Pain Measures Research Articles

Accuracy of point-of-care SARS-CoV-2 detection using buccal swabs in pediatric emergency departments.

To optimize the identification of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-infected children, specimen collection and testing method are crucial considerations. Ideally, specimen collection is easy and causes minimal discomfort, and the laboratory approach is simple, accurate, and rapid. In this prospective cohort study we evaluated the accuracy of a point-of care nucleic acid device using caregiver/patient self-collected buccal swabs. Participants were recruited in 14 Canadian tertiary care pediatric emergency departments. Children <18 years of age deemed to require SARS-CoV-2 testing were eligible. Caregivers or the patient-collected buccal swabs which were tested on the ABBOTT ID NOW. The reference standard was nasopharyngeal swab specimens collected by a healthcare provider tested via laboratory reverse transcription PCR (RT-PCR). We enrolled 2,640 study participants and 14.4% (381/2,640) were SARS-CoV-2 RT-PCR-positive. Eight percent (223/2,640) and 85.0% (2,244/2,640) were concordant test-positive and concordant test-negative, respectively. Sensitivity and specificity of the investigational approach were 58.5% [95% confidence interval (CI): 53.4, 63.5] and 99.3% (95% CI: 98.9, 99.6), respectively. Cycle threshold values were lower among concordant [median 17 (15, 21)] relative to discordant [median 30 (22, 35)] swabs (P < 0.001). Sensitivity was greatest among children <4 years of age, when caregivers performed the swabs, among unvaccinated children, and those with shorter symptom duration. Across multiple pain measures, less pain was associated with buccal swab testing. Although accuracy of the buccal swab point-of-care SARS-CoV-2 test was good and negative agreement was excellent, sensitivity was only 58.5%. Concordance was greater among those with higher viral loads, and the approach involving buccal swabs was less painful.IMPORTANCETo optimize the identification of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-infected children, specimen collection and testing method are crucial considerations. Ideally, specimen collection is easy and causes minimal discomfort, and laboratory approach is simple, accurate, and rapid. We evaluated the accuracy and pain associated with buccal swab specimen collection by caregivers or children themselves who were tested using a point-of-care isothermal nucleic acid amplification SARS-CoV-2 test. This novel approach was compared to nasopharyngeal swab specimens tested using laboratory-based PCR tests. While negative agreement was excellent, positive percent agreement was less than 60%. Concordance was greater among those with higher viral loads, and thus, sensitivity is excellent when transmissibility is more likely to occur. Importantly, the approach involving buccal swabs was significantly less painful, and thus, children and their caregivers are more likely to agree to testing using such an approach.CLINICAL TRIALSRegistered at ClinicalTrials.gov (NCT05040763).

Effectiveness of Local Glucocorticoid Infiltration Versus Traditional Gauze Bandaging for the Treatment of Onychocryptosis: A Randomized Controlled Trial

Background/objectives: Local intralesional corticosteroid injections into the periungual fold are used to treat patients with onychocryptosis, but their short- or medium-term effects are unknown. The goal was to compare the efficacy of this treatment in stages IIa, IIb, and III of the condition with a common conservative method such as gauze bandaging. Methods: A two-arm randomized trial with 40 patients with stage IIa, IIb, and III onychocryptosis equally assigned into two treatment groups—control (spiculotomy and application of gauze bandaging) and experimental group (spiculotomy and infiltration of corticosteroid)—was performed. Anthropometric data, initial clinical status, pain, and inflammatory measures were collected before and at least one month after the intervention. Results: Pain reduction was higher in the experimental group (5.5 vs. 4.8 points) but with no significant differences (p = 0.306).Corticosteroids significantly reduced inflammation over gauze bandaging (1.9 vs. 1) with significant differences between them (p = 0.029). Conclusions: Corticosteroid infiltration was more effective than gauze bandaging application in reducing inflammation in patients with onychocryptosis, with similar effects on pain. These findings support the clinical importance of corticosteroid treatment for this condition, although a single infiltration may not be sufficient to prevent relapses.

DETECTING CHANGES IN COMFORT, PAIN, AND MOBILITY OVER CLINICAL MILESTONES FOR INDIVIDUALS WITH LOWER LIMB LOSS

BACKGROUND: Functional mobility, comfort and the absence of pain are key goals of prosthetic treatment. Outcome measures (OMs) evaluate the impact of treatment and normative and minimal detectable change (MDC) values are key to interpreting these scores and measuring treatment outcomes. OBJECTIVES: This study seeks to 1) present practice-based normative values of four commonly used OMs at four prosthetic milestones and 2) explore the MDC of the measures over the treatment period. METHODOLOGY: A chart review was conducted of OMs collected with individuals with lower limb loss between January 1, 2015, and December 31, 2023. This included data for individuals with unilateral transtibial (TT), transfemoral (TF) and rotationplasty (RP) amputations and bilateral transtibial amputation (BTT). OMs included the Socket Comfort Score (SCS), Pain Scale (PS), 2 Minute Walk Test (2MWT), and Prosthetic Limb Users Survey of Mobility (PLUS-M). Data were collected at four milestone time points: (1) Baseline and (2) Discharge from Rehabilitation for those in initial prosthetic rehabilitation, and (3) Initial Evaluation and (4) Definitive Delivery for those receiving a replacement socket. Normative values and MDC values were calculated. FINDINGS: Data from 30 individuals undergoing in-patient rehabilitation and 74 individuals receiving a replacement socket were included. Practice-based normative data were different for each level of amputation and milestone and had the following ranges: SCS: 5.7 – 9.1, PS: 0.8 – 3.7, 2MWT: 68.4 – 146.3 m and PLUS-M: 38.9 – 57.3. MDC values also varied based on time in treatment (Rehabilitation: SCS = 2.5, PS = 1.6, 2MWT = 32.6, PLUS-M = 8.8; Replacement Socket: SCS = 3.1, PS = 2.6, 2MWT = 38.9, PLUS-M = 4.0). All measures had a statistically significant change over the intervention, however, no average scores changed by greater than the MDC. CONCLUSIONS: The normative data and MDC scores demonstrate the PS &amp; PLUS-M are useful measures of pain and mobility at all points within treatment. The 2MWT is indicated for individuals in rehabilitation, while the SCS is indicated for those receiving a replacement socket, as both effectively measure treatment goals that are particularly important for each phase of rehabilitation. This provides clinicians with practice-based evidence that enables them to interpret OM scores, a critical part of the decision-making process along the treatment journey. Layman's Abstract When someone receives a prosthesis, the key goals are to promote mobility and comfort and to reduce pain. Outcome measures are questionnaires or performance-based tests that measure the impact of prosthetic treatment. The scores are interpreted by comparing them to normal values and assessing changes over time against a predetermined threshold for what constitutes a significant amount of change. This study analyzed outcome measure scores collected in clinical practice over a 9-year period, from 2015 - 2023. We included individuals with lower limb loss and presented normal values along with threshold change values taken from a clinical setting for four commonly used measures that assess comfort, pain, and mobility. The data included 30 individuals currently attending initial rehabilitation and 74 individuals who had prior experience using a prosthesis. All the normal values were different for each level of amputation and each milestone within rehabilitation. Suggestions are provided regarding which outcome measures are most useful for assessing changes at different points in time. By providing clinicians with evidence based on clinical practice, we can help them use outcome measures to inform decision-making throughout the rehabilitation journey. Article PDF Link: https://jps.library.utoronto.ca/index.php/cpoj/article/view/43890/33243 How To Cite: Pousett B.M, Harasym C.C, Rapaport M.S, Richardson T, Spellen J, Moe D.W, et al. Detecting changes in comfort, pain, and mobility over clinical milestones for individuals with lower limb loss. Canadian Prosthetics &amp; Orthotics Journal. 2024; Volume 7, Issue 1, No.7. https://doi.org/10.33137/cpoj.v7i1.43890 Corresponding Author: Brittany Mae Pousett, CP(C), MSc.540 SE Marine Dr, Vancouver, BC, Canada, V5X 2T4Tel: 604.321.1115E-Mail: brittany@pousett.caORCID ID: https://orcid.org/0000-0002-2272-7847

How Much Does Prosthetic Joint Infection and Its Successful Treatment Affect Patient-reported Quality of Life?

Uncomplicated joint replacement improves pain and other patient-reported outcome measures (PROMs) such as joint function scores and quality-of-life measures. However, the overall impact of periprosthetic joint infection (PJI) and its successful treatment on PROMs is poorly defined. In this study, we describe quality-of-life scores using the 12-item Short Form survey, version 2 (SF-12v2), collected as part of a large, prospective, observational study of PJI. (1) Do patients with newly diagnosed PJI have lower quality-of-life scores than the general age-matched population? (2) Are lower quality-of-life scores for patients with PJI sustained for ≥ 12 months? (3) What factors are associated with a good functional outcome at 12 months, defined by achieving a physical component summary (PCS) score of > 50 on the SF-12v2 (that is, above the age-adjusted population mean) or an increase of > 8.9 or more from baseline? The PIANO (Prosthetic joint Infection in Australia and New Zealand, Observational study) cohort was a prospective, longitudinal, multicenter cohort study of 783 patients with newly diagnosed PJI recruited across 27 centers between July 2014 and December 2017. All participants were followed for 2 years. SF-12v2 scores were collected at diagnosis (baseline) and 3, 12, and 24 months after diagnosis. Treatment success was defined as being alive with no clinical or microbiological evidence of infection and no ongoing use of antibiotics for the index joint. After exclusion of 6.6% (52) who had died, 4.2% (33) with PJI of joints other than hips and knees, and those with incomplete data sets (200 [25.5%]), 498 patients had complete SF-12v2 data sets available. At baseline, the median (IQR) PCS score was 37 (30 to 46), which increased to 41 (34 to 49; p < 0.001) at 12 months. Both measures were lower than those for the general age-matched population norm. There was no further improvement in PCS scores between 12 and 24 months. By contrast, the median (IQR) mental component summary score of the SF-12v2 was similar to age-adjusted population norms (48 [37 to 57]) at baseline. Only 40% of patients with PJI achieved a good functional outcome at 12 months. After adjustment for other factors, treatment success of PJI increased the odds of a good functional outcome by 67% (95% CI 11% to 154%; p = 0.02). PJIs have a large effect on the PCS score of the SF-12v2 quality-of-life measure at baseline, which is sustained for at least 2 years. Successful treatment of PJI increases the likelihood of a good functional outcome. These data can be used to set expectations for patients presenting with PJI and can be used to inform future clinical studies in which quality-of-life measures are incorporated into clinical endpoints. Level II, therapeutic study.

Association Between Systemic Neuroinflammation, Pain Perception and Clinical Status in Fibromyalgia Patients: Cross-Sectional Study.

Fibromyalgia (FM) is characterized by chronic pain and a complex array of symptoms, with neuroinflammation implicated in its pathophysiology. This study aimed to explore the association between neuroinflammation, measured through interleukin levels (IL-1, IL-6, IL-8), and clinical outcomes in FM patients. Using a cross-sectional study design, blood levels of these interleukins were correlated with pain severity and disability, assessed via the Fibromyalgia Impact Questionnaire (FIQ) and pain measures. Results indicated that IL-6 and IL-8 may particularly serve as biomarkers for pain severity and disability in FM patients, showing significant associations with worse clinical outcomes. Elevated IL-8 levels, for instance, correlated strongly with increased pain perception and higher disability scores. These findings suggest that specific interleukins are not only elevated in FM but are actively involved in the modulation of pain and disability, underscoring the role of systemic neuroinflammation in the clinical severity of FM. This study contributes to a deeper understanding of the inflammatory mechanisms in FM and underscores the potential of targeting interleukins in therapeutic strategies.

Statistical analysis plan for the Petal trial: the effects of parental touch on relieving acute procedural pain in neonates

Background Infants undergo multiple clinically-required painful procedures during their time in hospital, and there is an increasing desire from both parents and clinical staff to have parents directly involved in their newborn’s pain relief. To avoid biases due to selective analysis and reporting, a clinical trial’s statistical analysis plan (SAP) should be finalised and registered prior to dataset lock and unblinding. Here, we outline the SAP for the Petal trial, which was registered on the ISRCTN registry prior to dataset lock and unblinding. Methods The Petal trial is a multicentre, individually randomised, parallel-group interventional superiority trial. The study involves in-patient neonates born at or after 35+0 weeks gestation with a postnatal age of ≤7 days, in two hospital research sites (John Radcliffe Hospital, Oxford, UK; Royal Devon and Exeter Hospital, Exeter, UK). The primary objective is to investigate the potential efficacy of a non-pharmacological parent-led stroking intervention on reducing the magnitude of neonates’ noxious stimulus-evoked brain activity. The primary outcome is the neonate’s brain activity recorded using electroencephalography (EEG) in response to a heel lance blood sampling procedure. Secondary outcomes include neonatal clinical pain scores and tachycardia, and parental anxiety. The study hypothesis is neonates’ pain responses and parents’ anxiety scores are lower in the intervention group. Randomisation will be via a minimisation algorithm to maintain balance in five prognostic factors. Conclusions Paediatric pain trials have been highlighted by regulatory bodies as an important and challenging topic, with interest increasing in brain imaging outcomes. The Petal trial, to which this SAP relates, is part of a larger effort of establishing a brain-based EEG outcome measure of infant pain for use in clinical trials. This SAP is thus likely to be of interest to those in academia, pharmaceutical companies, and regulatory bodies. Trial registration ClinicalTrials.gov: NCT04901611, 25/05/2021; ISRCTN: ISRCTN14135962, 23/08/2021).

Midterm Outcomes After Osteochondral Allograft Transplantation in the Knee Using High-Chondrocyte Viability Grafts.

Osteochondral allograft transplantation (OCAT) has become a standard-of-care treatment option for patients with large symptomatic articular defects. Recent advances in allograft science and OCAT protocols have been reported to result in consistently robust outcomes after OCAT in the knee. However, only short-term comparisons have been reported, and analyses are lacking for treatment failure risk factors that account for confounding variables. Midterm functional graft survival rate would exceed 80% for all OCATs combined, with consideration of risk factors for lower survivorship including older patient age, higher body mass index (BMI), tibiofemoral bipolar OCAT, and nonadherence to prescribed postoperative rehabilitation protocols. Case series; Level of evidence, 4. Patients with outcome data available at ≥5 years after primary OCAT using high chondrocyte-viability (HCV) osteochondral allografts were analyzed according to 2 clinically relevant definitions: (1) initial treatment failure, defined by revision or arthroplasty surgery performed for the primary OCAT at any time point during the study period; and (2) functional graft failure, defined by documented conversion to arthroplasty after primary or revision OCAT at any time point during the study period. Analyses were used to assess outcomes for each definition, separately for age group, sex, obesity status, tobacco use, type of OCAT surgery, osteotomy status, concurrent ligament surgery status, and adherence to postoperative protocols. Kaplan-Meier analyses were used to assess differences in survival rates, and Cox proportional hazards models were used to assess risk factors and multivariable relationships with survival. Patient-reported outcome measures for pain, function, mobility, and satisfaction were also analyzed. Analysis included 137 primary knee OCATs performed in 134 patients with a mean follow-up of 66 months (59 female, 75 male; mean age, 37.8 years; mean BMI, 28.5). The midterm (5- to 8-year) functional graft survival rate for patients undergoing primary OCAT in the knee using HCV grafts was 82% for all cases combined, ranging from 69% for tibiofemoral bipolar HCV OCATs to 89% for patellofemoral bipolar, 94% for multisurface unipolar, and 97% for single-surface unipolar. Initial treatment failure rates (revision or arthroplasty after primary OCAT) and OCAT nonsurvival rates (arthroplasty after primary or revision OCAT) were greater for older patient age, concurrent ligament reconstruction, tibiofemoral bipolar OCAT, and nonadherence to the prescribed postoperative rehabilitation protocols. When adjusted for patients' age, BMI, and tobacco use status, different surgery types did not demonstrate an increased risk for failure, while concurrent ligament reconstruction and nonadherence did. Patients who experienced functional graft survival after primary OCAT reported significantly greater improvements in PROMIS Physical Function and Mobility (Patient-Reported Outcomes Measurement Information System), International Knee Documentation Committee questionnaire, and Single Assessment Numeric Evaluation scores such that they were significantly higher at final follow-up as compared with patients who required arthroplasty. Patient-reported improvements in pain, function, and mobility exceeded minimal clinically important differences for ≥5 years after primary OCAT. When asked if they were satisfied with primary OCAT surgery, 76.2% of patients were very satisfied or satisfied with their results, while 8.5% were neutral and 15.4% were unsatisfied or very unsatisfied. With use of HCV osteochondral allografts, midterm (5- to 8-year) functional graft survival rates for patients undergoing primary OCAT in the knee were notably higher than previously reported midterm rates for traditional OCATs. When adjusted for patient characteristics, risk factors for nonsurvival included concurrent ligament reconstruction for knee instability and nonadherence to the prescribed postoperative rehabilitation protocols. Patients who experienced functional graft survival for ≥5 years after primary OCAT reported statistically significant and clinically meaningful improvements in pain, function, and mobility.

Combined Transcranial Direct Current Stimulation and Pain Neuroscience Education for Chronic Low Back Pain: A Randomized Controlled Trial.

Priming the neural circuity likely targeted by pain neuroscience education (PNE), using transcranial direct current stimulation (tDCS) may enhance the efficacy of PNE. The aim of this study was to compare the effects of active tDCS + PNE to sham tDCS + PNE on measures of pain, pain behaviors, and cognitive function in participants with chronic low back pain (CLBP) and high pain catastrophizing. 20 participants were recruited and randomly allocated into the active tDCS + PNE (n = 10) or sham tDCS + PNE (n = 10) groups. All participants received five sessions of their assigned interventions over a 2-week period. The active tDCS + PNE group received 20 minutes of 2 mA, anodal current applied to the left dorsolateral prefrontal cortex. Within groups, both interventions demonstrated significant improvement in NPRS, PCS, and TSK. The active tDCS + PNE group also demonstrated significant improvement on the SCWT, CTMT2-Inhibitory, and CTMT2-Set Shifting. Between groups, the active tDCS + PNE group showed significantly greater improvement on the PCS, SCWT, and CTMT2-Inhibitory. The results of this pilot study suggest that active tDCS + PNE appeared to provide greater improvement than sham tDCS + PNE on levels of pain catastrophizing and attentional interference in participants with CLBP and high pain catastrophizing, consistent with both interventions targeting brain regions involved in those processes. Considering the differences between groups, tDCS appears to provide a priming effect on PNE.

Does achieving apical patency increase postoperative pain during endodontics?

PubMed, Scopus, Embase, Web of Science, Cochrane Library, and gray literature up to May 2023. Twelve studies were included for meta-analysis. Two authors screened databases to identify suitable studies, with a third investigator resolving disagreements. Inclusion criteria were randomized controlled trials (RCTs) involving individuals without systemic diseases, who underwent root canal treatment in a permanent tooth with or without apical patency. Outcomes included pain, number of patients with pain and analgesic use. Exclusion criteria included patients who had undergone tooth extraction, incomplete data reports and studies which were not RCTs. There were no limits on publication language. A search of PubMed, Scopus, Embase, Web of Science, Cochrane Library, and gray literature from Google Scholar, ProQuest, OpenAire, and BASE identified 92 articles until May 2023. After removing 42 duplicates, 50 article full texts were assessed. Ultimately, 12 studies were included, seven of which were new relative to previous systematic reviews. Data were analysed using RevMan 5.4 software. Dichotomous categorical data were analysed through the Cochran-Mantel-Haenszel test, with the inverse variance method used for continuous data. Following assessment of heterogeneity with the χ2 test, fixed- or random- effects modeling was used. Pain scores were reported within one week by ten studies, but three were excluded from meta-analysis due to methodological issues. Studies involving participants aged 14-65 years, with pulp necrosis, apical periodontitis, or pulpitis, were included for analysis. Irrigation solutions varied from saline to sodium hypochlorite (2.25-5.25%), EDTA, citric acid, or chlorhexidine. Types of teeth treated included molars and anterior teeth. All studies used a 10# K-file for apical patency and various hand and nickel-titanium instruments for canal preparation. Generally, there was slightly reduced post-operative pain reported through the maintenance of patency. This was evident in the initial post-operative period of 24 h (OR = 1.69, P = 0.002), 1-day (MD = -1.69, P = 0.03) and 2-days (MD = -0.85, P = 0.04), but became non-significant over the remainder of the 7-day monitoring period. There was no significant difference in analgesic use between groups (OR = 0.82, P = 0.42). Studies were classified into three groups based on quality: four high quality with low risk of bias; three moderate quality with some concerns; and five low quality with high risk of bias. Evidence quality varied; pain scores on days 1 and 2 were of low quality, with very low quality for 12 h and days 3-6. High heterogeneity and imprecision were noted, especially in pain measurements and analgesic use. The meta-analysis indicates that during the initial post-operative period, apical patency significantly reduces postoperative pain. However, the findings should be interpreted cautiously due to high heterogeneity and variable evidence quality. Given that apical patency is seen as desirable for achieving the biological aims of endodontic treatment, the fact that it also appears to reduce post-operative pain helps to align patient reported outcome measures with traditional measures indicating success.

Implementing Evidence-Based Pain Management Interventions Into an Emergency Department: Outcomes Guided by Use of the Ottawa Model of Research Use.

To implement strategies to improve the care of patients with acute pain in the emergency department (ED). Pre-post implementation study using a Type 2 hybrid effectiveness-implementation design. Implementation strategies were introduced and monitored through the Ottawa Model of Research Uses' assessment, monitoring and evaluation cycles, supported by focused and sustained facilitation. Improvements in time-to-analgesia within 30 min (21%-27%), administration of nurse-initiated analgesia (NIA) (17%-27%) and measurement of pain (65%-75%) were achieved post-implementation. NIA was the strongest predictor of receiving analgesia within 30 min. Adoption of pain interventions into practice was not immediate yet responded to sustained facilitation of implementation strategies. Collaboration with local clinicians to introduce simple interventions that did not disrupt workflow or substantially add to workload were effective in improving analgesia administration rates, and the proportion of patients receiving analgesia within 30 min. The assessment, monitoring and evaluation cycles enabled agile and responsive facilitation of implementation activities within the dynamic ED environment. Improvements took time to embed into practice, trending upward over the course of the implementation period, supporting the sustained facilitation approach throughout the study. Sustained adoption of evidence-based pain interventions into the care of people presenting to the ED with acute pain can be achieved through sustained facilitation of implementation. NIA should be at the centre of acute pain management in the ED. This study addressed the lingering gap between evidence and practice for patients with acute pain in the ED. Implementation of locally relevant/informed implementation strategies supported by focused and sustained facilitation improved the care of patients with acute pain in the ED. This research will have an impact on people presenting to EDs with acute pain, and on clinicians treating people with acute pain in the ED. Relevant equator guidelines were followed and the StaRI reporting method used. No Patient or Public Contribution in this study.

Vimseltinib versus a placebo in patients with tenosynovial giant cell tumor: a plain language summary of the MOTION phase 3 trial.

This article presents a patient-friendly summary of the MOTION phase 3 clinical trial results, which were published in The Lancet in June 2024.The primary goal of the MOTION trial was to understand if treatment with a drug called vimseltinib shrank tumors more than a placebo in participants with symptomatic tenosynovial giant cell tumor, also known as TGCT, for which surgery was unlikely to provide benefit. A placebo is something that looks like the treatment being studied but does not contain any medicine.The MOTION trial compared the effects of vimseltinib versus a placebo using several different outcomes associated with TGCT. These outcomes included tumor size, active range of motion of the affected joint, and several patient-reported quality-of-life measures including physical function, stiffness, overall health, and pain. The trial showed that more participants treated with vimseltinib experienced significant tumor shrinkage, as defined by a 30% or greater reduction in tumor size, compared with those receiving a placebo. Participants receiving vimseltinib had improved active range of motion, and they reported improved physical function, stiffness, overall health, and pain, regardless of the amount of tumor shrinkage, compared with participants receiving a placebo. Most side effects in participants treated with vimseltinib were not severe and were manageable. Vimseltinib was better at shrinking tumors and improving active range of motion, stiffness, pain, and other health measures than the placebo for participants with TGCT. Vimseltinib has the potential to become a new treatment option for patients with TGCT for whom surgery may not provide benefit.

12589 Two Systematic Reviews Of Treatment Efficacy On Patient Important Outcomes In Adult X-linked Hypophosphatemia

Abstract Disclosure: D.S. Ali: None. R. Mirza: None. F. Alsarraf: None. S. Hussein: None. N. Appelman-Dijkstra: Consulting Fee; Self; Amgen Inc, Kyowa Kirin, UCB. Grant Recipient; Self; Kyowa Kirin. S. Beck-Nielsen: Consulting Fee; Self; Kyowa Kirin, Inozymes, Novo Nordisk. Grant Recipient; Self; Kyowa Kirin. Speaker; Self; Kyowa Kirin. M. Biosse-Duplan: Advisory Board Member; Self; Alexion Pharmaceuticals, Inc.. Grant Recipient; Self; Kyowa Kirin. Speaker; Self; Kyowa Kirin, Alexion Pharmaceuticals, Inc. M. Brandi: Consulting Fee; Self; Alexion Pharmaceuticals, Inc., Aboca, Amolyt, Bruno Farmaceutici, Calcilytix, Kyowa Kirin. Speaker; Self; Alexion Pharmaceuticals, Inc., Amgen Inc, Eli Lilly &amp; Company, Takeda, Kyowa Kirin. C. Chaussain: Grant Recipient; Self; Kyowa Kirin. M. Cohen-Solal: Grant Recipient; Self; Kyowa Kirin. Speaker; Self; Kyowa Kirin. R.K. Crowley: Advisory Board Member; Self; UCB, Amgen Inc. Consulting Fee; Self; Kyowa Kirin. Speaker; Self; Kyowa Kirin. K. Dandurand: Speaker; Self; Amgen Inc, Kyowa Kirin. P.F. Florenzano: None. S. Fukumoto: Consulting Fee; Self; Kyowa Kirin. C. Gagnon: Grant Recipient; Self; Takeda, Ascendis Pharma. P. Goodyer: None. C. Grasemann: Speaker; Self; Kyowa Kirin. E.A. Imel: Consulting Fee; Self; Ultragenyx, Kyowa Kirin, Inozyme. Grant Recipient; Self; Ultragenyx, Kyowa Kirin, Amgen Inc. S.M. Jan De Beur: Consulting Fee; Self; Kyowa Kirin, Ultragenyx. E.M. Lewiecki: Consulting Fee; Self; Amgen Inc. Research Investigator; Self; Amgen Inc, Ultragenyx. Speaker; Self; Amgen Inc, Ascendis. E. Morgante: None. L. Ward: Other; Self; Tier 1 (Senior) Research Chair in Pediatric Bone Disorders from the University of Ottawa and the Children’s Hospital of Eastern Ontario Research Institute. A.A. Khan: Advisory Board Member; Self; Amgen Inc, Takeda, Alexion, Ascendis. Grant Recipient; Self; Takeda, Ascendis, Amolyt, Calcilytix. G. Guyatt: None. Objective: Our objective was to examine the highest certainty evidence addressing the management of X-linked hypophosphatemia in adults, aiming to inform treatment recommendations. Eligibility criteria: We searched Embase, MEDLINE, Web of Science, and Cochrane from inception to March 2023 and included RCTs and observational studies enrolling individuals ≥ 18 years diagnosed with XLH on clinical grounds or with a confirmed pathogenic variant in PHEX. Manuscripts evaluating the effectiveness of burosumab compared to either no treatment or conventional therapy (phosphate salts and active vitamin D) or evaluating conventional therapy compared to no treatment were selected. Methods: Two reviewers independently determined eligibility, conducted data extraction, and assessed the risk of bias (RoB). GRADE was used to assess certainty of evidence. Results: After removing duplicates from 7,043 citations, we assessed 254 full texts. Of those, one RCT proved eligible. The RCT of burosumab versus no treatment was at low RoB with certainty of evidence on individual outcomes ranging from high to very low. Burosumab probably improves pain inferred from fracture and pseudofracture healing (moderate certainty); however, burosumab probably has little or no impact on direct pain measures (moderate certainty). While burosumab may reduce the need for parathyroidectomy, indicated by lowered PTH levels (low certainty), it has little or no impact on fatigue (high certainty), stiffness (moderate certainty), and mobility (low certainty) over 24 weeks. Burosumab may also increase dental abscesses (low certainty). No formal comparisons of burosumab and conventional therapy exist; therefore, our low certainty evidence inferences regarding burosumab versus conventional therapy were based on indirect evidence from comparisons of burosumab versus no treatment and from conventional therapy versus no treatment. Observational studies proved at high RoB providing very low certainty of evidence regarding the impact of conventional therapy versus no treatment. This evidence pertained to the reduction in the risk of parathyroidectomy, as well as the reduction in the burden of symptoms caused by chronic hypophosphatemia. Conclusion: Burosumab when compared to no treatment may improve pain through fracture healing and may reduce the need for parathyroidectomy, but it could also increase the risk of dental abscess. However, when using direct measures of pain and function, burosumab demonstrated probably little or no impact on pain and stiffness, little or no impact on fatigue, and may have had little to no impact on mobility. Very low certainty exists regarding conventional therapy versus no treatment in adults. Overall, our review highlights the need for more data to better understand the long-term impact of burosumab and conventional therapy on patient-important outcomes. Presentation: 6/2/2024

Content Evaluation of Pruritus, Skin Pain, and Sleep Disturbance Patient-Reported Outcome Measures in Adolescents and Adults With Moderate-to-Severe Atopic Dermatitis: Qualitative Interviews.

Pruritus, skin pain, and sleep disturbance are a significant burden to individuals with moderate-to-severe atopic dermatitis (AD) and negatively impact quality of life. Fit-for-purpose patient-reported outcome measures (PROMs) that assess AD-related pruritus, skin pain, and sleep disturbance are important for evaluating the effectiveness of new AD treatments. To evaluate content validity of five AD-related PROMs in adolescents and adults with moderate-to-severe AD (the Worst Pruritus Numeric Rating Scale [NRS], the AD Skin Pain NRS; the Sleep Disturbance NRS, the skin pain-specific Patient Global Impression of Change [PGIC], and the skin pain-specific Patient Global Impression of Severity [PGIS]) and to assess patient-reported experience with pruritus, skin pain, and sleep disturbance. A qualitative study in adolescents (aged 12-17 years) and adults with moderate-to-severe AD was conducted in two consecutive stages. In each stage, two iterative rounds of individual interviews were conducted by experienced interviewers. All interviews included concept elicitation and cognitive debriefing components. Data were analysed using thematic analysis. A total of 27 adults and 20 adolescents with moderate-to-severe AD participated in the initial content evaluation (Stage 1) of the Worst Pruritus NRS [1.0] and AD Skin Pain NRS [1.0] (n = 26; 16 adults, 10 adolescents) and in the subsequent content evaluation (Stage 2) of the revised Worst Pruritus NRS [1.1], revised AD Skin Pain NRS [1.1], Sleep Disturbance NRS, skin pain-specific PGIC, and skin pain-specific PGIS (n = 21; 11 adults, 10 adolescents). Results were generally aligned and consistent for both adult and adolescent participants. Additionally, we found that sleep disturbance is relevant and important for evaluation in adults and adolescents with moderate-to-severe AD (Stage 2), while also providing further confirmation of this for pruritus and skin pain (Stages 1 and 2). Our findings support the content validity of the revised Worst Pruritus NRS [1.1], revised AD Skin Pain NRS [1.1], Sleep Disturbance NRS, skin pain-specific PGIC, and skin pain-specific PGIS in individuals aged ≥12 years with moderate-to-severe AD. Furthermore, the findings support sleep disturbance, skin pain, and pruritus as being relevant and important features for both adolescents and adults with moderate-to-severe AD.

Effects of increasing walking cadence on gait biomechanics in adults with knee osteoarthritis

Gait retraining is a strategy to manage altered loading patterns and pain characteristic of knee osteoarthritis. Lower walking cadence is associated with higher knee joint loading, vertical ground reaction forces, and risk for cartilage worsening. Therefore, we determined the acute effects of increasing walking cadence on measures of lower extremity loading and knee pain in knee osteoarthritis. Twenty-five participants with knee osteoarthritis (age = 62.5 ± 7.2; 76.0 % female) walked at fixed speed on an instrumented treadmill from which baseline cadence was measured. Five, randomized experimental cadence conditions (2 %, 4 %, 6 %, 8 %, or 10 % over baseline cadence) were completed. Real-time auditory and visual feedback on cadence was provided while kinematics and ground reaction forces were sampled. Linear mixed effects models evaluated the effect of cadence on knee adduction and flexion moment peaks and impulses, impact loading metrics (vertical ground reaction force impact peak, vertical average and instantaneous loading rates), and knee pain. Increasing cadence by 2–10 % did not significantly change knee adduction moment peaks or impulse. Peak knee flexion moment increased by 3–32 % and knee flexion moment impulse reduced by 2–9 % with increases in cadence, but these results were not significant (peak knee flexion moment, p = 0.070; knee flexion moment impulse, p = 0.085). Increasing cadence significantly increased the vertical impact peak (p < 0.001), and the vertical average (p = 0.010), and instantaneous (p = 0.007) loading rates. Small increases in cadence at a fixed gait speed does not significantly change surrogate measures of knee joint loading or pain, but does increase measures of impact loading.

Patient Characteristics Influencing Knee Injury and Osteoarthritis Outcome Scores Vary with Time from Patellar Dislocation and Number of Dislocations

ObjectivesDemographic characteristics of the patient population influence patient reported outcome measures (PROMs) following patellar dislocations. The time from injury and number of dislocations can also vary within the patient population. The hypothesis of the study is that characteristics of the patient population influencing Knee injury and Osteoarthritis Outcome Score (KOOS) measures of pain, function and quality of life vary with time from patellar dislocation and number of dislocations. MethodsOutcome scores were evaluated for subjects in four groups: within five months of a first patellar dislocation (first-time group, n = 24), within five months of a recurrent dislocation (multiple group, n = 15), five to twelve months after a first dislocation (post-acute group, n = 14), and two years or longer after a first dislocation (two years group, n = 14). For each group, KOOS pain, physical function and quality of life scores were compared between males and females. KOOS scores were also correlated against age, body mass index (BMI), and time since first and most recent dislocation. ResultsFor the first-time dislocation group, physical function and quality of life scores were higher for men than women (p < 0.05). For the multiple dislocation group, pain and physical function improved as BMI decreased (p < 0.025), while quality of life improved as age decreased (p = 0.014). For the post-acute group, all three scores improved as BMI decreased (p < 0.05). For the two years group, all three scores worsened as time since first dislocation increased (p < 0.01). ConclusionsFollowing patellar dislocation, relationships between characteristics of the patient population and PROMs vary with time from injury and number of dislocations. In the acute phase following a first dislocation, PROMs likely reflect the traumatic injury. Based on relationships with BMI, outcomes likely reflect functional capacity of the knee in the acute phase of multiple dislocations and post-acute phase of a first dislocation. After multiple years, progressive degradation of the knee over time seems to influence PROMs. Level of EvidenceRetrospective study with more than one negative criterion (Level 4)

Evaluation of the Nordic Musculoskeletal Questionnaire for Measuring Prevalence and the Consequence of Pain in a Danish Adult OI Population: A Pilot Study.

Pain is a challenge in persons with OI and causes much concern in the Osteogenesis Imperfecta (OI) population. We aim to evaluate the usability of the Nordic Musculoskeletal Questionnaire (NMQ) to identify painful sites in adults with OI and to describe the occurrence of musculoskeletal (MSK) pain and its impact on their work and daily activities. This cross-sectional pilot study uses the OI-NMQ to study MSK pain prevalence in nine separate anatomical regions (neck, upper back, lower back, shoulder, elbow, hand/wrist, hip, knee, and ankle/foot) and its impact on regular work and daily activities in adults with OI. The questionnaire was distributed among participants of the 2023 annual meeting of The Danish OI Society. The response rate was 68%, and all participants considered the OI-NMQ helpful in assessing the presence of pain and its consequences. The analysis included 27 adults with OI type I, III, or IV above 18years. Among all 27 participants, MSK pain was present in 15-56% of the 9 sites within the last 7days and 33-89% of the nine anatomical regions during the last 12months. In 7-48% of all the participants, their regular work and daily activities had been affected by the presence of MSK pain. The OI-NMQ was feasible in assessing MSK pain among adults with OI and displayed a high prevalence of MSK pain with a moderate impact on their regular work and daily activities in this OI population. A larger and repeated measurement of MSK pain in adults with OI is needed to confirm these results.

Preoperative Osteoporosis Is Associated with Increased Healthcare Utilization and Compromised Pain and Function Improvement after Primary Total Hip Arthroplasty: A Prospective Cohort Analysis

Osteoporosis (OP) has been linked to complications after total hip arthroplasty (THA), but its impact on healthcare utilization and patient-reported outcomes remains unclear. This study aimed to evaluate the association between: 1) pre-THA OP and healthcare utilization as well as patient-reported pain and function outcome measures; and 2) Dual Energy X-ray Absorptiometry (DEXA) scan-based T-scores and the aforementioned outcomes. A retrospective analysis of prospectively collected data of primary THA (2015 to 2018) was performed (n = 5,321) from a validated academic institutional database of a large North American tertiary health care system; of which 4,074 (76.6%) completed one-year follow-up. Outcomes included prolonged length of stay [LOS] > 3 days, discharge disposition, 90-day readmission, and one-year reoperation, as well as Hip Disability and Osteoarthritis Outcome Score (HOOS]) Pain, HOOS-function (PS), and minimal clinically important difference thresholds (MCID), and satisfaction. The prevalence of OP pre-THA was 56.9%, of which 39.8% were not prescribed OP medications and 15.3% had a DEXA scan. Compared to those who did not have OP, those who had OP were independently associated with higher odds of prolonged LOS, non-home discharge, 90-day readmission, and 1-year reoperation (P < 0.005). Furthermore, they had significantly higher odds of failing to achieve MCID (odds ratio (OR): 1.41 (95% confidence interval (CI): 1.06 to 1.89)) for HOOS-PS and satisfaction (OR: 1.5 (95% CI: 1.16 to 1.93)) at 1-year. Higher T-scores were associated with lower odds of prolonged LOS, non-home discharge, failure to achieve MCID in HOOS-Pain, and HOOS-PS. Over half of patients had OP, however, only 15.3% of patients had a DEXA scan prior to THA. Patients who had OP were at higher risk of prolonged LOS, non-home discharge, 90-day readmission, and one-year reoperation in addition to poor pain/function improvement and dissatisfaction one year after THA.

Effects of immunosuppression after limb fracture in mice on nociceptive, cognitive, and anxiety-related outcomes.

Chronic pain is a common and problematic consequence of injuries with few proven methods for prevention or treatment. In addition to pain, functional limitations and neuropsychiatric changes such as cognitive impairment and anxiety worsen outcomes. To determine whether inhibiting activation of the adaptive immune response after limb fracture would reduce pain, functional loss, memory changes, and anxiety. These experiments used a murine tibial fracture/cast immobilization model that develops these adverse outcomes. Adaptive immunity was blocked using the immunosuppressant FK506 beginning at the time of fracture. The administration of FK506 reduced mechanical allodynia and hind limb unweighting for weeks after cast removal as well as nonevoked pain measures. Fracture was associated with working memory loss in the Y-maze assay in vehicle- but not FK506-treated mice. Object recognition memory was not improved with FK506 after fracture. Also, vehicle- but not FK506-treated mice developed an anxiety phenotype. Impaired running wheel performance after cast removal over the following 2 weeks was not improved with FK506 administration. In addition, FK506 treatment blocked Immunoglobulin M (IgM) accumulation in the skin of the fractured limbs, and hippocampal enhancement of matrix metalloproteinase-8 expression, a metalloproteinase associated with neuroplastic changes after injuries, was completely blocked. Taken together, our results show that blocking the adaptive immune response after limb trauma reduces the severity of nociceptive and biological changes. The same treatment may reduce the adverse consequences of anxiety and memory deficits using some measures, but other measures of memory are not affected, and activity is not enhanced.

The Effect of Using Virtual Reality Glasses on Pain During Fistula Cannulation in Hemodialysis Patients: A Randomized Controlled Trial

Objective: Fistula cannulation is performed very frequently for hemodialysis patients. Cannulation carried out repeatedly causes significant pain. In this study, it was aimed to determine the effect of watching videos with virtual reality glasses on reducing the pain during fistula cannulation in hemodialysis patients. Methods: The study was carried out with a total of 47 patients. The patients in the intervention group were shown a video for about five minutes during the procedure using virtual reality glasses as the intervention. The control group patients went through only the standard cannulation procedure. Results: There was no statistically significant difference between the first pain measurement scores of the intervention and control groups. There was a statistically significant difference in the mean pain score of the patients in the intervention group. Also, when the first and second pain measurements were compared within the groups, the second measurement scores were statistically significantly lower than the first in the intervention group. Conclusion: The study results revealed that virtual reality can reduce the pain experienced during fistula cannulation in hemodialysis patients.

Predicting chronic post-traumatic head and neck pain: the role of bedside parameters

Abstract Traumatic brain injury (TBI) annually impacts 69 million individuals worldwide. Mild TBI constitutes approximately 90% of all TBIs. Chronic pain post-mTBI occurs in 29% to 58% of patients. This study aims to introduce a predictive model for chronic pain development in individuals diagnosed with mild traumatic brain injury (mTBI) immediately postinjury. We included individuals who had sustained mTBI in motor vehicle accident (MVA). All patients had initial assessments within the first 72 hours (representing the subacute period) after the injury and performed follow-ups for 1 year. Machine learning model was applied to the integrated measures of clinical pain, pain-related psychological parameters, mTBI clinical signs, and sociodemographic information. This study included 203 patients experiencing acute head or neck pain attributable to mTBI post-MVA. We categorized these patients into 2 groups: patients who progressed to develop chronic head or neck pain (n = 89, 43.8%) and patients who recovered (low/mild pain) (n = 114, 56.2%). Severity of the subacute neck pain, number of painful body areas, and education years were identified as the most significant factors predicting chronic pain. The optimized predictive model demonstrated high efficacy, with an accuracy of 83%, a sensitivity of 92%, and an area under the receiver operating characteristic curve of 0.8. Our findings indicate feasibility in predicting chronic post-MVA pain within the critical 72-hour window postinjury using simple bedside metrics. This approach offers a promising avenue for the early detection of individuals at increased risk for chronic pain, enabling the implementation of targeted early interventions.