Numerical Rating Scale Change Research Articles

Mindfulness in Facilitating Pelvic Floor Botulinum Toxin Injection in Women with Chronic Pelvic Pain.

Botulinum toxin (BoNT) injection can safely be done as an office-based procedure, but can be painful itself, especially when injecting pelvic floor muscles to treat chronic pelvic pain (CPP). Mindfulness interventions may reduce procedure-associated acute anxiety and pain. We applied mindfulness techniques to increase the tolerability of office-based pelvic floor BoNT injections in women with CPP. Women enrolled in a clinical trial of BoNT for endometriosis-associated CPP were offered a brief, guided mindfulness session before and/or after transvaginal injection. Anxiety, pain, and dysphoria were rated on a 0-10 numerical rating scale (NRS) before and after each mindfulness session. Eight women underwent mindfulness sessions. Five participants had a session before and two after the transvaginal injection. One participant had two sessions: one before and one after separate injections. All six women completing a session prior to injection had at least moderate anxiety, which lessened after the mindfulness session (median NRS change: -3.3/10). All three women reporting injection-associated pain experienced less intense pain following the post-injection session (median NRS change: -3/10). Three women experiencing dysphoria improved after the session (median NRS change: -3/10). A brief, guided mindfulness session may lessen acute pain, anxiety, and dysphoria associated with office-based transvaginal BoNT injection.

Implementation of a robot-mediated upper limb rehabilitation protocol for a customized treatment after stroke: A retrospective analysis.

Many authors have emphasized the need for individualized treatments in rehabilitation, but no tailored robotic rehabilitation protocol for stroke patients has been established yet. To evaluate the effectiveness of a robot-mediated upper limb rehabilitation protocol based on clinical assessment for customized treatment of stroke patients. Clinical data from 81 patients with subacute stroke, undergoing an upper limb robot-mediated rehabilitation, were analyzed retrospectively. 49 patients were treated using a customized robotic protocol (experimental group, EG) based on a clinically guided flowchart, while 32 were treated without it (control group, CG). Fugl-Meyer Assessment for Upper Extremity (FMA-UE), Motricity Index (MI), modified Barthel Index (mBI) and Numerical Rating Scale (NRS) measured before (T0) and after (T1) rehabilitation intervention were used as clinical outcomes. There was statistically significant improvement in both groups in terms of FMA-UE, MI, and mBI, while no change in NRS. Intergroup analysis showed significantly greater improvement of the FMA-UE (P = 0.002) and MI (P < 0.001) in the EG, compared with the CG. The implementation of our robotic protocol for customized treatment of stroke patients yielded greater recovery in upper limb motor function and strength over robotic treatment without a defined protocol.

The Impact of Acute Postoperative Pain in Developing Chronic Pain after Total Knee Arthroplasty.

While total knee arthroplasties (TKAs) are performed with the intent to reduce pain, chronic postsurgical pain (CPSP) is one of the most well-documented complications that can occur following surgery. This study aimed to assess whether perioperative factors, focusing on acute postsurgical pain and perioperative opioid consumption, were associated with the development of chronic postsurgical pain. Under general anesthesia, 108 patients underwent TKA and were treated postoperatively with a multimodal analgesia approach. Numeric Rating Scale (NRS) pain scores at rest and with movement were recorded on postoperative days 0-3, 7, 14, and 30. Patients were sent a survey to assess chronic pain at months 22-66, which was examined as a single-group post hoc analysis. Based on the responses, patients were either classified into the CPSP or non-CPSP patient group. Chronic postsurgical pain was defined as an NRS score ≥ 4 with movement and the presence of resting pain. The primary outcome was a change in NRS. There were no differences in NRS pain scores with movement in the first 30 days postoperatively between patients with CPSP and without CPSP. Each unit increase in resting pain on postoperative days 3 and 14 was associated with significantly greater odds of CPSP presence (OR = 1.52; OR = 1.61, respectively), with a trend towards greater odds of CPSP at days 7 and 30 (OR = 1.33; OR = 1.43, respectively). We found that very intense pain in the initial phase seems to be related to the development of CPSP after TKA.

A Pilot Study of Urine Oxytocin as an Objective Biomarker for Chronic Pain

Background: Measuring pain objectively or quantitatively is difficult. Since urine oxytocin (OXT) concentration has been reported to be potentially associated with chronic pain. Purpose: We conducted a pilot study to evaluate the relationship between changes in numerical rating scale (NRS) score following nerve block and urine OXT concentration in patients with chronic pain. Methods: We investigated 19 chronic pain patients who were admitted to our hospital for nerve intervention. NRS score and urine OXT concentration were assessed before and after the nerve block. Results: NRS scores were 7 [6, 9] and 2 [1, 4] (median [interquartile range]) before and after the treatment intervention, respectively. Urinary OXT levels were 523 [293, 743] and 531 [308, 887] pg/mL (median [interquartile range]) before and after the treatment, respectively. We compared the group with greater improvement in NRS after the treatment intervention and those with less improvement. The group with greater improvement in NRS after the treatment intervention showed a greater increase in OXT level. However, baseline urine OXT concentrations were highly variable in patients with chronic pain and the changes in urinary OXT concentrations were also variable. Conclusion: Based on this pilot study, the utility of urine OXT concentration as an objective biomarker of chronic pain needs further investigation.

Subcutaneous injection of lidocaine around ischemic ankle provides safe and effective foot analgesia in patients with critical limb ischemia.

It is often difficult to alleviate foot pain associated with critical limb ischemia (CLI) using common analgesics. Neuraxial block is contraindicated in anticoagulant therapy. This study was designed to determine the response to subcutaneous injection of lidocaine around the network of peripheral nerves around the ankle in patients with CLI pain on anticoagulants and antiplatelets. Sixteen patients with CLI pain in the foot were enrolled in this double-blind placebo-controlled crossover study. Patients were randomized to receive either 2% lidocaine or saline via catheters inserted into the subcutaneous area around the ankle. After recurrence of pain, the patients were crossed over to receive the alternative treatment. Pain was assessed with a numerical rating scale (NRS) before and 15min after injection. Patients used a descriptive scale to grade pain control and were asked to determine the duration of analgesia in each arm of the study. No serious complications including protracted bleeding occurred. Lidocaine significantly decreased the NRS on movement from 10 (6, 10) [median (range)] to 2 (0, 10) (p < .001), and the differences in the Δ change in NRS between lidocaine and placebo were significant (p = .009). Of the 16 patients, 14 patients were very satisfied after lidocaine but only one described the same after saline. The effect of lidocaine and placebo lasted 11 (0, 28) and 1 (0, 22) h, respectively. Subcutaneous injection of lidocaine around the ischemic ankle affectively alleviated pain in patients with CLI without serious adverse effects under anticoagulant therapy.

The association between lumbar lordosis preoperatively and changes in PROMs for lumbar spinal stenosis patients 2years after spinal surgery: radiological and clinical results from the NORDSTEN-spinal stenosis trial.

Patients with lumbar spinal stenosis (LSS) sometimes have lower lumbar lordosis (LL), and the incidence of LSS correlates closely with the loss of LL. The few studies that have evaluated the association between LL and clinical outcomes after non-instrumented surgery for LSS show conflicting results. This study investigates the association between preoperative LL and changes in PROMs 2years after decompressive surgery. This prospective cohort study obtained preoperative and postoperative data for 401 patients from the multicenter randomized controlled spinal stenosis trial as part of the NORwegian degenerative spondylolisthesis and spinal STENosis (NORDSTEN) study. Before surgery, the radiological sagittal alignment parameter LL was measured using standing X-rays. The association between LL and 2-year postoperative changes was analyzed using the oswestry disability index (ODI), a numeric rating scale (NRS) for low back and leg pain, the Zurich claudication questionnaire (ZCQ), and the global perceived effect (GPE) score. The changes in PROMs 2years after surgery for quintiles of lumbar lordosis were adjusted for the respective baseline PROMs: age, sex, smoking, and BMI. The Schizas index and the Pfirrmann index were used to analyze multiple regressions for changes in PROMs. There were no associations in the adjusted and unadjusted analyses between preoperative LL and changes in ODI, ZCQ, GPE, and NRS for back and leg pain 2years after surgery. LL before surgery was not associated with changes in PROMs 2 years after surgery. Lumbar lordosis should not be a factor when considering decompressive surgery for LSS.

Efficacy and safety of mirogabalin for chemotherapy-induced peripheral neuropathy: a prospective single-arm trial (MiroCIP study)

BackgroundChemotherapy-induced peripheral neuropathy (CIPN) is a painful, dose-limiting adverse effect of commonly used chemotherapeutic agents. The purpose of this exploratory study was to evaluate the efficacy and safety of mirogabalin in patients with moderate to severe CIPN during chemotherapy and the effects of 12 weeks’ intervention on chemotherapy completion and CIPN severity.MethodsPatients experiencing moderate to severe CIPN while undergoing oxaliplatin- or taxane-containing chemotherapy for colorectal, gastric, non-small-cell lung, or breast cancer received mirogabalin at between 5 and 15 mg twice daily. The primary endpoint was change in numeric rating scale (NRS) score for pain from baseline to week 12. Secondary endpoints included NRS scores for tingling and sleep, completion of chemotherapy, severity of CIPN, and quality of life (QOL) scores. The safety endpoint was incidence of adverse events.ResultsOf 58 patients who consented to participation, 52 were eligible and constituted the full analysis set and safety analysis set. From baseline to week 12 (last observation carried forward [LOCF]), NRS score decreased by 30.9%: mean change (95% confidence interval [CI]), − 1.7 (− 2.4 to − 1.0) (p < 0.001). Patients with baseline NRS of ≥ 6 experienced a 44.0% reduction in score from baseline to week 12 (LOCF): mean change (95% CI), − 3.3 (− 5.0 to − 1.5) (p = 0.002). Chemotherapy was discontinued in 18 (34.6%) patients; CIPN led to discontinuation in only 2 (3.8%). There was no notable worsening of CIPN severity in terms of Common Terminology Criteria for Adverse Events grade or Modified Total Neuropathy Score-reduced, although use of pain medications during chemotherapy might cause worsening of CIPN due to underestimation of subjective symptoms. QOL score based on the EuroQol five-dimensional descriptive system did not worsen during the 12 weeks. Thirty-one percent of patients experienced adverse drug reactions, and the most common event was somnolence (13.5%). Serious adverse events and death occurred in 3 patients and 1 patient, respectively; however, they were unrelated to mirogabalin treatment.ConclusionsIntervention with mirogabalin during chemotherapy may be effective and safe for cancer patients with moderate to severe CIPN. It can contribute to completion of chemotherapy without worsening of CIPN.Trial registrationJapan Registry of Clinical Trials (jRCTs031210101, registered 20/5/2021).

Local anesthesia during S-ICD implantation gives similar post procedural pain perception as sedation

Abstract Introduction The PRAETORIAN-DFT trial hypothesises that subcutaneous implantable cardioverter defibrillator (S-ICD) implant without defibrillation test (DFT) but with PRAETORIAN score is non-inferior to S-ICD implant with DFT with regard to first shock efficacy in spontaneous events. Various anesthesia protocols are used for S-ICD implant, ranging from local to general anesthesia. Sedation of the patient during S-ICD implantation is required because of DFT. Without the need for DFT, local anesthesia may suffice, thereby reducing the logistical burden associated with sedation and general anesthesia. However, data comparing the effects of various anesthesia methods are lacking. Purpose This prespecified analysis of the PRAETORIAN-DFT trial aims to investigate the effect of three different anesthesia methods on (post-)operative pain during S-ICD implant. Methods In the PRAETORIAN-DFT trial (NCT03495297), 965 patients were randomised to DFT (N=483) or no DFT with PRAETORIAN Score calculation (N=482). Choice of anesthesia protocol was per local routine and physician discretion and was listed as local anesthesia (LA), monitored anesthesia care (MAC) or general anesthesia (GA). Patients under LA who underwent DFT, had MAC or GA during the test. Pain scores were assessed using the Numerical Rating Scale (NRS), prior to implant (baseline) and at 1-3 hours, 5-7 hours and 1 day post implant. Mean change in NRS compared to baseline was calculated at every time point. Exact pain scores as well as mean change in NRS were compared between anesthesia methods using a Kruskal Wallis Test. Results Pre-implant pain questionnaires were completed by 97% of patients. In the complete study cohort, 149/965 (15%) of implants were performed under LA, 327/965 (34%) under MAC and 489/965 (51%) under GA. This distribution did not differ between the randomised arms (p=0.301). There was no difference in NRS or mean change compared to baseline between the groups at any time post implant. The mean change in NRS compared to baseline was highest at 5-7 hours post implant in all groups (Figure). Analysis with patients under LA and MAC or GA during DFT as independent group showed similar results. Conclusion There was no difference in pain perception after S-ICD implantation between implant under local anesthesia, MAC and general anesthesia. These results confirm that S-ICD implantation under local anesthesia is feasible and sedation may be no longer necessary if defibrillation testing becomes redundant.Mean changes in NRS compared to baseline

A New, Effective, Safe, and Accurate Method of Cervical Selective Nerve Root Block

Objective: Cervical selective nerve root block (SNRB) is an effective procedure that has long been performed for patients with radiating pain or paresthesia. However, there are several delicate structures around the cervical nerve root, damage to which could lead to irreversible neurovascular injury. Therefore, cervical SNRB requires a high skill level and extensive experience to execute it safely. To overcome these disadvantages, we used biplane computed tomography (CT)-guided fluoroscopy and a needle guidance program to achieve symptom improvement in a safer and shorter procedure. This study aimed to investigate the new method and report on its excellent clinical effects.Methods: A total of 57 patients who experienced radiating pain due to cervical spinal stenosis resulting from a herniated disc were enrolled. From September 2020 to September 2021 subjects underwent a biplane CT-guided fluoroscopic nerve block at an outpatient clinic. All procedures were performed by biplane CT-guided fluoroscopy. We analyzed treatment effects with a numerical rating scale (NRS) at 2 and 4 weeks after the procedure. Logistic regression was performed to reveal the significance of changes in NRS after the injection.Results: Pain improved in 56 of 57 patients (98%) after 2 and 4 weeks of follow-up compared to pre-injection pain. At the 2-week follow-up, the mean reduction based on NRS scores was 3.226 (2.782-3.674, 0; 95% confidence interval [CI], p &lt; 0.001) indicating a 48% decrease in pain scores compared with the initial NRS. The mean reduction in NRS 4 weeks after the procedure was 3.544 (3.090-3.998, 0; 95% CI, p &lt; 0.001) indicating a 52% reduction compared with the initial NRS. The average duration of the procedure was 4 minutes. Conclusion: We demonstrate a clinically effective, safe, and accurate method using a biplane CT-guided fluoroscopy and needle guide program. This new method can be an easy and relatively uncomplicated alternative to treatment for patients with cervical radiculopathy and provides safe and accurate targeting, making it easy for inexperienced surgeons.

Increased intraoperative vein ligation in microsurgical varicocelectomy is associated with pain improvement.

Varicocele is a major cause of male infertility. However, few studies have discussed the potential associations between the pain caused by varicocele and preoperative and intraoperative factors. The aim of this study was to evaluate factors potentially associated with changes in pain score after microsurgical varicocelectomy. This retrospective study was conducted between August 2020 and August 2022 at China Medical University Hospital in Taichung, Taiwan. Patient characteristics including age, body mass index, semen analysis, testicular volume, and the number of veins ligated were collected. Preoperative and intraoperative factors were analyzed to determine if they were correlated with changes in numeric rating scale (NRS) after microsurgical varicocelectomy. A total of 44 patients with clinical varicocele underwent subinguinal microsurgical varicocelectomy and were analyzed. The overall pain resolution rate was 91%, and the average satisfaction score after surgery was 9.2 according to their subjective feelings. Multivariate analysis revealed that severe varicocele grade (odds ratio [OR] 16.5, 95% confidence interval [CI] 3.01-90.47; P = .018) and the number of veins ligated (OR 6, 95% CI 1.6-22.48; P = .013), were significantly associated with changes in NRS after surgery. In addition, the area under the receiver operating characteristic curve for changes in NRS and the total number of veins ligated was 0.869. Microsurgical varicocelectomy had a high success rate for scrotal pain and satisfaction. Severe varicocele grade and the number of veins ligated in microsurgical varicocelectomy were associated with postoperative pain improvement.

Multiphase Spinal Cord Stimulation in Participants With Chronic Back or Leg Pain: Results of the BENEFIT-02 Randomized Clinical Trial

ObjectiveThis study aimed to assess the safety and effectiveness of a new charge-distributed multiphase stimulation paradigm during an extended spinal cord stimulation (SCS) trial. Materials and MethodsThis prospective, multicenter, randomized, single-blind, feasibility study included participants with chronic low back and/or leg pain and baseline numerical rating scale (NRS) for overall pain intensity ≥6. After a successful commercial SCS trial, participants were randomized to multiphase SCS therapy A (approximately 600–1500 Hz) or B (approximately 300–600 Hz), delivered via an investigational external pulse generator and existing leads during an 11-to-12–day testing period. Primary end points were mean NRS change from baseline to final in-office visit for each multiphase therapy and between therapies. Secondary end points included mean NRS change from end of commercial trial to final study visit and incidence of device-related adverse events (AEs). Additional measures included patient-reported outcomes collected at home through electronic watches and written diaries. Power usage was compared between multiphase and commercial therapies. ResultsA total of 122 participants initiated a commercial trial; 77 were randomized to a multiphase arm, and 65 completed the study. Reductions in mean NRS scores from baseline to final study visit were significant for multiphase therapy A and B (−4.3 and −4.7, respectively; both p < 0.0001). There was no statistically significant difference in mean NRS reduction or percent pain relief between multiphase therapies. In an additional analysis, 63.9% of participants reported greater pain relief with multiphase than with commercial SCS therapy in the at-home setting. On average, multiphase required less power than did commercial devices. One non–serious device-related AE was reported, and no infections occurred during the extended trial. ConclusionsMultiphase SCS effectively reduced pain in participants with chronic low back and/or leg pain during a trial, with no unanticipated device-related AEs reported. Future studies should evaluate long-term effectiveness of multiphase stimulation. Clinical Trial RegistrationThe Clinicaltrials.gov registration number for the study is NCT03594266.

The effect of Hatha Yoga on pain intensity in severe primary dysmenorrhea among students: A randomized controlled trials

&lt;p&gt;&lt;strong&gt;&lt;em&gt;Background&lt;/em&gt;&lt;/strong&gt;&lt;em&gt;: Yoga has been known as an alternative therapeutic modality for reducing pain. The benefits of yoga for reducing pain have been proven. Women often suffer pain due to dysmenorrhea. The effect of Yoga on dysmenorrhea pain has not been widely studied&lt;/em&gt;&lt;/p&gt;&lt;p&gt;&lt;strong&gt;&lt;em&gt;Objectives&lt;/em&gt;&lt;/strong&gt;&lt;em&gt;: This study aimed to investigate the effect of hatha yoga on pain in primary dysmenorrhea (PD). &lt;/em&gt;&lt;/p&gt;&lt;p&gt;&lt;strong&gt;&lt;em&gt;Methods&lt;/em&gt;&lt;/strong&gt;&lt;em&gt;: This was a randomized controlled study (RCT) involving 50 female students, 25 each in control (C) and yoga group (Y). PD was diagnosed by Working ability, Location, Intensity (Wong-Baker scale), and Days of the Pain of Dysmenorrhea (WaLIDD) questionnaire. Pain intensity was assessed by the Numeric Rating Scale (NRS). Hatha yoga training was conducted for 12 weeks. The unpaired t-test, ANOVA and Tukey post hoc, and Pearson correlation test was applied. Significance was set at p&amp;lt;0.05&lt;/em&gt;&lt;em&gt;.&lt;/em&gt;&lt;em&gt; &lt;/em&gt;&lt;/p&gt;&lt;p&gt;&lt;strong&gt;&lt;em&gt;Results&lt;/em&gt;&lt;/strong&gt;&lt;em&gt;: The characteristics between groups were not different. ANOVA indicated the NRS score in control was not changed, while yoga was diminished (p=0.02). Tukey post hoc showed that the second and third NRS were lower than basal NRS (p=0.038 and 0.01, respectively). The third was also lower than the second NRS (p=0.039). The second and the third NRS in yoga were lower than in control (p=0.027 and &amp;lt;0.01, respectively). The second magnitude of change of NRS was significantly different from the first in yoga (&lt;/em&gt;&lt;em&gt;1.92 ±2.4 vs. 3.09 ± 2.8, p=0.018). The magnitude of NRS changes in the first (0.06±1.1 vs. 1.92±2.4, p=0.013) and second (0.02 ± 1.6 vs. 3.09 ± 2.8, p= 0.004) in yoga was significantly greater than the control. NRS score was not correlated with age, BMI, and age of menarche.&lt;/em&gt;&lt;em&gt; &lt;/em&gt;&lt;/p&gt;&lt;p&gt;&lt;strong&gt;&lt;em&gt;Conclusions&lt;/em&gt;&lt;/strong&gt;&lt;em&gt;: Hatha yoga exercise ameliorate pain intensity in primary dysmenorrhea among female university students.&lt;/em&gt;&lt;/p&gt;

Continuous Epidural Saline Infusion for the Treatment of Spontaneous Intracranial Hypotension.

Spontaneous intracranial hypotension (SIH) is an increasingly recognized cause of orthostatic headache, but treatment strategies remain controversial. The epidural blood patch is a well-known and widely used treatment in patients with conservative treatment-resistant SIH, but symptoms may not improve even after multiple epidural blood patches, and resistant patients suffer from a lack of appropriate treatment options. Therefore, this study assessed the safety and efficacy of continuous epidural saline infusion (CESI) for SIH treatment. CESI was performed in 11 consecutive patients affected by conservative treatment-resistant SIH. Patient characteristics were obtained by reviewing medical records retrospectively. Headache intensity was assessed using the numerical rating scale (NRS), and changes in NRS before and after treatment were recorded. The average treatment period for CESI was 21.3±9.6days, and the average follow-up period was 35.0±30.2months. CESI was without major complications or mortality, and no infections occurred, even without prophylactic antibiotics. The median NRS score before treatment was 10 points, improving to 5 points 1day after infusion (P < 0.05), 2 points 1week after infusion (P < 0.05), and 0 points at 3months after infusion and the final follow-up. No patients have since experienced recurrence of orthostatic headaches. CESI appears to be a safe and well-tolerated procedure for SIH. Further experience may demonstrate this technique to be a viable treatment option for SIH.

Radiofrequency Ablation for Chronic Lumbar Zygapophyseal Joint Pain Using a V-Shaped Active Tip Needle: An Observational Retrospective Study.

Lumbar zygapophyseal joint dysfunction represents one of the major sources of chronic low back pain. Radiofrequency ablation (RFA) using a V-shaped active tip needle may offer a larger lesion of the medial branch nerves, improving clinical outcome. The aim of our study is to evaluate the efficacy and the feasibility of RFA using V-shaped active tip needles. This is a single-center observational retrospective study. Clinical records were screened and analyzed if they met the following inclusion criteria: adult patients (>18 years), diagnosis of chronic lumbar zygapophyseal joint pain, failure of conservative treatments, ability to provide informed consent for data analysis and publication. Exclusion criteria: lumbar pain not related to zygapophyseal joints, previous spinal/lumbar surgery, incomplete data, absence or withdrawal of informed consent. The primary outcome of the study was a change in pain intensity at follow-up. The secondary outcomes were the evaluation of quality-of-life improvement, the occurrence of adverse events and the impact on post-procedural analgesic consumption. For these purposes, pre- and post-treatment numeric rating scale (NRS), neuropathic pain 4 questions (DN4), EuroQoL - EQ-5D-3L, EQ-VAS, EQ-index and North American Spine Society (NASS) index were retrieved and analysed. Sixty-four patients were included. 7.8% of patients at 1-month (CI95% 0.026, 0.173), 37.5% at 3-month (CI95% 0.257, 0.505), 40.6% at 6-month (CI95% 0.285, 0.536) and 35.9% at 9-month (CI95% 0.243, 0.489) follow-up reported a reduction of more than 80% in NRS Statistical analysis indicated a significant change in NRS, DN4, EQ-index and EQ-5D-VAS (p-value <0.001) at the different time-points. RFA using a V-shaped active tip needle might be a feasible and effective treatment for chronic lumbar zygapophyseal joint pain.

A184 EARLY SYMPTOM CONTROL WITH MIRIKIZUMAB IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS IN THE LUCENT-1 INDUCTION TRIAL

Abstract Background Mirikizumab (miri), an anti-IL23/p19 monoclonal antibody, demonstrated efficacy compared with placebo (PBO) in the Phase 3, multicentre, randomized, double-blind LUCENT-1 induction study in patients with moderately to severely active ulcerative colitis (UC, NCT03518086). Purpose This analysis assessed early onset of symptomatic improvement and symptomatic control during induction. Method During the 12-week (W) induction study, 1162 adult patients (pts) with inadequate response, loss of response, or were intolerant to conventional therapy or biologic or tofacitinib therapy for UC, received miri IV Q4W (N=868) or PBO (N=294). We evaluated improvement for symptoms of stool frequency (SF), rectal bleeding (RB) and bowel movement urgency (BU), abdominal pain and fatigue. BU Numeric Rating Scale (NRS) change from baseline (BL), BU Clinical Meaningful Improvement (CMI), BU Remission, Fatigue NRS change from BL, Abdominal Pain Improvement, as well as SF Remission, RB Remission, Symptomatic Response and Symptomatic Remission were assessed. Result(s) As early as W2, miri-treated pts achieved a significantly greater reduction in RB subscores (p=0.001) and in SF subscores (p=0.035). From W2 and W4, a significantly greater percentage achieved SF Remission and RB Remission, respectively compared to PBO. A significantly greater percentage of miri-treated pts achieved Symptomatic Response compared to PBO from W2 (p=0.003) and of Symptomatic Remission compared with PBO from W4 (p&amp;lt;0.001). Miri-treated pts showed a significantly greater mean reduction in BU NRS scores as early as W2 compared to PBO (p=0.004). From W4, a significantly greater percentage of miri-treated pts achieved BU CMI versus PBO (p=0.044). From W7 onwards, a significantly greater percentage achieved BU Remission (p=0.002). The pts showed a significantly greater mean reduction in Fatigue NRS scores from W2 compared to PBO (p=0.014). As early as W4, a significant reduction of at least 30% in Abdominal Pain NRS score from BL was observed in the miri-treated pts compared with PBO (p=0.007). At W12, a significantly greater proportion of miri-treated pts achieved Symptomatic Response, Symptomatic Remission, RB Remission, SF Remission, BU change from BL, BU CMI and Remission, as well as Fatigue and Abdominal Pain Improvement, compared to PBO (Table). Image Conclusion(s) Miri provides rapid control of UC symptoms, including BU and fatigue, as early as W2 compared with PBO in pts with moderately to severely active UC. Please acknowledge all funding agencies by checking the applicable boxes below Other Please indicate your source of funding; Eli Lilly and Company Disclosure of Interest S. Danese Consultant of: AbbVie, Alimentiv, Allergan, Amgen, AstraZeneca, Athos Therapeutics, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Celltrion, Dr. Falk Pharma, Eli Lilly and Company, Enthera, Ferring Pharmaceuticals, Gilead Sciences, Hospira, Inotrem, Janssen, Johnson &amp; Johnson, Merck Sharp &amp; Dohme, Mundipharma, Mylan, Pfizer, Roche, Sandoz Sublimity, Takeda, TiGenix, UCB Pharma, and Vifor Pharma, Speakers bureau of: AbbVie, Amgen, Ferring Pharmaceuticals, Gilead Sciences, Janssen, Mylan, Pfizer, and Takeda, A. Dignass Consultant of: AbbVie, Abivax, Amgen, Arena Pharmaceuticals, Bristol Myers Squibb (Celgene), Celltrion, Dr. Falk Pharma, Eli Lilly and Company, Ferring Pharmaceuticals, Fresenius Kabi, Galapagos, Gilead Sciences, Janssen, Merck Sharp &amp; Dohme, Novartis, Pfizer, Pharmacosmos, Roche, Sandoz/Hexal, Takeda, Tillotts Pharma AG, and Vifor Pharma, Speakers bureau of: AbbVie, Amgen, Bristol Myers Squibb, Dr. Falk Pharma, Ferring Pharmaceuticals, Galapagos, High5Md, Janssen, Materia, Merck Sharp &amp; Dohme, Pfizer, Sandoz, Takeda, Tillotts Pharma AG, and Vifor Pharma, K. Matsuoka Grant / Research support from: AbbVie, EA Pharma, JIMRO, Kissei Pharmaceutical, Kyowa Kyorin, Mitsubishi Tanabe, Mochida Pharmaceutical, and Zeria Pharmaceutical Nippon, Speakers bureau of: AbbVie, EA Pharma, JIMRO, Kissei Pharmaceutical, Kyowa Kyorin, Mitsubishi Tanabe, Mochida Pharmaceutical, Takeda, and Zeria Pharmaceutical Nippon, M. Ferrante Grant / Research support from: AbbVie, Amgen, Biogen, Janssen Cilag, Pfizer, Takeda, and Viatris, Consultant of: AbbVie, Boehringer Ingelheim, Celltrion, Eli Lilly and Company, Janssen Cilag, Medtronic, Merck Sharp &amp; Dohme, Pfizer, Regeneron, Sandoz, Takeda, and Thermo Fisher Scientific, Speakers bureau of: AbbVie, Amgen, Biogen, Boehringer Ingelheim, Celltrion, Dr. Falk Pharma, Eli Lilly and Company, Ferring Pharmaceuticals, Janssen, Lamepro, Medtronic, Merck Sharp &amp; Dohme, Mylan, Pfizer, Samsung Bioepis, Sandoz, Takeda, and Thermo Fisher Scientific, M. Long Consultant of: AbbVie, Bristol Myers Squibb, Calibr, Eli Lilly and Company, Genentech, Janssen, Pfizer, Prometheus Biosciences, Roche, Takeda, TARGET PharmaSolutions, and Theravance Biopharma, I. Redondo Employee of: Eli Lilly and Company, T. Gibble Employee of: Eli Lilly and Company, R. Moses Employee of: Eli Lilly and Company, N. Morris Employee of: Eli Lilly and Company, X. Li Employee of: Eli Lilly and Company, C. Milch Employee of: former employee, was employed at Eli Lilly and Company at the time of study, M. Abreu Grant / Research support from: Pfizer, Prometheus Biosciences, and Takeda, Consultant of: AbbVie, Arena Pharmaceuticals, Bristol Myers Squibb, Eli Lilly and Company, Gilead Sciences, Janssen, Microba Life Sciences, Prometheus Biosciences, UCB Pharma, and WebMD, Speakers bureau of: Alimentiv, Intellisphere LLC (HCP Live Institutional Perspectives in GI), Janssen, Prime CME, and Takeda, J. Jones: None Declared

The Benefit of Early Epidural Corticosteroid Injections for Acute Sciatica-Associated Lower Back Pain: A Four-Year Case Series in Lebanon.

Background Early epidural steroid injections are currently widely used for patients experiencing lumbago. However, there is uncertainty about their efficacy, such as the limitation of continuous drug infusion and the need for well-trained physicians on this technique. The main objective of this study was to evaluate the effectiveness of early epidural steroid injections in treating patients with acute sciatica in the lower back in terms of symptom relief and recurrence rate. Methods A case series was conducted in Lebanon from 2015 to 2019. We recruited 98patients suffering from sciatica due to disc disease over three-time intervals: two weeks, one, and three months. The immediate results accounted for the intensity of various symptoms (numerical rating scale (NRS) for pain) and the assessment of patient satisfaction (Macnab criteria). Results The clinical results showed at least a three-pointpain relief according to Numerical Rating Scale (NRS) and a good grade according to MacNab (P <0.001), with only 10.4% of the total population having a positive leg raise test post-injection. The maximum benefit was noted after two weeks from the injection with a 5.7 mean change in NRS (p<0.001) with a good/excellent response in MacNaband a 4.9 change with only a good response after one month. This study noticed a rebound phenomenon where around half of the patients needed two steroid injections after three months (39.6 % after three monthsand 17.9 % after six months). Conclusion Even though current guidelines worldwide may suggest the use of conservative treatmentfor low back pain with acute sciatica, our study has demonstrated the effectiveness of epidural steroid injections in the Lebanese population with a significant outcome.

Correlation between Oral Thiamine as an Opioid Adjuvant and Cathecol-O-Methyltransferase Enzyme Levels in Cervical Cancer Patients

BACKGROUND: The high prevalence of cancer pain shows that a lot of the patients are undertreatment. Vitamin B is one of the additional alternative substances studied in cancer pain management. Thiamine is believed to modulate pain mechanisms in lowering the Cathecol-O-Methyltransferase (COMT) enzyme level. AIM: The aim of the study was to assess the correlation between Oral Thiamine as an Opioid Adjuvant and COMT Enzyme Levels in Cervical Cancer Patients METHODS: This research is a quasi-experimental study with a pre-test and post-test control group design. Patients in this study were 32 cervical cancer patients who experienced cancer pain, divided into two groups (treatment and control groups). The treatment group received morphine plus thiamine 500 mg/8 h/oral, and the control group received morphine alone. Measurement and evaluation of pain scores were carried out after 72 h of thiamine administration and blood collection was carried out again 4 h after the last thiamine administration to check thiamine levels and COMT. Then, data collection and analysis is being evaluated. RESULTS: From 32 cervical cancer patients studied, there were differences in changes in numeric rating scale (NRS) levels and COMT levels in the thiamine treatment group. CONCLUSIONS: The administration of thiamine can reduce COMT enzyme levels and clinically reduce NRS in cervical cancer patients. If it confirmed by other findings, thiamine might be considered for its use in the treatment of cancer pain.

Efficacy and Safety of Pregabalin Prolonged Release-Etoricoxib Combination Compared to Etoricoxib for Chronic Low Back Pain: Phase3, Randomized Study.

Currently available treatments for chronic lower back pain (CLBP) do not adequately address both nociceptive and neuropathic components of pain. We evaluated efficacy and safety of fixed-dose combination (FDC) of low-dose pregabalin prolonged release 75mg-etoricoxib 60mg to address both pain components. This randomized phase3 trial conducted at 12 centres across India evaluated efficacy (based on mean change in numeric rating scale [NRS], Roland-Morris disability questionnaire [RDQ], visual analogue scale [VAS], patient global impression of improvement [PGI-I], clinical global impression of improvement [CGI-I] and rescue medication consumption) and safety of FDC in comparison to etoricoxib alone in adult patients with CLBP. Treatment duration was 8weeks. Of the 371 patients screened, 319 were randomized and considered for efficacy and safety analysis. Both treatment groups had no significant difference in terms of demography and baseline disease characteristics. Significantly better outcomes with FDC compared to etoricoxib were observed at week4 onwards. At week8, both groups showed significant reduction in mean NRS score from baseline (-4.00 ± 1.65 in FDC; -2.92 ± 1.59 in etoricoxib) with mean NRS score being significantly less in the FDC group compared to etoricoxib group (3.26 ± 1.56 vs 4.31 ± 1.56; p < 0.0001). The FDC was more effective than etoricoxib in terms of significantly greater reduction in RDQ score (-9.28 ± 4.48 vs -6.78 ± 4.34; p < 0.0001) and VAS score (-37.66 ± 18.7 vs -28.50 ± 16.31; p < 0.0001) at week8. The FDC was also better in terms of significantly more patients reporting their condition as 'very much better' (36.9% vs 5.0%; p < 0.0001) and clinicians reporting patient's condition as 'very much improved' (36.3% vs 5.7%; p < 0.0001). Overall, study medications were well tolerated. FDC of pregabalin and etoricoxib provided significant benefits in reducing pain and improving functional status compared with etoricoxib alone in patients with CLBP. Pregabalin prolonged release-etoricoxib FDC could be one of the treatment options for early and sustained pain relief and improvement in quality-of-life in treating CLBP as it addresses both neuropathic and nociceptive components of pain. CTRI/2018/10/015886.

S755 Early Symptom Control With Mirikizumab in Patients With Moderately to Severely Active Ulcerative Colitis in the LUCENT-1 Induction Trial

Introduction: Mirikizumab (miri), an anti-IL23/p19 monoclonal antibody, demonstrated efficacy compared with placebo (PBO) in the Phase 3, multicentre, randomized, double-blind LUCENT-1 induction study in patients with moderately to severely active ulcerative colitis (UC, NCT03518086)). This analysis assessed early onset of symptomatic improvement and symptomatic control during induction. Methods: During the 12-week (W) induction study, 1162 adult patients (pts) with inadequate response, loss of response, or were intolerant to conventional therapy or biologic or tofacitinib therapy for UC, received miri IV Q4W (N=868) or PBO (N=294). We evaluated improvement for symptoms of stool frequency (SF), rectal bleeding (RB) and bowel movement urgency (BU), abdominal pain and fatigue. BU Numeric Rating Scale (NRS) change from baseline (BL), BU Clinical Meaningful Improvement (CMI), BU Remission, Fatigue NRS change from BL, Abdominal Pain Improvement, as well as SF Remission, RB Remission, Symptomatic Response and Symptomatic Remission were assessed. Results: As early as W2, miri-treated pts achieved a significantly greater reduction in RB subscores (p=0.001) and in SF subscores (p=0.035). From W2 and W4, a significantly greater percentage achieved SF Remission and RB Remission, respectively compared to PBO. A significantly greater percentage of miri-treated pts achieved Symptomatic Response compared to PBO from W2 (p=0.003) and of Symptomatic Remission compared with PBO from W4 (p< 0.001). Miri-treated pts showed a significantly greater mean reduction in BU NRS scores as early as W2 compared to PBO (p=0.004). From W4, a significantly greater percentage of miri-treated pts achieved BU CMI versus PBO (p=0.044). From W7 onwards, a significantly greater percentage achieved BU Remission (p=0.002). The pts showed a significantly greater mean reduction in Fatigue NRS scores from W2 compared to PBO (p=0.014). As early as W4, a significant reduction of at least 30% in Abdominal Pain NRS score from BL was observed in the miri-treated pts compared with PBO (p=0.007). At W12, a significantly greater proportion of miri-treated pts achieved Symptomatic Response, Symptomatic Remission, RB Remission, SF Remission, BU change from BL, BU CMI and Remission, as well as Fatigue and Abdominal Pain Improvement, compared to PBO (Table). Conclusion: Miri provides rapid control of UC symptoms, including BU and fatigue, as early as W2 compared with PBO in pts with moderately to severely active UC. Table 1. - Assessment of improvement for UC symptomatic components in patients treated with miri vs PBO at W12 Endpoint (W12) PBO IVQ4WN=294 Miri 300 mg IVQ4WN=868 Risk difference vs PBO (95% CI) * P-value RB Remission a , n (%) 129 (43.9) 555 (63.9) 20.6 (14.2, 27.0) < 0.001 SF Remission b , n (%) 117 (39.8) 495 (57.0) 17.1 (10.7, 23.6) < 0.001 Symptomatic Response c , n (%)Symptomatic Remission d , n (%) 154 (52.4)82 (27.9) 625 (72.0)395 (45.5) 20.2 (13.8, 26.6)17.5 (11.4, 23.6) < 0.001< 0.001 BU Clinical Meaningful Improvement e , n (%) N=276** 89 (32.2) N=811** 395 (48.7) 16.2 (9.7, 22.7) < 0.001 BU Remission f , n (%) N=276** 34 (12.3) N=811** 179 (22.1) 9.7 (4.9, 14.5) < 0.001 BU NRS, LSM change from baseline (SE)Fatigue NRS, LSM change from baseline (SE) -1.63 (0.14)-1.29 (0.13) -2.59 (0.08)-1.96 (0.08) -0.95 (-1.47, -0.44)-0.66 (-0.96, -0.37) < 0.001< 0.001 Abdominal Pain NRS ≥30% reduction g , n (%) N=246** 121 (49.2) N=711** 472 (66.4) 17.4 (10.3, 24.6) < 0.001 *The Cochran-Mantel-Haenszel (CMH) test, with missing data imputed as nonresponse, was used to assess the outcomes. Mixed Model for Repeated Measures was used to assess BU NRS. The risk difference and CMH test were both adjusted for the stratification factors of prior biologic or tofacitinib failure, baseline corticosteroid use, region, and baseline modified mayo score.**Baseline population differs according to definition of each endpoint.aRB subscore of 0.bSF subscore 0, or 1 with ≥1-point decrease from BL.cAt least a 30% decrease from BL in the sum of SF and RB subscores.dSF subscore 0, or 1 with ≥1-point decrease from BL, and RB subscore of 0.eBU NRS improvement of ≥3 points pts with BL BU NRS ≥3.fNRS 0 or 1 in pts with BL BU NRS ≥3.gNRS pain score ≥30% improvement from baseline in patients with baseline AP NRS ≥3.Abbreviations: PBO= placebo; miri= mirikizumab; Q4W= every 4 weeks; CI= confidence interval; n= number of patients in the specified category, RB= rectal bleeding; LSM = least square mean; SE= standard error; SF= stool frequency; BU= bowel movement urgency; NRS = numeric rating scale.

Mid-term efficacy grading evaluation and predictive factors of magnetic resonance-guided focused ultrasound surgery for painful bone metastases: a multi-center study.

MR imaging-guided focused ultrasound surgery (MRgFUS) is an emerging non-invasive treatment. It is helpful in investigating the mid-term grading efficacy and safety of MRgFUS, and possible risk factors in participants with painful bone metastases. This four-center prospective study enrolled 96 participants between June 2016 and May 2019 with painful bone metastases. The Numerical Rating Scale (NRS), Brief Pain Inventory-Quality of Life (BPI-QoL) score, morphine equivalent daily dose (MEDD), and the adverse events (AEs) were recorded before and at 1 week, 1 month, 2 months, and 3 months after MRgFUS. The repeated ANOVA tests were used to analyze the change in NRS and BPI-QoL, and logistic regression analysis was used to analyze the possible risk factors. A total of 82 participants completed the 3-month follow-up period. And 16 (19.5%) participants were complete responders (CR), 46 (56.1%) participants were effective responders (ER), and the other 20 (24.4%) participants were non-responders (NR). The NRS (2.67 ± 2.47 at 3 months compared to 6.38 ± 1.70 before treatment) and BPI-QoL score (3.11 ± 2.51 at 3 months compared to 5.40 ± 1.85 before treatment) significantly decreased after the treatment at all time points (p < 0.001). Eleven adverse events were recorded and they were all cured within 1 to 52 days after treatment. The non-perfused volume (NPV) ratio (p = 0.001) and the bone metastases lesion type (p = 0.025) were the key risk factors. MRgFUS can be used as a non-invasive, effective, and safe modality to treat painful bone metastases. NPV ratio and the lesion type may be used as affecting factors to predict the mid-term efficacy of MRgFUS. • MRgFUS can be considered a non-invasive, effective, and safe modality to treat painful bone metastases. • The NRS and BPI-QoL score at 1 week, 1 month, 2 months, and 3 months all decreased significantly (p < 0.001) after receiving MRgFUS. Among 82 participants, 16 (19.5%) were complete responders, 46 (56.1%) were effective responders, and the other 20 (24.4%) were non-responders. • According to logistic regression analysis, non-perfused volume ratio and the bone metastases lesion type were the affecting factors to predict the mid-term efficacy of MRgFUS. The adjusted OR of non-perfused volume ratio was 0.86 (p = 0.001), and osteoblastic lesion type was 0.06 (p = 0.025).