Pain Intensity Numerical Rating Scale Research Articles

CPL-01, an investigational long-acting ropivacaine, demonstrates safety and efficacy in open inguinal hernia repair.

There is an unmet medical need for effective nonopioid analgesics that can decrease pain while reducing systemic opioid use. CPL-01, an extended-release injectable formulation of ropivacaine, is designed to safely provide analgesia and reduce or eliminate opioid use in the postoperative period. Subjects undergoing open inguinal hernia with mesh were prospectively randomized to 1 of 3 doses of CPL-01 (10, 20, or 30ml of 2% CPL-01, n = 14, 12, and 14, respectively), Naropin (150mg, n = 40), or saline placebo (n = 13) infiltrated into the surgical site prior to closure. Pain and rescue medication usage was assessed, and Numeric Rating Scale (NRS) pain scores were adjusted for opioid usage using windowed worst observation carried forward (wWOCF) imputation. The primary efficacy endpoint was the mean area under the curve (AUC) of the NRS pain intensity scores with activity. Ninety-three subjects were treated, and 91 subjects completed 72h of post-operative monitoring. Subjects who received the highest dose of CPL-01 in Cohort 3 showed a clinically meaningful reduction in postoperative pain intensity scores, which was the lowest value for any treatment in all cohorts, showing a trend towards statistical significance as compared to the pooled placebo group (p = 0.08), and numerically better than the 40 subjects who received Naropin. Opioid use through 72h in subjects who received CPL-01 in Cohort 3 was approximately half of that shown in the placebo and Naropin groups; approximately 2/3 of the CPL-01 subjects (9/14) required no opioids at all through the first 72h after the operation. More CPL-01 subjects avoided severe pain and were ready for discharge earlier than other groups. CPL-01 was safe and well-tolerated, with no clinically meaningful safety signals, and showed predictable and consistent extended-release pharmacokinetics. Results suggest that CPL-01 may be the first long-acting ropivacaine to address postoperative pain while reducing the need for opioids.

124 Numerical Cut Points for Mild, Moderate and Severe Pain in Adult Burn Survivors

Abstract Introduction The optimal numerical cut points for mild, moderate, and severe burn pain have been established. Investigators at a single center determined that average burn pain can be categorized as mild (0-2), moderate (3-5), and severe (6-10). To address concerns about small sample size and limited diversity, we aimed to identify the most suitable average pain intensity rating scores for mild, moderate, and severe pain in a large, diverse cohort of adult burn survivors using a Patient Reported Outcome Measures Pain Interference (PROMIS-PI) short form. Methods Average 11-point pain intensity Visual Analog Scale (VAS) or Numerical Rating Scale (NRS) scores (0-10) and a customized PROMIS-PI 4-question short form were administered to adults with burn injury treated at 5 centers in the US at hospital discharge (baseline) and 6, 12, 24-months and 5-years post-injury. To identify pain intensity scores that best represent mild, moderate, and severe pain, F value statistics associated with multiple ANOVA comparisons for mean pain interference scores by various pain intensity cut points were computed. Based on previous research, 6 possible cut points (CP) were compared: CP 3,6; 3,7; 4,6; 4,7; 2,5; and 3,5. The optimal cut points were considered those with the highest ANOVA F statistic. Results Data from 1,190 participants (68% male, 80% white, 22% Hispanic, mean age 46 years) and 5 study centers with VAS/NRS pain intensity and PROMIS-PI scores at one or more study timepoints were analyzed. The optimal classification for mild, moderate, and severe pain was CP 2,5 at all timepoints (see table). Conclusions This study confirms that for a diverse cohort of burn-injured adults from multiple centers within the United States, burn intensity ratings of mild (0-2), moderate (3-5), and severe (6-10) is appropriate for up to 5 years post-injury. These findings support previous research findings and continue to advance our understanding of burn pain and pain intensity reporting while providing clinicians and researchers with an objective measure that can be used for screening, treatment, quality improvement, and research. Applicability of Research to Practice Use of this numerical classification for burn pain in the adult burn survivor can be used with greater confidence in diverse populations.

The Fremantle Back Awareness Questionnaire: cross-cultural adaptation, reliability, and validity of the Italian version in people with chronic low back pain

Background and aimThere is evidence to suggest that assessing back-specific altered self-perception may be useful when seeking to understand and manage low back pain (LBP). The Fremantle Back Awareness Questionnaire (FreBAQ) is a patient-reported measure of back-specific body perception that has never been adapted and psychometrically analysed in Italian. Hence, the objectives of this research were to cross-culturally adapt and validate the Italian version of this outcome measure (namely, the FreBAQ-I), to make it available for use with Italians suffering from chronic LBP.MethodsThe FreBAQ-I was developed by forward and backward translation, review by a committee skilled in patient-reported measures and test of the pre-final version to assess its clarity, acceptability, and relevance. The statistical analyses examined: structural validity based on Rasch analysis; hypotheses testing by investigating correlations of the FreBAQ-I with the Roland Morris Disability Questionnaire (RMDQ), a pain intensity numerical rating scale (PI-NRS), the Pain Catastrophising Scale (PCS), and the Tampa Scale of Kinesiophobia (TSK) (Pearson’s correlations); reliability by internal consistency (Cronbach’s alpha) and test–retest repeatability (intraclass correlation coefficient, ICC (2,1)); and measurement error by determining the minimum detectable change (MDC). After the development of a consensus-based translation of the FreBAQ-I, the new outcome measure was delivered to 100 people with chronic LBP.ResultsRasch analysis confirmed the substantial unidimensionality and the structural validity of the FreBAQ-I. Hypothesis testing was considered good as at least 75% of the hypotheses were confirmed; correlations: RMDQ (r = 0.35), PI-NRS (r = 0.25), PCS (r = 0.41) and TSK (r = 0.38). Internal consistency was acceptable (alpha = 0.82) and test–retest repeatability was excellent (ICC (2,1) = 0.88, 95% CI: 0.83, 0.92). The MDC95 corresponded to 6.7 scale points.ConclusionThe FreBAQ-I was found to be a unidimensional, valid, and reliable outcome measure in Italians with chronic LBP. Its application is advised for clinical and research use within the Italian speaking community.

Fluoroscopy-guided high-intensity focused ultrasound neurotomy of the lumbar zygapophyseal joints: a prospective, open-label study

ObjectiveThe objective of this study is to investigate safety and effectiveness of a fluoroscopy-guided high-intensity focused ultrasound (HIFU) system for thermal ablation of the lumbar medial branch nerves.MethodsThis dual center...

[Comparison of pain intensity measurements among patients with low-back pain].

<p>Pain intensity is the most frequently assessed health domain in clinical studies among patients with low-back pain. Visual analogue scale (VAS) and Numeric rating scale (NRS) have been the mostly used measurement tools for pain intensity. We proposed to correlate these instruments to a generic health-related quality of life measurement tool in order to show the scale with superior clinical relevance.</p>. <p>We used cross-sectional, convenience sampling. 120 patients with chronic low-back pain administered the 29-item Patient Reported Outcomes Measurement Information System Profile with NRS included, and the VAS scale in the National Institute of Mental Health, Neurology and Neurosurgery. We determined the correlation between PROMIS domain T-scores and VAS and NRS scores.</p>. <p>We performed Spearman rank correlation test to calculate the correlation coefficient. We found VAS scales measuring pain had weak to moderate correlations with all PROMIS health domains (r = 0.24&ndash;0.55). Therefore, we compared correlation of PROMIS domain scores with PROMIS pain intensity numeric rating scale and VAS scales. PROMIS domains had moderate to strong correlations with pain intensity scale (r = 0.45&ndash;0.71). PROMIS physical function short form [r = &ndash;0.65, 95% CI (&ndash;0.75) &ndash; (&ndash;0.55)] and PROMIS pain interference short form (r = 0.71, 95% CI 0.63 &ndash; 0.79) had the strongest correlation with pain intensity item.</p>. <p>NRS has showed greater correlation with PROMIS domain T-scores than VAS scale. This may prove that NRS has greater connection to another health domains, thus it correlated more to health-related quality of life than visual scale. We recommend NRS to use in further clinical studies conducted among patients with low-back pain.</p>.

DOP49 Guselkumab improves health-related quality of life as measured by PROMIS-29 in patients with moderately to severely active Ulcerative Colitis: Phase 3 QUASAR induction study

Abstract Background Patients (pts) with ulcerative colitis (UC) suffer from symptoms that impair health-related quality of life (HRQoL). The Phase 3 QUASAR induction study (NCT04033445) evaluated the efficacy and safety of guselkumab (GUS), an IL-23 p19 subunit antagonist, in pts with moderately to severely active UC who had demonstrated inadequate response, loss of response, or intolerance to conventional and/or advanced therapies (ie, tumor necrosis factor-alpha antagonists, integrin receptor antagonists, and/or Janus kinase inhibitors). Here we report the effect of GUS IV induction on HRQoL at Week (Wk) 12 as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)-29. Methods Pts were randomized 3:2 to receive GUS 200 mg IV or placebo (PBO) IV at Wks 0/4/8. PROMIS-29 consists of 7 domains (anxiety, depression, fatigue, pain interference, sleep disturbance, physical function, and social participation) and a pain intensity numeric rating scale (NRS, range 0-10). The raw score of each domain was converted into a standardized T-score based on a general population mean of 50 and standard deviation (SD) of 10. Higher scores indicate better outcomes for physical function and social participation and worse outcomes for all other domains. The physical component summary (PCS) and mental component summary (MCS) scores were calculated based on the domain T-scores for physical and mental HRQoL, with higher scores representing better outcomes. Minimum clinically meaningful improvement was defined as a ≥3-point improvement in the pain intensity NRS score, a ≥5-point (one-half SD of the population) improvement in each domain, and a ≥5-point improvement in the PCS/MCS scores. More stringent thresholds (eg, ≥7- or ≥9-point improvements) were also examined and will be presented. Results Among the primary analysis population, baseline mean PROMIS-29 domain scores were similar between treatment groups, with functional domain scores &amp;lt;50 and symptom domain scores &amp;gt;50, indicating impaired HRQoL (Table). GUS-treated pts achieved a greater mean change from baseline at Wk 12 in each domain T-score, the pain intensity NRS score, and the PCS/MCS than PBO-treated pts. Additionally, the percentage of pts achieving minimum clinically meaningful improvement at Wk 12 was greater for GUS vs PBO in each domain, the pain intensity NRS score, and the PCS/MCS scores (Figure). Conclusion Pts with moderately to severely active UC treated with GUS IV induction experienced broad and clinically meaningful improvements in HRQoL as measured by the PROMIS-29 at Wk 12.

Robot-assisted rehabilitation of people with breast cancer developing upper limb lymphedema: protocol of a randomized controlled trial with a 6-month follow‑up

Upper limb lymphedema (ULLy) is an external (and/or internal) manifestation of lymphatic system insufficiency and deranged lymph transport for more than 3 months and frequently affects people as a consequence of breast cancer (BC). ULLy is often underestimated despite diminished motor skills, mood, and cognitive-behavioral complaints negatively condition the health-related quality of life (HRQoL) of persons. BC can also metastasize to the jawbone, further impacting on the HRQoL. In time, the implementation of robot-assisted rehabilitation (RR) for neurological diseases has grown to improve HRQoL and pain. This study aims to evaluate the effectiveness of a RR program in the treatment of individuals who develop an ULLy; as a further analysis, the study will assess the effectiveness of the same program in people with jawbone metastases from BC who will also develop ULLy. A randomized, parallel-group superiority-controlled trial will be conducted. 44 participants will be randomly allocated to either the experimental (receiving a RR program) or the control group (regular rehabilitation). Both groups will follow individual-based programs three times a week for 10 weeks. The main outcome measure will be the Lymphedema Quality of Life Questionnaire. Secondary outcomes will be a pain intensity numerical rating scale and the Cranio-Facial Pain Disability Inventory. Evaluations are before and after training and 6 months later. Findings may provide evidence on the effectiveness of a RR program on inducing improvements in the HRQoL and pain of individuals with ULLy due to BC. People with ULLy and jawbone metastases from BC are expected for similar or higher improvements as per the same comparisons above. This trial might contribute towards defining guidelines for good clinical rehabilitation routines and might be used as a basis for health authorities’ endorsements.Trial registration OSF REGISTRIES, osf-registrations-jz7ax-v1. Registered on 26 June 2023.

Similar improvements in patient-reported outcomes for non-specific low back pain patients with and without lumbar spinal stenosis symptoms following a structured education and exercise therapy program

BackgroundPeople with nonspecific low back pain (NSLBP) can also experience overlapping symptoms of lumbar spinal stenosis (LSS), but the impact on treatment outcomes is unknown. This study investigated differences in treatment outcomes for disability, back pain intensity, and leg pain intensity following an education and exercise therapy program for NSLBP patients with and without comorbid LSS symptoms.MethodsThis was a longitudinal analysis of 655 Danish participants in the GLA:D® Back program; an education and exercise therapy program for people with persistent NSLBP. Participants were classified as having comorbid LSS symptoms based on self-report. Linear mixed models were used to assess differences in change in disability (Oswestry Disability Index [0-100]) and back and leg pain intensity (Numeric Rating Scale [0–10]) at 3-, 6-, and 12-months between those with and without LSS symptoms.Results28% of participants reported LSS symptoms. No certain differences in change in disability or back pain intensity improvement were observed at any time-point between those with and without LSS symptoms. Participants with LSS symptoms had slightly greater improvement in leg pain intensity at 6- (-0.7, 95% CI -1.2 to -0.2) and 12-months (-0.6, 95% CI -1.2 to -0.1).ConclusionCompared to those without LSS symptoms, patients with persistent NSLBP and LSS symptoms can expect similar improvements in disability and back pain intensity, and slightly greater improvements in leg pain intensity with treatment. Therefore, education and exercise therapy programs designed for NSLBP are likely helpful for those also experiencing LSS symptoms.

The HortONS study. Treatment of chronic cluster headache with transcutaneous electrical nerve stimulation and occipital nerve stimulation: study protocol for a prospective, investigator-initiated, double-blinded, randomized, placebo-controlled trial

BackgroundChronic cluster headache (CCH) is a debilitating primary headache disorder. Occipital nerve stimulation (ONS) has shown the potential to reduce attack frequency, but the occipital paresthesia evoked by conventional (tonic) stimulation challenges a blinded comparison of active stimulation and placebo. Burst ONS offers paresthesia-free stimulation, enabling a blinded, placebo-controlled study.Identification of a feasible preoperative test would help select the best candidates for implantation.This study aims to explore ONS as a preventive treatment for CCH, comparing burst stimulation to tonic stimulation and placebo, and possibly identifying a potential preoperative predictor.MethodsAn investigator-initiated, double-blinded, randomized, placebo-controlled trial is conducted, including 40 patients with CCH. Eligible patients complete a trial with the following elements: I) four weeks of baseline observation, II) 12 weeks of transcutaneous electrical nerve stimulation (TENS) of the occipital nerves, III) implantation of a full ONS system followed by 2 week grace period, IV) 12 weeks of blinded trial with 1:1 randomization to either placebo (deactivated ONS system) or burst (paresthesia-free) stimulation, and V) 12 weeks of tonic stimulation.The primary outcomes are the reduction in headache attack frequency with TENS and ONS and treatment safety. Secondary outcomes are treatment efficacy of burst versus tonic ONS, the feasibility of TENS as a predictor for ONS outcome, reduction in headache pain intensity (numeric rating scale), reduction in background headache, the patient’s impression of change (PGIC), health-related quality of life (EuroQoL-5D), self-reported sleep quality, and symptoms of anxiety and depression (Hospital Anxiety and Depression Scale, HADS).Data on headache attack characteristics are registered weekly. Data on patient-reported outcomes are assessed after each trial phase.DiscussionThe study design allows a comparison between burst ONS and placebo in refractory CCH and enables a comparison of the efficacy of burst and tonic ONS. It will provide information about the effect of burst ONS and explore whether the addition of this stimulation paradigm may improve stimulation protocols.TENS is evaluated as a feasible preoperative screening tool for ONS outcomes by comparing the effect of attack prevention of TENS and tonic ONS.Trial registrationThe study is registered at Clinicaltrials.gov (trial registration number NCT05023460, registration date 07–27-2023).

Clinician perspectives on postamputation pain assessment and rehabilitation interventions.

The purpose of this study was to explore self-reported Veterans Affairs (VA) amputation clinician perspectives and clinical practices regarding the measurement and treatment for amputation-related pain. Cross-sectional survey with 73 VA rehabilitation clinicians within the VA Health Care System. The most frequent clinical backgrounds of respondents included physical therapists (36%), prosthetists (32%), and physical medicine and rehabilitation specialist (21%). Forty-one clinicians (56%) reported using pain outcome measures with a preference for average pain intensity numeric rating scale (generic) (97%), average phantom limb pain intensity numeric rating scale (80%), or Patient-Reported Outcomes Measurement Information System pain interference (12%) measures. Clinicians' most frequently recommended interventions were compression garments, desensitization, and physical therapy. Clinicians identified mindset, cognition, and motivation as factors that facilitate a patient's response to treatments. Conversely, clinicians identified poor adherence, lack of belief in interventions, and preference for traditional pain interventions (e.g., medications) as common barriers to improvement. We asked about the frequently used treatment of graded motor imagery. Although graded motor imagery was originally developed with 3 phases (limb laterality, explicit motor imagery, mirror therapy), clinicians reported primarily using explicit motor imagery and mirror therapy. Most clinicians who use standardized pain measures prefer intensity ratings. Clinicians select pain interventions based on the patient's presentation. This work contributes to the understanding of factors influencing clinicians' treatment selection for nondrug interventions. Future work that includes qualitative components could further discern implementation barriers to amputation pain rehabilitation interventions for greater consistency in practice.

Efficacy and Safety of Low-dose Oral Prednisolone for Patients with Refractory Hunner-type Interstitial Cystitis.

Hunner-type interstitial cystitis (HIC) is an immunological, chronic inflammatory disease. The efficacy of corticosteroid as a treatment for HIC is unclear. To assess the efficacy and safety of low-dose oral prednisolone (PSL) treatment for patients with refractory HIC. This retrospective observational study reviewed the clinical outcomes of 31 patients with refractory HIC who received oral PSL daily (initial dose, 5.0 or 7.5 mg) for at least 12 mo between 2016 and 2023. The dose was tapered to the minimum that maintained symptom relief during follow-up. Treatment outcomes were evaluated using a seven-graded global response assessment (scores ≥+2, moderately or markedly improved, were defined as treatment response), O'Leary and Sant symptom and problem indices (OSSI/OSPI), overactive bladder symptom score (OABSS), an 11-point pain intensity numerical rating scale, a quality of life (QOL) score, and frequency-volume chart variables. Related complications were also documented. The mean follow-up period was 20.1±14.6 mo. The overall response rates at 1, 3, 6, 9, and 12 mo at doses of 6.7, 6.7, 5.2, 4.0, and 3.0 mg were 38.7%, 48.4%, 54.8%, 61.3%, and 64.5%, respectively. Compared with baseline, OSSI/OSPI and pain intensity improved significantly from 1 mo after PSL induction. The OABSS, QOL score, urinary frequency, and voided volume improved significantly from 9 mo after PSL induction. No patients discontinued treatment due to adverse events, although hypertension and glucose intolerance occurred in two patients, but these were resolved by temporal medications. This study showed that low-dose oral PSL significantly improves bladder pain, urinary symptoms, and QOL in patients with HIC, without serious adverse events. Further prospective evaluation is warranted to verify the potential efficacy and safety of low-dose PSL for HIC. This retrospective observational study reviewed the clinical outcomes of 31 patients suffering from refractory Hunner-type interstitial cystitis treated with low-dose oral prednisolone. Low-dose prednisolone improved bladder pain, urinary symptoms, and quality of life significantly, without serious adverse events. The response rate of 64.5% at 12 mo was comparable with the rates reported in previous studies that used higher doses of prednisolone. This study provides a rationale for further prospective evaluation of low-dose prednisolone for this intractable disease.

Liposomal Bupivacaine via Combined Sciatic and Saphenous Block after Lower Extremity Procedures: a Randomized, Double-Blind, Phase 3 Trial

Category: Bunion; Midfoot/Forefoot Introduction/Purpose: Combined sciatic and saphenous nerve blocks are commonly used for pain management after lower extremity procedures. Liposomal bupivacaine (LB) is a formulation of the local anesthetic bupivacaine that gradually releases bupivacaine for prolonged periods of analgesia. The objective of this phase 3 multicenter, randomized, double-blind, active- controlled study (NCT04518462) was to evaluate the postoperative analgesic effect of combined sciatic and saphenous nerve blocks with LB with or without admixed bupivacaine hydrochloride (HCl) versus bupivacaine HCl alone in adults undergoing bunionectomy or other lower extremity procedures. Methods: This study enrolled 2 parallel cohorts: pharmacokinetics, pharmacodynamics, efficacy, and safety were assessed in cohort 1 (bunionectomy), and efficacy and safety were further assessed in cohort 2 (bunionectomy, other lower extremity procedures). Eligibility criteria included American Society of Anesthesiologists physical status classification ≤3 and body mass index ≥18 to &lt; 40 kg/m2. Participants were randomized 1:1:1 to receive LB 266 mg admixed with saline (LB266), LB 266 mg admixed with bupivacaine HCl 50 mg (LB266-ADMIX), or bupivacaine HCl 100 mg (BUP100), administered as a combined sciatic and saphenous block. No additional regional blocks were administered. For 96 hours after surgery, rescue medication included nonsteroidal anti- inflammatory drugs and acetaminophen and escalation to opioids if necessary. The primary endpoint was the area under the curve (AUC) of the numerical rating scale (NRS) pain intensity scores 0-96 hours after surgery. Total postsurgical opioid consumption 0- 96 hours after surgery was a secondary endpoint. Results: In total, 119 participants were enrolled (LB266: n=40; LB266-ADMIX: n=41; BUP100: n=40). The least squares mean (LSM) AUC of the NRS pain intensity score was nonsignificantly lower 0-96 hours after surgery for LB266 versus BUP100 (LSM [standard error], 286.9 [32.9] vs 348.6 [34.4]; LSM difference vs BUP100, −61.7 [95% confidence interval (CI), −147.0, 23.6]; P=0.1564). LB266 pain intensity scores were significantly higher 6-18 hours after surgery but were significantly lower at 36-96 hours than BUP100 (Figure). Cumulative opioid consumption differences 0-96 hours after surgery for LB266 versus BUP100 were not significant (LSM [95% CI], 20.7 [13.5, 31.7] vs 19.8 [12.7, 31.0]; P=0.8857). Mirroring pain scores, opioid consumption with LB266 versus BUP100 was higher at 0-24 hours but lower 24-96 hours (Figure); adverse events were similar. Conclusion: Cumulative pain intensity and opioid consumption were not significantly different between the LB266 and BUP100 groups 0-96 hours after surgery; however, consistent with the known mechanism of LB, pain intensity scores were significantly lower with LB266 36-96 hours after surgery, and opioid consumption was significantly lower 24-96 hours after surgery.

Ultrasound-guided anterior quadratus lumborum block at the L2 level for postsurgical analgesia in patients undergoing laparoscopic gynaecological surgery: a single-centre, randomised, double-blinded trial at a university-affiliated hospital in China

ObjectiveThis study aimed to investigate the analgesic effect of an ultrasound-guided anterior quadratus lumborum block (QLB) at the L2 level on postoperative pain after laparoscopic gynaecological surgery.DesignProspective single-centre randomised double-blind...

Effectiveness of single-dose 6 mg pegfilgrastim in mobilizing peripheral blood stem cells in allogeneic hematopoietic cell transplantation donors.

A single injection of 12 mg pegfilgrastim was used to mobilize peripheral blood progenitor cells (PBPCs) from healthy donors in some studies. The purpose of this study was to determine if 6 mg of pegfilgrastim was effective and safe for mobilizing CD34+ cells in donors for allogeneic hematopoietic stem cell transplantation. We conducted a retrospective case-matched design. A single dosage of 6 mg pegfilgrastim was used to mobilize PBPCs from 60 healthy donors. Granulocyte colony-stimulating factor (G-CSF, 10 μg/kg) was administered daily to the matched donors. Leukapheresis was scheduled to commence on day 4 of the mobilization regimen. The median yielded CD34+ cell in the pegfilgrastim group was higher than those in the G-CSF group, at 5.06 × 106/kg recipient weight. The 73.3% of donors mobilized with pegfilgrastim yielded >4 × 106 cells/kg CD34+ cells in a single apheresis procedure when compared to the 33.3% of donors mobilized with G-CSF (P < 0.001). The myeloid-derived suppressor cells (MDSC) proportion in the pegfilgrastim group was significantly higher than that in the G-CSF group (P < 0.001). The cumulative incidence of grade II-IV acute graft-versus-host disease (aGVHD) was higher in the G-CSF group than that in the pegfilgrastim group (26.7% vs. 11.7%), without statistical difference. In comparison to the G-CSF group, the pegfilgrastim group had a reduced median pain intensity numerical rating scale score (1 vs. 2). A single 6 mg dosage of pegfilgrastim is effective and safe for allogeneic PBPCs collection from healthy donors. Pegfilgrastim may decrease the incidence of aGVHD by boosting MDSCs, which need further investigation.

Do insurance and socioeconomic status affect outcomes for children who undergo surgery for medial epicondyle fractures?

Background: Low socioeconomic status (SES) and Medicaid insurance have been associated with poorer outcomes. The purpose of this study is to compare outcomes among children with Medicaid vs private insurance, and children with low vs high SES who undergo surgery for medial epicondyle fractures. Methods: This is a retrospective review of patients who underwent surgery for medial epicondyle fractures at a large pediatric hospital between 2015 and 2020. SES was measured using the Opportunity Atlas and the United States Small-Area Life Expectancy Estimate Project. A subset of patients were prospectively administered the PROMIS Pediatric Pain Intensity Numeric Rating Scale and PROMIS Pediatric Upper Extremity Short Form to gather additional information on outcomes as they relate to SES. Results: Of 117 patients, 59 (50.4%) were females, 90 (76.9%) were Caucasian, and average age was 11.1. The average household income was $44,889 (SD=$11,417) and most patients (72.6%) were privately insured. Higher household income was associated with increased number of follow-up appointments (β=0.29, 95% CI=0.08, 0.50) and increased likelihood of using physical therapy (OR=1.67, 95% CI=1.15, 2.42). Patients with private insurance returned to activity 20.5 days sooner than those with public insurance (β=−20.52, 95% CI=−39.5, −1.53). Private insurance tended to be related to less likelihood of complications and more likelihood of use of physical therapy. Conclusions: Insurance and SES may play a role in shaping healthcare outcomes for pediatric patients receiving surgery for medial epicondyle fractures. Level of Evidence: Prognostic Level III.

Comparison of cognitive functional therapy and movement system impairment treatment in chronic low back pain patients: a randomized controlled trial

BackgroundThis study aimed to compare the effects of cognitive functional therapy (CFT) and movement system impairment (MSI)-based treatment on pain intensity, disability, Kinesiophobia, and gait kinetics in patients with chronic non-specific low back pain (CNSLBP).MethodsIn a single-blind randomized clinical trial, we randomly assigned 91 patients with CNSLBP into CFT (n = 45) and MSI-based treatment (n = 46) groups. An 8-week training intervention was given to both groups. The researchers measured the primary outcome, which was pain intensity (Numeric rating scale), and the secondary outcomes, including disability (Oswestry disability index), Kinesiophobia (Tampa Kinesiophobia Scale), and vertical ground reaction force (VGRF) parameters at self-selected and faster speed (Force distributor treadmill). We evaluated patients at baseline, at the end of the 8-week intervention (post-treatment), and six months after the first treatment. We used mixed-model ANOVA to evaluate the effects of the interaction between time (baseline vs. post-treatment vs. six-month follow-up) and group (CFT vs. MSI-based treatment) on each measure.ResultsCFT showed superiority over MSI-based treatment in reducing pain intensity (P < 0.001, Effect size (ES) = 2.41), ODI (P < 0.001, ES = 2.15), and Kinesiophobia (P < 0.001, ES = 2.47) at eight weeks. The CFT also produced greater improvement in VGRF parameters, at both self-selected (FPF[P < 0.001, ES = 3], SPF[P < 0.001, ES = 0.5], MSF[P < 0.001, ES = 0.67], WAR[P < 0.001, ES = 1.53], POR[P < 0.001, ES = 0.8]), and faster speed, FPF(P < 0.001, ES = 1.33, MSF(P < 0.001, ES = 0.57), WAR(P < 0.001, ES = 0.67), POR(P < 0.001, ES = 2.91)] than the MSI, except SPF(P < 0.001, ES = 0.0) at eight weeks.ConclusionThis study suggests that the CFT is associated with better results in clinical and cognitive characteristics than the MSI-based treatment for CNSLBP, and the researchers maintained the treatment effects at six-month follow-up. Also, This study achieved better improvements in gait kinetics in CFT. CTF seems to be an appropriate and applicable treatment in clinical setting.Trial registrationThe researchers retrospectively registered the trial 10/11/2022, at https://www.umin.ac.jp/ with identifier number (UMIN000047455).

Patterns of movement-evoked pain during tendon loading and stretching tasks in Achilles tendinopathy: A secondary analysis of a randomized controlled trial

BackgroundThis study aimed to characterize movement-evoked pain during tendon loading and stretching tasks in individuals with Achilles tendinopathy, and to examine the association between movement-evoked pain with the Achilles tendinopathy type (insertional and midportion), biomechanical, and psychological variables. MethodsIn this laboratory-based, cross-sectional study, 37 individuals with chronic Achilles tendinopathy participated. Movement-evoked pain intensity (Numeric Rating Scale: 0 to 10) and sagittal-plane ankle biomechanics were collected simultaneously during standing, fast walking, single-leg heel raises, and weight-bearing calf stretch. Description of symptoms, including location of Achilles tendon pain and duration of tendon morning stiffness, as well as pain-related psychological measures, including the Tampa Scale of Kinesiophobia were collected. Linear mixed effects models were built around two paradigms of movement-evoked pain (tendon loading and stretching tasks) with each model anchored with pain at rest. FindingsMovement-evoked pain intensity increased as task demand increased in both models. Lower peak dorsiflexion with walking (β = −0.187, 95% CI: −0.305, −0.069), higher fear of movement (β = 0.082, 95% CI: 0.018, 0.145), and longer duration of tendon morning stiffness (β = 0.183, 95% CI: 0.07, 0.296) were associated with greater pain across tendon loading tasks (R2 = 0.47). Lower peak dorsiflexion with walking (β = −0.27, 95% CI: −0.41, −0.14), higher dorsiflexion with the calf stretch (β = 0.095, 95% CI: 0.02, 0.16), and insertional Achilles tendinopathy (β = −0.93, 95% CI: −1.65, −0.21) were associated with higher pain across tendon stretching tasks (R2 = 0.53). InterpretationIn addition to exercise, the ideal management of Achilles tendinopathy may require adjunct treatments to address the multifactorial aspects of movement-evoked pain.

Internet-Delivered Cognitive Behavioral Treatment for Chronic Pain in Adolescent Survivors of Childhood Cancer: Protocol for a Single-Group Feasibility Trial.

There are over 500,000 survivors of childhood cancer in North America alone. One in 4 survivors experiences chronic pain after treatment has been completed. Youths with chronic pain report increased anxiety, depression, activity limitations, and sleep disturbances. An 8-week web-based cognitive behavioral treatment for chronic pain (Web-Based Management of Adolescent Pain [WebMAP]) has demonstrated a reduction in pain in youths but has not yet been explored in survivors. The objectives of this study are to (1) test the feasibility and acceptability of WebMAP for a sample of survivors with chronic pain and their parents; (2) assess the acceptability of WebMAP using qualitative interviews; (3) assess WebMAP's effect on activity limitations, pain intensity, depression and anxiety symptoms, and sleep disturbances; and (4) assess WebMAP's effect on parent pain catastrophizing and parental response to their child's pain. A single-arm mixed methods pre-post intervention study design will be used. Participants will be 34 survivors and at least one of their parents or caregivers. Inclusion criteria are (1) a cancer history, (2) current age of 10-17 years, (3) >2 years post treatment or >5 years post diagnosis, (4) pain present over prior 3 months impairing >1 area of daily life and occurring >1 time per month, and (5) computer access with broadband internet. Survivors will complete a pretreatment questionnaire, which will include the following: the Child Activity Limitations Interview, the pain intensity Numerical Rating Scale, Patient-Reported Outcomes Measurement Information System (PROMIS)-Pain Interference, Anxiety, Depression, Insomnia Severity Index, and Adolescent Sleep Wake Scale. Parents will complete the Pain Catastrophizing Scale-Parent Version and the Adult Responses to Child Symptoms. Upon completion of pretreatment questionnaires (T0), survivors will begin WebMAP. After the 8-week intervention, survivors will complete the same measures (T1), and at 3-month follow-up (T2). Posttreatment interviews will be conducted to determine acceptability. Feasibility will be assessed via recruitment and retention rates. Treatment engagement will be measured by number of modules completed. Pre-post outcome data will be assessed using linear mixed models. Qualitative data will be analyzed using thematic analysis. Patient partners will be involved in study design, recruitment, interpretation of results, and knowledge translation. This study has been funded in January 2022. Data collection started in May 2022 and is projected to end in August 2023. We have enrolled 10 participants as of December 2022. Investigating whether WebMAP is useful to survivors will be an important step in improving pain management in this population. ClinicalTrials.gov NCT05241717; https://clinicaltrials.gov/ct2/show/NCT05241717. DERR1-10.2196/45804.

Pain sensitivity after Roux-en-Y gastric bypass- associations with chronic abdominal pain and psychosocial aspects.

The aims of this study were to investigate modifications in pain sensitivity after RYGB and to explore associations between pain sensitivity and weight loss, chronic abdominal pain, total body pain, anxiety, depression, and pain catastrophizing. In total, 163 patients with obesity were examined with a cold pressor test for pain sensitivity before and two years after RYGB. Two aspects of pain sensitivity were registered: Pain intensity (numeric rating scale, range 0-10) and pain tolerance (seconds). Associations between pain sensitivity and the explanatory variables were assessed with linear regression. Two years after RYGB the pain intensity increased (mean±SD 0.64±1.9 score units, p<0.001). Pain tolerance decreased (7.2±32.4 s, p=0.005). A larger reduction in body mass index was associated with increased pain intensity, β=-0.090 (95 % CI-0.15 to-0.031, p=0.003), and decreased pain tolerance β=1.1 (95 % CI 0.95 to 2.2, p=0.03). Before surgery, participants with chronic abdominal pain reported 1.2±0.5 higher pain intensity (p=0.02) and had 19.2±9.3 s lower pain tolerance (p=0.04) than those without abdominal pain. No differences in pain sensitivity were observed between participants who did or did not develop chronic abdominal pain after RYGB. Pain sensitivity was associated with symptoms of anxiety but not with pain catastrophizing, depression or bodily pain. The pain sensitivity increased after RYGB and was associated with larger weight loss and anxiety symptoms. Changes in pain sensitivity were not associated with development of chronic abdominal pain after RYGB in our study.

The efficacy of hydrocolloid dressing as a prophylactic use for hand-foot skin reaction induced by multitargeted kinase inhibitors: A phase 3 randomized self-controlled study, J-SUPPORT 1701 APRON trial.

12107 Background: Hand-foot skin reaction (HFS) is a well-known adverse event that affects the quality of life in patients (pts) who receive multichines inhibitors (TKIs). To prevent HFS, prophylactic depressurization is considered to be one of the important strategies. However, the evidence of depressurization as a prophylactic use for HFS is limited. Therefore, we conducted a phase 3 trial to evaluate the efficacy of depressurization using hydrocolloid dressing, which was usually used for wounds such as decubitus ulcers. Methods: This is a phase 3 randomized self-controlled study to evaluate the efficacy of hydrocolloid dressing by comparing whether or not to add hydrocolloid dressing to prophylactic moisturizing for HFS. The eligible pts were to have unresectable colorectal cancer (CRC), gastrointestinal tumor (GIST), or hepatocellular carcinoma (HCC) and planned to receive either regorafenib or sorafenib. From the start of regorafenib or sorafenib, standard supportive care with moisturizing care alone was performed on one sole of the foot. Moisturizing care plus hydrocolloid dressing was applied to the other side soles of the foot. The primary endpoint was an incidence of grade 2 or more severe HFS (soles of the feet only) assessed by NCI CTCAE v.4.0. Grading of HFS was done according to pre-determined criteria, which consists of blinded central review of photographs of the foot, pain intensity (numerical rating scale) and interference score assessed by pts. The ethical approval was obtained from National Cancer Center Hospital. This study was registered with UMIN Clinical Trial Registry (UMIN000034853). Results: Between Jan 2019 and May 2021, 50 pts were enrolled. The median age was 62.5 years old, and cancer types were CRC in 78%, GIST in 12%, and HCC in 10% of the patients. 48 pts received regorafenib, and 2 pts received sorafenib. The table shows the summary of HFS in each arm. The primary endpoint of the incidence of grade 2 or more severe HFS was significantly lower in the hydrocolloid dressing arm than in the control arm (20% vs. 50%, p &lt; 0.0001). Time to grade 2 or more severe HFS was significantly longer in the hydrocolloid dressing arm (hazard ratio 0.32, p = 0.0017). The incidence of moderate, severe, or very severe in patient-reported HFS using PRO-CTCAE was also lower in the hydrocolloid dressing arm (10% vs. 32%, p = 0.0002). Conclusions: Our study showed the efficacy of the prophylactic use of hydrocolloid dressing for HFS induced by multitargeted kinase inhibitors. Prophylactic moisturizing plus depressurization is the standard of care for this population. Multidisciplinary care plays an important role in the success of treatment with TKIs. Clinical trial information: UMIN000034853 . [Table: see text]