Brief Pain Inventory Interference Research Articles

Duloxetine for individuals with chronic back pain: A systematic review and meta‑analysis of randomized controlled trials.

The current study aimed to assess the efficacy of duloxetine in reducing pain and improving the quality of life of individuals with chronic low back pain (CLBP). An extensive literature search was conducted to identify relevant studies that examined the efficacy of duloxetine in CLBP management. The primary objective of the present study was to assess the role of duloxetine use on pain levels, as well as improvements in quality of life, using validated instruments. The results were synthesized using a random-effects model. A total of 8 studies were included in the analysis. Duloxetine demonstrated clear benefits in pain reduction, evidenced by improvements across multiple scales including the visual analogue scale, brief pain inventory-interference (BPI), BPI-severity, weekly worst pain over 24 hours and Roland-Morris Disability Questionnaire scores. Quality of life improved with duloxetine treatment, as indicated by the 36-item short form survey (SF-36). However, there was no significant impact on the physical function component of SF-36. The present study provides evidence to affirm the efficacy of duloxetine in treating CLBP. Further research is required to validate these findings and to establish whether combining duloxetine with other CLBP treatments yields superior outcomes.

Disease Phenotypes in Refractory Musculoskeletal Pain Syndromes Identified by Unsupervised Machine Learning.

Overlapping chronic pain syndromes, including fibromyalgia, are heterogeneous and often treatment-resistant entities carrying significant socioeconomic burdens. Individualized treatment approaches from both a somatic and psychological side are necessary to improve patient care. The objective of this study was to identify and visualize patient clusters in refractory musculoskeletal pain syndromes through an extensive set of clinical variables, including immunologic, psychosomatic, wearable, and sleep biomarkers. Data were collected during a multimodal pain program involving 202 patients. Seventy-eight percent of the patients fulfilled the criteria for fibromyalgia, 77% had a concomitant psychiatric-mediated disorder, and 22% a concomitant rheumatic immune-mediated disorder. Five patient phenotypes were identified by hierarchical agglomerative clustering as a form of unsupervised learning, and a predictive model for the Brief Pain Inventory (BPI) response was generated. Based on the clustering data, digital personas were created with DALL-E (OpenAI). The most relevant distinguishing factors among clusters were living alone, body mass index, peripheral joint pain, alexithymia, psychiatric comorbidity, childhood pain, neuroleptic or benzodiazepine medication, and response to virtual reality. Having an immune-mediated disorder was not discriminatory. Three of five clusters responded to the multimodal treatment in terms of pain (BPI intensity), one cluster responded in terms of functional improvement (BPI interference), and one cluster notably responded to the virtual reality intervention. The independent predictive model confirmed strong opioids, trazodone, neuroleptic treatment, and living alone as the most important negative predictive factors for reduced pain after the program. Our model identified and visualized clinically relevant chronic musculoskeletal pain subtypes and predicted their response to multimodal treatment. Such digital personas and avatars may play a future role in the design of personalized therapeutic modalities and clinical trials.

Using Haptic Technology for Pain Reduction and Functional Improvement

Advancements to reduce pain severity and improve functionality are generally lacking. Chronic or recurrent pain is the most common reason patients consult primary care clinicians. Adverse events associated with existing pharmacological pain treatments have incentivized researchers to identify effective pain treatment strategies that have limited side effects, including non-invasive and non-pharmacologic options. Research has shown that a clearer understanding of the pain neuromatrix may assist in identifying alternative approaches and improving patient outcomes. A network consisting of neuronal pathways and circuits responding to sensory (nociceptive) stimulation makes up the neuromatrix of pain. Research provides strong support that these pathways and areas of the brain have elicited change in response to external stimuli. Advancements in the understanding of how external tactile stimuli, specifically “haptic vibrotactile trigger technology (VTT)” disrupts the neuromatrix of pain, has led to the development of technology that shows promise in targeting the nociceptive pathways. Through ongoing research, the technology has been incorporated into non-invasive, non-pharmacological topical patches and other routes of delivery to evaluate response as it relates to different health concerns and conditions. The purpose of this IRB-approved, minimal risk, randomized, and blinded study was to evaluate patients’ experiences and/or perceptions and patient response for those who received a haptic vibrotactile trigger technology (VTT) embedded non-pharmacologic, non-invasive, over-the-counter pain patch (FREEDOM Super Patch with VTT; Srysty Holding CO, Toronto, Canada) and those who received a placebo patch without the embedded technology. This final outcome data from the HARMONI Study adds to previously published interim data. Methods: Baseline, 7- and 14-day data were recorded in one hundred sixty-eight (168) adult subjects (107 females and 61 males) in a Treatment Group (n=148) or Control Group (n=20) with a mean age of 53 years who presented with mild, moderate and even severe musculoskeletal, arthritic and neurological pain. The study evaluated changes in overall severity and interference scores via a validated scale (Brief Pain Inventory (BPI)), changes in the use of prescription and OTC medications, patient satisfaction, and any side effects reported while using an active or placebo patch. Results: For the Treatment Group, results showed statistically significant decreases in mean BPI severity and interference scores after using the VTT embedded pain patch. After 14 days, the vast majority of patients reported “less” or “a lot less” usage of oral medications and were very/extremely satisfied with the patch. Results also showed statistically significant and positive outcomes in all measured Quality of Life (QoL) components with improvements in general activity, mood, relations with other people, sleep, normal work, walking ability, and enjoyment of life. In the Control Group, there were no significant changes in pain severity, interference levels, usage of medications, and patient satisfaction was poor during the 14 day study period. Conclusions: Study results indicate that this non-pharmacologic, non-invasive, haptic vibrotactile trigger technology (VTT) embedded topical patch reduces pain severity and interference scores and may reduce the use of concurrent medications, including prescribed anti-inflammatory and other oral medication for adult patients with arthritic, neuropathic, and musculoskeletal pain. Results reported suggest that the non-pharmacological topical pain patch should be added to the current arsenal of noninvasive and nonpharmacological pain therapies.

SUPPORT AND TREATMENT AFTER JOINT REPLACEMENT (STAR): LONG-TERM FOLLOW-UP OF A CARE PATHWAY FOR PATIENTS WITH CHRONIC PAIN AFTER KNEE ARTHROPLASTY

AbstractIntroductionApproximately 15–20% of patients report chronic pain three months after total knee replacement (TKR). The STAR care pathway is a clinically important and cost-effective personalised intervention for patients with pain 3 months after TKR. The pathway comprises screening, assesment, onward referral for treatment and follow-up over one year. In a multicentre randomised controlled trial comparing the pathway with usual care, the pathway improved pain at 6 and 12 months. This study examined the longer-term clinical and cost-effectiveness of the STAR care pathway.MethodologySTAR trial participants were followed-up at a median of 4 years post-randomisation. Co-primary outcomes were self-reported pain severity and interference in the replaced knee, assessed with the Brief Pain Inventory (BPI). Resource use from electronic hospital records was valued with UK reference costs.ResultsOf the 337 participants active at trial completion, 326 had confirmed vital status, and 226 (69%) provided outcome data at a median of 4 years. The between-group difference in mean BPI severity score was −0.42 (95% CI −1.07, 0.23; p=0.20) and for BPI interference was −0.64 (95% CI −1.41, 0.12; p=0.10), favouring the intervention. Multiple imputation analyses led to attenuations of about 0.2 points.Mean hospital admission costs over four years were £2461.49 (95% CI £1354.42, £3568.57) in the intervention arm and £3791.68 (95% CI £2095.12, to £5488.24) in usual care.ConclusionThese data are consistent with sustained benefits from the STAR care pathway at 4 years, albeit attenuated and with wider confidence intervals, in part attributable to attrition after 1 year.

Economic analysis of patient-related effects of an interdisciplinary pain self-management program.

Active Day Patient Treatment (ADAPT) is a well-established 3 week intensive cognitive-behavioural, interdisciplinary pain management program for patients with disabling chronic pain. The aim of this analysis was to conduct an economic analysis of patient-related effects of ADAPT using hospital administrative data, specifically, to compare the costs and health outcomes for patients 1 month after participating in the program, with the preprogram period when they were receiving standard care. This retrospective cohort study included 230 patients who completed ADAPT (including follow-ups) between 2014 and 17 at the Pain Management and Research Centre at the Royal North Shore Hospital in Sydney, Australia. Data on pain-related healthcare utilization and costs before and after the program were assessed. Primary outcome measures were labour force participation for patients' average weekly earnings and cost per clinically meaningful change in Pain Self-efficacy Questionnaire, Brief Pain Inventory (BPI) Severity, and BPI interference scores (n = 224). We estimated patients, on average, earned $59 more each week at 1 month follow-up compared with baseline. The cost per clinically meaningful change in pain severity and interference score based on the BPI severity and BPI interference were AU$9452.32 (95% CI: $7031.76-$12,930.40) and AU$3446.62 (95% CI: $2851.67-$4126.46), respectively. The cost per point improvement and per clinically meaningful change in the Pain Self-efficacy Questionnaire were $483 (95% CI: $411.289-$568.606) and $3381.02, respectively. Our analysis showed a better health outcome, reduced healthcare services' cost, and reduced number of medications taken 1 month after participating in ADAPT.

Effect of cerebral dopamine metabolism genetic polymorphism on patient-reported quality-of-life (QOL): An analysis of the E3805 CHAARTED trial.

123 Background: QOL outcomes have been associated with specific genetic variants in neurotransmitter metabolism. One such variant associated with reduced symptoms in placebo studies is in the rs4680 SNP of Carboxy-O-Methyltransferase (COMT). This variant is associated with reduced COMT enzymatic activity, higher cerebral dopamine levels, and improved mood. The interaction between this germline variant and cancer-directed treatment on QOL is undefined. A priori, we hypothesized that the COMT rs4680 SNP would be associated with better pain and QOL patient reported outcomes (PROs), than wildtype (WT) COMT within the E3805 CHAARTED Trial. Methods: E3805 compared docetaxel + androgen deprivation therapy (ADT+D) vs ADT in patients with metastatic hormone sensitive prostate cancer (mHSPC). PROs were collected at baseline, 3, 6, 9, and 12 months. Blood samples were genotyped prior to treatment. We compared PROs between patients with COMT WT vs rs4680 SNP within treatment arms longitudinally. PROs include Brief Pain Inventory (BPI) classified as: no (0), minimal (1), or more (≥2) pain, and BPI interference (range 0-10, 0= no pain or interference), and the Functional Assessment of Cancer Therapy-Prostate (FACT-P, higher score= better QOL, clinically important difference (CID)= 6). Descriptive statistics were used to characterize QOL over time. Fisher’s exact test, Wilcoxon rank sum test and mixed effects models were used to evaluate the associations between SNP and QOL in each arm. Results: Of 790 participants, 550 with SNP data were included. In the ADT+D arm, SNPs were not associated with PROs at any time point. In contrast, in the ADT alone arm, when compared to WT, rs4680 was associated with less pain at 3 months, less interference at 3, 6 and 9 months, and better QOL at 6 months (met criteria for CID). Conclusions: The rs4680 SNP, often associated with higher cerebral dopamine levels and improved QOL, was associated with less pain and superior QOL among patients with mHSPC treated with ADT, but not chemohormonal therapy. This is the first hypothesis driven genotyping study to demonstrate that genetics are associated with QOL in patients with cancer, especially when treatment does not cause profound symptoms. Clinical trial information: NCT00309985 . [Table: see text]

Signs of Nervous System Sensitization in Female Runners with Chronic Patellofemoral Pain.

Patellofemoral pain (PFP) is a common overuse injury among runners, affecting females at a higher rate than males. PFP can often become chronic, with evidence suggesting it may be linked to both peripheral and central sensitization of the nervous system. Sensitization of the nervous system can be identified through quantitative sensory testing (QST). The primary objective of this pilot study was to quantify and compare pain sensitivity as identified through QST measures, in active female runners with and without PFP. Cohort Study. Twenty healthy female runners and 17 female runners with chronic PFP symptoms were enrolled. Subjects completed the Knee injury and Osteoarthritis Outcome Score for Patellofemoral Pain (KOOS-PF), University of Wisconsin Running Injury and Recovery Index (UWRI), and the Brief Pain Inventory (BPI). QST consisted of pressure pain threshold testing to three local and three distant sites to the knee, heat temporal summation, heat pain threshold, and conditioned pain modulation. Data was analyzed utilizing independent t-tests for comparison of between-group data, effect sizes for QST measures (Pearson's r), and Pearson's correlation coefficient between pressure pain threshold values at the knee and functional testing. The PFP group exhibited significantly lower scores on the KOOS-PF (p<0.001), BPI Pain Severity and Interference Scores (p<0.001), and UWRI (p<0.001). Primary hyperalgesia, identified through decreased pressure pain threshold at the knee, was detected in the PFP group at the central patella (p<0.001), lateral patellar retinaculum (p=0.003), and patellar tendon (p=0.006). Secondary hyperalgesia, a sign of central sensitization, was observed via differences in pressure pain threshold testing for the PFP group at the uninvolved knee (p=0.012 to p=0.042), involved extremity remote sites (p=0.001 to p=0.006), and uninvolved extremity remote sites (p=0.013 to p=0.021). Compared to healthy controls, female runners with chronic PFP symptoms exhibit signs of both peripheral sensitization. Despite actively participating in running, nervous system sensitization may contribute to continued pain in these individuals. For female runners with chronic PFP, physical therapy management may need to include interventions which address signs of central and peripheral sensitization. Level 3.

Haptic Vibrotactile Trigger Technology: Disrupting the Neuromatrix to Reduce Pain Severity and Interference: Results from the HARMONI Study

The prevalence of pain and pain-related diseases are so vast that they are the leading causes of disability and disease burden across the globe. Over 100 million people are estimated to live with chronic or recurrent pain in the United States and it is the most common reason patients consult primary care clinicians. Conventional pharmacological treatments for pain have been associated with dangerous adverse effects. Identifying effective, alternative treatment strategies, including those that are non-invasive and non-pharmacologic and that have reduced and limited side effect profiles, will provide options that may be preferable in how clinicians traditionally treat pain. Understanding the pain neuromatrix may assist in identifying these alternative approaches that reduce pain severity and interference, and that improve patient outcomes. The neuromatrix of pain is a network of neuronal pathways and circuits responding to sensory (nociceptive) stimulation. Researchers have shown that these pathways and areas of the brain that are associated with the neuromatrix can change in response to external stimuli. Haptic vibrotactile trigger technology (VTT) is designed to target the nociceptive pathways and theorized to disrupt the neuromatrix of pain. The technology has been incorporated into non-invasive, non-pharmacological topical patches and other routes of delivery. The purpose of this IRB-approved, minimal risk study was to evaluate patients’ experiences and/or perceptions and patient response for those who received a haptic vibrotactile trigger technology (VTT) embedded non-pharmacologic, non-invasive, over-the-counter pain patch (FREEDOM Super Patch with VTT; Srysty Holding Co, Toronto, Canada). Methods: Baseline, 7- and 14-day data were recorded in one hundred forty-eight (148) adult subjects (96 females and 52 males) with a mean age of 53 years who presented with mild, moderate and even severe musculoskeletal, arthritic and neurological pain. The study evaluated changes in overall severity and interference scores via a validated scale (Brief Pain Inventory (BPI)), changes in the use of prescription and OTC medications, patient satisfaction, and any side effects reported while using the patch. Future analyses will compare the outcomes reported here with non-active control and crossover treatment groups. Results: The results showed statistically significant decreases in mean BPI severity and interference scores after using the VTT embedded pain patch. After 14 days, the vast majority of patients reported “less” or “a lot less” usage of oral medications and were very/extremely satisfied with the patch. Results also showed statistically significant and positive outcomes in all measured Quality of Life (QoL) components with improvements in general activity, mood, relations with other people, sleep, normal work, walking ability, and enjoyment of life. Conclusions: Study results indicate that this non-pharmacologic, non-invasive, haptic vibrotactile trigger technology (VTT) embedded topical patch reduces pain severity and interference scores and may reduce the use of concurrent medications, including prescribed anti-inflammatory and other oral medication for adult patients with arthritic, neuropathic, and musculoskeletal pain. Results reported suggest that the non-pharmacological topical pain patch has incredible potential to be added to the current arsenal of noninvasive and nonpharmacological pain therapies.

Axial postural abnormalities and pain in Parkinson’s disease

Axialpostural abnormalities and pain are two main determinants of poor quality of life in patients with Parkinson's disease (PD). Indeed, a detailed characterization of pain and other non-motor symptoms in patients with PAs has not been provided yet. The aim of this study is to assess the phenomenology of pain and other non-motor symptoms in PD patients with Pisa syndrome and camptocormia compared to PD patients withoutaxial postural abnormality. Forty-five PD participants were equally distributed in three groups: patients with Pisa syndrome (PS), patients with Camptocormia (CC), and patients without postural abnormalities (PD). Pain characteristics were assessed by Kings Parkinson's Pain Scale (KPPS), brief pain inventory (BPI), and numeric pain rating scale (NRS). All participants completed clinical assessments by non-motor symptom scale (NMSS), and movement disorder society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) parts II-III. Patients with and without axialpostural abnormalities showed one or more types of pain, being fluctuation, nocturnal, chronic, and musculoskeletal the most frequently reported in Pisa Syndrome and camptocormia. PD group compared with PS and CC groups showed differences in the KPPS, NMSS, BPI pain severity and interference, and NRS total scores. No significant differences were found between PS group compared with CC group with exception of the NMSS total scores. PD patients with Pisa syndrome or camptocormia have a higher burden of musculoskeletal, chronic and fluctuation pain than PD patients without axialpostural abnormalities, suggesting different etiologies of pain and possible different treatments.

Exploring the contributions of sex and traditionally genderized interpersonal-expressive traits to variability in post-trauma pain ratings.

Multiple intra- and inter-individual variabilities sculpt the experience of pain. However, integration of sex and gender has been under-explored in explanatory models of pain. This study aimed to examine the role of sex and traditionally genderized interpersonal-expressive traits, and their interactions in explaining the variability of pain ratings. Data from 113 participants following acute non-catastrophic musculoskeletal (MSK) injuries were included. Participants completed the Brief Pain Inventory (BPI) and the Gender, Pain and Expectations Scale (GPES). An independent T-test was used to compare differences in BPI subscales between the sexes. Pearson correlations explored the associations between BPI and GPES subscale scores for the overall sample and also for the sample when disaggregated by sex. Multiple linear regression was used to investigate the interaction of sex and gender traits in explaining the BPI scores. No differences were found between the sexes in mean BPI Severity and Interference. Across sexes, Relationship-oriented was positively associated with greater BPI Severity (r = 0.20) and Emotive was positively associated with BPI Interference (r = 0.24). In sex-disaggregated analyses, these associations were significant in females only. Goal-oriented was associated with neither BPI Severity nor Interference. In multivariate regression, only Emotive was a significant predictor of BPI Interference. The findings suggest that variances in pain-related interference are partially explained by scores on a scale measuring self-perceptions of Emotive qualities. Sex was not predictive of either pain outcome in both bivariate and multivariate analyses. Researchers and clinicians are encouraged to consider both sex- and gender-based variables when interpreting patient pain reports.

The Role of Resilience Among Women with Chronic Pelvic Pain

<h3>Study Objective</h3> In other chronic pain syndromes resilience has correlated with reduced disease severity and better overall function among chronic pain patients. Our objective was to investigate the impact of resilience on the number of missed days of work, days spent in bed and quality of life for women with chronic pelvic pain. <h3>Design</h3> Retrospective cross-sectional study of new patients presenting to tertiary care chronic pelvic pain consultative clinic. <h3>Setting</h3> A tertiary care teaching hospital. <h3>Patients or Participants</h3> Consecutive new patients (n=1143) at a tertiary care, outpatient chronic pelvic pain clinic between 2019 and 2021. <h3>Interventions</h3> All patients completed validated self-report measures of resilience, physical function, social role satisfaction, pain interference, pain severity, average pain rating, purpose and meaning before their first appointment. <h3>Measurements and Main Results</h3> Patient population was self-reported 78% white, 8.75% Black/African American, 3.14% Asian, and 0.87% Native American/Alaskan Native. Twenty eight percent were married, 31% single, 1.8% divorced, 2.9% partnered. The average age was 35.6 y.o. (SD, 9.8), average pain days per month was 19.0 (SD,9.6), average Brief Pain Inventory (BPI) severity was 19.6 (SD, 8.9) and average BPI interference 33.43 (SD, 20.6). In a multivariate linear regression model controlling for age and average reported pain, a higher degree of resilience was positively correlated with Patient-Reported Outcomes Measurement Information System (PROMIS) physical function (Beta 0.205; p<.001), PROMIS social role satisfaction (Beta 0.223; p<.001) and PROMIS purpose and meaning (Beta 0.610; p<.001). However, resilience was negatively correlated with missed days of work (Beta -0.141; p<.001) and days spent in bed (Beta -0.183;p<.001). <h3>Conclusion</h3> Resilience appears to have a protective effect on patients' physical function, satisfaction and feeling of purpose, and engagement in work, irrespective of the severity of their pelvic pain. This offers a novel target for future research to investigate the effect of interventions to modify resilience would impact patient quality of life.

Responder Analysis of Pain Relief After Surgery for the Treatment of Spinal Metastatic Tumors.

Central tendency analysis studies demonstrate that surgery provides pain relief in spinal metastatic tumors. However, they preclude patient-specific probability of treatment outcome. To use responder analysis to study the variability of pain improvement. In this single-center, retrospective analysis, 174 patients were studied. Logistic regression modeling was used to associate preoperative characteristics with rating the Brief Pain Inventory (BPI) worst pain item 0 to 4. Linear regression modeling was used to associate preoperative characteristics with minimal clinically important improvement (MCI) in physical functioning defined by a 1-point decrease in the BPI Interference Construct score from preoperative baseline to 6 months postoperatively. Patient-level analysis revealed that 60% of patients experienced an improvement in pain. At least half experienced a decrease in pain resulting in MCI in physical functioning. Cutpoint analysis revealed that 48% were responders. Increasing scores on the preoperative pain intensity BPI items, the MD Anderson Symptom Inventory (MDASI) Core Symptom Severity Construct, the MDASI Spine Tumor-Specific Construct, the presence of preoperative neurologic deficits, and postoperative complications were associated with lower probability of treatment success while increasing severity in all BPI pain items, and MDASI constructs were associated with increased probability of MCI in physical function. Significant mortality and loss to follow-up intrinsic to this patient population limit the strength of these data. Although patients with milder preoperative symptoms are likely to achieve better pain relief after surgery, patients with worse preoperative symptom also benefit from surgery with adequate pain relief with an improvement in physical function.

The Impact of Rapid Weight Loss on Pain in Non-Hispanic Black and Hispanic/Latino/a/x Adults with Obesity

Significant weight loss with bariatric surgery improves self-reported pain, but the impact of weight loss on pain severity, interference, and number of painful sites after bariatric surgery, specifically in ethnically diverse adults, is unclear. The purpose of this study was to examine longitudinal changes and racial differences in pain intensity, interference, and number of sites 12 months after bariatric surgery. This is a secondary analysis from a study of patients undergoing a sleeve gastrectomy. Participants completed the Brief Pain Inventory (BPI) before surgery (BL), 3 months post-surgery (3M) and 12 months post-surgery (12M). Weight loss was calculated as a percentage of weight lost minus baseline weight (%TWL). Racial group differences were analyzed using t-test or Wilcoxon rank-sum test. A linear regression model was fitted to test which factors were associated with pain change (p <0.05). Data from 213 adults were analyzed (Mean(SD)) Age: 39.7(12.0); BMI: 43.3(6.4); Peak %TWL: 28.4(7.6); BPI Severity: 4.2(2.8); BPI Interference: 3.7(3.0); pain sites: 6.3(6.3). There were significant reductions in pain intensity, pain interference, and in the number of painful sites that plateaued between 3M and 12M. Hispanic/Latino/a/x and NH Black patients have greater pain severity at BL, but not at 3M and 12M compared with NH White patients. Hispanic/Latino/a/x participants have a significantly greater number of painful sites compared with other racial groups at BL but not at 3M and 12M. There was a trend toward higher %TWL being associated with a greater reduction in pain interference between BL and 3M. Findings from this study suggest that pain reduction after weight loss is influenced by time and race. Pain assessment during the early and late stages of weight loss could help clinicians use culturally informed strategies to address pain after rapid weight loss in ethnically diverse adults. Grant support from NYU Grossman School of Medicine Office of Research (internally funded, no grant number).

Using A Novel, Non-Drug, Topical Pain-Relief Patch to Improve Pain and Function: Final Analysis of the PREVENT Study

Background and Aims: The Global Burden of Disease Study 2016 confirmed that the high prevalence of pain and pain-related diseases is the leading cause of disability and disease burden globally. Pain is the most common reason patients consult primary care providers in the United States. According to recent literature, over 40% of adult Americans, an estimated 100 million people, live with chronic or recurrent pain. Of these, approximately 11 million adults in the US have high-impact chronic pain, or pain that lasts 3 months or longer and is accompanied by at least one major activity restriction. Ongoing research is needed to identify alternative strategies to existing treatment approaches as a means to reduce pain severity, pain interference with function, and to improve patients’ overall quality of life. Optimal treatment strategies employ multimodal approaches that provide optimal benefit and minimal harm. Chronic pain is often categorized as either nociceptive (caused by damage to tissue or inflammatory stimuli) or neuropathic (damage to somatosensory nervous system). Mainstay therapies for pain include anti-inflammatory agents, opioids, and other oral and topical analgesics. Despite this approach, a large percentage of pain patients do not achieve adequate pain relief, and these traditional medication approaches are often associated with undesirable and potentially dangerous adverse effects. Alternative evidence-based multimodal approaches of pain management are therefore needed. Potential therapies include use of combination pharmacotherapies, which target both central and peripheral nociceptive mechanisms, and nonpharmacological interventions. Incorporation of micro and nanotechnologies into the development of novel treatment formulations has shown to have positive effects on patients. Topical analgesics, including pain relief patches, are a potentially valuable strategy in the management of a variety of conditions associated with musculoskeletal and various neuropathic pain disorders. The purpose of this minimal risk, observational study was to evaluate patients with mild or moderate pain and evaluate perceptions of pain treatment and associated symptoms with the use of a novel, non-drug and micro/nanotechnology-based topical pain-relieving patch via validated scales over the course of 30 days. Methods: This analysis of the PREVENT IRB-approved study evaluated the efficacy of a topical pain-relieving patch (Kailo Pain Relieving Patch (Pain Relief Technologies, USA) in reducing Brief Pain Inventory (BPI) scores in patients experiencing mild, moderate, or severe pain. The Treatment Group (TG) of 128 adult patients (89 females,39 males) with arthritic, neuropathic, or musculoskeletal pain received patches for 30 days. A Control Group (CG) of 20 adult patients (15 females, 5 males) did not initially receive the patch, and then crossed over to the Crossover Treatment Group (CROSSG), Surveys were administered to all patients at baseline, 14 days, and 30 days to assess changes in pain severity and interference by BPI Short Form. Changes in oral pain medication use, side effects and satisfaction with patch use were also assessed. Results: Over 30 days, treatment group mean BPI Severity score decreased 61% (4.9 to 1.9/10?P&lt; .001) and mean BPI Interference score decreased 61% (3.8 to 1.5/10?P&lt; .001) The control group showed an increase in both BPI Severity of 23% (3.0 to 3.7/10) and BPI Interference Score of 58% (1.2 to 1.9/10). After crossing over to treatment, patients in the crossover group reported a decrease in BPI Severity score of 76% (3.7 to .9/10) and a decrease in BPI Interference score of 79% (1.9 to .4/10). No side effects of treatment were reported. After 30 days, 91% of patients reported “less” or “a lot less” usage of oral medications. 86% of patients were very/extremely satisfied with the patch and preferred the pain-relieving patch to oral medications. Results also showed improvements in Quality of Life (QoL), mood, and relations with other people, sleep, walking ability, and enjoyment of life. Conclusions: Study results indicate that this novel, micro/nanotechnology-based topical pain-relieving patch can reduce BPI pain severity and interference scores and related pain for adult patients with arthritic, neuropathic, and musculoskeletal pain. Options such as this should be considered by healthcare clinicians and patients as part of a multimodal treatment approach. Patient outcomes further encourage more research to be conducted to confirm these results.

The STAR care pathway for patients with pain at 3 months after total knee replacement: a multicentre, pragmatic, randomised, controlled trial

SummaryBackgroundApproximately 20% of people experience chronic pain after total knee replacement, but effective treatments are not available. We aimed to evaluate the clinical effectiveness and cost-effectiveness of a new care pathway for chronic pain after total knee replacement.MethodsWe did an unmasked, parallel group, pragmatic, superiority, randomised, controlled trial at eight UK National Health Service (NHS) hospitals. People with chronic pain at 3 months after total knee replacement surgery were randomly assigned (2:1) to the Support and Treatment After Replacement (STAR) care pathway plus usual care, or to usual care alone. The STAR intervention aimed to identify underlying causes of chronic pain and enable onward referrals for targeted treatment through a 3-month post-surgery assessment with an extended scope practitioner and telephone follow-up over 12 months. Co-primary outcomes were self-reported pain severity and pain interference in the replaced knee, assessed with the Brief Pain Inventory (BPI) pain severity and interference scales at 12 months (scored 0–10, best to worst) and analysed on an as-randomised basis. Resource use, collected from electronic hospital records and participants, was valued with UK reference costs. Quality-adjusted life-years (QALYs) were calculated from EQ-5D-5L responses. This trial is registered with ISRCTN, ISRCTN92545361.FindingsBetween Sept 6, 2016, and May 31, 2019, 363 participants were randomly assigned to receive the intervention plus usual care (n=242) or to receive usual care alone (n=121). Participants had a median age of 67 years (IQR 61 to 73), 217 (60%) of 363 were female, and 335 (92%) were White. 313 (86%) patients provided follow-up data at 12 months after randomisation (213 assigned to the intervention plus usual care and 100 assigned to usual care alone). At 12 months, the mean between-group difference in the BPI severity score was −0·65 (95% CI −1·17 to −0·13; p=0·014) and the mean between-group difference in the BPI interference score was −0·68 (−1·29 to −0·08; p=0·026), both favouring the intervention. From an NHS and personal social services perspective, the intervention was cost-effective (greater improvement with lower cost), with an incremental net monetary benefit of £1256 (95% CI 164 to 2348) at £20 000 per QALY threshold. One adverse reaction of participant distress was reported in the intervention group.InterpretationSTAR is a clinically effective and cost-effective intervention to improve pain outcomes over 1 year for people with chronic pain at 3 months after total knee replacement surgery.FundingNational Institute for Health Research.

Stroke - shoulder pain and upper limb function

Introduction: Stroke causes disability and pain, especially shoulder pain. Often, shoulder pain, has a not completely known mechanism and evolution.1,2 Objectives: Assess shoulder pain and its impact in upper limb function, in patients who had suffered a stroke within 6 months. Methods: Observational study. Included patients at discharge from an inpatient rehabilitation centre, from November 2019 until February 2020. Assessment was done using validated Portuguese versions of the Brief Pain Inventory (BPI) and Fugl Meyer Assessment Scale (FMAS). Results: Of 32 patients screened, 26 fulfilled the inclusion criteria, 7 were females (26,9 %), with mean age of 60,7±10 years. Mean values of BPI Severity and Interference were 3,2±1,6 and 2,4±1,8, respectively. The mean values of the FMAS Motor Function and Passive Articular Movement were 38,8±23,2 and 20,3±2,3, respectively. Analysing the association between both subscales of BPI and both Subscales of FMAS negative correlations were found to be statistically significant with a confidence interval of 95% but there was no correlation between BPI Severity and FMAS motor function. Six patients (23%) received a local injection for shoulder pain. Analysing both groups, BPI Severity and both subscales of FMAS showed a statistically significant difference (p values of 0,0083, 0,0031 and 0,0056, respectively) for a Wilcoxon/Kruskal-Wallis test with a confidence interval of 95%. Discussion/Conclusions: Patients with voluntary upper limb movements after a stroke tend to have less shoulder pain. Local injection was an effective intervention for shoulder pain. The greatest limitation of this study is the small sample size.

Improvement of Non-motor Symptoms and Quality of Life After Deep Brain Stimulation for Refractory Dystonia: A 1-Year Follow-Up.

Introduction: Deep brain stimulation (DBS) is a treatment option for refractory dystonia's motor symptoms, while its non-motor symptoms (NMS) have been less systematically assessed. We aimed to describe the effects of DBS on NMS in refractory generalized inherited/idiopathic dystonia prospectively.Methods: We evaluated patients before and 1 year after DBS surgery and applied the following scales: Burke–Fahn–Marsden Rating Scale (BFMRS), NMS Scale for Parkinson's Disease (NMSS-PD), Parkinson's Disease Questionnaire-8, short-form Brief Pain Inventory (BPI), Neuropathic Pain Symptom Inventory (NPSI), and short-form McGill Pain Questionnaire (MPQ).Results: Eleven patients (38.35 ± 11.30 years) underwent surgery, all with generalized dystonia. Motor BFMRS subscore was 64.36 ± 22.94 at baseline and 33.55 ± 17.44 1 year after DBS surgery (47.9% improvement, p = 0.003). NMSS-PD had a significant change 12 months after DBS, from 70.91 ± 59.07 to 37.18 ± 55.05 (47.5% improvement, p = 0.013). NMS changes were mainly driven by changes in the gastrointestinal (p = 0.041) and miscellaneous domains (p = 0.012). Seven patients reported chronic pain before DBS and four after it. BPI's severity and interference scores were 4.61 ± 2.84 and 4.12 ± 2.67, respectively, before surgery, and 2.79 ± 2.31 (0.00–6.25) and 1.12 ± 1.32 (0.00–3.00) after, reflecting a significant improvement (p = 0.043 and p = 0.028, respectively). NPSI score was 15.29 ± 13.94 before, while it was reduced to 2.29 ± 2.98 afterward (p = 0.028). MPQ's total score was 9.00 ± 3.32 before DBS, achieving 2.71 ± 2.93 after (p = 0.028).Conclusions: DBS improves NMS in generalized inherited/idiopathic dystonia, including chronic pain.

A prospective observational study of persistent opioid use after complex foot and ankle surgery.

The incidence of persistent postsurgical opioid use (PPOU) after complex foot and ankle surgery is unknown. We aimed to determine the incidence and characteristics of PPOU in opioid-naïve, occasional, and regular opioid users at baseline and at six weeks, three months, and six months postoperatively. We conducted a prospective observational study in patients undergoing complex foot and ankle surgery over an 18-month period. Daily opioid consumption was recorded at the indicated intervals. Logistic regression models were fit to predict the risk of opioid use at these intervals. The Brief Pain Inventory (BPI) was used to record pain intensity and interference. Correlations were tested between opioid use and BPI interference parameters. Eighty-two out of 139 consecutively approached patients were included in the final analysis. Six percent (98.3% confidence interval [CI], 2 to 20) of patients who were not using opioids preoperatively at baseline were using opioids daily at three and six months after surgery. Fifty percent (98.3% CI, 26 to 73) of patients who were regular opioid users preoperatively continued to use opioids daily six months after surgery. All associations between BPI interference parameters and opioid use were estimated to be positive. The probability of using opioid analgesia six months after complex foot and ankle surgery was significantly higher in patients who used opioids preoperatively. Regular preoperative opioid use was associated with a greater risk of PPOU compared with occasional or "as required" opioid use prior to surgery.

Opioid Use as a Predictor of Pain Outcomes in Iraq and Afghanistan Veterans with Chronic Pain: Analysis of a Randomized Controlled Trial.

Our objectives were to: 1) assess the relationship between self-reported opioid use and baseline demographics, clinical characteristics and pain outcomes; and 2) examine whether baseline opioid use moderated the intervention effect on outcomes at 9 months. We conducted a secondary analysis of data from the Evaluation of Stepped Care for Chronic Pain (ESCAPE) trial, which found stepped-care to be effective for chronic pain in military veterans. A post-deployment clinic and five general medicine clinics at a Veteran Affairs Medical Center. In total 241 veterans with chronic musculoskeletal pain; 220 with complete data at 9 months. Examination of baseline relationships and multivariable linear regression to examine baseline opioid use as a moderator of pain-related outcomes including Roland Morris Disability Questionnaire (RMDQ), Brief Pain Inventory (BPI) Interference scale, and Graded Chronic Pain Scale (GCPS) at 9 months. Veterans reporting baseline opioid use (n = 80) had significantly worse RMDQ (16.0 ± 4.9 vs. 13.4 ± 4.2, P < .0001), GCPS (68.7 ± 12.0 vs. 65.0 ± 14.4, P = .049), BPI Interference (6.2 ± 2.2 vs. 5.0 ± 2.1, P < .0001), and depression (PHQ-9 12.5 ± 6.2 vs. 10.6 ± 5.7, P = .016) compared to veterans not reporting baseline opioid use. Using multivariable modeling we found that baseline opioid use moderated the intervention effect on pain-related disability (RMDQ) at 9 months (interaction Beta = -3.88, P = .0064) but not pain intensity or interference. In a stepped-care trial for pain, patients reporting baseline opioid use had greater improvement in pain disability at 9 months compared to patients not reporting opioid use.

Effects of childhood trauma on pain-related distress in adults.

Much of the work in post-musculoskeletal (MSK) trauma and distress has been conducted through frameworks that start from the injury and go forward to better understand the trajectories and predictors of recovery. However, stress-diatheses models suggest that reactions to trauma are shaped by pre-existing experiences of the person more than the parameters of the event itself. In this study, we explore the effects of adverse childhood experiences (ACEs) on traumatic threat appraisal, distress and pain-related functional interference in adulthood. Adult participants with acute, non-catastrophic musculoskeletal trauma completed a battery of questionnaires that included the Adverse Childhood Experiences Questionnaire (ACEQ), the Brief Illness Perceptions Questionnaire (BIPQ), the Traumatic Injuries Distress Scale (TIDS) and the Brief Pain Inventory (BPI). An a priori model was evaluated through path analysis to determine the variance in BPI Interference scores explained through direct or indirect pathways between these variables (ACEQ->BIPQ, BIPQ->TIDS, TIDS->BPI). The analysis was repeated for the sample when disaggregated by sex. In n=114, the base model was saturated. After removing non-significant pathways, the ACEQ->BIPQ->TIDS->BPI paths were significant and in the expected direction, explaining 57.1% of variance in acute BPI Interference score. When disaggregated by sex, the effect of ACEs on threat appraisal was only significant in men and not women, although this analysis was exploratory. Acute pain-related interference could be predicted by post-traumatic distress and threat appraisal. Threat appraisal could be further predicted through ACEs, more childhood adversities were associated with more threatening appraisal of trauma in adulthood. The disaggregated finding that the effects of childhood adversities were only significant in males requires further exploration. This study explores the potential pathways of the stress-diathesis model while focusing on adverse childhood experiences as a novel contribution to the field of acute post-trauma pain. The findings may inform future research design and interpretation of acute-to-chronic pain risk stratification tools.