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BackgroundChronic or persistent pain affects one’s ability to work or be productive at work, generating high societal and economic burden. However, the provision of work-related advice and support for people with chronic pain is variable or lacking. The Pain-at-Work (PAW) Toolkit was cocreated with people who live with pain, health care professionals, and employers. It aims to increase knowledge about employee rights and how to access support for managing a painful chronic condition in the workplace and provides advice on lifestyle behaviors that facilitate the management of chronic pain. ObjectiveWe aimed to establish the feasibility of conducting a definitive cluster randomized controlled trial comparing access to the PAW Toolkit and telephone support calls from an occupational therapist (PAW) with treatment as usual (ie, standard support from their employer). Our primary outcomes are establishing parameters of feasibility, acceptability, usability, and safety of this digital workplace health intervention. We will assess the candidate primary and secondary outcomes’ feasibility and test research processes for a definitive trial. MethodsThis is an open-label, parallel 2-arm pragmatic feasibility cluster randomized controlled trial with exploratory health economics analysis and a nested qualitative interview study. We aim to recruit 120 participants from at least 8 workplace clusters (any type, >10 employees) in England. The recruitment of workplaces occurs via personal approach, and the recruitment of individual participants is web based. Eligible participants are vocationally active adults aged ≥18 years with internet access and self-reporting chronic pain interfering with their ability to undertake or enjoy productive work. A restricted 1:1 cluster-level randomization is used to allocate employment settings to PAW or treatment as usual; participants are unblinded to group allocation. Following site- and individual-level consent, participants complete a web-based baseline survey (time 0), including measures of work capacity, health and well-being, and health care resource use. Follow-up is performed at 3 months (time 1) and 6 months (time 2). Feasibility outcomes relate to recruitment; intervention fidelity (eg, delivery, reach, uptake, and engagement); retention; and follow-up. Qualitative evaluation (time 2) is mapped to the Capability, Opportunity, Motivation–Behavior model and will explore intervention acceptability to employees and employers, along with individual and contextual factors influencing the delivery and uptake of the intervention. ResultsEthics approval was obtained in March 2023. Trial recruitment began in June 2023. ConclusionsThe PAW Toolkit is the first evidence-based digital health intervention aimed at supporting the self-management of chronic or persistent pain at work. This study will inform the design of a definitive trial, including sample size estimation, approaches to cluster site identification, primary and secondary outcomes’ selection, and the final health economic model. Findings will inform approaches for the future delivery of this digital health intervention. Trial RegistrationClinicalTrials.gov NCT05838677; https://clinicaltrials.gov/study/NCT05838677 International Registered Report Identifier (IRRID)DERR1-10.2196/51474

The gut microbiome is a significant contributor to mental health, with growing evidence linking its composition to anxiety and depressive disorders. Gut microbiome composition is associated with signs of anxiety and depression both in clinically diagnosed mood disorders and subclinically in the general population and may be influenced by dietary fibre intake and the presence of chronic pain. We provide an update of current evidence on the role of gut microbiome composition in depressive and anxiety disorders or symptoms by reviewing available studies. Analysing data from three independent cohorts (osteoarthritis 1 (OA1); n = 46, osteoarthritis 2 (OA2); n = 58, and healthy controls (CON); n = 67), we identified microbial composition signatures of anxiety and depressive symptoms at genus level and cross-validated our findings performing meta-analyses of our results with results from previously published studies. The genera Bifidobacterium (fixed-effect beta (95% CI) = −0.22 (−0.34, −0.10), p = 3.90e-04) and Lachnospiraceae NK4A136 group (fixed-effect beta (95% CI) = −0.09 (−0.13, −0.05), p = 2.53e-06) were found to be the best predictors of anxiety and depressive symptoms, respectively, across our three cohorts and published literature taking into account demographic and lifestyle covariates, such as fibre intake. The association with anxiety was robust in accounting for heterogeneity between cohorts and supports previous observations of the potential prophylactic effect of Bifidobacterium against anxiety symptoms.

Introduction Pain is the main symptom of osteoarthritis (OA) with approximately 50% of patients reporting moderate-to-severe pain. Total knee replacement (TKR) is the ultimate treatment option to alleviate pain in knee OA. Nevertheless, TKR does not provide complete relief for all as approximately 20% of patients experience chronic postoperative pain. Painful peripheral stimuli may alter the central nociceptive pathways leading to central sensitisation that can influence treatment response in patients with OA. Currently, there is no objective protocol for detecting whether a patient will respond to a given treatment. Therefore, there is a need for a better mechanistic understanding of individual factors affecting pain relief, consequently informing personalised treatment guidelines. The purpose of this research is to examine the feasibility of conducting a full-scale mechanistic clinical trial in painful knee OA investigating the analgesic response to intra-articular bupivacaine between those with or without evidence of central sensitisation.Methods and analysis The Understanding Pain mechanisms in KNEE osteoarthritis (UP-KNEE) study is a feasibility, double-blinded, placebo-controlled randomised parallel study in participants with radiographically defined knee OA and with self-reported chronic knee pain. The study involves the following assessments: (1) a suite of psychometric questionnaires; (2) quantitative sensory testing; (3) magnetic resonance imaging (MRI) scan of the knee and brain; (4) a 6-minute walk test; and (5) an intra-articular injection of bupivacaine or placebo (sodium chloride 0.9%) into the index knee. Assessments will be repeated post intra-articular injection apart from the MRI scan of the knee. Our aim is to provide proof of concept and descriptive statistics to power a future mechanistic trial.Ethics and dissemination Ethical approval was obtained from the Health Research Authority (HRA) (REC: 20/EM/0287). Results will be disseminated via peer-reviewed journals and scientific conferences. The results will also be shared with lay audiences through relevant channels, such as Pain Centre Versus Arthritis website and patient advocacy groups.Trial registration number NCT05561010.

ObjectivesThe overall purpose of this research programme is to develop and test the feasibility of a complex intervention for knee pain delivered by a nurse, and comprising both non-pharmacological and pharmacological interventions. In this first phase, we examined the acceptability of the non-pharmacological component of the intervention; issues faced in delivery, and resolved possible challenges to delivery.MethodsEighteen adults with chronic knee pain were recruited from the community. The intervention comprised holistic assessment, education, exercise, weight-loss advice (where appropriate) and advice on adjunctive treatments such as hot/cold treatments, footwear modification and walking aids. After nurse training, the intervention was delivered in four sessions spread over five weeks. Participants had one to one semi-structured interview at the end of the intervention. The nurse was interviewed after the last visit of the last participant. These were audio recorded and transcribed verbatim. Themes were identified by one author through framework analysis of the transcripts, and cross-checked by another.ResultsMost participants found the advice from the nurse easy to follow and were satisfied with the package, though some felt that too much information was provided too soon. The intervention changed their perception of managing knee pain, learning that it can be improved with self-management. However, participants thought that the most challenging part of the intervention was fitting the exercise regime into their daily routine. The nurse found discussion of goal setting to be challenging.ConclusionThe nurse-led package of care is acceptable within a research setting. The results are promising and will be applied in a feasibility randomised-controlled trial.

Abstract Background Neuropathic-like knee pain (NKP) is often reported in individuals with knee pain (KP), but the contribution of specific central and peripheral risk factors to NKP has not been studied previously. The aims of the present study were to determine the prevalence of NKP in a community-derived sample with KP and to identify risk factors associated with NKP. Methods A cross-sectional study was undertaken (n = 9506) in the East Midlands community among responders (aged 40+ years) to a postal questionnaire. Questions included KP severity (numerical rating scale) and type (neuropathic versus nociceptive) using the modified painDETECT questionnaire, as well as age, body mass index (BMI), significant knee injury, widespread pain, pain catastrophising and fatigue. Multinomial regression analysis was used to determine ORs and 95% CIs. Risk factors were categorised into central and peripheral, and proportional risk contribution (PRC) and 95% CI were estimated using ROC. Results KP was reported in 28.2% of responders, of whom 13.65% had NKP (i.e., 3.9% of the total population). Women reported more NKP. After adjustment for age, gender, BMI and pain severity, definite NKP showed associations (aOR, 95% CI) with fibromyalgia (4.07, 2.49–6.66), widespread pain (1.93, 1.46–2.53), nodal osteoarthritis (1.80, 1.28–2.53), injury (1.50, 1.12–2.00), pain catastrophising (5.37, 2.93–9.84) and fatigue (5.37, 3.08–9.35) compared with non-NKP participants. Although only central risk factors contributed to NKP (PRC 8%, 95% CI 2.5–12.5 for central vs. PRC 3%, 95% CI −0.25 to 7.5 for peripheral), both central and peripheral risk factors contributed equally to non-NKP (PRC 10%, 95% CI 5–20 for both). Conclusions NKP appears to be driven largely by central risk factors and may require different prevention/treatment strategies. Trial registration ClinicalTrials.gov, NCT02098070. Registered on 27 March 2014.

SUMMARY: STUDY DESIGN In a prospective interventional study, problems with performance were evaluated in 101 consecutive patients with chronic low-back pain for more than 12 months, before and after participation in an outpatient-based multidisciplinary pain management program in Mansfield, United Kingdom.OBJECTIVES To describe problems identified as most important by patients with chronic low-back pain and to evaluate the Canadian Occupational Performance Measure (COPM) as a tool for measuring problem-specific outcomes.SUMMARY OF BACKGROUND DATA Patients with chronic low-back pain report difficulties with a variety of activities. The COPM permits the identification and measurement of problems of particular concern to the patient.MATERIALS AND METHODS COPM, likert-modified Roland and Morris Disability Questionnaire, Pain Self-Efficacy Questionnaire, and 5-minute walk test were administered at baseline, immediately after, and 9 months after intervention. Differences and statistical interactions were determined by nonparametric tests.RESULTS Participants identified 60 different types of problem activity, 45 of which were identified by nine or fewer participants. Decreased walking tolerance was the most frequently identified problem (56% of participants). Improvements were observed in all outcomes following intervention. Approximately one third of participants reported improvements two or more COPM units in overall performance and satisfaction with their performance at 9 months. Higher reported performance and satisfaction were associated with greater self-efficacy. Increased reported walking performance was associated with increased observed 5-minute walk distance (R = 0.35, P = 0.02).CONCLUSIONS Patients with chronic low-back pain report problems with diverse activities. The COPM provides a patient-centered outcome measure that displays good external validity and responsiveness to change when addressing the individual's goals. [ABSTRACT FROM AUTHOR]