Understanding the biopsychosocial knee osteoarthritis pain experience: an ecological momentary assessment.

Introduction: Psychological, social, and lifestyle factors contribute to the knee osteoarthritis (OA) pain experience. These factors could be measured more accurately using smartphone ecological momentary assessment (EMA). Objectives: The objective of this study was to characterise the pain experiences of those with knee OA by a smartphone EMA survey and explain how momentary psychological and social states influence knee OA pain experiences. Methods: A smartphone EMA survey was designed and piloted. Eligible participants completed smartphone EMA assessing the knee OA pain experience 3 times daily for 2 weeks. Descriptive statistics were used to characterise factors involved in knee OA pain followed by the development of mixed-effects location scale models to explore heterogeneity and relationships between symptoms involved in the knee OA pain experience. Results: Eighty-six community-dwelling volunteers with knee OA were recruited. Pain, psychosocial, and lifestyle factors involved in knee OA pain experience were heterogeneous and variable. Those with greater variability in pain, fatigue, negative affect, and stress had worse levels of these symptoms overall. In addition, fatigue, negative affect, stress, anxiety, loneliness, and joint stiffness demonstrated within-person relationships with knee OA pain outcomes. Conclusions: Knee OA pain is a heterogeneous biopsychosocial condition. Momentary experiences of psychological, social, fatigue, and joint stiffness explain individual and between-individual differences in momentary knee OA pain experiences. Addressing these momentary factors could improve pain and functional outcomes in those with knee OA. Validation studies, including individuals with more severe knee OA presentations, are required to support findings and guide clinical interventions to improve outcomes for those with knee OA.

Activity-related pain and sensitization predict within- and between-person pain experience in people with knee osteoarthritis: An ecological momentary assessment study.

Background and objectives: Knee Osteoarthritis (OA) is a prevalent musculoskeletal condition that often results in pain and disability. Determining factors predicting variability in pain experience is critical to improving clinical outcomes. Underlying pain sensitization and its clinical manifestations, such as activity-related pain, may better predict the knee OA pain experience. This study aimed to determine whether Quantitative Sensory Testing (QST) derived sensitization measures and activity-related pain predict knee OA pain experiences collected via smartphone ecological momentary assessment (EMA). Design: Individuals with knee OA were recruited from an urban community in New Zealand. Those eligible to participate underwent baseline QST with clinical measures of activity-related pain also being collected. The knee OA pain experience was collected via smartphone EMA three times daily for two weeks. Mixed effects location scale models were developed using a multilevel modelling approach. Results: Eighty-six participants with knee OA participated in the study. Mean age was 67.3 years, with most of the participants being female (64%) and New Zealand European (90.6%). Activity-related pain predicted worse and more variable pain intensity, pain interference, and bothersomeness outcomes within and between individuals with knee OA. Widespread cold hyperalgesia and local mechanical hyperalgesia were shown to predict higher within-person variability in pain intensity and pain interference respectively, while mechanical temporal summation predicted less within-person variability in pain intensity and interference. Discussion: Those demonstrating activity-related pain and sensitization could be at risk of experiencing worse and more variable knee OA pain in the subsequent weeks. Testing for sensitization in clinical practice could therefore identify those at greatest risk of higher and more variable knee OA pain experiences and in greatest need of treatment. Larger validation studies are required, which include individuals with more severe knee OA.

EEG-Based Cortical Alterations in Individuals With Chronic Knee Pain Secondary to Osteoarthritis: A Cross-sectional Investigation.

Chronic painful knee osteoarthritis (OA) is a disabling physical health condition. Alterations in brain responses to arthritic changes in the knee may explain persistent pain. This study investigated source localized, resting-state electroencephalography activity and functional connectivity in people with knee OA, compared to healthy controls. Adults aged 44 to 85 years with knee OA (n = 37) and healthy control (n = 39) were recruited. Resting-state electroencephalography was collected for 10 minutes and decomposed into infraslow frequency (ISF) to gamma frequency bands. Standard low-resolution electromagnetic brain tomography statistical nonparametric maps were conducted, current densities of regions of interest were compared between groups and correlation analyses were performed between electroencephalography (EEG) measures and clinical pain and functional outcomes in the knee OA group. Standard low-resolution electromagnetic brain tomography nonparametric maps revealed higher (P = .006) gamma band activity over the right insula (RIns) in the knee OA group. A significant (P < .0001) reduction in ISF band activity at the pregenual anterior cingulate cortex, whereas higher theta, alpha, beta, and gamma band activity at the dorsal anterior cingulate cortex, pregenual anterior cingulate cortex, the somatosensory cortex, and RIns in the knee OA group were identified. ISF activity of the dorsal anterior cingulate cortex was positively correlated with pain measures and psychological distress scores. Theta and alpha activity of RIns were negatively correlated with pain interference. In conclusion, aberrations in infraslow and faster frequency EEG oscillations at sensory discriminative, motivational-affective, and descending inhibitory cortical regions were demonstrated in people with chronic painful knee OA. Moreover, EEG oscillations were correlated with pain and functional outcome measures. PERSPECTIVE: This study confirms alterations in the rsEEG oscillations and its relationship with pain experience in people with knee OA. The study provides potential cortical targets and the EEG frequency bands for neuromodulatory interventions for managing chronic pain experience in knee OA.

Test-retest reliability of movement-evoked pain and sensitivity to movement-evoked pain in patients with rotator cuff-related shoulder pain.

BACKGROUND: The number of researchers and clinicians using movement-evoked pain and sensitivity to movement-evoked pain to assess shoulder pain has increased. However, the intrarater test-retest reliability of movement-evoked pain and sensitivity to movement-evoked pain in people with rotator cuff-related shoulder pain (RCRSP) is still unknown. OBJECTIVE: We examined the intrarater test-retest reliability of movement-evoked pain and sensitivity to movement-evoked pain in participants with RCRSP. METHODS: Seventy-four participants with RCRSP performed five trials of active shoulder abduction to elicit pain under two experimental conditions: active shoulder abduction to the onset of pain and maximum range of motion (ROM). The primary outcome measures were pain intensity and ROM. Test-retest reliability of movement-evoked pain and sensitivity to movement-evoked pain was examined using intraclass correlation coefficient (ICC3,1) and minimal detectable change (MDC90). RESULTS: The reliability of movement-evoked pain under both experimental conditions was good to excellent (ICC: 0.81 to 0.95), while the reliability of sensitivity to movement-evoked pain was poor in both conditions (ICC≤0.45). The MDC90 for pain intensity was 1.6 and 1.8 during shoulder abduction to the onset of pain and maximum ROM, respectively. The MDC90 for ROM was 17.5° and 11.2° during shoulder abduction to the onset of pain and maximum ROM condition, respectively. CONCLUSION: This study confirms movement-evoked pain testing during active shoulder abduction to the onset of pain or maximum ROM condition is reliable to assess pain associated with movement in patients with RCRSP. The minimal detectable change score of movement-evoked pain can guide clinicians and researchers on how to interpret changes in these outcomes.

Initial effect of high-volume mobilisation with movement on shoulder range of motion and pain in patients with rotator cuff-related shoulder pain: protocol for a randomised controlled trial (Evolution Trial).

INTRODUCTION: Mobilisation with movement (MWM) is commonly used for treating patients with rotator cuff-related shoulder pain (RCRSP). However, the evidence supporting MWM efficacy for improving shoulder range of motion (ROM) and pain in patients with RCRSP is limited. It is also unclear whether higher volume MWM leads to better clinical outcomes compared with lower volume MWM in patients with RCRSP. The primary aim of this study is to assess the effect of MWM on the angular onset of pain during shoulder abduction in patients with RCRSP. METHODS AND ANALYSIS: Sixty participants with RCRSP will be randomised to receive either MWM or sham MWM intervention. The primary outcome is the angular onset of pain during shoulder abduction, and secondary outcomes are pain intensity at the angular onset of pain during shoulder abduction, maximum shoulder ROM, pain intensity during maximum shoulder abduction, pressure pain threshold, mechanical temporal summation, global rating of change scale (GROC) and Brief Pain Inventory-Short Form (BPI-SF). The angular onset of pain and the pain intensity at that range will be assessed at baseline, after 1 set and 3 sets of 10 repetitions of MWM or sham MWM. The GROC will be measured immediately after receiving 3 sets of interventions and on day 3 after interventions. The BPI-SF will be measured on days 1, 3, 5 and 7 after interventions. Other secondary outcomes will be assessed at baseline and after 3 sets of interventions. A linear mixed effects model with a random intercept will be used to compare changes in the outcome measures between MWM and sham MWM interventions. ETHICS AND DISSEMINATION: This study has been approved by the University of Otago Ethics Committee (Ref. H21/117). Findings from this study will be disseminated through presentations at international and national conferences and will be submitted for publication in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: ACTRN 12621001723875.

Experiences and Perceptions of Using Smartphone Ecological Momentary Assessment for Reporting Knee Osteoarthritis Pain and Symptoms.

BACKGROUND: Knee osteoarthritis (OA) is a prevalent, painful, and disabling musculoskeletal condition. One method that could more accurately monitor the pain associated with knee OA is ecological momentary assessment (EMA) using a smartphone. OBJECTIVES: The aim of this study was to explore participant experiences and perceptions of using smartphone EMA as a way of communicating knee OA pain and symptoms following participating in a 2-week smartphone EMA study. MATERIALS AND METHODS: Using a maximum variation sampling method, participants were invited to share their thoughts and opinions in semistructured focus group interviews. Interviews were recorded and transcribed verbatim before thematic analysis using the general inductive approach. RESULTS: A total of 20 participants participated in 6 focus groups. Three themes and 7 subthemes were identified from the data. Identified themes included: user experience of smartphone EMA, data quality of smartphone EMA, and practical aspects of smartphone EMA. DISCUSSION: Overall, smartphone EMA was deemed as being an acceptable method for monitoring pain and symptoms associated with knee OA. These findings will assist researchers in designing future EMA studies alongside clinicians implementing smartphone EMA into practice. PERSPECTIVE: This study highlights that smartphone EMA is an acceptable method for capturing pain-related symptoms and experiences of those expereiencing knee OA. Future EMA studies should ensure design features are considered that reduce missing data and limit the responder burden to improve data quality.

Tracing the origins of midlife despair: association of psychopathology during adolescence with a syndrome of despair-related maladies at midlife.

BACKGROUND: Midlife adults are experiencing a crisis of deaths of despair (i.e. deaths from suicide, drug overdose, and alcohol-related liver disease). We tested the hypothesis that a syndrome of despair-related maladies at midlife is preceded by psychopathology during adolescence. METHODS: Participants are members of a representative cohort of 1037 individuals born in Dunedin, New Zealand in 1972-73 and followed to age 45 years, with 94% retention. Adolescent mental disorders were assessed in three diagnostic assessments at ages 11, 13, and 15 years. Indicators of despair-related maladies across four domains - suicidality, substance misuse, sleep problems, and pain - were assessed at age 45 using multi-modal measures including self-report, informant-report, and national register data. RESULTS: We identified and validated a syndrome of despair-related maladies at midlife involving suicidality, substance misuse, sleep problems, and pain. Adults who exhibited a more severe syndrome of despair-related maladies at midlife tended to have had early-onset emotional and behavioral disorders [ß = 0.23, 95% CI (0.16-0.30), p < 0.001], even after adjusting for sex, childhood SES, and childhood IQ. A more pronounced midlife despair syndrome was observed among adults who, as adolescents, were diagnosed with a greater number of mental disorders [ß = 0.26, 95% CI (0.19-0.33), p < 0.001]. Tests of diagnostic specificity revealed that associations generalized across different adolescent mental disorders. CONCLUSIONS: Midlife adults who exhibited a more severe syndrome of despair-related maladies tended to have had psychopathology as adolescents. Prevention and treatment of adolescent psychopathology may mitigate despair-related maladies at midlife and ultimately reduce deaths of despair.

Sensitivity to movement-evoked pain, central sensitivity symptoms, and pro-nociceptive profiles in people with chronic shoulder pain: A parallel-group cross-sectional investigation.

OBJECTIVE: To investigate whether sensitivity to movement-evoked pain (SMEP), central sensitivity symptom burden, and quantitative sensory testing (QST) outcomes differ between healthy controls and people with chronic shoulder pain. METHODS: People with chronic shoulder pain (n = 39) and healthy controls (n = 26) completed validated questionnaires measuring demographic, pain characteristics, psychological factors, social support, sleep quality, central sensitivity inventory (CSI), and physical activity levels. A blinded assessor administered QST measuring pressure pain threshold, temporal summation, conditioned pain modulation, and cold hyperalgesia. All participants performed repeated lifting of weighted canisters and reported severity of pain over successive lifts of the weighted canisters. Between-group differences in the QST, SMEP and CSI scores were investigated. Demographic and psychosocial variables were adjusted in the analyses. RESULTS: Dynamic mechanical allodynia, mechanical temporal summation, movement-evoked pain scores, SMEP index, and CSI scores were significantly (p ≤ 0.05) higher in the chronic shoulder pain group than in healthy controls. A significant proportion of people with chronic shoulder pain presented with pro-nociceptive profiles and experienced higher pain severity, interference, and disability. CONCLUSIONS: People with chronic shoulder pain displayed symptoms and signs of central sensitization. Future research should investigate the predictive role of central sensitization on clinical outcomes in shoulder pain.

Exploring electroencephalographic infraslow neurofeedback treatment for chronic low back pain: a double-blinded safety and feasibility randomized placebo-controlled trial.

Chronic low back pain (CLBP) is a disabling condition worldwide. In CLBP, neuroimaging studies demonstrate abnormal activities in cortical areas responsible for pain modulation, emotional, and sensory components of pain experience [i.e., pregenual and dorsal anterior cingulate cortex (pgACC, dACC), and somatosensory cortex (SSC), respectively]. This pilot study, conducted in a university setting, evaluated the feasibility, safety, and acceptability of a novel electroencephalography-based infraslow-neurofeedback (EEG ISF-NF) technique for retraining activities in pgACC, dACC and SSC and explored its effects on pain and disability. Participants with CLBP (n = 60), recruited between July'20 to March'21, received 12 sessions of either: ISF-NF targeting pgACC, dACC + SSC, a ratio of pgACC*2/dACC + SSC, or Placebo-NF. Descriptive statistics demonstrated that ISF-NF training is feasible [recruitment rate (7 participants/month), dropouts (25%; 20-27%), and adherence (80%; 73-88%)], safe (no adverse events reported), and was moderate to highly acceptable [Mean ± SD: 7.8 ± 2.0 (pgACC), 7.5 ± 2.7 (dACC + SCC), 8.2 ± 1.9 (Ratio), and 7.7 ± 1.5 (Placebo)]. ISF-NF targeting pgACC demonstrated the most favourable clinical outcomes, with a higher proportion of participants exhibiting a clinically meaningful reduction in pain severity [53%; MD (95% CI): - 1.9 (- 2.7, - 1.0)], interference [80%; MD (95% CI): - 2.3 (- 3.5, - 1.2)], and disability [73%; MD (95% CI): - 4.5 (- 6.1, - 2.9)] at 1-month follow-up. ISF-NF training is a feasible, safe, and an acceptable treatment approach for CLBP.

Are Ecological Momentary Assessments of Pain Valid and Reliable? A Systematic Review and Meta-analysis.

OBJECTIVES: This systematic review and meta-analysis aimed to determine the level of evidence for the psychometric properties of Ecological Momentary Assessment (EMA) in populations with persistent pain. MATERIALS AND METHODS: Five databases were searched from 1980 to December 2021. Two reviewers independently screened the titles, abstracts, and full text, extracted data, and assessed adherence to reporting standards and methodological rigor before evaluating the quality of evidence. A meta-analysis, including the pooling of correlations for the relevant EMA pain outcomes, was completed. RESULTS: Overall, 3270 studies were identified, with 14 studies meeting inclusion criteria. Meta-analyses confirmed good to excellent relationships demonstrated between EMA and recalled pain intensity and interference across different timeframes. Many of the included studies did not fully adhere to recommended reporting standards, and the quality of included studies was either doubtful or inadequate due to methodological flaws. The level of evidence for measurement properties of pain outcomes was low for the criterion validity of pain intensity and interference and very low for reliability and construct validity of pain intensity and interference. DISCUSSION: Ecological momentary assessment of pain experience appears both valid and reliable. Although the levels of evidence were low or very low, these findings provide preliminary support for the use of EMA in clinical practice and research settings. Potential strengths of EMA include providing measures with greater ecological validity while also reducing recall bias, both pertinent in pain outcome measurement. More research, including higher-quality studies, is needed to demonstrate further support for EMA, including the need for establishing other types of validity.

High-Definition Transcranial Infraslow Pink-Noise Stimulation Can Influence Functional and Effective Cortical Connectivity in Individuals With Chronic Low Back Pain: A Pilot Randomized Placebo-Controlled Study.

INTRODUCTION: Pain can be regarded as an emergent property of multiple interacting, dynamically changing brain networks and thus needs a targeted treatment approach. A novel high-definition transcranial infraslow pink-noise stimulation (HD-tIPNS) technique was developed to modulate the key hubs of the three main nociceptive pathways simultaneously, ie, the pregenual anterior cingulate cortex (pgACC) (descending inhibitory pathway), the dorsal anterior cingulate cortex (dACC) (medial nociceptive pathway), and both somatosensory cortices (S1) (lateral nociceptive pathway). This study aimed to evaluate safety and verify whether a single session of HD-tIPNS may disrupt functional and effective connectivity between targeted cortical regions. MATERIALS AND METHODS: A pilot double-blind randomized two-arm placebo-controlled parallel trial was conducted. Participants (N = 30) with chronic low back pain were equally randomized to receive a single session of either sham stimulation or HD-tIPNS (targeting the pgACC, dACC, and bilateral S1). Primary outcomes included safety and electroencephalographic measures, and secondary outcomes included pain measures, collected after treatment. A Mann-Whitney U test was used to compare between-group differences in percentage changes with baseline for each outcome measures. A Wilcoxon signed-rank test was used to identify difference in effective connectivity measure before and after HD-tIPNS. RESULTS: No serious adverse events were reported. A significant decrease in instantaneous functional connectivity was noted between the pgACC and dACC (U = 47.0, Z = -2.72, p = 0.007) and the pgACC and left S1 (U = 41.0, Z = -2.97, p = 0.003) in the infraslow band after HD-tIPNS when compared with sham stimulation. A significant decrease in instantaneous effective connectivity was noted in the direction of the dACC to the pgACC (Z = -2.10, p = 0.035), in the infraslow band after HD-tIPNS when compared with baseline. No changes in clinical pain measures were detected. CONCLUSIONS: HD-tIPNS can safely modulate the functional and effective connectivity between targeted pain-related cortical hubs. Further studies are warranted to evaluate whether repeated exposures to HD-tIPNS can incur clinical benefits through inducing changes in functional and effective connectivity at targeted cortical regions. CLINICAL TRIAL REGISTRATION: The Clinicaltrials.gov registration number for the study is ACTRN12621001438842.

Self-regulation training for people with knee osteoarthritis: a protocol for a feasibility randomised control trial (MiNT trial).

Introduction: Knee osteoarthritis (OA) is a chronic secondary musculoskeletal pain condition resulting in disability, reduced quality of life, and high societal costs. Pain associated with knee OA is linked to increased sensitivity in sensory, cognitive, and emotional areas of the brain. Self-regulation training targeting brain functioning related to pain experience could reduce pain and its associated disability. Self-regulatory treatments such as mindfulness meditation (MM) and electroencephalography neurofeedback (EEG-NF) training improve clinical outcomes in people with knee OA. A feasibility clinical trial can address factors that could inform the design of the full trial investigating the effectiveness of self-regulation training programmes in people with knee OA. This clinical trial will evaluate the feasibility, safety, acceptability, experience and perceptions of the self-regulatory training programmes. Methods: The proposed feasibility trial is based on a double-blind (outcome assessor and investigators), three-arm (MM usual care, EEG-NF + usual care and usual care control group) randomised controlled parallel clinical trial. Participants with knee OA will be recruited from the community and healthcare practices. A research assistant (RA) will administer both interventions (20-min sessions, four sessions each week, and 12 sessions over three successive weeks). Feasibility measures (participant recruitment rate, adherence to interventions, retention rate), safety, and acceptability of interventions will be recorded. An RA blinded to the group allocation will record secondary outcomes at baseline, immediately post-intervention (4th week), and 3 months post-intervention. The quantitative outcome measures will be descriptively summarised. The qualitative interviews will evaluate the participants' experiences and perceptions regarding various aspects of the trial, which includes identifying the barriers and facilitators in participating in the trial, evaluating their opinions on the research procedures, such as their preferences for the study site, and determining the level of acceptability of the interventions as potential clinical treatments for managing knee OA. Maori participant perceptions of how assessment and training practices could be acceptable to a Maori worldview will be explored. The interviews will be audio-recorded and analysed thematically. Discussion: This trial will provide evidence on the feasibility, safety, and acceptability of the MM and EEG-NF training in people with knee OA, thus informing the design of a full randomised clinical control trial.

Infraslow Neurofeedback Training Alters Effective Connectivity in Individuals with Chronic Low Back Pain: A Secondary Analysis of a Pilot Randomized Placebo-Controlled Study.

This study explored the effect of electroencephalographic infraslow neurofeedback (EEG ISF-NF) training on effective connectivity and tested whether such effective connectivity changes are correlated with changes in pain and disability in people with chronic low back pain. This involved secondary analysis of a pilot double-blinded randomised placebo-controlled study. Participants (n = 60) were randomised to receive ISF-NF targeting either the pregenual anterior cingulate cortex (pgACC), dorsal anterior cingulate and somatosensory cortex (dACC + S1), ratio of pgACC*2/dACC + S1, or Sham-NF. Resting-state EEG and clinical outcomes were assessed at baseline, immediately after intervention, and at one-week and one-month follow-up. Kruskal-Wallis tests demonstrated significant between-group differences in effective connectivity from pgACC to S1L at one-month follow up and marginal significant changes from S1L to pgACC at one-week and one-month follow up. Mann-Whitney U tests demonstrated significant increases in effective connectivity in the ISF-NF up-training pgACC group when compared to the Sham-NF group (pgACC to S1L at one-month (p = 0.013), and S1L to pgACC at one-week (p = 0.008) and one-month follow up (p = 0.016)). Correlational analyses demonstrated a significant negative correlation (ρ = -0.630, p = 0.038) between effective connectivity changes from pgACC to S1L and changes in pain severity at one-month follow-up. The ISF-NF training pgACC can reduce pain via influencing effective connectivity between pgACC and S1L.

Source localized infraslow neurofeedback training in people with chronic painful knee osteoarthritis: A randomized, double-blind, sham-controlled feasibility clinical trial.

Persistent pain is a key symptom in people living with knee osteoarthritis (KOA). Infra-slow Neurofeedback (ISF-NF) training is a recent development focusing on modulating cortical slow-wave activity to improve pain outcomes. A parallel, two-armed double-blinded, randomized sham-controlled, feasibility clinical trial aimed to determine the feasibility and safety of a novel electroencephalography-based infraslow fluctuation neurofeedback (EEG ISF-NF) training in people with KOA and determine the variability of clinical outcomes and EEG changes following NF training. Eligible participants attended nine 30-min ISF-NF training sessions involving three cortical regions linked to pain. Feasibility measures were monitored during the trial period. Pain and functional outcomes were measured at baseline, post-intervention, and follow-up after 2 weeks. Resting-state EEG was recorded at baseline and immediate post-intervention. Participants were middle-aged (61.7 ± 7.6 years), New Zealand European (90.5%), and mostly females (62%) with an average knee pain duration of 4 ± 3.4 years. The study achieved a retention rate of 91%, with 20/22 participants completing all the sessions. Participants rated high levels of acceptance and "moderate to high levels of perceived effectiveness of the training." No serious adverse events were reported during the trial. Mean difference (95% CI) for clinical pain and function measures are as follows for pain severity [active: 0.89 ± 1.7 (-0.27 to 2.0); sham: 0.98 ± 1.1 (0.22-1.7)], pain interference [active: 0.75 ± 2.3 (-0.82 to 2.3); Sham: 0.89 ± 2.1 (-0.60 to 2.4)], pain unpleasantness [active: 2.6 ± 3.7 (0.17-5.1); sham: 2.8 ± 3 (0.62-5.0)] and physical function [active: 6.2 ± 13 (-2.6 to 15); sham: 1.6 ± 12 (-6.8 to 10)]. EEG sources demonstrated frequency-specific neuronal activity, functional connectivity, and ISF ratio changes following NF training. The findings of the study indicated that the ISF-NF training is a feasible, safe, and acceptable intervention for pain management in people with KOA, with high levels of perceived effectiveness. The study also reports the variability in clinical, brain activity, and connectivity changes following training.

High-definition transcranial infraslow pink noise stimulation for chronic low back pain: protocol for a pilot, safety and feasibility randomised placebo-controlled trial.

INTRODUCTION: Chronic low back pain (CLBP) is a common disabling health condition. Current treatments demonstrate modest effects, warranting newer therapies. Brain imaging demonstrates altered electrical activities in cortical areas responsible for pain modulation, emotional and sensory components of pain experience. Treatments targeting to change electrical activities of these key brain regions may produce clinical benefits. This pilot study aims to (1) evaluate feasibility, safety and acceptability of a novel neuromodulation technique, high-definition transcranial infraslow pink noise stimulation (HD-tIPNS), in people with CLBP, (2) explore the trend of effect of HD-tIPNS on pain and function, and (3) derive treatment estimates to support sample size calculation for a fully powered trial should trends of effectiveness be present. METHODS AND ANALYSIS: A pilot, triple-blinded randomised two-arm placebo-controlled parallel trial. Participants (n=40) with CLBP will be randomised to either sham stimulation or HD-tIPNS (targeting somatosensory cortex and dorsal and pregenual anterior cingulate cortex). Primary outcomes include feasibility and safety measures, and clinical outcomes of pain (Brief Pain Inventory) and disability (Roland-Morris disability questionnaire). Secondary measures include clinical, psychological, quantitative sensory testing and electroencephalography collected at baseline, immediately postintervention, and at 1-week, 1-month and 3 months postintervention. All data will be analysed descriptively. A nested qualitative study will assess participants perceptions about acceptability of intervention and analysed thematically. ETHICS AND DISSEMINATION: Ethical approval has been obtained from Health and Disability Ethics Committee (Ref:20/NTB/67). Findings will be reported to regulatory and funding bodies, presented at conferences, and published in a scientific journal. TRIAL REGISTRATION NUMBER: ACTRN12620000505909p.

Implementation of the Diabetes Community Exercise and Education Programme (DCEP) for the management of type 2 diabetes: qualitative process evaluation.

OBJECTIVES: To examine context-specific delivery factors, facilitators and barriers to implementation of the Diabetes Community Exercise and Education Programme (DCEP) for adults with type 2 diabetes (T2D) using the Reach, Effectiveness, Adoption, Implementation and Maintenance framework. DESIGN: A qualitative evaluation embedded within the DCEP pragmatic randomised controlled trial. Data collected via focus groups and interviews and analysed thematically. SETTING: Community-based in two cities (Dunedin and Invercargill) in the lower south island of New Zealand. PARTICIPANTS: Seventeen adults diagnosed with T2D attending DCEP and 14 healthcare professionals involved in DCEP delivery. INTERVENTION: DCEP is a twice weekly session of exercise and education over 12 weeks, followed by a twice weekly ongoing exercise class. RESULTS: While our reach target was met (sample size, ethnic representation), the randomisation process potentially deterred Maori and Pasifika from participating. The reach of DCEP may be extended through the use of several strategies: promotion of self-referral, primary healthcare organisation ownership and community champions. DCEP was considered effective based on perceived benefit. The social and welcoming environment created relationships and connections. People felt comfortable attending DCEP and empowered to learn. Key to implementation and adoption was the building of trusting relationships with local health providers and communities. This takes time and care and cannot be rushed. Training of staff and optimising communication needed further attention. To maintain DCEP, delivery close to where people live and a generic approach catering for people with multiple chronic conditions may be required. CONCLUSIONS: For success, lifestyle programmes such as DCEP, need time and diligence to build and maintain networks and trust. Beyond frontline delivery staff and target populations, relationships should extend to local healthcare organisations and communities. Access and ongoing attendance are enabled by healthcare professionals practicing in a nuanced person-centred manner; this, plus high staff turnover, necessitates ongoing training. TRIAL REGISTRATION NUMBER: ACTRN12617001624370.

Somatosensory assessments in patients with inflammatory bowel disease: a cross-sectional study examining pain processing pathways and the role of multiple patient factors.

BACKGROUND: Pain affects the majority of patients with inflammatory bowel disease (IBD), where pain experiences may be influenced by multiple patient factors and changes within central pain processing pathways, termed central sensitization. The current study aimed to investigate pain processing pathways in patients with IBD through somatosensory testing and associations with multiple patient factors. METHODS: A cross-sectional study of adults with IBD. Assessments included: somatosensory tests [i.e. pressure pain thresholds (PPT), temporal summation (TS), conditioned pain modulation (CPM)], and patient factors (i.e. demographics, comorbidity, sleep quality, psychological, pain severity and interference, and IBD features). Multiple regression analyses explored associations between somatosensory tests and multiple patient factors. RESULTS: Decreased CPM in participants (N = 51) was associated with worse abdominal pain severity and use of biologic therapies (R2 = 0.30, F(5,44) = 5.18, P = 0.001). Increased TS was associated with biologic use (R2 = 0.11, F(1,49) = 6.13, P = 0.017). Decreased PPT at the low back (R2 = 0.29, F(2,48) = 11.21, P < 0.001) and Tibialis anterior (R2 = 0.41, F(2,48) = 18.26, P < 0.001) were associated with female sex and the absence of a stoma. CONCLUSION: Study results demonstrated associations between multiple patient factors and somatosensory tests in patients with IBD. The absence of a stoma and female sex was associated with greater sensitivity to pressure in two remote body regions, suggestive of widespread hyperalgesia. Worse abdominal pain severity and biologic use were associated with decreased pain inhibition, and biologic use was also associated with increased pain facilitation. These findings suggest the presence of altered pain processing and mechanisms of central sensitization in patients with IBD.

The experiences of Indian people living in New Zealand with stroke.

PURPOSE: Stroke can cause lifelong disability and participatory limitations. Stroke survivors thus manage their recovery long term. Health professionals can support self-management, tailoring this support to be culturally appropriate. This study explored the unique culture and ethnicity specific experiences of Indian people living in New Zealand with stroke, focussing on self-management and facilitators and challenges to recovery. METHODS: Eight individuals with stroke took part in semi-structured interviews. Data were analysed using the General Inductive Approach. RESULTS: Four themes were identified: (1) helping myself, in any way that I can, (2) family and support, (3) social connections, and (4) ethnicity was not a barrier. CONCLUSION: All participants felt well looked after within the New Zealand healthcare context but highlighted the need for long term support. Self-management strategies participants considered important included changes to their diet, acceptance by oneself and society, returning to work, the role of family, and the use of technology and social media. Health professionals should consider these factors when providing self-management support to individuals of Indian ethnicity.IMPLICATIONS FOR REHABILITATIONAdvice and help around diet, lifestyle, and return to work were important priorities identified by our Indian stroke survivor participants.Our Indian stroke survivor participants requested more long-term specialist support and stroke information.Although the family willingly take increased responsibility for the wellbeing of the individual with stroke, it is not a substitute for professional input which needs to be tailored and offered proactively.

Activity-related pain predicts pain and functional outcomes in people with knee osteoarthritis: A longitudinal study.

Knee Osteoarthritis (OA) is a prevalent musculoskeletal condition, commonly resulting in pain and disability. However, pain and disability in this population are poorly related with the degree of structural joint damage. Underlying pain mechanisms, including activity-related pain and sensitization assessed via Quantitative Sensory Testing (QST), may better predict pain and functional outcomes of those with knee OA. Therefore, the aim of this study was to explore whether activity-related pain and sensitization assessed via QST predict future pain, function, fatigue, physical performance and quality of life outcomes in those living in the community with knee OA. Eighty-six participants with knee OA were recruited in Dunedin, New Zealand. Those eligible to participate underwent baseline testing including QST as well as measures of activity-related pain including Movement-evoked Pain (MEP) and Sensitivity to Physical Activity (SPA). Outcome measures exploring pain, function, fatigue and quality of life outcomes were collected at baseline, and two follow-up periods (two and nine weeks). Univariable linear regression models were developed followed by multivariable linear regression models for each prognostic marker adjusting for age, gender, BMI, OA duration, baseline pain intensity and socioeconomic status. Activity-related measures of pain, including MEP and SPA, demonstrated predictive associations with pain and functional outcomes prospectively in those with knee OA. Therefore, those demonstrating activity-related pain are at future risk of greater pain, disability and reduced quality of life. Larger, externally validated longitudinal studies are required which include individuals with more severe knee OA.

Thoracic Spinal Manipulation Effect on Neuroendocrine Response in People With Achilles Tendinopathy: A Randomized Crossover Trial.

OBJECTIVE: The purpose of the present study was to determine the neuroendocrine response after a thoracic spinal manipulation in people with Achilles tendinopathy. METHODS: This was a randomized 2-sequence, 2-period crossover trial. A total of 24 participants, mean (standard deviation) age of 48 (7) years, with a diagnosis of Achilles tendinopathy (>3 mo) were randomly assigned into sequence 1 (sham intervention and then thoracic spinal manipulation) or sequence 2 (thoracic spinal manipulation and then sham intervention). The trial was conducted at a university laboratory with a washout period of 1 week. The primary outcome measure was the testosterone/cortisol (T/C) ratio (salivary samples). The secondary outcome measures included heart rate variability (measured with electrocardiography) and total oxygenation index (nmol/L) of calf muscle and Achilles tendon (measured with near-infrared spectroscopy). A 2-way mixed-model analysis of variance was performed. The statistic of interest was the condition by time interaction. RESULTS: A statistically significant condition by time interaction was found for the T/C ratio (mean difference: -0.16; confidence interval: -0.33 to 0.006; interaction: P < .05) and the total oxygenation index (mean difference: 1.35; confidence interval: -1.3 to 4.1; interaction: P < .05) of calf muscle but not for Achilles tendon (P = .6); however, no difference was found for heart rate variability (P = .5). CONCLUSION: In people with Achilles tendinopathy, thoracic spinal manipulation resulted in immediate increase in the total oxygenation index in the calf muscle followed by an increase in the T/C ratio 6 hours post-intervention.