The Psychologically Informed Practice Consultation Roadmap: A Clinical Implementation Strategy.

Psychologically informed practice (PiP) includes a special focus on psychosocial obstacles to recovery, but research trials have revealed significant difficulties in implementing PiP outside of research environments. Qualitative studies have identified problems of both competence and confidence in tackling the psychosocial aspects of care, with a tendency to prefer dealing with the more mechanical aspects of care. In PiP, the distinction between assessment and management is not clear-cut. Analysis of the problem is part of the intervention, and guided self-management begins with the initial detective work by the patient, who is encouraged to develop successful and relevant behavior change. This requires a different style and focus of communication that some clinicians find difficult to enact. In this Perspective, the PiP Consultation Roadmap is offered as a guide for clinical implementation to establish a therapeutic relationship, develop patient-centered communication, and guide effective pain self-management. These strategies are illustrated through the metaphor of the patient learning to drive, with the therapist as a driving instructor and the patient as a student driver. For convenience, the Roadmap is depicted in 7 stages. Each stage represents aspects of the clinical consultation in a recommended order, although the Roadmap should be viewed as a general guide with a degree of flexibility to accommodate individual differences and optimize PiP interventions. It is anticipated that the experienced PiP clinician will find it progressively easier to implement the Roadmap as the building blocks and style of consultation become more familiar.

Psychologically Informed Practice: The Importance of Communication in Clinical Implementation.

There has been increasing interest in the secondary prevention of chronic pain and pain-associated disability over the past 3 decades. In 2011, psychologically informed practice (PiP) was suggested as a framework for managing persistent and recurrent pain, and, since then, it has underpinned the development of stratified care linking risk identification (screening). Although PiP research trials have demonstrated clinical and economic advantage over usual care, pragmatic studies have been less successful, and qualitative studies have identified implementation difficulties in both system delivery and individual clinical management. Effort has been put into the development of screening tools, the development of training, and the assessment of outcomes; however, the nature of the consultation has remained relatively unexplored. In this Perspective, a review of the nature of clinical consultations and the clinician-patient relationship is followed by reflections on the nature of communication and the outcome of training courses. Consideration is given to the optimization of communication, including the use of standardized patient-reported measures and the role of the therapist in facilitating adaptive behavior change. Several challenges in implementing a PiP approach in day-to-day practice are then considered. Following brief consideration of the impact of recent developments in health care, the Perspective concludes with a brief introduction to the PiP Consultation Roadmap (the subject of a companion paper), the use of which is suggested as a way of structuring the consultation with the flexibility required for a patient-centered approach to guided self-management of chronic pain conditions.

Bilateral Failure of Oxidized Zirconium Implants in Total Knee Arthroplasty.

Oxidized zirconium was first introduced in total hip arthroplasty procedures to merge the strengths of metal and ceramic into one prosthetic. The subsequent adoption of oxidized zirconium (oxinium) for total knee arthroplasty is attributed to the theory of causing less wear on the tibial components compared to the alternative, cobalt chromium. However, the superficial layer of the femoral component is occasionally breached, exposing the softer zirconium substrate. Multiple mechanisms leading to zirconium substrate exposure have been explained, including collateral ligament instability and polyethylene wear. Such a failure may lead to damage to the periprosthetic tissues and often requires a revision procedure. In the current case report, we present a case of bilateral total knee arthroplasty with oxidized zirconium components that resulted in catastrophic failure and subsequent revision with hinged knee prostheses.

Clinical Outcomes of Amniotic Membrane/Umbilical Cord Particulate in Spinal Disorders: A Retrospective Study.

Background: Musculoskeletal spinal disorders significantly impact patient populations from everyday workers to military soldiers. Effective treatment is critical to minimize the time between injury and returning to work and daily activities. Injection of amniotic membrane/umbilical cord (AMUC) tissue has demonstrated great potential in reducing patients' pain and has become an increasingly popular treatment option for painful orthopedic disorders. Methods: A single-center, retrospective study was conducted on patients diagnosed with musculoskeletal spinal disorders and subsequently treated with AMUC via epidural and facet injections. Demographics and outcomes related to pain were assessed. Pain was verbally reported by the patient on a scale of 0-10 where 0 indicated no pain and 10 indicated worst imaginable pain. Complications and adverse events were also reported. Results: A total of 52 patients (average age 40.8 ± 9.6 years) were included in the analysis with diagnoses of spondylosis (n = 44), intervertebral disc degeneration (n = 31), radiculopathy (n = 18), stenosis (n = 2), or other conditions. The cohort's average baseline pain score was 4.9 ± 2.2 with a mean duration of symptoms for 54.2 months (range: 1-300 months). After AMUC injection, pain significantly decreased to 3.4 ± 2.3 at two weeks (p < 0.0001) and 3.5 ± 2.2 at 3-4 weeks (p = 0.0023). For the mean follow-up period of 10.6 ± 5.4 weeks, pain was reduced to 2.8 ± 2.1 (p < 0.0001 vs baseline). No significant complications or adverse events were reported. Conclusion: Use of an injectable AMUC, such as CLARIX FLO, may alleviate pain in patients with painful spinal indications of various pathologies. This study provides further evidence of its safety and efficacy in epidural and facet injections. Further studies are warranted to verify these promising results.

Cannabidiol counters the effects of a dominant-negative pathogenic Kv7.2 variant.

Epilepsy and neurodevelopmental disorders can arise from pathogenic variants of KCNQ (Kv7) channels. A patient with developmental and epileptic encephalopathy exhibited an in-frame deletion of histidine 260 on Kv7.2. Coexpression of Kv7.2 mutant (mut) subunits with Kv7.3 invoked a decrease in current density, a depolarizing shift in voltage for activation, and a decrease in membrane conductance. Biotinylation revealed an increased level of surface Kv7.2mut compared to Kv7.3 with no change in total membrane protein expression. Super-resolution and FRET imaging confirmed heteromeric channel formation and a higher expression density of Kv7.2mut. Cannabidiol (1 µM) offset the effects of Kv7.2mut by inducing a hyperpolarizing shift in voltage for activation independent of CB1 or CB2 receptors. These data reveal that the ability for cannabidiol to reduce the effects of a pathogenic Kv7.2 variant supports its use as a potential therapeutic to reduce seizure activity.

Pain psychology in the 21st century: lessons learned and moving forward.

Background and aims In the spring of 2019, Professor Steven J. Linton, the founder of the Center for Health and Medical Psychology (CHAMP) at Örebro University, Sweden, formally retired. As a tribute to his scholarly work covering decades of influence and inspiration to the field of pain psychology, the research center organized a topical conference titled "Pain in the 21st century: Where do we come from and where are we going?", which resulted in this state-of the-art synthesis. The aim of this declaration is to highlight lessons learned but not in the least is meant to inspire and guide our continued journey forward, developing pain psychology into the 21st century. Methods Several collaborators of Professor Linton have summarized and reflected on the current state-of-the-art of pain psychology from the perspective of his input to the field, as well as on developments from the last years of advancements in pain psychology. Results The topics have been divided into six themed sections covering the fear avoidance model, transdiagnostics, secondary prevention, risk- and protective factors, communication and contextual factors. The sections cover a broad spectrum, from basic experimental studies, integrating emotion and motivational theories into current theoretical models, to applied research on the effect of early interventions as well as sophisticated emotion-focused treatment models for pain patients with concurrent emotional ill-health. Conclusions There have been major advancements within pain psychology research during the last decades, moving the field towards a more comprehensive picture, taking emotional and motivational aspects into account to understand pain sufferers. Although psychologically informed interventions in general mainly focus on the individual, it has been put forward that pain management is highly influenced by the surrounding environment, including communication with health care providers, and the occupational and social context. Implications Professor Steven J. Linton has been at the forefront of pain psychology research during the last decades, and inspired by his work this journey will continue into the 21st century, with the ultimate goal of enhancing the understanding and treatment for all people suffering from persistent and disabling pain.

Effects of Biopsychosocial Education on the Clinical Judgments of Medical Students and GP Trainees Regarding Future Risk of Disability in Chronic Lower Back Pain: A Randomized Control Trial.

BACKGROUND: Chronic lower back pain (CLBP) is a major health care burden and often results in workplace absenteeism. It is a priority for appropriate management of CLBP to get individuals back to work as early as possible. Interventions informed by the flags approach, which integrates cognitive and behavioral approaches via identification of biopsychosocial barriers to recovery, have resulted in reduced pain-related work absences and increased return to work for individuals with CLBP. However, research indicates that physicians' adherence to biopsychosocial guidelines is low. OBJECTIVE: The current study examined the effects of a flags approach-based educational intervention on clinical judgments of medical students and general practitioner (GP) trainees regarding the risk of future disability of CLBP patients. DESIGN: Randomized controlled trial (trial registration number: ISRCTN53670726). SETTING: University classroom. SUBJECTS: Medical students and GP trainees. METHODS: Using 40 fictional CLBP cases, differences in clinical judgment accuracy, weighting, and speed (experimental N = 32) were examined pre- and postintervention, as were flags approach knowledge, pain attitudes and beliefs, and empathy, in comparison with a no-intervention control group (control N = 31). RESULTS: Results revealed positive effects of the educational intervention on flags approach knowledge, pain-related attitudes and beliefs, and judgment weighting of psychologically based cues; results are discussed in light of existing theory and research. CONCLUSIONS: Short flags approach-based educational video interventions on clinical judgment-making regarding the risk of future disability of CLBP patients may provide opportunities to gain biopsychosocial knowledge, overcome associated attitude barriers, and facilitate development of clinical judgment-making more aligned with psychological cues.

The effectiveness of self-management interventions in adults with chronic orofacial pain: A systematic review, meta-analysis and meta-regression.

BACKGROUND: Psychosocial risk factors associated with chronic orofacial pain are amenable to self-management. However, current management involves invasive therapies which lack an evidence base and has the potential to cause iatrogenic harm. OBJECTIVES: To determine: (a) whether self-management is more effective than usual care in improving pain intensity and psychosocial well-being and (b) optimal components of self-management interventions. DATABASES AND DATA TREATMENT: Cochrane Oral Health Group Trials Register, Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, PsycINFO, WHO International Clinical Trials Registry Platform and Clinical Trials.gov were searched. Meta-analysis was used to determine effectiveness, and GRADE was used to rate quality, certainty and applicability of evidence. RESULTS: Fourteen trials were included. Meta-analyses showed self-management was effective for long-term pain intensity (standardized mean difference [SMD] -0.32, 95% confidence interval [CI] -0.47 to -0.17) and depression (SMD -0.32, 95% CI -0.50 to -0.15). GRADE analysis showed a high score for certainty of evidence for these outcomes and significant effects for additional outcomes of activity interference (-0.29 95% CI -0.47 to -0.11) and muscle palpation pain (SMD -0.58 95% CI -0.92 to -0.24). Meta-regression showed nonsignificant effects for biofeedback on long-term pain (-0.16, 95% CI -0.48 to 0.17, p-value = 0.360) and depression (-0.13, 95% CI -0.50 to 0.23, p-value = 0.475). CONCLUSIONS: Self-management interventions are effective for patients with chronic orofacial pain. Packages of physical and psychosocial self-regulation and education appear beneficial. Early self-management of chronic orofacial pain should be a priority for future testing. SIGNIFICANCE: This systematic review provides clear evidence for effectiveness of combined biomedical and psychological interventions (incorporating self-management approaches) on long-term outcomes in the management of chronic orofacial (principally TMD) pain. Self-management should be a priority for early intervention in primary care in preference to invasive, irreversible and costly therapies. Further research is needed firstly to clarify the relative effectiveness of specific components of self-management, both individually and in conjunction, and secondly on outcomes in other types of chronic orofacial pains.

Effect of Intensive Patient Education vs Placebo Patient Education on Outcomes in Patients With Acute Low Back Pain: A Randomized Clinical Trial.

Importance: Many patients with acute low back pain do not recover with basic first-line care (advice, reassurance, and simple analgesia, if necessary). It is unclear whether intensive patient education improves clinical outcomes for those patients already receiving first-line care. Objective: To determine the effectiveness of intensive patient education for patients with acute low back pain. Design, Setting, and Participants: This randomized, placebo-controlled clinical trial recruited patients from general practices, physiotherapy clinics, and a research center in Sydney, Australia, between September 10, 2013, and December 2, 2015. Trial follow-up was completed in December 17, 2016. Primary care practitioners invited 618 patients presenting with acute low back pain to participate. Researchers excluded 416 potential participants. All of the 202 eligible participants had low back pain of fewer than 6 weeks' duration and a high risk of developing chronic low back pain according to Predicting the Inception of Chronic Pain (PICKUP) Tool, a validated prognostic model. Participants were randomized in a 1:1 ratio to either patient education or placebo patient education. Interventions: All participants received recommended first-line care for acute low back pain from their usual practitioner. Participants received additional 2 × 1-hour sessions of patient education (information on pain and biopsychosocial contributors plus self-management techniques, such as remaining active and pacing) or placebo patient education (active listening, without information or advice). Main Outcomes and Measures: The primary outcome was pain intensity (11-point numeric rating scale) at 3 months. Secondary outcomes included disability (24-point Roland Morris Disability Questionnaire) at 1 week, and at 3, 6, and 12 months. Results: Of 202 participants randomized for the trial, the mean (SD) age of participants was 45 (14.5) years and 103 (51.0%) were female. Retention rates were greater than 90% at all time points. Intensive patient education was not more effective than placebo patient education at reducing pain intensity (3-month mean [SD] pain intensity: 2.1 [2.4] vs 2.4 [2.2]; mean difference at 3 months, -0.3 [95% CI, -1.0 to 0.3]). There was a small effect of intensive patient education on the secondary outcome of disability at 1 week (mean difference, -1.6 points on a 24-point scale [95% CI, -3.1 to -0.1]) and 3 months (mean difference, -1.7 points, [95% CI, -3.2 to -0.2]) but not at 6 or 12 months. Conclusions and Relevance: Adding 2 hours of patient education to recommended first-line care for patients with acute low back pain did not improve pain outcomes. Clinical guideline recommendations to provide complex and intensive support to high-risk patients with acute low back pain may have been premature. Trial Registration: Australian Clinical Trial Registration Number: 12612001180808.

Advancing Psychologically Informed Practice for Patients With Persistent Musculoskeletal Pain: Promise, Pitfalls, and Solutions.

There has been growing interest in psychologically oriented pain management over the past 3 to 4 decades, including a 2011 description of psychologically informed practice (PIP) for low back pain. PIP requires a broader focus than traditional biomechanical and pathology-based approaches that have been traditionally used to manage musculoskeletal pain. A major focus of PIP is addressing the behavioral aspects of pain (ie, peoples' responses to pain) by identifying individual expectations, beliefs, and feelings as prognostic factors for clinical and occupational outcomes indicating progression to chronicity. Since 2011, the interest in PIP seems to be growing, as evidenced by its use in large trials, inclusion in scientific conferences, increasing evidence base, and expansion to other musculoskeletal pain conditions. Primary care physicians and physical therapists have delivered PIP as part of a stratified care approach involving screening and targeting of treatment for people at high risk for continued pain-associated disability. Furthermore, PIP is consistent with recent national priorities emphasizing nonpharmacological pain management options. In this perspective, PIP techniques that range in complexity are described, considerations for implementation in clinical practice are offered, and future directions that will advance the understanding of PIP are outlined.

Enhancing delivery of osteoarthritis care in the general practice consultation: evaluation of a behaviour change intervention.

BACKGROUND: Professionally-focussed behaviour change intervention (BCI) workshops were utilised in the Management of OsteoArthritis in Consultations (MOSAICS) trial investigating the feasibility of implementing the National Institute for Health and Care Excellence (NICE) Osteoarthritis (OA) Guideline in general practice. The workshops aimed to implement the general practitioner (GP) component of the trial intervention: an enhanced consultation for patients presenting with possible OA. This study presents an evaluation of the BCI workshops on GP competency in conducting these enhanced consultations. METHODS: A before-and-after evaluation of the workshops, delivered to GPs participating in the intervention arm of the MOSAICS trial, using video-recorded GP consultations with simulated OA patients. GPs attended four workshops, which had been developed using an implementation framework. Videos were undertaken at three time-points (before workshops and at one- and five-months after) and were assessed by independent observers, blinded to time points, for GP competency in undertaking 14 predetermined consultation tasks. RESULTS: Videos of 15 GPs were assessed. GP competency increased from a median of seven consultation tasks undertaken by each GP at baseline to 11 at both time-points after the workshops. Specific tasks which were undertaken more frequently after the workshops related to explaining that OA is treatable and not inevitably progressive, eliciting and addressing patient expectations of the consultation, and providing written OA information. However, the use of the word "osteoarthritis" in giving the diagnosis of OA was not enhanced by the workshops. CONCLUSIONS: BCI workshops can enhance GP competency in undertaking consultations for OA. Further initiatives to implement the NICE OA Guideline and enhance the care of people with OA in primary care can be informed by the content and delivery of the workshops evaluated in this study.

Effectiveness and costs of a vocational advice service to improve work outcomes in patients with musculoskeletal pain in primary care: a cluster randomised trial (SWAP trial ISRCTN 52269669).

Musculoskeletal pain is a common cause of work absence, and early intervention is advocated to prevent the adverse health and economic consequences of longer-term absence. This cluster randomised controlled trial investigated the effect of introducing a vocational advice service into primary care to provide occupational support. Six general practices were randomised; patients were eligible if they were consulting their general practitioner with musculoskeletal pain and were employed and struggling at work or absent from work <6 months. Practices in the intervention arm could refer patients to a vocational advisor embedded within the practice providing a case-managed stepwise intervention addressing obstacles to working. The primary outcome was number of days off work, over 4 months. Participants in the intervention arm (n = 158) had fewer days work absence compared with the control arm (n = 180) (mean 9.3 [SD 21·7] vs 14·4 [SD 27·7]) days, incidence rate ratio 0·51 (95% confidence interval 0·26, 0·99), P = 0·048). The net societal benefit of the intervention compared with best care was £733: £748 gain (work absence) vs £15 loss (health care costs). The addition of a vocational advice service to best current primary care for patients consulting with musculoskeletal pain led to reduced absence and cost savings for society. If a similar early intervention to the one tested in this trial was implemented widely, it could potentially reduce days absent over 12 months by 16%, equating to an overall societal cost saving of approximately £500 million (US $6 billion) and requiring an investment of only £10 million.

A randomized, placebo-controlled trial of patient education for acute low back pain (PREVENT Trial): statistical analysis plan.

BACKGROUND: Statistical analysis plans increase the transparency of decisions made in the analysis of clinical trial results. The purpose of this paper is to detail the planned analyses for the PREVENT trial, a randomized, placebo-controlled trial of patient education for acute low back pain. RESULTS: We report the pre-specified principles, methods, and procedures to be adhered to in the main analysis of the PREVENT trial data. The primary outcome analysis will be based on Mixed Models for Repeated Measures (MMRM), which can test treatment effects at specific time points, and the assumptions of this analysis are outlined. We also outline the treatment of secondary outcomes and planned sensitivity analyses. We provide decisions regarding the treatment of missing data, handling of descriptive and process measure data, and blinded review procedures. CONCLUSIONS: Making public the pre-specified statistical analysis plan for the PREVENT trial minimizes the potential for bias in the analysis of trial data, and in the interpretation and reporting of trial results. TRIAL REGISTRATION: ACTRN12612001180808 (https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12612001180808).