Overlap and cumulative effects of pancreatic duct obstruction, abnormal pain processing and psychological distress on patient-reported outcomes in chronic pancreatitis

ObjectiveSeveral factors have been suggested to mediate pain in patients with chronic pancreatitis. However, it is unknown whether these factors are overlapping and if they have cumulative effects on patient-reported outcomes (PROs).DesignWe performed a multicentre cross-sectional study of 201 prospectively enrolled subjects with definitive chronic pancreatitis. All subjects underwent evaluation for pancreatic duct obstruction, abnormalities in pain processing using quantitative sensory testing, and screening for psychological distress (anxiety, depression and pain catastrophising) based on validated questionnaires. Abnormality was defined by normal reference values. PROs included pain symptom severity (Brief Pain Inventory short form) and quality of life (EORTC-QLQ-C30 questionnaire). Associations between pain-related factors and PROs were investigated by linear trend analyses, multiple regression models and mediation analyses.ResultsClinical evaluation suggestive of pancreatic duct obstruction was observed in 29%, abnormal pain processing in 23%, anxiety in 47%, depression in 39% and pain catastrophising in 28%; each of these factors was associated with severity of at least one PRO. Two or more factors were present in 51% of subjects. With an increasing number of factors, there was an increase in pain severity scores (p<0.001) and pain interference scores (p<0.001), and a reduction in quality of life (p<0.001). All factors had independent and direct effects on PROs, with the strongest effect size observed for psychological distress.ConclusionPain-related factors in chronic pancreatitis are often present in an overlapping manner and have a cumulative detrimental effect on PROs. These findings support a multidisciplinary strategy for pain management.Trial registration numberThe study was registered with ClinicalTrials.gov (NCT03434392).

Factors associating with disability of non-specific low back pain in different subgroups: A hierarchical linear regression analysis

This study aimed to explore factors associating with disability, which means physical impairment affecting a person’s mobility, capacity, stamina, or agility, of non-specific low back pain (NSLBP) of the acute and non-acute groups. Two hundred thirty-five patients with NSLBP of less than 8 weeks’ duration as acute groups (n = 124) and more than 8 weeks’ duration as non-acute group (n = 111) were recruited. It was collected data on pain intensity, disability and psychosocial factors, including pain catastrophising, fear of movement and pain self-efficacy. Disability was measured Roland Morris Disability Questionnaire. A hierarchical multiple regression analysis was performed to analyse factors associating with disability of the acute and non-acute groups. The Result was that explanatory power increased with each additional variable of the order of demographic characteristics, pain intensity and psychosocial factors for both groups. Pain intensity, pain catastrophising and pain self-efficacy had significant explanatory power, with pain self-efficacy having the most significant association on the acute group. Only pain self-efficacy having the most significant association on disability of the non-acute group. In conclusion, the factors associating with disability differed depending on the duration of the disease, and pain self-efficacy might be one of the factors associating with disability of patients with NSLBP.

Effect of perioperative cognitive behavioral therapy on chronic post-surgical pain among breast cancer patients with high pain catastrophising characteristics: Protocol for a double-blinded randomised controlled trial.

BackgroundSurgery is regarded as the primary treatment for breast cancer. Chronic post-surgical pain (CPSP) is a recognised complication after breast cancer surgery, and it is estimated to affect 20–30% of women. Pain catastrophizing has emerged as one of the most influential psychological variables associated with CPSP.MethodsThis trial will be a single-centre, prospective, double-blinded, noninferiority, randomised controlled trial (RCT). Patients scheduled for elective breast cancer surgery (wide local excision or mastectomy with or without axillary lymph node dissection) will be screened preoperatively for high pain catastrophising. Patients with high pain catastrophising, defined as a score of ≥ 24 on the Pain Catastrophising Scale will be deemed eligible for inclusion in the study. Participants will be randomly assigned to receive either a cognitive behavioural therapy or an educational mindfulness based program during their perioperative period. The primary outcome is the Brief Pain Inventory short form average pain severity score at three months postoperatively. Secondary outcomes include patient-reported quality of recovery at Day 1–2 after surgery, levels of pain catastrophising, reported depressed mood and anxiety. ]DiscussionTo the best of our knowledge, this protocol describes the first RCT which directly examines the effect of perioperative cognitive behavioural therapy on CPSP among breast cancer patients with high pain catastrophising characteristics. The outcomes of this trial may have significant implications for these patients because perioperative cognitive behavioural therapy has the potential to become an important perioperative intervention to complement patient management.Trial registrationThis trial is registered on ClinicalTrials.gov Identifier: NCT04924010 on 11th June 2021. All item from the World Health Organisation Trial Registration Data set have been included. https://clinicaltrials.gov/ct2/show/NCT04924010

Design and rationale of the ATtune Knee Outcome Study (ATKOS): multicenter prospective evaluation of a novel uncemented rotating platform knee system

Background Total Knee Arthroplasty (TKA) remains the gold standard for treatment of debilitating symptoms of knee osteoarthritis (OA). Even though providing satisfactory results for the majority of patients, some studies report dissatisfaction after TKA to be as high as 20%. Among other things, pain catastrophising and self-efficacy are thought to compromise results of TKA. Implant manufacturers keep improving upon their designs in an attempt to improve functional outcomes. One of these novel knee systems is the Attune. To our knowledge, there are no clinical follow-up studies reporting results of the uncemented version. The main objective of this multicentre prospective observational study is to evaluate revision rate, complications, radiographic outcomes (i.e. alignment and radiolucent lines) and patient reported outcomes of the uncemented Attune mobile bearing TKA. Secondary objectives are (1) to assess physical function, return to sport and return to work after TKA and (2) to evaluate the long-term effect of preoperative psychological factors on satisfaction after TKA. Methods All patients presenting in the participating centres with knee pathology warranting joint replacement therapy will be considered for inclusion, an absolute indication for cemented fixation is the only exclusion criterium. Evaluation of clinical and radiographic performance (e.g. radiolucent lines) is done at 6 weeks, 6 months, 1 year, 5 years and 10 years after surgery using validated patient reported outcome measures. Cumulative revision rates are calculated after 5 and 10 years using Kaplan–Meier methods. Physical function is assessed with performance based measurements before and 1 year after surgery. Return to sports is assessed using the Tegner and University of California Los Angeles (UCLA) activity rating scale before and 1 year after surgery. Return to work is evaluated by inviting patients of working age to complete a short questionnaire 1 year after surgery. Psychologic factors are assessed using questionnaires for pain catastrophising, pain self-efficacy and mental health before, 5 years and 10 years after surgery. Preoperative psychologic scores are correlated to functional outcomes. Discussion The current study aims to report the clinical performance of a novel implant and can help provide insight in factors that play a role in satisfaction after TKA. Trial registration ClinicalTrials.gov identifier: NCT04247672 (January 30, 2020)

Cross-cultural adaptation, reliability and validity of the Fremantle Knee Awareness Questionnaire in Italian subjects with painful knee osteoarthritis

Background and aim Growing attention is being given to utilising physical function measures to better understand and manage knee osteoarthritis (OA). The Fremantle Knee Awareness Questionnaire (FreKAQ), a self-reported measure of body-perception specific to the knee, has never been validated in Italian patients. The aims of this study were to culturally adapt and validate the Italian version of the FreKAQ (FreKAQ-I), to allow for its use with Italian-speaking patients with painful knee OA. Methods The FreKAQ-I was developed by means of forward–backward translation, a final review by an expert committee and a test of the pre-final version to evaluate its comprehensibility. The psychometric testing included: internal structural validity by Rasch analysis; construct validity by assessing hypotheses of FreKAQ correlations with the knee injury and osteoarthritis outcome score (KOOS), a pain intensity numerical rating scale (PI-NRS), the pain catastrophising scale (PCS), and the Hospital anxiety and depression score (HADS) (Pearson’s correlations); known-group validity by evaluating the ability of FreKAQ scores to discriminate between two groups of participants with different clinical profiles (Mann–Whitney U test); reliability by internal consistency (Cronbach’s alpha) and test–retest reliability (intraclass correlation coefficient, ICC2.1); and measurement error by calculating the minimum detectable change (MDC). Results It took one month to develop a consensus-based version of the FreKAQ-I. The questionnaire was administered to 102 subjects with painful knee OA and was well accepted. Internal structural validity confirmed the substantial unidimensionality of the FreKAQ-I: variance explained was 53.3%, the unexplained variance in the first contrast showed an eigenvalue of 1.8, and no local dependence was detected. Construct validity was good as all of the hypotheses were met; correlations: KOOS (rho = 0.38–0.51), PI-NRS (rho = 0.35–0.37), PCS (rho = 0.47) and HADS (Anxiety rho = 0.36; Depression rho = 0.43). Regarding known-groups validity, FreKAQ scores were significantly different between groups of participants demonstrating high and low levels of pain intensity, pain catastrophising, anxiety, depression and the four KOOS subscales (p ≤ 0.004). Internal consistency was acceptable (α = 0.74) and test–retest reliability was excellent (ICC = 0.92, CI 0.87–0.94). The MDC95 was 5.22 scale points. Conclusion The FreKAQ-I is unidimensional, reliable and valid in Italian patients with painful knee OA. Its use is recommended for clinical and research purposes.

“Big girls don’t cry”: the effect of the experimenter’s sex and pain catastrophising on pain

Objectives The expression of pain in males and females involves complex socio-psychological mechanisms. Males may report lower pain to a female experimenter to appear strong, whereas females may report higher pain to a male experimenter to appear weak and to seek protection. However, evidence to support these stereotypes is inconclusive. Individuals who catastrophise about pain rate higher pain than those who do not. How pain catastrophising interacts with the effect of the experimenter’s sex on pain reports is yet to be explored. Thus, the aim of this study was to determine whether pain catastrophising moderated the effect of the experimenter’s sex on pain reports in healthy males and females. Methods Participants (n=60, 30 males) were assigned to one of four experimental conditions: males tested by male experimenters, males tested by female experimenters, females tested by male experimenters, and females tested by female experimenters. Participants completed the Pain Catastrophising Scale, and then sensitivity to heat and to blunt (pressure-pain threshold) and sharp stimuli was assessed on both forearms, and to high frequency electrical stimulation (HFS) administered to one forearm. Results Females reported lower pressure-pain thresholds than males irrespective of the experimenters’ sex. Females reported lower sharpness ratings to male than female experimenters only when the test stimuli were moderately or intensely sharp. Higher pain catastrophising scores were associated with higher sharpness ratings in females but not males. Additionally, higher pain catastrophising scores were associated with greater temporal summation of pain to HFS, and with lower pressure-pain thresholds in females who were tested by male experimenters. Conclusions These findings indicate that the experimenters’ sex and the participant’s pain catastrophising score influence pain reports, particularly in females. Awareness of these psychosocial factors is important in order to interpret pain responses in a meaningful way, especially when females are tested by male experimenters. A greater awareness of sex/gender role biases and their potential interaction with pain catastrophising may help researchers and clinicians to interpret pain reports in meaningful ways. In turn, this may help to improve delivery of treatments for patients with chronic pain.

Adverse effects of COVID-19-related lockdown on pain, physical activity and psychological well-being in people with chronic pain

Countries across the world imposed lockdown restrictions during the COVID-19 pandemic. It has been proposed that lockdown conditions, including social and physical distancing measures, may disproportionately impact those living with chronic pain and require rapid adaptation to treatment and care strategies. Using an online methodology, we investigated how lockdown restrictions in the United Kingdom impacted individuals with chronic pain (N = 431) relative to a healthy control group (N = 88). Data were collected during the most stringent period of lockdown in the United Kingdom (mid-April to early-May 2020). In accordance with the fear-avoidance model, we hypothesised lockdown-related increases in pain and psychological distress, which would be mediated by levels of pain catastrophising. Responses indicated that people with chronic pain perceived increased pain severity, compared to their estimation of typical pain levels prior to lockdown (p < .001). They were also more adversely affected by lockdown conditions compared to pain-free individuals, demonstrating greater self-perceived increases in anxiety and depressed mood, increased loneliness and reduced levels of physical exercise (p ⩽ .001). Hierarchical regression analysis revealed that pain catastrophising was an important factor relating to the extent of self-perceived increases in pain severity during lockdown (β = .27, p < .001) and also mediated the relationship between decreased mood and pain. Perceived decreases in levels of physical exercise also related to perceptions of increased pain (β = .15, p < .001). Interestingly, levels of pain intensity (measured at two time points at pre and during lockdown) in a subgroup (N = 85) did not demonstrate a significant change. However, individuals in this subgroup still reported self-perceived pain increases during lockdown, which were also predicted by baseline levels of pain catastrophising. Overall, the findings indicate that people with chronic pain suffer adverse effects of lockdown including self-perceived increases in their pain. Remote pain management provision to target reduction of pain catastrophising and increase health behaviours including physical activity could be beneficial for this vulnerable population.