ± 0.29 mA. Above the mean oculomotor threshold of 1.61 ± 0.35 mA, combined horizontal and torsional nystagmus was more frequent toward the cathode (86%) than toward the anode (p < 0.001, chi-square one-variable test). The mean oculomotor threshold was significantly higher than both the vestibular (p < 0.001, Mann–Whitney U-test) and cutaneous (p < 0.001, Mann–Whitney U-test) thresholds, which were comparable (p = 0.317, Mann–Whitney U-test). There was no significant disparity in these specific thresholds between the two GVS paradigms. The vestibular threshold was significantly higher in males than in females [1 (0.5–1.25) mA vs. 0.75 (0.625–1.125) mA, Z = −2.241, p = 0.025, Mann–Whitney U-test]. However, the thresholds of cutaneous perception and oculomotor response did not differ by sex.ConclusionThe findings indicate that thresholds for vestibular and somatosensory perception are lower than the oculomotor threshold. Therefore, a strategy to reduce GVS current intensity to the level of vestibular or somatosensory perception threshold could elicit beneficial vestibular effects while avoiding undesirable effects such as oculomotor consequences.

Management of frozen shoulder by leech therapy and adjuvant phytotherapy

BACKGROUND: Frozen shoulder is also known as adhesive capsulitis. It is one of the common musculoskeletal disorders. Its common symptoms such as pain and restricted movement of the shoulder joint. Conventional management of frozen shoulder include oral analgesics, range of motion exercises, intra- capsular corticosteroids injection, local application of analgesic oils and ointments but no such effective results have been found yet. As per Ayurveda perspective the condition can be correlated with Avabahuka. Further, Jalaukavacharana (~leech therapy) is one of the ancient para-surgical procedure described in Ayurveda for treatment of variety of such inflammatory condition along with other para surgical procedure and internal herbal drugs. METHODOLOGY: A 52 -year female patient having chief complaints of pain with restricted movement of left shoulder joint, pain in cervical region radiating towards left shoulder joint and mild tingling sensation on lower back region, was clinically diagnosed as case of frozen shoulder. This patient was treated with specific regimen such as Jalaukavacharana (~leech therapy) locallyalong with Ashwagandhaghanvati and Panchatikta ghrita guggulu internally. The parameters observed for prognosis were pain, stiffness, range of movements. Therapeutic evaluation of treatment was done based on improvement in the symptoms.

P.222 Subjective pattern of postoperative neurological recovery in degenerative cervical myelopathy varies by preoperative severity of disease

Background: Degenerative cervical myelopathy is a spinal disorder resulting in progressive spinal cord compression and consequent neurological deficits that can be assessed and tracked using the modified Japanese Orthopedic Association (mJOA) questionnaire. However, it is difficult to predict which patients will recover neurological function after surgery, making it difficult for clinicians to set reliable postoperative patient expectations. Methods: Sixty-eight operative myelopathy patients (50 male, 14 female) consented to complete the mJOA questionnaire both preoperatively and 6-months postoperatively. Fifteen of these patients had mild, twenty-three had moderate, and thirty had severe preoperative disease. Results: We found that in mild myelopathy, sensation and strength recover in similar proportions. In moderate myelopathy, a greater proportion of patients recover in each domain except for sensation. Recovery in severe myelopathy was comparable to moderate disease, but showed more dramatic recovery in sensation and sphincter function. Conclusions: This study shows that the severity of myelopathic disease influences the pattern of postoperative recovery. Though limited in sample size, the recovery patterns identified above are an important first step in recognizing myelopathy as a disease that patients experience heterogeneously both pre- and post-operatively. Our results will aid clinicians in goals-of-surgery discussions and assist with managing postoperative patient expectations.

Ultrasound to facilitate passage of distal ureteral stones

Feasibility of ultrasonic propulsion and burst wave lithotripsy (BWL) to noninvasively reposition distal ureteral stones to facilitate passage and relieve pain was tested. Patients presenting to the clinic or emergency department were recruited. Thirteen subjects underwent ultrasonic propulsion (lower amplitude, longer duration pulses) alone, and 10 subjects also received intermittent BWL (higher amplitude, shorter duration pulses). All participants were awake and underwent a pain assessment pre- and post-procedure. For analysis, subjects were sub-categorized based on whether their stone was acute or chronic (present for ≤10 days or &gt;10 days from their initial ED or symptomatic presentation, respectively). Seventeen subjects were enrolled in the acute study population and 6 subjects were enrolled in the chronic population. Overall, 94% of acute stones passed in an average of 3.4 days post-procedure relative to 54% in 7.5 days in the American Urological Association guidelines. 67% of chronic cases passed stones or fragments, and two surgeries were cancelled. Pain reduction was statistically significant ( p = 0.0215). Adverse events were limited to hematuria on initial urination post-procedure (BWL only, n = 3) and a mild sensation, akin to a pinprick, associated with fewer than 10 of 620 propulsion bursts ( n = 3). [Work supported by NIH-P01-DK04331.]

MP18-07 ULTRASOUND TO REPOSITION AND ACCELERATE PASSAGE OF DISTAL URETERAL STONES

You have accessJournal of UrologyStone Disease: Surgical Therapy II (MP18)1 Sep 2021MP18-07 ULTRASOUND TO REPOSITION AND ACCELERATE PASSAGE OF DISTAL URETERAL STONES M. Kennedy Hall, Jeff Thiel, Patrick C. Samson, Ross Kessler, Peter Sunaryo, Robert M. Sweet, Ian S. Metzler, Martin L. Gunn, Layla Anderson, Barbrina Dunmire, Christina Popchoi, Ravi Managuli, Bryan W. Cunitz, Barbara Burke, Adam D. Maxwell, Michael R. Bailey, Mathew D. Sorensen, Hunter Wessells, and Jonathan D. Harper M. Kennedy HallM. Kennedy Hall More articles by this author , Jeff ThielJeff Thiel More articles by this author , Patrick C. SamsonPatrick C. Samson More articles by this author , Ross KesslerRoss Kessler More articles by this author , Peter SunaryoPeter Sunaryo More articles by this author , Robert M. SweetRobert M. Sweet More articles by this author , Ian S. MetzlerIan S. Metzler More articles by this author , Martin L. GunnMartin L. Gunn More articles by this author , Layla AndersonLayla Anderson More articles by this author , Barbrina DunmireBarbrina Dunmire More articles by this author , Christina PopchoiChristina Popchoi More articles by this author , Ravi ManaguliRavi Managuli More articles by this author , Bryan W. CunitzBryan W. Cunitz More articles by this author , Barbara BurkeBarbara Burke More articles by this author , Adam D. MaxwellAdam D. Maxwell More articles by this author , Michael R. BaileyMichael R. Bailey More articles by this author , Mathew D. SorensenMathew D. Sorensen More articles by this author , Hunter WessellsHunter Wessells More articles by this author , and Jonathan D. HarperJonathan D. Harper More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002003.07AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: The feasibility of ultrasonic propulsion and burst wave lithotripsy (BWL) to noninvasively reposition distal ureteral stones to facilitate passage and relieve pain was tested. METHODS: Patients presenting to the kidney stone clinic or emergency department (ED) with a distal ureteral stone were recruited after standard of care pain management. To attempt to move the stone, 10 subjects underwent ultrasonic propulsion (lower amplitude, longer duration bursts) alone, and 10 subjects also received intermittent BWL (higher amplitude, shorter duration bursts). All participants were awake without anesthesia and underwent:· a screening ultrasound to ensure the stone was visible· a pain assessment pre- and post-procedure · contact once a week for three weeks to assess for adverse events· follow-up imaging and chart review within 12 weeksSubjects were sub-categorized based on whether their stone was acute or chronic (≤10 days or >10 days from their ED visit, respectively). RESULTS: Demographic data and effectiveness outcomes are presented in Tables 1 and 2. Overall, 93% of acute stones passed in an average of 3.6 days post-procedure. There was no control group, but Table 2 includes published passage rates and times for potentially similar untreated groups as reference. Stone motion was observed in 16 of 20 cases, including a stone pushed into the bladder, ureteral jets were observed following propulsion bursts in 9 of 20 cases and fragmentation was observed in 3 of 10 BWL cases. Pain reduced post-procedure in 10 of 20 subjects, while pain increased in only one subject; although, the average score was low prior to treatment, and the average decrease was not statistically significant (p=0.13). Adverse events were limited to slight reddening of the skin (N=6), hematuria on only the initial urination post-procedure (BWL only, N=3), and a mild sensation, akin to a pinprick, on fewer than 10 of 620 propulsion bursts among 3 subjects. CONCLUSIONS: This feasibility study showed the potential for facilitating stone passage of distal ureteral stones and relieving pain with ultrasonic propulsion and BWL. Source of Funding: Work supported by NASA, NIH P01 DK043881, and NIH K01 DK104854 © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e320-e320 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information M. Kennedy Hall More articles by this author Jeff Thiel More articles by this author Patrick C. Samson More articles by this author Ross Kessler More articles by this author Peter Sunaryo More articles by this author Robert M. Sweet More articles by this author Ian S. Metzler More articles by this author Martin L. Gunn More articles by this author Layla Anderson More articles by this author Barbrina Dunmire More articles by this author Christina Popchoi More articles by this author Ravi Managuli More articles by this author Bryan W. Cunitz More articles by this author Barbara Burke More articles by this author Adam D. Maxwell More articles by this author Michael R. Bailey More articles by this author Mathew D. Sorensen More articles by this author Hunter Wessells More articles by this author Jonathan D. Harper More articles by this author Expand All Advertisement Loading ...

Working Out Your Pain: Why Intense Exercise Is Painful

When it comes to experiencing pain, most people will agree that it is an uncomfortable sensation that we would rather avoid. Pain can vary in intensity—ranging from the mild sensation of stubbing your toe to the intense pain of a broken bone—and we generally think of it as a bad thing. But pain can be thought of in two ways: sometimes it is a warning signal that something is wrong with our bodies, but other times it is benign, meaning it is not an indication that something is necessarily wrong. Warning-signal pain occurs when certain areas of your body get hurt or experience tissue damage, like when a sibling accidentally closes the car door on your fingers. Benign pain, on the other hand, is the type of pain you feel during intense physical exercise, and as you will come to see, is not always something you need to avoid!