Numerical Rating Scale Change Research Articles

Prehospital analgesia with nalbuphine and paracetamol compared to piritramide by paramedics-A multicenter observational study

Following recent changes to the German Narcotics Act, this article examines prehospital analgesia by paramedics using piritramide vs. nalbuphine + paracetamol. Prehospital analgesia administered by paramedics from the Fulda (piritramide) and Gütersloh (nalbuphine + paracetamol) emergency services was compared regarding pain intensity at the beginning and end of the mission, measured using the numeric rating scale (NRS). Additionally, an analysis of the resulting complications was carried out. In this study 2429 administrations of analgesia were evaluated (nalbuphine + paracetamol: 1635, 67.3%, initial NRS: 8.0 ± 1.4, end of NRS: 3.7 ± 2.0; piritramide: 794, 32.7%, initial NRS: 8.5 ± 1.1, end of NRS: 4.5 ± 1.6). Factors influencing NRS change were initial NRS (regression coefficient, RC: 0.7075, 95% confidence interval, CI: 0.6503-0.7647, p < 0.001), treatment with nalbuphine + paracetamol (RC: 0.6048, 95% CI: 0.4396-0.7700, p < 0.001). Treatment with nalbuphine + paracetamol (n = 796 (48.7%)) compared to piritramide (n = 190 (23.9%)) increased the odds of achieving NRS < 4 (odds ratio, OR: 2.712, 95% CI: 2.227-3.303, p < 0.001). Complications occurred in n = 44 (5.5%) with piritramide and in n = 35 (2.1%) with nalbuphine + paracetamol. Risk factors for complications were analgesia with piritramide (OR: 2.699, 95% CI: 1.693-4.301, p < 0.001), female sex (OR: 2.372, 95% CI: 1.396-4.029, p = 0.0014), and age (OR: 1.013, 95% CI: 1.002-1.025, p = 0.0232). Compared with piritramide, prehospital analgesia with nalbuphine + paracetamol has favorable effects in terms of analgesic efficacy and complication rates and should therefore be considered in future recommendations for paramedics.

The Effect of Intra-Articular Injections of Hyaluronic Acid for the Treatment of Trapezio-Metacarpal Joint Osteoarthritis.

Osteoarthritis of the basal thumb joint is a debilitating disease with a high prevalence. Among pharmacological treatments, intra-articular injections of hyaluronic acid have been clinically applied. This study aimed to investigate the effectiveness and safety of intra-articular injections of hyaluronic acid for the treatment of trapezio-metacarpal joint osteoarthritis (TMOA), over a one-year period. Patients with TMOA were enrolled and treated with five consecutive intra-articular injections of hyaluronic acid (20 mg/2 mL, 500-750 KDa, HyalganBio) at weekly intervals. Primary outcomes were pain during different activities (changes in numerical rating scale) and function (pinch and grip strength), and secondary outcomes were safety (adverse events) and patient-reported outcomes (quick-DASH and SF-12). The outcomes were evaluated at baseline and 1-, 3-, 6-, and 12- months after the last injection. A total of 29 patients were included. All participants completed the five injective sessions and the first follow-up. A total of 15 patients completed the study. During the follow-up period, intra-articular injections of hyaluronic acid have significantly reduced spontaneous and provoked pain and improved disability. No severe systemic adverse events were reported. At a follow-up of up to 12 months, patients with TMOA treated with intra-articular hyaluronic acid injections reported improvements in pain relief and quality of life.

Long-term efficacy and safety of difelikefalin in moderate-to-severe pruritus in Japanese hemodialysis patients: a 52-week open-label extension period of a phase 3 trial

BackgroundDifelikefalin, a potent and highly selective agonist of kappa opioid receptors, is used to treat moderate-to-severe pruritus in hemodialysis patients.MethodsThis was a 52-week, open-label phase 3 trial following a 6-week randomized double-blind placebo-controlled treatment period to investigate the efficacy and safety of difelikefalin in Japanese hemodialysis patients. Having completed the 6-week double-blind period, patients received difelikefalin 0.5 μg/kg three times per week intravenously for 52 weeks. Efficacies were assessed using numerical rating scale (NRS) scores, proportion of patients whose NRS score improved by ≥ 3 points and ≥ 4 points, Shiratori severity score, proportion of patients with a nighttime Shiratori severity score of ≤ 2, the Skindex-16 score, 5-D itch scale score, and patient global impression of change (PGIC). Safety was assessed on the basis of adverse events, clinical laboratory tests, vital signs, body weight, 12-lead electrocardiography, and dependency.ResultsThe number of patients who entered the extension treatment period from the difelikefalin (MR–MR) and placebo (P-MR) groups was 85 and 83, respectively. The weekly mean NRS scores (mean ± SD) in the MR–MR group at baseline, week 6, and week 58 were 6.57 ± 1.32, 4.04 ± 2.24, and 2.36 ± 1.86, respectively. The weekly mean scores in the P-MR group, at baseline, week 6, and week 58 were 6.42 ± 1.29, 4.85 ± 1.90, and 2.73 ± 2.14, respectively. In patients receiving difelikefalin, there was a decline in the score from treatment initiation, and this decline continued until week 58. Similarly, improvements were seen until week 58 in the proportion of responders, Shiratori severity score, proportion of responders based on the Shiratori severity score, the Skindex-16 score, 5-D itch scale score, and PGIC. A correlation was seen between the change in NRS and itch-related quality of life (QOL), including the Shiratori severity score, Skindex-16 score, 5-D itch scale score, and PGIC. Difelikefalin was well tolerated and safe even when used long term.ConclusionsDifelikefalin improved itching and itch-related quality of life during long-term treatment in hemodialysis patients with moderate-to-severe pruritus whose response to conventional medications had been inadequate. It also demonstrated excellent safety and tolerability.Trial registration: ClinicalTrials.gov; NCT04711603. Registered 15 January 2021, https://www.clinicaltrials.gov/study/NCT04711603?term=NCT04711603&rank=1.

Relationship between pruritus and sleep in participants with primary biliary cholangitis in the Phase 2b GLIMMER trial

BackgroundCholestatic pruritus and fatigue are debilitating conditions associated with primary biliary cholangitis (PBC) and can significantly impact patients’ quality of life. Pruritus in PBC often worsens at night and patients frequently report sleep disturbance, which contributes to cognitive symptoms and fatigue. Linerixibat is an ileal bile acid transporter inhibitor in clinical development for the treatment of pruritus associated with PBC and was recently assessed versus placebo in the Phase 2b GLIMMER trial. This post-hoc analysis assesses the relationship between pruritus severity and sleep disturbance in participants of GLIMMER regardless of treatment group.MethodsGLIMMER (NCT02966834), a multicenter, double-blind, randomized, placebo-controlled trial, recruited 147 patients with PBC and moderate-to-severe pruritus. Following 4 weeks single-blind placebo, patients (randomized 3:1) received linerixibat or placebo for 12 weeks (to Week 16). Participants graded their itch (twice daily) and its interference with sleep (once daily) in an electronic diary using a 0–10 numerical rating scale (NRS). Weekly and monthly itch scores were calculated as the mean of the worst daily itch score over the respective time period. At study visits, participants completed the 5-D itch scale and the PBC-40 quality of life questionnaire, both of which contain an item specific to itch-related sleep disturbance. The impact of pruritus on sleep was assessed post hoc through correlations between the changes in NRS, 5-D itch, and PBC-40.ResultsStrong correlations were found between change from baseline in weekly itch and sleep NRS scores (r = 0.88 [95% confidence interval (CI): 0.83; 0.91]) at the end of treatment (Week 16), as well as in monthly itch and sleep NRS scores (r = 0.84 [95% CI: 0.80; 0.87]). Patients with improved weekly pruritus score severity category demonstrated reduced perceived sleep interference on average. Itch responders (≥2-point improvement in weekly itch score from baseline) displayed larger improvements in weekly sleep NRS score, 5-D itch, and PBC-40 sleep items, than itch non-responders (<2-point improvement).ConclusionsA strong correlation exists between changes in pruritus severity and sleep interference in patients with PBC; pruritus reduction could generate concomitant improvement in sleep.

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.

Intradiscal Steroid Injections for Degenerative Disc Disease With Modic Changes: A Retrospective Study of Therapeutic and Diagnostic Features.

Anterior column pain refers to axial low back pain (LBP) originating from the intervertebral disc or vertebral endplates (discogenic or vertebrogenic pain). We sought to assess the safety and effectiveness of intradiscal steroid injection (IDSI) in diagnosing and treating patients with LBP arising from the anterior column. This is a retrospective chart review of 66 patients who underwent 77 injections in an outpatient, private practice setting for the treatment of chronic lower back with history and physical exam findings indicating an origin within the anterior column and magnetic resonance imaging (MRI) findings of Modic changes associated with disc degeneration of grade 4 or above on the modified Pfirrmann scale. Patients reported pain as measured by the numerical rating scale (NRS) before the injection, at the time of their follow-up, and their maximum pain relief. The primary outcome was the change in NRS before and after the injections. The secondary outcome determined if the changes in the subjects' NRS met the minimal clinically important change (MCIC) criteria for LBP. We conducted a statistical analysis using a paired sample t-test. There was a statistically significant difference between the pre-injection and follow-up NRS scores (p < 0.001) and a significant difference between pre-injection and maximum relief NRS scores (p < 0.001). Most subjects (55/77, 71.4%) met the MCIC to relieve their chronic LBP at the time of the follow-up evaluation. For patients with chronic LBP and degenerative endplate changes, IDSIs provided these patients with significant short-term pain relief from pain arising from the anterior column.

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 2 years after spinal surgery: radiological and clinical results from the NORDSTEN-spinal stenosis trial

BackgroundPatients 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 2 years after decompressive surgery.MethodThis 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 2 years 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.ResultsThere 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 2 years after surgery.ConclusionLL 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