Improvement In Numeric Rating Scale Research Articles

Pragmatic randomized controlled trial of pharmacopuncture therapy for adhesive capsulitis: A pilot study

BackgroundAlthough several studies have reported the effectiveness of acupuncture treatment for adhesive capsulitis (AC), research on pharmacopuncture therapy for AC remains limited. We compared the effectiveness and safety of pharmacopuncture and physiotherapy for AC. MethodsThis pragmatic, randomized, controlled, parallel-group pilot study enrolled patients with limitations of shoulder movement and a numeric rating scale (NRS) score for shoulder pain ≥5 randomized (1:1) to the pharmacopuncture therapy (PPT) and physiotherapy (PT) groups. The participants were recruited from April 20, 2022 to September 16, 2022. Treatment sessions were administered twice weekly for 6 weeks, and the participants were followed up for 13 weeks after randomization. The primary outcome was the NRS score for shoulder pain, and the secondary outcomes were the visual analog scale (VAS), Shoulder Pain and Disability Index (SPADI), range of motion (ROM), patient global impression of change (PGIC), EuroQol 5-Dimension 5-Level (EQ-5D-5L), and Short Form 12 Health Survey (SF-12) scores. The intention-to-treat (ITT) analysis was set as the primary analysis. ResultsAmong 50 participants, for the primary endpoint (week 7) the PPT group showed a significantly superior improvement in NRS, VAS, SPADI, ROM for flexion, ROM for abduction, and EQ-5D-5L scores. The ROM for extension, ROM for adduction, physical component summary, and patient global impression of change were significantly better in the PPT than in the PT group, and these effects were sustained until week 13. ConclusionIn this pilot study, PPT showed better effects than PT, confirming the feasibility of a follow-up main study. Trial registrationClinicaltrials.gov (NCT05292482) and cris.nih.go.kr (KCT0007198)

Improvement of Dyspnea and Palpitations of Cardiac Origin Using Comprehensive Traditional Korean Medicine Treatment Including <italic>Bangibokryeong-tang</italic> (<italic>Fangji Fuling</italic> Decoction) : A Case Report

This case report demonstrates the effect of modified <i>Bangibokryeong-tang</i> (<i>Fangji Fuling</i> Decoction), a traditional herbal prescription in treating dyspnea and palpitations, symptoms that often lead to anxiety and reduced quality of life of cardiac patients. A female patient in her late 70s with congenital valve malformation and atrial fibrillation presented with dyspnea and palpitations, each rated at a severity of 8 on a numeric rating scale (NRS). After voluntarily discontinuing Western medication, she received modified BGBRT for 25 days, leading to significant symptom relief and NRS improvement to 0-2. The patient reported maintaining an improved condition and showed a significant increase in vitality. This improvement was sustained for 7 months, but the symptoms recurred; thus, modified BGBRT was restarted. Modified BGBRT showed substantial effects on persistent cardiac-origin dyspnea and palpitations. Thus, this TKM has the potential to manage symptoms and enhance the quality of life of cardiac patients.

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.

517 - Lebrikizumab demonstrates significant efficacy versus placebo across racial and ethnic subgroups in patients with moderate-to-severe atopic dermatitis

Abstract Introduction/Background The efficacy of monotherapy lebrikizumab to treat moderate-to-severe atopic dermatitis (AD) has been established in phase 3 studies. Disease characteristics and efficacy outcomes may vary among racial and ethnic subgroups. Objectives To report the week 16 efficacy results of lebrikizumab-treated patients by racial and ethnic subgroups from ADvocate1 (NCT04146363) and ADvocate2 (NCT04178967). Methods Eligible patients were randomized 2:1 to receive lebrikizumab or placebo every 2 weeks. Other AD treatments during this induction period were prohibited. The week 16 efficacy endpoints reported here include Investigator’s Global Assessment 0 or 1 with ≥2-point improvement from baseline (IGA 0/1), ≥75% improvement in the Eczema Area and Severity Index from baseline (EASI 75), ≥90% improvement in EASI from baseline (EASI 90), and ≥4-point Pruritus Numeric Rating Scale (NRS) improvement from baseline. Race and ethnicity were self-reported. Data were collected globally. Data were pooled from ADvocate1 (Intent to Treat [ITT]) and ADvocate2 (modified ITT). Subsequent data from patients who received topical or systemic rescue medication or discontinued treatment due to lack of efficacy were imputed as nonresponders. Subsequent data from patients who discontinued treatment for other reasons were set to missing. Missing data were handled with multiple imputation. Logistic regression tested the interaction between the treatment by subgroup. P>0.1 indicated consistent treatment effect of lebrikizumab versus placebo across subgroups. For each outcome, the Cochran-Mantel-Haenszel method evaluated treatment effect within each subgroup after adjusting for stratification factors. Results Most patients (818/851 [96.1%]) were Asian (192 [22.6%]), Black/African American (84 [9.9%]), or White (542 [63.7%]). Due to the low proportion of patients identifying as another racial category (33/851 [3.9%]) including American Indian or Alaska Native, Native Hawaiian or other Pacific Islander, multiple, other, and not reported, only results of Asian, Black/African American, and White subgroups are reported. In patients with completed ethnicity data (N=839), 10.8% (91/839) identified as Hispanic/Latino and 89.2% (748/839) identified as not Hispanic/Latino. At baseline, Asian patients reported a numerically earlier mean age of AD onset (8.3 years) compared to White (16.5 years) and Black/African American (16.9 years) patients. A numerically greater proportion of Asian patients presented with severe (IGA 4) disease at baseline (49.5%) and prior use of systemic treatment for AD (75.5%) compared with White (35.1% and 51.1%, respectively) and Black/African American (33.3% and 36.9%, respectively) patients. At week 16, no significant treatment differences were observed for the proportion of patients achieving or reporting IGA 0/1, EASI 75, EASI 90, or ≥4-point Pruritus NRS improvement across racial or ethnic subgroups (p>0.1). In Asian patients, a higher proportion treated with lebrikizumab vs placebo (p<0.001) achieved or reported IGA 0/1 (25.1%, 4.1%), EASI 75 (45.5%, 8.5%), EASI 90 (26.5%, 4.3%), and Pruritus NRS ≥4-point improvement (36.4%, 5.7%). In Black/African American patients, a greater proportion treated with lebrikizumab versus placebo achieved or reported IGA 0/1 (33.2%, 13.2%) EASI 75 (51.7%, 18.8%), EASI 90 (26.9%, 13.2%), and ≥4-point Pruritus NRS improvement (41.7%, 17.4%). No statistical comparisons were performed due to limited sample size. In White patients treated with lebrikizumab, statistical significance was observed versus placebo (p<0.001) for IGA 0/1 (43.3%, 14.1%), EASI 75 (59.7%, 20.4%), EASI 90 (38.3%, 10.9%), and Pruritus NRS ≥4-point improvement (45.9%, 14.8%). Significant and similar differences with lebrikizumab-treatment versus placebo were observed among IGA 0/1, EASI 75, and ≥4-point Pruritus NRS improvement in Hispanic/Latino (p<0.05) and non-Hispanic/Latino (p<0.001) patients. The proportion of lebrikizumab-treated patients achieving EASI 90 versus placebo was numerically greater in Hispanic/Latino patients (p=0.057) but only reached statistical significance in non-Hispanic/Latino patients (p<0.001). Conclusions In ADvocate1 and ADvocate2, lebrikizumab was effective across racial and ethnic subgroups for the treatment of moderate-to-severe AD after 16 weeks of monotherapy treatment.

Percutaneous pulsed radiofrequency ablation of articular nerves of the hip joint in patients with chronic hip pain refractory to conventional analgesics.

Total Hip Arthroplasty (THA) may be a risky proposition in patients with comorbidities, and they may require systemic analgesics for chronic hip pain (CHP). Since traditional pain medications may not provide complete pain relief or carry prohibitive adverse effects, pulsed radiofrequency (PRF) treatment of the hip articular nerves (HAN) has been proposed for effective clinical outcomes. We determined the efficacy of PRF-HAN in improvement in CHP compared to baseline pain on conventional systemic analgesics. Between August 2015 and December 2021, 31 adult patients with severe comorbid conditions and excruciating chronic hip pain were subjected to a PRF-HAN procedure following a diagnostic block. All 31 patients received PRF of the articular branches of the femoral and obturator nerves. Demographic parameters, numerical rating scale (NRS), Harris Hip Score (HHS), WOMAC scores, the change of these scores from baseline, and any adverse effects were recorded before treatment and on day 1, 1st week, 6 weeks, and 6 months after treatment. All the patients who underwent the PRF-HAN reported a significant improvement in NRS, HHS, and WOMAC scores compared to the baseline values on day 1, at the end of the 1st week, and the 6th week (p<0.001). No adverse events were documented in the study post-procedure until the end of 6 months. PRF-HAN is a strong alternative for chronic pain management and augments physical functioning and a return to daily activity in patients who would be deprived of arthroplasty considering associated comorbid conditions.

Clinical efficacy and metabolomic analysis of ozone major autohemotherapy for the treatment of herpes zoster.

It is essential to understand the underlying changes in the patients' metabolic profiles that may be indicative of the therapy's effectiveness. To prospectively analyse the clinical efficacy of ozone autohemotherapy in the treatment of acute herpes zoster and investigate its impact on serum metabolomics. A total of 76 patients with acute herpes zoster between May 2018 and June 2020 were enrolled and divided into an experimental group and a control group. The pain location, Numeric Rating Scale (NRS) scores before and after treatment (1 week, 1 month, 3 months, and 6 months post-treatment), medication usage, and Quality of Sleep (QS) scores were prospectively analysed. Additionally, serum metabolomic data were obtained and analysed before and 6 months after the treatment. There were statistically significant differences in the total NRS scores before and after ozone autohemotherapy (p < 0.05). The NRS scores of both groups significantly decreased (p < 0.05). At the 6-month follow-up, no patients were lost, and 83 patients completed the follow-up. The NRS improvement at 1 week, 1 month, 3 months, and 6 months post-treatment in the experimental group was significantly lower than that in the control group (p < 0.05). There was no significant difference in the medication usage (pregabalin or tramadol sustained-release tablets) between the two groups (p > 0.05). One month after treatment, the QS score improvement in the diabetes group was significantly lower than that in the non-diabetes group (p < 0.05). Serum metabolomics analysis revealed three significantly decreased metabolites, namely creatine, adipate, and glucose, after treatment. Ozone autohemotherapy is an effective treatment for acute herpes zoster patients and can rapidly and effectively alleviate pain symptoms in the short term. The changes in serum metabolomics may provide further insights into the treatment mechanism.

Painful total knee arthroplasty: Infrapatellar branch of the saphenous nerve selective denervation. A case series

Introduction: Total knee arthroplasty (TKA) is a reliable and widespread solution for knee osteoarthritis treatment, but about 20% of the patients complains of persisting pain. Neuroma formation in the IPBSN (infrapatellar branch of the saphenous nerve) is an undervalued cause of persistent anterior pain after TKA. The aim of this study was to evaluate the effectiveness of the selective neuroma denervation on patients satisfaction and pain improvement.Matherial and methods: Between 2014 and 2020, we evaluated 13 patients suffering from persistent anterior knee pain and numbness after TKA who underwent a surgical neurectomy of the IPBSN. After clinical assessment and diagnosis confirmation, we carried out the surgery. Short Form 12 Health (SF12), Oxford Knee Score (OKS), and Numeric Rating Scale (NRS) have been collected before and after the procedure. After the surgical treatment, the symptom's resolution and patients’ satisfaction were attested by the achievement of the Minimal ClinicallyImportantDifference(MCID) of the self-administered patient-reported outcome measures (PROMs).Results: Our results showed a statistically significant improvement (p < 0.05) of patients pain perception (mean NRS improvement –4.2, SD 2.5) and overall satisfaction (with a mean increase in OKS of 14.5 points SD 9.4, and in SF12 of 6.5 points SD 4.0).Conclusions: Hence, our study suggests that selective neuroma denervation may be an effective solution to improve the quality of life of patients who develop this complication after TKA.

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.

Is the Erector Spinae Plane Block Effective for More than Perioperative Pain? A Retrospective Analysis.

Introduction: The thoracic Erector Spinae Plane Block (ESPB) is an ultrasound-guided block that has gained popularity and is widely used in acute pain setups. However, data regarding its role in chronic and cancer-related pain are anecdotal. Material and Methods: The study is a retrospective analysis of patients who underwent ESPB. The cohort was divided into subgroups based on three determinants: etiology, pain type, and chronicity. Results: One hundred and ten patients were included, and genders were affected equally. The average age was 61.2 ± 16.1 years. The whole group had a statistically significant reduction in a numerical rating scale (NRS) (7.4 ± 1.4 vs. 5.0 ± 2.6, p-value > 0.001). NRS reduction for 45 patients (41%) exceeded 50% of the pre-procedural NRS. The mean follow-up was 7.9 ± 4.6 weeks. Baseline and post-procedure NRS were comparable between all subgroups. The post-procedural NRS was significantly lower than the pre-procedural score within each group. The proportion of patients with over 50% improvement in NRS was lower for those with symptom duration above 12 months (p-value = 0.02). Conclusions: Thoracic ESPB is a simple and safe technique. The results support the possible role of ESPB for chronic as well as cancer-related pain.

161. Expectations of clinical improvement following corrective surgery for adult cervical deformity based on functional disability at presentation

161. Expectations of clinical improvement following corrective surgery for adult cervical deformity based on functional disability at presentation

Tralokinumab Plus Topical Corticosteroids as Needed Provides Progressive and Sustained Efficacy in Adults with Moderate-to-Severe Atopic Dermatitis Over a 32-Week Period: An ECZTRA 3 Post Hoc Analysis.

BackgroundThe efficacy and safety of tralokinumab, a fully human monoclonal antibody that specifically neutralizes interleukin-13, plus topical corticosteroids (TCS) as needed were evaluated over 32 weeks in the phase III ECZTRA 3 trial. Significantly more tralokinumab- versus placebo-treated patients achieved the primary endpoints of Investigator’s Global Assessment (IGA) score of 0/1 and 75% improvement in Eczema Area and Severity Index (EASI-75) and all confirmatory endpoints at Week 16.ObjectiveThis post hoc analysis investigated the impact of tralokinumab plus TCS on atopic dermatitis (AD) severity, symptoms, and health-related quality of life (QoL) over the entire 32-week treatment period of ECZTRA 3, including all patients initiated on tralokinumab irrespective of the response achieved at Week 16.MethodsPatients were randomized 2:1 to receive subcutaneous tralokinumab 300 mg or placebo every 2 weeks (q2w) with TCS as needed for an initial 16 weeks. At Week 16, patients who achieved the clinical response criteria (IGA 0/1 and/or EASI-75) with tralokinumab were re-randomized 1:1 to tralokinumab q2w or every 4 weeks (q4w), with TCS as needed, for another 16 weeks. Patients not achieving the clinical response criteria with tralokinumab received tralokinumab q2w plus TCS from Week 16. All patients randomized to tralokinumab in the initial treatment period were pooled for this analysis, irrespective of response at Week 16 or dosing regimen beyond Week 16.ResultsContinued tralokinumab (q2w, N = 164; q4w, N = 69) plus TCS treatment provided progressive improvements from Week 16 onwards in AD signs, with 70.2% (177/252) of patients achieving EASI-75 and 50.4% (127/252) achieving EASI-90 at Week 32. Improvements in patient-reported outcomes were observed within the first few weeks of tralokinumab q2w plus TCS treatment and were sustained throughout the 32-week period. At Week 32, patients initiated on tralokinumab q2w plus TCS achieved a relative improvement versus baseline of 70.8% (standard error (SE), 2.4) in eczema-related sleep interference numeric rating scale (NRS) and 66.8% (SE, 3.1) in Dermatology Life Quality Index (DLQI). Mean TCS use during Weeks 16–32 ranged from 9.2 to 13.6 g (SE, 1.2–2.0) q2w. Most patients (89.9% (222/247)) initiated on tralokinumab q2w plus TCS achieved a meaningful improvement in at least one of the three disease domains, including AD signs (EASI-50), symptoms (pruritus NRS improvement ≥ 3), and QoL (DLQI improvement ≥ 4) at Week 16. Of patients initiated on tralokinumab q2w plus TCS, 53.4% (132/247) achieved a clinically meaningful improvement in all three domains at Week 16 (vs. placebo, 28.5% (35/123); p < 0.001).ConclusionsContinued tralokinumab treatment plus TCS as needed provides progressive and sustained improvements in AD signs, symptoms, and health-related QoL over 32 weeks.Clinical trial registrationNCT03363854; study start date: 22 February 2018; primary completion date: 8 March 2019; study completion date: 26 September 2019.Supplementary InformationThe online version contains supplementary material available at 10.1007/s40257-022-00702-2.

Longitudinal efficacy of acellular dermal allograft following superior capsular reconstruction of irreparable rotator cuff tears

BackgroundSuperior capsular reconstruction (SCR) remains an option for irreparable rotator cuff tears, especially for active patients. While fascia lata grafts were first used with SCRs, acellular dermal allografts have demonstrated similar postoperative outcomes and complication rates. Few studies report long-term clinical outcomes following use of acellular dermal allografts. The aim of the current study is to evaluate long-term efficacy of allograft usage in SCR through patient reported clinical outcomes. MethodsA retrospective review of patients undergoing SCR with use of dermal allografts from 2015 to 2021 was performed. Exclusion criteria included patients lost to follow up, revision or removal of graft, and inadequate follow up timepoints. Demographics and operative characteristics were collected. To evaluate efficacy of graft, numerical rating scale (NRS), American Shoulder and Elbow Score (ASES) were assessed postoperatively. Shoulder range of motion (ROM) was also evaluated by the 6-month postoperative timepoint. Improvement in NRS, ASES, and shoulder ROM from baseline values were evaluated using a t-test. ResultsThe final cohort was 21 patients with two patients undergoing revision and removal of the graft. Mean follow up time was 36.9 months. No major postoperative complications were recorded. Mean preoperative NRS and ASES score was 5.7 and 38.4, which both significantly improved postoperatively (p < 0.001). Patients demonstrated improvements in forward flexion, abduction in 90° rotation, and external and internal rotation. ConclusionUse of acellular dermal grafts in SCR procedures for irreparable rotator cuff tears remains a viable long-term solution to restore shoulder function.

Efficacy of dupilumab in chronic prurigo and chronic idiopathic pruritus: a systematic review of current evidence and analysis of response predictors.

Dupilumab has demonstrated a great reduction in chronic pruritus that is the hallmark of atopic dermatitis (AD). Underscoring relevant pathogenesis similarities emerging from AD, chronic idiopathic pruritus (CIP) and chronic prurigo (CP), several authors suggested the beneficial role of dupilumab in these conditions. The evidence on this subject is limited with no precise data available. In this study, we carried out a systematic literature review in order to evaluate the efficacy of dupilumab on both pruritus and skin manifestations in the two largest retrospective cohorts of patients with CP and CIP and tried to identify potential response predictors. Electronic searches were conducted on 4 databases. Our primary outcome was the improvement in pruritus measured by a reduction in the patient's reported numerical rating scale of itch (NRSI) by >4. Secondary outcomes included the proportion of patients with a complete response at the end of treatment, reduction in the number of lesions by the Investigator Global Assessment (IGA), improvement in numerical rating scale of sleep (NRSS), improvement in quality of life measured by the Dermatology Life Quality Index (DLQI), time until patient perceived any improvement (Time-First) and time until the patient-reported absence of pruritus (Time-Final). Descriptive statistics were calculated for each demographic and clinical variable. Univariate logistic regression analyses were conducted to explore the association between response to dupilumab and potential predictive factors. We included 25 articles in the analysis, counting a total of 153 patients. Based on CP patients' cohort (n = 132), the mean NRSI at baseline was 8.79 ± 0.86 and the NRSI final was 2.32 ± 1.27. The mean time to first improvement was 5.18 ± 3.13 weeks, while the time to complete improvement of pruritus (Time-final) was 13.6 ± 12.0 weeks. Ninety patients out of 109 (83%) noticed an improvement in pruritus before 4 weeks of dupilumab therapy. At the end of treatment, 18 patients out of 126 (14%) had a complete remission of pruritus and 110 patients out of 123 (89%) had a reduction of NRSI >4. The reduction in NRSI was significantly greater in patients improving before 4 weeks of treatment (6.57 ± 1.71) compared with patients improving in more than 4 weeks (5.49 ± 1.39, P < 0.001). Patients with history of AD and those who have been previously treated with cyclosporine or methotrexate had a significantly lower reduction in NRSI (e.g. 6.05 ± 1.34 vs. 7.08 ± 1.90, P < 0.01 for nonassociated AD patients). Based on CIP patient's cohort (n = 21), the mean NRSI at baseline was 8.33 ± 0.80 and the NRSI final was 0.95 ± 0.59. The mean time to first improvement was 2 ± 0 weeks, while the time to complete improvement (Time-final) was 14.6 ± 10 weeks. At the end of treatment, 3 patients out of 21 (14%) had a complete remission of pruritus and 100% of patients had a reduction of NRSI >4. No serious treatment-emergent adverse events were reported. The most common adverse event was mild conjunctivitis (13 cases). We highlight the importance of one early sign of improvement as a predictor of the future response to dupilumab: the improvement before 4 weeks of treatment that leads significantly to a greater final reduction in NRSI. Furthermore, patients with the presence or history of atopy appear to be less responsive to dupilumab than nonatopic patients and develop more side effects, in particular conjunctivitis.

Chiropractic Clinical Outcomes Among Older Adult Male Veterans With Chronic Lower Back Pain: A Retrospective Review of Quality-Assurance Data

ObjectiveThe purpose of this study was to determine whether a sample of older adult male U.S. veterans demonstrated clinically and statistically significant improvement in chronic lower back pain on validated outcome measures after a short course of chiropractic care. MethodsWe performed a retrospective review of a quality-assurance data set of outcome metrics for male veterans, aged 65 to 89 years, who had chronic low back pain, defined as pain in the lower back region present for at least 3 months before evaluation. We included those who received chiropractic management from January 1, 2010, to December 31, 2018. Paired t tests were used to compare outcomes after 4 treatments on both a numeric rating scale (NRS) and the Back Bournemouth Questionnaire (BBQ). The minimum clinically important difference (MCID) was set at 30% change from baseline. ResultsThere were 217 individuals who met the inclusion criteria. The mean NRS score change from baseline was 2.2 points, representing a 34.1% reduction (t = 13.5, P < .001). The mean score change for BBQ was 14.7 points, representing a 35.9% reduction (t = 16.7, P < .001). The percentage of participants reaching the MCID for the NRS was 57% (n = 124) and for the BBQ was 59% (n = 126), with 41% (n = 90) of the sample reaching the MCID for both the NRS and BBQ. ConclusionThis retrospective review revealed clinically and statistically significant improvement in NRS and BBQ scores for this sample of older male U.S. veterans treated with chiropractic management for chronic low back pain.

Rapid Improvement in Skin Pain Severity and Its Impact on Quality of Life in Adult Patients With Moderate-to-Severe Atopic Dermatitis From a Double-Blind, Placebo-Controlled Baricitinib Phase 3 Study

Skin pain (discomfort/soreness) is a common symptom associated with atopic dermatitis (AD). To evaluate rapid changes in skin pain severity with baricitinib, and its impact on patient quality of life (QoL) in adults with moderate-to-severe AD who were inadequate responders to topical therapy. Adult patients with moderate-to-severe AD who were inadequate responders to topical therapies (N = 440, BREEZE-AD5 [NCT03435081]) were randomized to once-daily placebo, baricitinib 1 mg, or baricitinib 2 mg for 16 weeks. Change in Skin Pain Numeric Rating Scale (NRS) scores were assessed for the randomized population. Skin Pain NRS and Dermatology Life Quality Index (DLQI) scores were assessed for Skin Pain Response groups and patients with Body Surface Area (BSA) 10% to 50%. Skin Pain NRS improvement was significant versus placebo by day 1 baricitinib 2 mg (least squares mean [LSM] difference -4.4%, P = .048) and by day 2 for baricitinib 1 mg (-6.7%, P = .011). As measured weekly, improvement was significant starting at Week 1 and remained significant through Week 16 for both doses. At Week 16, 70.9% of Skin Pain NRS responders vs 10.4% of nonresponders had a clinically meaningful improvement in DLQI (P < .0001). At week 16, LSM DLQI change from baseline was -11.1 for all Skin Pain NRS responders versus -3.5 for nonresponders (P < .0001). Patients with BSA 10% to 50% showed similar trends. Patients with moderate-to-severe AD, treated with baricitinib, reported rapid improvements in skin pain severity by day 1 for baricitinib 2 mg and day 2 for baricitinib 1 mg and remained effective through 16 weeks of treatment, which positively impacted patient QoL.

365 Sciatica of Non-Disc Origin

INTRODUCTION: Sciatica resulting from piriformis muscle compression may respond to surgical decompression of the sciatic nerve via piriformis release. The topic has been very controversial. Pre-operative evaluation with MRI is useful to identify potential changes in either the piriformis muscle or the sciatic nerve that may help confirm the diagnosis of piriformis syndrome. METHODS: A retrospective analysis of all patients who underwent piriformis release to decompress the sciatic nerve. All surgeries were performed using a transgluteal approach. All patients (15) had preoperative localization of the piriformis muscle via percutaneous wire placement by interventional radiology using either CT or ultrasound guidance. 30 patients, who had MRI scans of their pelvis unrelated to sciatica, served as the control cohort. We also looked for signal changes in the sciatic nerve seen on MRI, piriformis muscle thickness, and pre versus post-operative numeric rating scale (NRS) assessment. RESULTS: Between treatment and control cohorts, there was no difference in basic demographics (other than age). In comparing the surgical and control cohorts, we found that a significant number of patients in the surgical cohort had the sciatic nerve riding over the ischial spine. Distance between the midpoint of the sciatic nerve to the ischial spine was also significantly lower in the surgical cohort. Piriformis thickness was essentially identical between the cohorts. In comparing pre and postoperative NRS pain scores, the aggregate of surgically treated patients had a significant improvement in their pain scores by approximately 4 points. Subgroup analysis of the surgical cohort demonstrated trends toward a larger improvement in NRS when the distance between the midpoint of the sciatic nerve to the ischial spine was &lt;9mm, BMI &lt;25, and piriformis thickness &lt;2cm. CONCLUSION: Identifying clear MRI findings related to the sciatic nerve and its trajectory through the pelvis can potentially help identify patients who will better respond to surgery.

Cooled-radiofrequency neurotomy for the treatment of chronic lumbar facet (zygapophyseal) joint pain: A retrospective study.

Cooled-radiofrequency (CRFA) is a newer technique and may have some theoretical advantages over traditional radiofrequency ablation (TRFA). In this study, we aimed to investigate the efficacy and safety of CRFA for the treatment of lumbar facet joint-mediated pain. In this retrospective study, we evaluated 185 CRFA performed on 105 patients. All patients with axial lower back who received the preliminary diagnosis of lumbar facet joint-mediated pain and refractory to conservative therapy underwent diagnostic medial branch blocks. CRFA was recommended to those patients who responded favorably to two sets of diagnostic medial branch blocks. Pain scores in numeric rating scale (NRS) were recorded pre-treatment and post-treatment at different time-points. The primary outcome measure was to report descriptive NRS score and average % improvement from baseline at each time point. A significant pain relief was determined by a decrease of ≥50% of mean NRS. Secondary outcome measure was the time to repeat treatment with subsequent CRFA. Adverse events were also recorded.Primary outcome measure determined as the improvement in NRS, for at least 50% or more, was achieved in both 1st (4–8 weeks) and 2nd (>2–6 months) follow-up (FU) with 60.5% and 53.6% reduction in NRS respectively. Our subgroup analysis comparing the younger (<50) and older (≥50) age groups showed superior pain relief with CRFA in the older (≥50) age group, both in the 1st (4–8 weeks) and 2nd (>2–6 months) FU time points (63.4% and 58.4% reduction in NRS, respectively). Cooled-radiofrequency ablation is an effective and safe procedure for the treatment of chronic lumbar facet joint related pain. The duration of pain relief was comparable to traditional radiofrequency ablation as reported in the literature.

Early Results of a Novel Treatment Technique with Autologous Blood for Chronic Lateral Epicondylitis

Background: Chronic lateral epicondylitis can be a severe disabling condition. There is still lack of consensus on best treatment, as no single intervention has been proven to be superior regarding pain relief and improvement of function. Due to the self-limiting nature of this elbow condition, we are looking for a fast and safe treatment method to break through this pattern of pain and loss of elbow function. Autologous blood injection therapy by means of an automatic injection system, can be a promising new treatment option for this group of patients suffering from chronic lateral epicondylitis. In this study, we evaluated the short-term results of autologous blood injection therapy in a standardized way by using an automatic injection system (=ITEC device) for the treatment of chronic lateral epicondylitis. Methods: A total of 141 patients with chronic lateral epicondylitis (88 female, 53 male) were enrolled in this clinical treatment evaluation being treated with the ITEC device. The mean age of the patients was 50.0 years (19 years-73 years). Numeric rating scale (NRS) and a patient reported outcome measurement tool (Oxford Elbow Score (OES)) were measured at baseline, six weeks and three months follow-up. Results: Pain (NRS, OES) and elbow function / quality of life (OES) were significantly improved within 6 weeks after ITEC treatment. This improvement in NRS and OES sustained during the 3 months follow-up period. Conclusion: Autologous blood injection therapy by means of a new automatic injection system (ITEC device) is a safe and effective treatment method for patients with chronic lateral epicondylitis. More research is necessary to see if this effectiveness sustains in the long-term follow-up.

Can dogs and cats really help our spinal cord stimulation patients?

ObjectivesPet ownership has been shown to decrease morbidity and mortality in several aspects of health but has not been studied in chronic pain patients. We evaluate whether subjects who underwent spinal cord stimulation (SCS) and own a pet have improved outcomes compared to non-pet owners. MethodsAfter obtaining IRB approval, we re-contacted 38 subjects who underwent SCS surgery with preoperative and 1-year postoperative data on Numerical Rating Scale (NRS), McGill Pain Questionnaire (MPQ), Oswestry Disability Index (ODI), Beck Depression Inventory (BDI), and Pain Catastrophizing scale (PCS). We examined influence of pets and pet ownership-specific behaviors on improvement in SCS outcomes. ResultsPatients included 24 males/14 females with a mean age of 59.9 ± 11.5 years. At mean follow-up of 12.2 months (range 10–14), there were improvements in NRS, ODI, BDI, PCS and MPQ. Twenty subjects owned pets and 18 did not; all believed pet ownership could improve health. Pet owners improved more on NRS-right now (p = 0.05) and BDI (p = 0.05), and were more satisfied with SCS (p = 0.04). No significant improvement was seen in ODI, MPQ, or PCS. However, PCS did improve in pet owners who exercised their pet (PCS-total, p < 0.01; PCS-helplessness, p < 0.01; PCS-rumination, p = 0.05; PCS-magnification, p = 0.02). ConclusionsWe provide preliminary evidence that pet ownership is associated with improved pain, depression and SCS satisfaction. Exercising with a pet also appears to be beneficial in limiting pain catastrophizing. Pets show promise as a novel means to improve patient SCS outcomes.

Sativex\xae (nabiximols) cannabinoid oromucosal spray in patients with resistant multiple sclerosis spasticity: the Belgian experience

BackgroundThis retrospective study evaluates patient-reported outcomes in patients with multiple sclerosis (MS) spasticity who were treated with a cannabinoid oromucosal spray (Sativex®, USAN name: nabiximols) after not sufficiently responding to previous anti-spasticity medications.MethodsOf 276 patients from eight centers in Belgium who began treatment prior to 31 December 2017, effectiveness assessment data were available for 238 patients during the test period of 4 to 8/12 weeks, and for smaller patient cohorts with continued treatment for 6/12 months.ResultsMean 0–10 spasticity Numerical Rating Scale (NRS) scores improved from 8.1 at baseline to 5.2 (week 4), 4.6 (week 8) and 4.1 (week 12). Mean EuroQoL Visual Analogue Scale (EQ VAS) scores increased from 39 at baseline to 52 (week 4), 57 (week 8) and 59 (week 12). Mean NRS and EQ VAS scores remained in the same 12 weeks’ range in patients with longer-term data. The average dose of cannabinoid oromucosal spray was 6 sprays/day. Most of the 93 out of 276 patients, with initial prescription (33.7%), who discontinued treatment by week 12 did so within the first 8 weeks, mainly due to lack of effectiveness. By week 12, 171 (74%) of the 230 effectiveness evaluable patients reported a clinically meaningful response, corresponding to ≥30% NRS improvement. The tolerability of cannabinoid oromucosal spray was consistent with its known safety profile.ConclusionsMore than 60% of the patients with MS who started add-on treatment with cannabinoid oromucosal spray reported a clinically relevant symptomatic effect and continued treatment after 12 weeks.