Sleep Interference Research Articles

Association ofChronic Pain With Alcohol Consumption andTobacco Use inActive Duty Soldiers.

Chronic pain and lifestyle habits, namely alcohol consumption and tobacco use, impact soldier readiness. This study examines the relationship between chronic pain and these lifestyle habits in soldiers seen at the Interdisciplinary Pain Management Center (IPMC). This cross-sectional retrospective review utilized data from active duty soldiers receiving treatment at the IPMC. Soldiers (N = 203, 85% men) treated at the IPMC completed an intake questionnaire that included the Defense and Veterans Pain Rating Scale, the Alcohol Use Disorders Identification Test-Concise, and inquiries about tobacco use. Tobacco use was quantified as the amount and frequency of cigarettes smoked. Other tobacco products were converted to an equivalent number of cigarettes. Data were analyzed using descriptive statistics, Pearson's correlation, and independent samples t-test analyses. The mean duration of pain reported was 34.73 ± 38.66 months (median = 24.00). Soldiers engaging in hazardous drinking reported significantly higher interference with sleep (mean = 6.53 versus 5.40, P = .03) and greater negative effect on mood (mean = 6.33 versus 5.30, P = .04) compared to the no hazardous drinking group. Nonsignificant differences were found between tobacco users and non-tobacco users regarding pain intensity and pain effect on activity, sleep, mood, and stress (all P > .05). Among tobacco users, a significant negative correlation was found between a daily number of cigarettes used and sleep interference (r = -0.29, P = .024) as well as effect on mood (r = -0.33, P = .010). Years of tobacco use showed a significant negative correlation with the average pain intensity (r = -0.32, P = .025). The results suggest that addressing alcohol consumption is an essential part of chronic pain treatment. The finding of a negative association between years of nicotine use and pain intensity suggests that nicotine use may have served as a coping mechanism. Further research is needed.

Impacts of covid-19 on sleep quality and autonomic function in elderly diabetic women.

to analyze the quality of sleep and cardiac autonomic modulation of elderly diabetic women in the post-covid-19 syndrome. 41 elderly women, aged 60-75years, with a diagnosis of Type 2 Diabetes Mellitus and who had covid-19 were included, divided into three groups: 14 in the Diabetes without covid-19 group (DG), 15 in the Diabetes with covid-19 group (CG), 12 in the Diabetes with covid-19 group who had Pulmonary Compromise (IG). Sleep quality was assessed using the Pittsburgh questionnaire, anamnesis, capillary blood glucose, blood pressure collection, anthropometry, resting electrocardiogram for 10min for heart rate variability (HRV) analysis. Data were analyzed by 1-way ANOVA followed by Tukey-Kramer Multiple Comparisons Test, significance for p≤0.05. there was no significant difference in age, blood glucose, blood pressure, and body composition between the groups. In the analysis of sleep quality, there was significance in the following indices: sleep duration, sleep efficiency, sleep disturbances, and daytime sleepiness. Further, there was a reduction in autonomic indices between CG vs. DG: VarRR (ms2), SDNN (ms), SD1 (ms), TINN (ms), HF-log (ms2), LF-log (ms2); and between IG vs. DG: VarRR (ms2), SDNN (ms), RMSSD (ms), SD1 (ms), SD2 (ms), and HF-log (ms2). it is suggestive that diabetic elderly women who had covid-19, with and without pulmonary impairment, have impaired sleep quality and interference on HRV with decreased parasympathetic autonomic modulation.

42928 The patient-reported impact of itch and sleep interference on pediatric and adolescent patients with moderate and severe atopic dermatitis: a real-world study in the United States and Europe

42928 The patient-reported impact of itch and sleep interference on pediatric and adolescent patients with moderate and severe atopic dermatitis: a real-world study in the United States and Europe

Relationship of Sleep Health and Endoscopic Disease Activity in Inflammatory Bowel Disease: Endoscopic Disease Activity and Sleep.

Among adults with inflammatory bowel disease (IBD), self-reported sleep disturbances are associated with active symptoms, but the association between sleep measures and endoscopic disease activity is unknown. This study aimed to (1) compare sleep-wake behaviors among IBD patients based on endoscopic and clinical disease activity and (2) describe associations between actigraphy, self-reported sleep measures, and symptoms of fatigue, anxiety, and depression. Participants wore a wrist actigraph for 10 consecutive days and completed self-reported sleep questionnaires (Pittsburgh Sleep Quality Index [PSQI] and Patient-Reported Outcome Measures System [PROMIS] Sleep Disturbance and Sleep Interference questionnaires). Clinical and endoscopic disease activity were assessed. Based on actigraphic recordings ( n = 26), average total nighttime sleep was 437 minutes and sleep efficiency was 84%. Objective sleep measures did not differ based on endoscopic or clinical disease activity. Individuals with active clinical disease had higher PROMIS Sleep Disturbance (57.3 vs. 49.7, d = 1.28) and PROMIS Sleep-Related Impairment (58.1 vs. 52.8, d = 0.51) compared with those with inactive clinical disease. Self-reported sleep was significantly associated with anxiety, depression, and fatigue. Further research is needed to better characterize the relationship between sleep and endoscopic disease activity, and determine underlying mechanisms related to poor sleep in the IBD population.

Gaming passion contributes to the definition and identification of problematic gaming

Even if for most people playing video games is a healthy leisure activity, a minority of vulnerable users present an excessive use associated to negative consequences (e.g., psychosocial maladjustment, sleep interference) and functional impairment. The current study first aims to identify psychological factors that contribute to discriminate highly involved (but healthy) gamers from problematic gamers. For that purpose, we used a cluster analysis approach to identify different groups of gamers based on their profiles of passion towards gaming (using the Dualistic Model of Passion). Another objective of the present study is to explore, using supervised machine-learning, how gaming disorder symptoms, assessed within the substance use disorder framework (e.g., tolerance, withdrawal), might be linked to harmonious and/or an obsessive passion for gaming. Three distinct clusters of gamers were identified based on their passion profiles, including risky gamers, engaged gamers, and casual gamers. Supervised machine-learning algorithms identified that specific gaming disorder symptoms (salience, mood modification, tolerance, low level of conflict) were predominantly related to harmonious passion, whereas others (withdrawal, high level of conflict, relapse) were more directly related to obsessive passion. Our results support the relevance of person-centered approaches to the treatment of problematic gaming.

The Underlying Mechanisms of Sleep Deprivation Exacerbating Neuropathic Pain.

Pain disrupts sleep, and sleep deprivation or interference can alter pain perception in animals and humans, for example by increasing sensitivity to pain. However, the mechanism by which sleep affects neuropathic pain remains unclear. In this review, we discuss the available evidence from the epidemiologic, clinical, and human, as well as laboratory studies. In previous studies, we have found that sleep deprivation affects various injurious systems, including opioids, dopaminergic, immune, orexins, hypothalamic-pituitary-adrenal axis, and adenosine. At the same time, these systems play a crucial role in neuropathic pain regulation. In the complex interactions between these neurobiological systems, there may be potential regulatory pathways through which sleep deprivation amplifies neuropathic pain. Because of the impact sleep problems and neuropathic pain can have on the patients' quality of life, studying the link between sleep and neuropathic pain is important for neuropathic pain prevention and public health.

Ultrasound- Versus Computed Tomography-Guided Cervical Dorsal Root Ganglia Pulsed Radiofrequencies via Intervertebral Foramen for the Treatment of Postherpetic Neuralgia: A Retrospective Cohort Study

BACKGROUND: Pulsed radiofrequency (PRF) treatment of the dorsal root ganglia (DRG) has recently been used as an important option for postherpetic neuralgia (PHN) patients who do not respond well to drugs. This procedure is commonly guided by computed tomography (CT) or fluoroscopy, but they cannot be performed in real time and are associated with radiation exposure. Ultrasound (US) is a potential alternative option, but no reliable method of US-guided DRG PRF treatment has been reported. OBJECTIVES: The goal of this study was to propose a method for performing US-guided transforaminal PRF on cervical DRG. By comparing the results with those of CT guidance, we also sought to assess the accuracy, safety, and efficacy of this new approach in the treatment of PHN. STUDY DESIGN: A retrospective cohort study. SETTING: The study took place at the department of pain management of a single academic medical center. METHODS: The data of 73 PHN patients receiving 2 sessions of US-guided (US group, n = 26) or CT-guided (CT group, n = 47) cervical DRG PRF were reviewed. US-guided DRG PRF was performed using our proposed protocol. The one-time success rate was used to assess accuracy. The average radiation dose, the number of scans per operation, and the rate of complications were recorded for safety assessment. For the evaluation of pain amelioration, a Numeric Rating Scale (NRS-11), the daily sleep interference score (SIS), and oral medication (i.e., anticonvulsants and analgesics) usage 2 weeks, 4 weeks, 12 weeks, and 24 weeks after treatment were compared to the baseline values and between groups. RESULTS: The one-time success rate in the US group was significantly higher than that in the CT group (P < 0.05). Compared those of the CT group, the mean radiation dose and number of scans per operation were both obviously lower in the US group (P < 0.05). The average operation time was also shorter in the US group (P < 0.05). No obvious serious complications occurred in either group. No obvious between-group difference was found in the NRS-11 score, daily SIS, or rate of oral medications at any of the time points (P > 0.05). The NRS-11 score and SIS significantly decreased after treatment at each follow-up time point (P < 0.05) in both groups. Compared with those at baseline, the use rate of anticonvulsants and analgesics obviously decreased 4 weeks, 12 weeks, and 24 weeks after treatment (P < 0.05). LIMITATIONS: This study was limited by its nonrandomized and retrospective design. CONCLUSIONS: US-guided transforaminal DRG PRF is a safe and effective method for the treatment of cervical PHN. It is a reliable alternative option to the CT-guided procedure, demonstrating great advantages in reducing radiation exposure and the operation time. KEY WORDS: Ultrasound, pulsed radiofrequency, dorsal root ganglion, postherpetic neuralgia, transforaminal

0674 The role of PTSD symptoms in the relationship between sleep quality and pain following Moderate-to-Severe Traumatic Brain Injury

Abstract Introduction Poor sleep quality and chronic pain are common after moderate-to-severe traumatic brain injury (msTBI). Prior studies have not examined the role of PTSD symptoms in the relationship between sleep quality and chronic pain experience (i.e., severity and pain-related interference) in those with msTBI. Yet, PTSD is known to be associated with both sleep and pain. The purpose of this analysis is to determine the role of PTSD symptoms in the sleep-pain relationship among this at-risk clinical population. Methods Secondary analyses were performed on data (n=1537) from the TBI Model Systems follow-up study. Participants were an average age of 46.21 years old, predominantly male (72.61%), and followed at an average of 8.5 years post injury. Participants completed measures of sleep quality (Pittsburgh Sleep Quality Index; PSQI), pain severity and interference (Brief Pain Inventory; BPI), depression (Patient Health Questionnaire-9; PHQ-9) and PTSD symptoms (PTSD Checklist, PCL-5). Analysis of covariance (ANCOVA) was used to examine differences in pain outcomes controlling for relevant covariates, adjusting for item redundancy prior to analyses. Results Sleep quality and pain interference are associated such that “good sleepers” (PSQI≤8, mean=4.92±2.17) have lower pain interference scores than “poor sleepers” (PSQI>8, mean=12.63±2.87), with a mean pain interference of 3.41±2.32 vs 5.26±2.45 (p< 0.0001). “Good sleepers” also had lower pain severity (4.22±1.78 vs 5.28±1.84, p< 0.0001), lower PTSD symptoms (14.62±13.46 vs 28.35±17.82, p< 0.0001), and less depression symptoms (5.32±4.97 vs 10.57±6.22, p< 0.0001) when compared to “poor sleepers.” Pain interference and severity were significantly related to all covariates at a <.001 level. Further, a significant effect of PSQI score cut-off (“good” v “poor sleeper”) in both pain interference and severity remained after controlling for the effect of age, depression, and PTSD symptom scores. Conclusion In patients with msTBI, sleep quality and pain interference are positively associated such that better sleep quality corresponds with lower pain interference, a relationship which remains when controlling for PTSD and multiple covariates. Addressing the sleep needs of patients with msTBI through behavioral intervention (e.g., cognitive behavioral therapy for insomnia), even in the presence of additional psychiatric comorbidities, may assist those who experience chronic pain following injury. Support (if any)

Prednisolone 20 mg vs 40 mg in complex regional pain syndrome type I: A randomized controlled trial

BackgroundHigh dose of corticosteroid has been found beneficial in complex regional pain syndrome type I (CRPS-I). We report the efficacy and safety of prednisolone 20 mg versus 40 mg in CRPS-I in an open label randomized controlled trial. MethodsThe patients with CRPS-I of the shoulder joint with a CRPS score of ≥8 were included. Their demographic details, comorbidities, and underlying etiology were noted. The severity of CRPS was assessed using a 0–14 CRPS scale, the pain using a 0–10 Visual Analogue Scale (VAS), and sleep quality using a 0–10. Daily Sleep Interference Scale (DSIS). Patients were randomized to prednisolone 40 mg/day (group I) or 20 mg/day (group II) for 14 days, then tapered to 10 mg in group I and to 5 mg in group II by 1 month. Thereafter both groups received prednisolone 5 mg/day for 2 months. The primary outcome was a >50% reduction in VAS score, and secondary outcomes were a reduction in CRPS score, DSIS score, and adverse events. ResultsFifty patients were included, and their baseline characteristics were comparable. At one month, all the patients had >50% reduction in the VAS score. The effect size was 0.38 (95% CI 0.93–0.20; p = 0.20). On the Kaplan-Mayer analysis, the improvement in the VAS score (Hazard ratio−1.43, 95 % CI-0.80–2.56, p = 0.22) and the CRPS score (HR-0.79,95 % CI-0.45–1.39; p = 0.41) was insignificant between the two groups. The DSIS score improved in group II (HR-1.85,95 % Cl-1.04–3.31,p = 0.04). Group I patients needed frequent adjustment of antidiabetic drugs (14 vs 6; p = 0.04). ConclusionThe efficacy of prednisolone 20 mg is not inferior to 40 mg in CRPS-I, and is safe in diabetic patients. LimitationsThis is an open label randomized controlled trial with small sample size without a placebo arm.

Why a Complete Response Is the Treatment Aim in Chronic Spontaneous Urticaria.

This study investigated the association between urticaria activity and health-related quality of life (HRQoL). Patient evaluations from the ligelizumab Phase 2b clinical trial (N = 382) were pooled (NCT02477332). Daily patient diaries assessed urticaria activity, sleep and activity interference, the dermatology life quality index (DLQI), and work productivity and activity impairment-chronic urticaria (WPAI-CU). The number of DLQI scores, weekly sleep interference scores (SIS7), weekly activity interference scores (AIS7), and overall work impairment (OWI) evaluations with a complete response per weekly urticaria activity score (UAS7) using bands (0, 1-6, 7-15, 16-27, and 28-42) were reported. Over 50% of the patients had a mean DLQI of > 10 at baseline, indicating a significant effect of chronic spontaneous urticaria (CSU) on their HRQoL. Complete response (UAS7 = 0) evaluations corresponded with no impacts on other patient-reported outcomes. In total, 91.1% of UAS7 = 0 evaluations corresponded to DLQI scores of 0-1, 99.7% to SIS7 scores of 0, 99.7% to AIS7 scores of 0, and 85.3% to OWI scores of 0. This was significantly different compared with the UAS7 = 1-6 evaluations (61.9%, 68.5%, 67.7%, and 65.4%, respectively; p < 0.0001). Complete responses to treatment were associated with no impairments on the dermatology-QoL, no interferences with sleep and activity, and significantly improved capacities to work compared to patients who continued to have signs and symptoms, even for those with minimal disease activity.

440 10 kHz Spinal Cord Stimulation (SCS) Provides Significant, Durable Pain Relief for Patients with Painful Diabetic Neuropathy (PDN): 24-Month Results

INTRODUCTION: Approximately 37 million Americans have diabetes, 1 with 25-30% experiencing PDN. 2 High-frequency (10 kHz) SCS has been shown to provide substantial symptom relief for PDN, 3 and here we report durability of these outcomes to 24 months (24M). METHODS: This prospective, multicenter, RCT evaluated 10 kHz SCS with these key inclusion criteria: PDN symptoms ≥12 M refractory to medications, lower limb pain intensity ≥5 cm (0-10 cm visual analog scale [VAS]), and hemoglobin A1c ≤ 10%. Patients (n = 216) were randomized 1:1 to 10 kHz SCS plus CMM or CMM alone, with optional crossover at 6M. RESULTS: At 6M, patients receiving 10 kHz SCS experienced average pain relief of 76.1% (95% CI: 70.5–81.6%), which increased to 82.0% (95% CI: 77.3–86.6%) at 24M. At 24M, 10 kHz SCS patients experienced 70% decreases in pain-associated sleep disturbance and interference with mood and daily activities. At 24M, neurological improvements were observed in 72% of patients receiving 10 kHz SCS. After 6M, 93% of eligible CMM patients elected to cross over to 10 kHz SCS, while zero 10 kHz patients crossed over. With 10 kHz SCS, both groups experienced similar, significant reductions in pain and pain-associated interference. There were zero device explants due to lack of efficacy and eight (5.2%) procedure-related infections (n = 3 resolved with antibiotics; n=5 explanted), which is within the range reported for SCS in non-diabetic patients (2.5-10%).4 CONCLUSIONS: This is the largest RCT to date for SCS management of PDN. The 24M results support that 10 kHz SCS can provide safe, durable pain and symptom relief for PDN. REFERENCES: 1 CDC. National Diabetes Statistics Report; 2022. 2 Finnerup et al. Lancet Neurol 2015; 14(2):162-73. 3 Petersen et al. Diabetes Care; 45(1):e3-e6. 4 Eldabe et al. Pain Med 2016; 17(2):325-36.

Pregabalin in Patients with Post-Traumatic Peripheral Neuropathic Pain: A Meta-Analysis of Randomized Controlled Trials.

To investigate the safety and efficacy of pregabalin versus placebo in post-traumatic peripheral neuropathic pain (PTNP). PubMed, Cochrane Library, Web of Science, and Google Scholar were searched for relevant evidence up to January 2022. The Cochran tool was used to assess the quality of randomized clinical trials (RCTs). Data analysis was performed using Comprehensive Meta-Analysis software. Three RCTs involving 821 patients were included in the meta-analysis. A significant difference was observed between pregabalin and placebo in terms of the pain score (the standardized mean difference [SMD] = -0.481, 95% CI: -0.75 to 0.20, P=0.04) and sleep interference (MD= -0.481, 95% CI: -0.75 to 0.20, P=0.00). There was also a significant difference between pregabalin and placebo regarding somnolence (risk ratio [RR] = 2.78; 95% CI: 1.64 to 4.71, P=0.00), dizziness (RR=4.13; 95% CI: 2.71 to 6.28, P=0.00), and disturbance in attention (RR: 2.97; 95% CI: 1.02 to 8.65, P=0.04). However, no significant difference was observed between pregabalin and placebo in terms of headache (RR=1.20; 95% CI: 0.70 to 2.06, P=0.50), fatigue (RR=1.42; 95% CI: 0.82 to 2.47, P=0.20), nausea (RR=1.52; 95% CI: 0.88 to 2.62, P=0.13), constipation (RR=1.84; 95% CI: 0.78 to 4.29, P=0.15), and discontinuation (RR=1.52; 95% CI: 0.45 to 5.06, P=0.49). Compared with placebo, pregabalin showed better efficacy in reducing PTNP and improving sleep interference. However, it was associated with higher adverse events. Further RCTs is needed to confirm these findings.

Existing standardised questionnaires do not adequately capture quality-of-life outcomes of greatest importance for those living with type 1 diabetes in pregnancy.

No standardised questionnaires have been specifically developed to assess the considerable demands of managing type 1 diabetes (T1D) during pregnancy. This study aimed to explore what domains of measurement are important to quality of life during pregnancy with TID and to assess if standardised questionnaires, used by previous researchers, adequately capture patients' reported experience of TID in pregnancy. A qualitative inquiry was conducted using semi-structured focus groups with Canadian women who have experienced T1D in pregnancy. Participants were asked open-ended questions about experiences managing T1D during pregnancy and whether options on standardised tools captured their pregnancy experiences. Audio from focus groups was transcribed verbatim. Two researchers independently analysed the transcripts using inductive thematic analysis. Salient ideas, experiences and key words were coded iteratively and grouped into broader themes and subsequently reviewed by five participants. The sample included nine participants. Emergent themes included changes in day-to-day routines to manage T1D in pregnancy, fear of hyperglycaemia during pregnancy and of hypoglycaemia postpartum. Participants felt that existing options on standardised questionnaires did not adequately quantify diabetes interference in work, family time, planned activities and sleep, and did not address hyperglycaemia fear. Existing standardised questionnaires do not adequately capture patient-reported outcomes of greatest importance for those living with T1D in pregnancy. Future research assessing the impact of therapies on quality-of-life measures in TID pregnancies should quantify their influence on day-to-day activities, adjust measures of sleep quality and capture fear of hyperglycaemia in pregnancy and hypoglycaemia postpartum.

Safety and efficacy of duloxetine versus gabapentin in painful diabetic polyneuropathy

To evaluate safety and efficacy of Gabapentin and Duloxetine in patients with painful diabetic neuropathy.This is a prospective randomized double blinded parallel group study done for a period of 12 weeks. Total of 60 patients were enrolled and randomly allocated to two groups with 30 patients each, group A received Duloxetine 30 mg twice daily and group B received Gabapentin 300mg twice daily and followed every 2 weeks. Patients of age 35 to 60 years with painful diabetic peripheral polyneuropathy are included in the study. Primary objective is improvement in pain assessed by NPRS; Secondary objective is improvement in sleep and clinical condition of the patient, assessed by Sleep Interference Score and Clinical Global Impression of Change (CGIC). Assessment was done at beginning and at four, eight and twelve weeks. Data was analysed using SPSS 12.0 version.Numerical pain rating scores and daily sleep interference scores were reduced significantly with course of treatment within both groups (p = &amp;#60;0.05 in both groups), but there was no significant difference observed between two groups at baseline, 4th week, 8th week and 12th week. There is significant reduction in CGIC severity scores with course of treatment within both groups (p = &amp;#60;0.05 in both groups), but there was no significant difference observed between groups at baseline and at end of treatment. Common adverse events seen are nausea, dry mouth, dizziness, somnolence and constipation in both groups. There is high incidence of nausea and dry mouth with Duloxetine when compared to Gabapentin.Monotherapy with either Duloxetine or Gabapentin was equally effective at 12 weeks treatment with minor side effects. In addition, Gabapentin showed fewer side effects. It can be concluded that for preventing side effects, Gabapentin can be used. Further large head to- head comparator and combination trials are required.

REMIBRUTINIB TREATMENT IMPROVES SLEEP AND ACTIVITY IN CHRONIC SPONTANEOUS URTICARIA PATIENTS: PHASE 2B STUDY RESULTS

<h3>Introduction</h3> Chronic spontaneous urticaria (CSU) is characterized by spontaneous occurrence of wheals (hives) and/or angioedema for ≥6-weeks and has a major impact on patients' wellbeing. We explored the effect of remibrutinib (LOU064), a novel oral Bruton's Tyrosine Kinase inhibitor, on sleep and activity in patients with CSU. <h3>Methods</h3> In this Phase-2b study (NCT03926611), 311 patients with CSU were equally randomized to remibrutinib 10mg once-daily (q.d.)/35mg q.d./100mg q.d./10mg twice-daily (b.i.d)/25mg b.i.d./100mg b.i.d. or placebo for 12-weeks. Outcomes included change from baseline in sleep interference score (SIS) and activity interference score (AIS) and proportion of patients with SIS=0 and AIS=0 (no sleep/activity interference) at Weeks 4 and 12. <h3>Results</h3> Changes from baseline in SIS and AIS and proportion of patients with SIS=0 and AIS=0 are summarized in Table-1. The percentage decrease in SIS was higher with remibrutinib (any dose) versus placebo at Week-4 (50.53–74.15% vs 24.39%) and Week-12 (59.16–76.97% vs 23.19%). Proportion of patients with SIS=0 was higher with remibrutinib versus placebo at Week-4 (31.9–58.1% vs 15.0%) and Week-12 (48.9–64.1% vs 33.3%). The percentage decrease in AIS at Week-4 (58.23–77.66% vs 21.50%) and Week-12 (65.69–76.66% vs 33.13%) was higher with remibrutinib versus placebo. Proportion of patients with AIS=0 was higher with remibrutinib versus placebo at Week-4 (37.0–55.0% vs 15.0%) and Week-12 (51.1–60.0% vs 24.3%). <h3>Conclusion</h3> Remibrutinib demonstrated improvements in sleep and activity versus placebo at Weeks 4 and 12. Also, more patients on remibrutinib versus placebo achieved no interference in sleep and activity.

FREEDOM FROM ITCH AND HIVES IN CHRONIC SPONTANEOUS URTICARIA IS ASSOCIATED WITH IMPROVED QUALITY-OF-LIFE MEASURES

<h3>Introduction</h3> Patients' sleep, daily activities, and work are negatively impacted in chronic spontaneous urticaria. We evaluated the association between complete response (Urticaria Activity Score [UAS7]=0) and various patient reported outcomes (PRO) using the ligelizumab Phase 2b data (NCT02477332). <h3>Methods</h3> Data from patients treated with ligelizumab 72mg or 240mg, omalizumab 300mg, or placebo every 4 weeks for 20 weeks were used for this analysis. The percentage of evaluations achieving Weekly Sleep Interference Score (SIS7)=0 response, Weekly Activity Interference (WAI)=0 response, and Overall Work Impairment (OAI)=0 response per UAS7 disease activity band (wheal and itch free=0, well-controlled=1–6, mild=7–15, moderate=16–27 and severe=28–42) were assessed. Odds ratios (ORs), 95% confidence intervals, and nominal P values for UAS7=0 (complete response) vs UAS7=1–6 (well-controlled disease) were estimated. <h3>Results</h3> Data from 382 patients were analyzed. At any timepoint, UAS7=0 was strongly associated with evaluations of complete response on other PROs: 99.7% (total number of evaluations [N]=2,895) with SIS7=0; 99.7% (N=2,898) with WAI=0; and 85.3% (N=209) with OWI=0. In patients with UAS7=0 vs. those with UAS7 1–6, there was 137 times (95% CI 37.2 – 502.8) higher likelihood of having SIS7=0, 178 times (95% CI 29.2 – 1085.8) higher likelihood of having WAI=0, and 3 times (95% CI 1.8 – 5.1) higher likelihood of having OWI=0. <h3>Conclusion</h3> Control of urticaria symptoms leads to improvements in daily activities, sleep, and work, with best outcomes observed in patients with complete response to treatment.

Stress-, Anxiety-, and Cellphone use-induced Sleep Deficits and Psychological Conditions during the Pandemic and a Potential Remedy: a Randomized, Parallel, Blinded, Placebo-controlled Study

Healthier environments could prevent almost one quarter of the global burden of disease. The COVID-19 pandemic is a further reminder of the delicate relationship between people and our planet (WHO 2022). Since the appearance of the cell phone, the anomalous use of this device has called into question, as a new healthier environment issue, especially during this COVID-19 virus pandemic spreading, which may be linked to social isolation. This problem is identical to the one regarding the existence of behavioral addictions, including rigidity and muscle pain, ocular afflictions resulting from Computer Vision Syndrome reflected in fatigue, dryness, blurry vision, irritation, or ocular redness, auditory and tactile illusions – the sensation of having heard a ring or felt a vibration of a cell phone, and pain and weakness in the thumbs and wrists leading to an increased number of cases of de Quervain’s tenosynovitis. With respect to the psychological problems derived from cellphone dependence, the research focuses on the sub-consequence of cellphone dependence, sleep interference and its coexistence with using substances such as alcohol and tobacco and with symptomatology and psychiatric comorbidities, particularly anxiety, stress, and depression. In this study, authors surveyed 288 volunteers to gain insight regarding how stress, anxiety, and time spent on cellphones affected sleep and mood, and how a novel herb compound preparation, dihydromyricetin (DHM)-containing product improves these syndromes. The results clearly showed a negative linear correlation between sleep duration vs stress level and time on cellphone, and a negative correlation between wake-up mood/symptoms vs stress. Interestingly, volunteers taking DHM-containing product, but not placebo, showed substantial improvements in stress levels, hours of sleep, especially cellphone dependence, and wake-up mood/symptoms. This is a highly interesting study that addresses the current health problems, new healthier environment issue and suggests a potential therapeutic roles of DHM and/or herbs in behavioral addictions and associated mental health and wellbeing.

P78. Assessment of preoperative barriers to appropriate opioid use and the ability of these barriers to change after elective spine surgery

<h3>BACKGROUND CONTEXT</h3> Various barriers to appropriate postoperative opioid use have been identified in patients undergoing spine surgery. However, knowledge is limited on whether or not these barriers change as a result of going through the experience of surgery. <h3>PURPOSE</h3> The aim of this study is to assess how barriers to appropriate opioid use change in patients following elective spine surgery. <h3>STUDY DESIGN/SETTING</h3> Retrospective chart review. <h3>PATIENT SAMPLE</h3> Adult patients (18 years old) who underwent elective spine surgery and completed the short version of the Barriers Questionnaire Taiwan (S-BQT) and Patient Reported Outcomes Measures Information System (PROMIS) questionnaires preoperatively and at 1-year postoperative followup. <h3>OUTCOME MEASURES</h3> Opioid barriers score (OBS) derived from the summation of subscores within the S-BQT questionnaire, patient reported comfort with the use of naloxone and confidence in nonopioid medications to effectively manage postoperative pain. <h3>METHODS</h3> A preoperative and 1-year postoperative OBS (0-35) was calculated for each patient using their S-BQT surveys. A high opioid barriers score (hOBS) was defined as a score above the sample 75th percentile (OBS > 16). Postoperative changes in patient reported confidence in nonopioid medications and comfort with the use of naloxone were assessed. Abnormal PROMIS scores were defined as: high pain interference, sleep disturbance, anxiety, depression, fatigue for scores 60; and low physical function and social roles satisfaction for scores 40. Bivariate statistics and multivariate regression were used to assess for factors associated with high OBS and postoperative changes, while controlling for age, sex, Charlson Comorbidity Index (CCI), prior opioid use, procedure and spinal region. <h3>RESULTS</h3> Within 98 patients who met inclusion criteria, there were no differences in preoperative versus postoperative OBS (11.9 ± 6.4 vs 12.2 ± 7.1, p = 0.80). At both time points, fear of addiction was the highest S-BQT subdomain score. Postoperatively, there was an increase in patient reported confidence in nonopioid medications for pain control (p = 0.01), but no changes were observed in confidence with the use of naloxone (p = 0.70). Preoperatively, the odds of having hOBS (OBS >16) were increased with high anxiety (Odds Ratio [OR] 9.8, 95% Confidence Interval [CI] 1.8 - 66.7) and decreased with prior opioid use (OR 0.10, 95%CI 0.02-0.40). Postoperatively, high sleep interference (OR 7.0, 95%CI 1.2 - 44.9), depression (OR 8.7, 95%CI 1.2-82) and low social satisfaction (OR 7.5, 95%CI 1.3 -54.3) were associated with increased odds of developing hOBS in patients with previously normal barrier scores (OBS <16). <h3>CONCLUSIONS</h3> No significant changes in barriers to appropriate opioid use or patient reported comfort with naloxone were observed following the experience of spine surgery. These findings underscore the need for standardized preoperative opioid counseling to promote safe and appropriate opioid use following surgery. Patients with high levels of anxiety are likely to benefit most from these sessions as they may be predisposed to having significant barriers to appropriate postoperative opioid use. <h3>FDA DEVICE/DRUG STATUS</h3> This abstract does not discuss or include any applicable devices or drugs.

Relationship Between Attitudes and Beliefs About Sleep, Sleep Disturbance, and Pain Interference in Patients With Spinal Pain.

Sleep impairments are a strong predictor of pain, making sleep a potential interest when treating patients with spine pain. Typical beliefs about the importance of sleep in patients seeking care for spinal pain are unknown. The purpose of this study was to describe the beliefs and attitudes about sleep in patients seeking care for spinal pain and to examine the relationships between dysfunctional beliefs and attitudes about sleep (DBAS), disordered sleep, and pain interference. This cross-sectional study included patients presenting to physical therapy with spine pain. Participants completed questionnaires including demographics, medical history, pain interference (pain, enjoyment, and general activity), DBAS-16, and sleep-related impairment (Patient-Reported Outcome Measurement Information System). Correlations were calculated between DBAS-16 scores and measures of sleep quality/quantity, and a generalized linear model was used to investigate the predictive ability of DBAS-16 scores on pain interference. The mean DBAS-16 score was 4.22 (SD=2.03), with 52.5% of participants having DBAS. There was a strong relationship between DBAS-16 and Patient-Reported Outcome Measurement Information System ( rs =0.7; P <0.001). For every point higher score on the DBAS-16, pain interference scores increased by approximately half a point (B=0.46; 95% CI 0.33, 0.59, 1.80; P <0.001). These results highlight a strong relationship between beliefs and attitudes about sleep and measures of sleep quality/quantity and a linear association with pain interference scores. These findings provide a rationale for targeting beliefs and attitudes about sleep when managing pain-related symptoms in patients seeking care for spine pain.

Xiaoketongbi Formula vs pregabalin for painful diabetic neuropathy: A single-center, randomized, single-blind, double-dummy, and parallel controlled clinical trial.

BackgroundWe assessed the efficacy and safety of the Xiaoketongbi Formula (XF) vs. pregabalin in patients with painful diabetic neuropathy (PDN).MethodsPatients with PDN (n = 68) were included in a single‐center, randomized, single‐blind, double‐dummy, parallel controlled clinical trial. The primary outcome was the change in the Brief Pain Inventory for Diabetic Peripheral Neuropathy (BPI‐DPN). Secondary outcomes evaluated included the reduction of BPI‐DPN >50%, changes in the numeric rating scale‐11 (NRS‐11) score for pain, Daily Sleep Interference Diary (DSID), Patient Global Impression of Change (PGIC), nerve conduction velocity (NCV), and adverse events.ResultsAfter 10 weeks of treatment, the BPI‐DPN score reduced from 42.44 ± 17.56 to 26.47 ± 22.22 and from 52.03 ± 14.30 to 37.85 ± 17.23 in the XF and pregabalin group (P s < 0.001), respectively. The difference in the absolute change in BPI‐DPN score between both groups was −1.79 (95% CI: −9.09, 5.50; p = 0.625). In the XF and pregabalin groups, 44.1% (15/34) and 20.6% (7/34) of patients reported a BPI‐DPN reduction >50% (p = 0.038), respectively. There were no significant differences between groups in NRS‐11 and DSID (P s > 0.05). A significantly greater number of patients in the XF group felt “significantly improved” or “improved” than in the pregabalin group (35.3% (12/34) vs. 11.8% (4/34), p = 0.045). The absolute change in motor nerve conduction velocity of the right median nerve was significantly different between both groups (XF group 0.7 ± 2.3 vs. pregabalin group −2.2 ± 4.1, p = 0.004). No serious adverse events were reported in either group.ConclusionsXF is equivalent to pregabalin in reducing pain symptoms and improves the quality of life in patients with PDN. In addition, XF has the potential to improve nerve function by increasing NCV.