Cognitive functional therapy with or without movement sensor biofeedback versus usual care for chronic, disabling low back pain (RESTORE): a randomised, controlled, three-arm, parallel group, phase 3, clinical trial.

BACKGROUND: Low back pain is the leading cause of years lived with disability globally, but most interventions have only short-lasting, small to moderate effects. Cognitive functional therapy (CFT) is an individualised approach that targets unhelpful pain-related cognitions, emotions, and behaviours that contribute to pain and disability. Movement sensor biofeedback might enhance treatment effects. We aimed to compare the effectiveness and economic efficiency of CFT, delivered with or without movement sensor biofeedback, with usual care for patients with chronic, disabling low back pain. METHODS: RESTORE was a randomised, controlled, three-arm, parallel group, phase 3 trial, done in 20 primary care physiotherapy clinics in Australia. We recruited adults (aged ≥18 years) with low back pain lasting more than 3 months with at least moderate pain-related physical activity limitation. Exclusion criteria were serious spinal pathology (eg, fracture, infection, or cancer), any medical condition that prevented being physically active, being pregnant or having given birth within the previous 3 months, inadequate English literacy for the study's questionnaires and instructions, a skin allergy to hypoallergenic tape adhesives, surgery scheduled within 3 months, or an unwillingness to travel to trial sites. Participants were randomly assigned (1:1:1) via a centralised adaptive schedule to usual care, CFT only, or CFT plus biofeedback. The primary clinical outcome was activity limitation at 13 weeks, self-reported by participants using the 24-point Roland Morris Disability Questionnaire. The primary economic outcome was quality-adjusted life-years (QALYs). Participants in both interventions received up to seven treatment sessions over 12 weeks plus a booster session at 26 weeks. Physiotherapists and patients were not masked. This trial is registered with the Australian New Zealand Clinical Trials Registry, ACTRN12618001396213. FINDINGS: Between Oct 23, 2018 and Aug 3, 2020, we assessed 1011 patients for eligibility. After excluding 519 (51·3%) ineligible patients, we randomly assigned 492 (48·7%) participants; 164 (33%) to CFT only, 163 (33%) to CFT plus biofeedback, and 165 (34%) to usual care. Both interventions were more effective than usual care (CFT only mean difference -4·6 [95% CI -5·9 to -3·4] and CFT plus biofeedback mean difference -4·6 [-5·8 to -3·3]) for activity limitation at 13 weeks (primary endpoint). Effect sizes were similar at 52 weeks. Both interventions were also more effective than usual care for QALYs, and much less costly in terms of societal costs (direct and indirect costs and productivity losses; -AU$5276 [-10 529 to -24) and -8211 (-12 923 to -3500). INTERPRETATION: CFT can produce large and sustained improvements for people with chronic disabling low back pain at considerably lower societal cost than that of usual care. FUNDING: Australian National Health and Medical Research Council and Curtin University.

Illness perceptions in people with chronic and disabling non-specific neck pain seeking primary healthcare: a qualitative study.

BACKGROUND: Illness perceptions can affect the way people with musculoskeletal pain emotionally and behaviorally cope with their health condition. Understanding patients illness perceptions may help facilitate patient-centered care. The purpose of this study was to explore illness perceptions and the origin of those perceptions in people with chronic disabling non-specific neck pain seeking primary care. METHODS: A qualitative study using a deductive and inductive analytical approach was conducted in 20 people with persistent (> 3 months) and disabling (i.e., Neck Disability Index ≥ 15) neck pain. Using a semi-structured format, participants were interviewed about their illness perceptions according to Leventhal's Common Sense Model. Purposive sampling and member checking were used to secure validity of study results. RESULTS: Participants reported multiple symptoms, thoughts and emotions related to their neck pain, which continuously required attention and action. They felt trapped within a complex multifactorial problem. Although some participants had a broader biopsychosocial perspective to understand their symptoms, a biomedical perspective was dominant in the labelling of their condition and their way of coping (e.g., limiting load, building strength and resilience, regaining mobility, keep moving and being meaningful). Their perceptions were strongly influenced by information from clinicians. Several participants indicated that they felt uncertain, because the information they received was contradictory or did not match their own experiences. CONCLUSION: Most participants reported that understanding their pain was important to them and influenced how they coped with pain. Addressing this 'sense making process' is a prerequisite for providing patient-centered care.

Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)-Specific Memory B Cells From Individuals With Diverse Disease Severities Recognize SARS-CoV-2 Variants of Concern.

The unprecedented severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic has called for substantial investigations into the capacity of the human immune system to protect against reinfection and keep pace with the evolution of SARS-CoV-2. We evaluated the magnitude and durability of the SARS-CoV-2-specific antibody responses against parental WA-1 SARS-CoV-2 receptor-binding domain (RBD) and a representative variant of concern (VoC) RBD using antibodies from 2 antibody compartments: long-lived plasma cell-derived plasma antibodies and antibodies encoded by SARS-CoV-2-specific memory B cells (MBCs). Thirty-five participants naturally infected with SARS-CoV-2 were evaluated; although only 25 of 35 participants had VoC RBD-reactive plasma antibodies, 34 of 35 (97%) participants had VoC RBD-reactive MBC-derived antibodies. Our finding that 97% of previously infected individuals have MBCs specific for variant RBDs provides reason for optimism regarding the capacity of vaccination, prior infection, and/or both, to elicit immunity with the capacity to limit disease severity and transmission of VoCs as they arise and circulate.

Visual attention and dietary supplementation in children with perinatal brain injury.

AIM: To investigate whether children with perinatal brain injury have impairments in specific components of visual attention, and whether early dietary supplementation can reduce any deficits. METHOD: Children participating in the Dolphin neonatal trial of dietary supplementation were tested at age 6 months with the Infant Fixation Shift Attention Test, and at 4 to 5 years with four subtests of the Early Childhood Attention Battery (ECAB) assessing different components of attention (selective, sustained, and executive function), and the Fluid Crystallized Intelligence Index of the Kaufman Assessment Battery for Children, Second Edition (KABC-II). From 59 children originally assigned to trial groups, 33 were available for testing at 4 to 5 years (18 treatment group of whom seven, six, and five showed mild, moderate, or severe neonatal brain injury; 15 controls with one, seven, and seven in the neonatal brain injury categories respectively). Given the imbalance in numbers with mild brain injury, analysis of trial group differences is restricted to moderate and severe brain injury severities (n=25). RESULTS: Children with perinatal brain injury showed poorer attention across all components relative to age norms (mean standard scores 75-87; p<0.001 for three of the four subtests), with the greatest impairment in sustained attention. These impairments remained when compared with cognitive age assessed using the Fluid Crystallized Intelligence Index. Impairment was reduced in the treatment compared to the control group (p=0.04 for flanker test, p=0.002 for counterpointing, and p=0.027 for the overall ECAB score). INTERPRETATION: Perinatal brain injury is associated with later impaired attention, beyond that predicted from any general cognitive disability. Impairment varies across attention components, being most severe for sustained attention. The effects on flanker and counterpointing suggest that dietary supplementation from 0 to 2 years of age may reduce attention problems. Measuring the different components of attention is important when considering assessment and interventions for children with perinatal brain injury.

Concurrent validity of DorsaVi wireless motion sensor system Version 6 and the Vicon motion analysis system during lifting.

BACKGROUND: Wearable sensor technology may allow accurate monitoring of spine movement outside a clinical setting. The concurrent validity of wearable sensors during multiplane tasks, such as lifting, is unknown. This study assessed DorsaVi Version 6 sensors for their concurrent validity with the Vicon motion analysis system for measuring lumbar flexion during lifting. METHODS: Twelve participants (nine with, and three without back pain) wore sensors on T12 and S2 spinal levels with Vicon surface markers attached to those sensors. Participants performed 5 symmetrical (lifting from front) and 20 asymmetrical lifts (alternate lifting from left and right). The global-T12-angle, global-S2-angle and the angle between these two sensors (relative-lumbar-angle) were output in the sagittal plane. Agreement between systems was determined through-range and at peak flexion, using multilevel mixed-effects regression models to calculate root mean square errors and standard deviation. Mean differences and limits of agreement for peak flexion were calculated using the Bland Altman method. RESULTS: For through-range measures of symmetrical lifts, root mean squared errors (standard deviation) were 0.86° (0.78) at global-T12-angle, 0.90° (0.84) at global-S2-angle and 1.34° (1.25) at relative-lumbar-angle. For through-range measures of asymmetrical lifts, root mean squared errors (standard deviation) were 1.84° (1.58) at global-T12-angle, 1.90° (1.65) at global-S2-angle and 1.70° (1.54) at relative-lumbar-angle. The mean difference (95% limit of agreement) for peak flexion of symmetrical lifts, was - 0.90° (-6.80 to 5.00) for global-T12-angle, 0.60° (-2.16 to 3.36) for global-S2-angle and - 1.20° (-8.06 to 5.67) for relative-lumbar-angle. The mean difference (95% limit of agreement) for peak flexion of asymmetrical lifts was - 1.59° (-8.66 to 5.48) for global-T12-angle, -0.60° (-7.00 to 5.79) for global-S2-angle and - 0.84° (-8.55 to 6.88) for relative-lumbar-angle. CONCLUSION: The root means squared errors were slightly better for symmetrical lifts than they were for asymmetrical lifts. Mean differences and 95% limits of agreement showed variability across lift types. However, the root mean squared errors for all lifts were better than previous research and below clinically acceptable thresholds. This research supports the use of lumbar flexion measurements from these inertial measurement units in populations with low back pain, where multi-plane lifting movements are assessed.

Predicting Knee Joint Kinematics from Wearable Sensor Data in People with Knee Osteoarthritis and Clinical Considerations for Future Machine Learning Models.

Deep learning models developed to predict knee joint kinematics are usually trained on inertial measurement unit (IMU) data from healthy people and only for the activity of walking. Yet, people with knee osteoarthritis have difficulties with other activities and there are a lack of studies using IMU training data from this population. Our objective was to conduct a proof-of-concept study to determine the feasibility of using IMU training data from people with knee osteoarthritis performing multiple clinically important activities to predict knee joint sagittal plane kinematics using a deep learning approach. We trained a bidirectional long short-term memory model on IMU data from 17 participants with knee osteoarthritis to estimate knee joint flexion kinematics for phases of walking, transitioning to and from a chair, and negotiating stairs. We tested two models, a double-leg model (four IMUs) and a single-leg model (two IMUs). The single-leg model demonstrated less prediction error compared to the double-leg model. Across the different activity phases, RMSE (SD) ranged from 7.04° (2.6) to 11.78° (6.04), MAE (SD) from 5.99° (2.34) to 10.37° (5.44), and Pearson's R from 0.85 to 0.99 using leave-one-subject-out cross-validation. This study demonstrates the feasibility of using IMU training data from people who have knee osteoarthritis for the prediction of kinematics for multiple clinically relevant activities.

Does intra-lumbar flexion during lifting differ in manual workers with and without a history of low back pain? A cross-sectional laboratory study.

Advice to limit or avoid a flexed lumbar curvature during lifting is widely promoted to reduce the risk of low back pain (LBP), yet there is very limited evidence to support this relationship. To provide higher quality evidence this study compared intra-lumbar flexion in manual workers with (n = 21) and without a history of LBP (n = 21) during a repeated lifting task. In contrast to common expectations, the LBP group demonstrated less peak absolute intra-lumbar flexion during lifting than the noLBP group [adjusted difference -3.7° (95%CI -6.9 to -0.6)]. The LBP group was also further from the end of range intra-lumbar flexion and did not use more intra-lumbar range of motion during any lift condition (both symmetrical and asymmetrical lifts and different box loads). Peak absolute intra-lumbar flexion was more variable in the LBP group during lifting and both groups increased their peak absolute intra-lumbar flexion over the lift repetitions. This high-quality capture of intra-lumbar spine flexion during repeated lifting in a clinically relevant cohort questions dominant safe lifting advice.Practitioner summary: Lifting remains a common trigger for low back pain (LBP). This study demonstrated that people with LBP, lift with less intra-lumbar flexion than those without LBP. Providing the best quality in-vivo laboratory evidence, that greater intra-lumbar flexion is not associated with LBP in manual workers, raising questions about lifting advice.

A role of the frontotemporal lobar degeneration risk factor TMEM106B in myelination.

TMEM106B encodes a lysosomal membrane protein and was initially identified as a risk factor for frontotemporal lobar degeneration. Recently, a dominant D252N mutation in TMEM106B was shown to cause hypomyelinating leukodystrophy. However, how TMEM106B regulates myelination is still unclear. Here we show that TMEM106B is expressed and localized to the lysosome compartment in oligodendrocytes. TMEM106B deficiency in mice results in myelination defects with a significant reduction of protein levels of proteolipid protein (PLP) and myelin oligodendrocyte glycoprotein (MOG), the membrane proteins found in the myelin sheath. The levels of many lysosome proteins are significantly decreased in the TMEM106B-deficient Oli-neu oligodendroglial precursor cell line. TMEM106B physically interacts with the lysosomal protease cathepsin D and is required to maintain proper cathepsin D levels in oligodendrocytes. Furthermore, we found that TMEM106B deficiency results in lysosome clustering in the perinuclear region and a decrease in lysosome exocytosis and cell surface PLP levels. Moreover, we found that the D252N mutation abolished lysosome enlargement and lysosome acidification induced by wild-type TMEM106B overexpression. Instead, it stimulates lysosome clustering near the nucleus as seen in TMEM106B-deficient cells. Our results support that TMEM106B regulates myelination through modulation of lysosome function in oligodendrocytes.

Management of Gastrointestinal and Nutritional Problems in Children With Neurological Impairment: A Survey of Practice.

OBJECTIVES: The main aim of this study was to determine the impact on clinical practice of the first European Society of Gastroenterology, Hepatology, and Nutrition (ESPGHAN) position paper on the diagnosis and management of nutritional and gastrointestinal problems in children with neurological impairment (NI). METHODS: In this pilot-study, a web-based questionnaire was distributed between November, 2019 and June, 2020, amongst ESPGHAN members using the ESPGHAN newsletter. Fifteen questions covered the most relevant aspects on nutritional management and gastrointestinal issues of children with NI. A descriptive analysis of responses was performed. RESULTS: A total of 150 health professionals from 23 countries responded to the survey. A considerable variation in clinical practice concerning many aspects of nutritional and gastrointestinal management of children with NI was observed. The most frequently used method for diagnosing oropharyngeal dysfunction was the direct observation of meals with or without the use of standardised scores (n = 103). Anthropometric measurements were the most commonly used tools for assessing nutritional status (n = 111). The best treatment for gastroesophageal reflux disease (GERD) was considered to be proton pump inhibitor therapy by most (n = 116) participants. Regarding tube feeding, nearly all respondents (n = 114) agreed that gastrostomy is the best enteral access to be used for long-term enteral feeding. Fundoplication was indicated at the time of gastrostomy placement especially in case of uncontrolled GERD. CONCLUSIONS: More studies are required to address open questions on adequate management of children with NI. Identifying knowledge gaps paves the way for developing updated recommendations and improving patient care.

Phormidepistatin from the Cyanobacterium UIC 10484: Assessing the Phylogenetic Distribution of the Statine Pharmacophore.

A new linear lipopeptide, phormidepistatin (1), containing an epi-statine amino acid was isolated from cf. Phormidium sp. strain UIC 10484. The planar structure was elucidated by 1D and 2D NMR experimentation. The relative configuration was determined by J-based configurational analysis and the absolute configuration by advanced Marfey's analysis. Given that the statine moiety is an established pharmacophore known to inhibit aspartic proteases, phormidepistatin was evaluated against cathepsin D and displayed limited activity. With 1 containing a statine-like moiety, we sought to assess the distribution of this γ-amino acid within the phylum Cyanobacteria. In-depth MS/MS analysis identified the presence of phormidepistatin in cf. Phormidium sp. UIC 10045 and cf. Trichormus sp. UIC 10039. A structure database search identified 33 known cyanobacterial metabolites containing a statine or statine-like amino acid and, along with phormidepistatin, were grouped into 10 distinct compound classes. A phylogenetic tree was built comprising all cyanobacteria with established 16S rRNA sequences known to produce statine or statine-like-containing compound classes. This analysis suggests the incorporation of the γ-amino acid into secondary metabolites is taxonomically widespread within the phylum. Overall, it is our assessment that cyanobacteria are a potential source for statine or statine-like-containing compounds.

'You're the best liar in the world': a grounded theory study of rowing athletes' experience of low back pain.

OBJECTIVES: Low back pain (LBP) is common in rowers and leads to considerable disability and even retirement. The athlete voice can help clinicians to better understand sport-related pain disorders. We aimed to capture the lived experience of LBP in rowers. METHODS: Cross-sectional qualitative study using a grounded theory approach. Adult competitive rowers with a rowing-related LBP history were recruited in Australia and Ireland. Data were collected through interviews that explored: context around the time of onset of their LBP and their subsequent journey, experiences of management/treatment, perspectives around present beliefs, fears, barriers and expectations for the future. RESULTS: The 25 rowers (12 women/13 men) who participated were aged 18-50 years; they had a mean 12.1 years of rowing experience. They discussed a culture of concealment of pain from coaches and teammates, and fear of being judged as 'weak' because of the limitations caused by LBP. They reported fear and isolation as a result of their pain. They felt that the culture within rowing supported this. They reported inconsistent messages regarding management from medical staff. Some rowers reported being in a system where openness was encouraged-they regarded this a leading to better outcomes and influencing their LBP experience. CONCLUSIONS: Rowers' lived experience of LBP was influenced by a pervasive culture of secrecy around symptoms. Rowers and support staff should be educated regarding the benefits of early disclosure and rowers should be supported to do so without judgement.

Human Activity Recognition for People with Knee Osteoarthritis-A Proof-of-Concept.

Clinicians lack objective means for monitoring if their knee osteoarthritis patients are improving outside of the clinic (e.g., at home). Previous human activity recognition (HAR) models using wearable sensor data have only used data from healthy people and such models are typically imprecise for people who have medical conditions affecting movement. HAR models designed for people with knee osteoarthritis have classified rehabilitation exercises but not the clinically relevant activities of transitioning from a chair, negotiating stairs and walking, which are commonly monitored for improvement during therapy for this condition. Therefore, it is unknown if a HAR model trained on data from people who have knee osteoarthritis can be accurate in classifying these three clinically relevant activities. Therefore, we collected inertial measurement unit (IMU) data from 18 participants with knee osteoarthritis and trained convolutional neural network models to identify chair, stairs and walking activities, and phases. The model accuracy was 85% at the first level of classification (activity), 89-97% at the second (direction of movement) and 60-67% at the third level (phase). This study is the first proof-of-concept that an accurate HAR system can be developed using IMU data from people with knee osteoarthritis to classify activities and phases of activities.

Physiotherapists' Approaches to Patients' Concerns in Back Pain Consultations Following a Psychologically Informed Training Program.

Guidelines advocate a combined physical and psychological approach to managing non-specific chronic low back pain (NSCLBP), referred to as psychologically informed practice (PIP). PIP is underpinned by patient-centered principles and skilled communication. Evidence suggests that a physiotherapist-focused style of communication prevails in physiotherapy. There is a recognized need for observational research to identify specific communication practices in physiotherapy interactions. This observational study explored the interactional negotiation of agenda setting following a PIP training intervention, by identifying and describing how physiotherapists solicit and respond to the agenda of concerns that patients with NSCLBP bring to primary care initial encounters. The research setting was primary care. Nineteen initial physiotherapy consultations were video-recorded, transcribed, and analyzed using conversation analysis, a qualitative observational method. These data revealed a patient-focused style of communication where trained physiotherapists demonstrated a collaborative and responsive style of verbal and nonverbal communication to solicit, explore, and validate patients' concerns.

Development of a Machine Learning Model for the Estimation of Hip and Lumbar Angles in Ballet Dancers.

OBJECTIVE: Accurate field-based assessment of dance kinematics is important to understand the etiology, and thus prevention and management, of hip and back pain. The study objective was to develop a machine learning model to estimate thigh elevation and lumbar sagittal plane angles during ballet leg lifting tasks, using wearable sensor data. METHODS: Female dancers (n=30) performed ballet-specific leg lifting tasks to the front, side, and behind the body. Dancers wore six wearable sensors (100 Hz). Data were simultaneously collected using an 18-camera motion analysis system (250 Hz). Due to synchronization and hardware malfunction issues, only 23 dancers had usable data. Using leave-one-out cross-validation, machine learning models were compared with the optic motion capture system using root mean square error (RMSE) in degrees and correlation coefficients (r) over the complete movement profile of each leg lift and mean absolute error (MAE) and Bland Altman plots for peak angle accuracy. RESULTS: The average RMSE for model estimation was 6.8° for thigh elevation angle and 5.6° for lumbar spine sagittal plane angle, with respective MAE of 6.3°and 5.7°. There was a strong correlation between the machine learning model and optic motion capture for peak angle values (thigh r=0.86, lumbar r=0.96). CONCLUSION: The models developed demonstrated an acceptable degree of accuracy for the estimation of thigh elevation angle and lumbar spine sagittal plane angle during dance-specific leg lifting tasks. This provides potential for a near-real-time, field-based measurement system.

Cognitive Functional Therapy for People with Nonspecific Persistent Low Back Pain in a Secondary Care Setting-A Propensity Matched, Case-Control Feasibility Study.

BACKGROUND: Effective, inexpensive, and low-risk interventions are needed for patients with nonspecific persistent low back pain (NS-PLBP) who are unresponsive to primary care interventions. Cognitive functional therapy (CFT) is a multidimensional behavioral self-management approach that has demonstrated promising results in primary care and has not been tested in secondary care. OBJECTIVE: To investigate the effect of CFT and compare it with usual care for patients with NS-PLBP. DESIGN: Case-control study. SETTING: A secondary care spine center. SUBJECTS: Thirty-nine patients received a CFT intervention and were matched using propensity scoring to 185 control patients receiving usual care. METHODS: The primary outcome was Roland Morris Disability Questionnaire (0-100 scale) score. Group-level differences at six- and 12-month follow-up were estimated using mixed-effects linear regression. RESULTS: At six-month follow-up, a statistically significant and clinically relevant difference in disability favored the CFT group (-20.7, 95% confidence interval [CI] = -27.2 to -14.2, P < 0.001). Significant differences also occurred for LBP and leg pain, fear, anxiety, and catastrophizing in favor of CFT. At 12-month follow-up, the difference in disability was smaller and no longer statistically significant (-8.1, 95% CI = -17.4 to 1.2, P = 0.086). Differences in leg pain intensity and fear remained significantly in favor of CFT. Treatment satisfaction was significantly higher in the CFT group at six- (93% vs 66%) and 12-month (84% vs 52%) follow-up. CONCLUSIONS: These findings support that CFT is beneficial for patients with NS-PLBP who are unresponsive to primary care interventions. Subsequent randomized controlled trials could incorporate booster sessions, which may result in larger effects at 12-month follow-up.

Time-to-completed-imaging, survival and function in patients with spinal epidural abscess: Description of a series of 34 patients, 2015-2018.

INTRODUCTION: Spinal epidural abscess (SEA) is a rare and life-threatening infection with increasing incidence over the past two decades. Delays in diagnosis can cause significant morbidity and mortality among patients. OBJECTIVE: The objective of this study was to describe trends in time-to-imaging and intervention, risk factors, and outcomes among patients presenting to the emergency department with SEA at a single academic medical center in Portland, Oregon. METHODS: This retrospective cohort study analyzed data from patients with new SEA diagnosis at a single hospital from October 1, 2015 to April 1, 2018. We describe averages to time-to-imaging and interventions, and frequencies of risk factors and outcomes among patients presenting to the emergency department with SEA. RESULTS: Of the 34 patients included, 7 (20%) died or were discharged with plegia during the study period. Those who died or were discharged with plegia (n = 7) had shorter mean time-to-imaging order (20.8 h versus 29.2 h). Patients with a history of intravenous drug use had a longer mean time-to-imaging order (30.2 h versus 23.7 h) as compared to those without intravenous drug use. Patients who died or acquired plegia had longer times from imaging completed to final imaging read (20.9 h versus 7.1 h), but shorter times from final imaging read to surgical intervention among patients who received surgery (4.9 h versus 46.2 h). Further, only three (42.9%) of the seven patients who died or acquired plegia presented with the three-symptom classic triad of fever, neurologic symptoms, and neck or back pain. CONCLUSIONS: SEA is a potentially deadly infection that requires prompt identification and treatment. This research provides baseline data for potential quality improvement work at the study site. Future research should evaluate multi-center approaches for identifying and intervening to treat SEA, particularly among patients with intravenous drug use.

What Influences Patient Satisfaction after TKA? A Qualitative Investigation.

BACKGROUND: Patient satisfaction is a common measure of the success of an orthopaedic intervention. However, there is poor understanding of what satisfaction means to patients or what influences it. QUESTIONS/PURPOSES: Using qualitative study methodology in patients undergoing TKA, we asked: (1) What does it mean to be satisfied after TKA? (2) What factors influence satisfaction levels after TKA? METHODS: People in a hospital registry who had completed 12-month follow-up questionnaires and were not more than 18 months post-TKA at the time of sampling were eligible (n = 121). To recruit a sample that provided insight into a range of TKA experiences, we divided eligible candidates on the registry into quadrants based on their responder status and satisfaction level. A responder was an individual who experienced a clinically meaningful change in pain and/or function on the WOMAC according to the Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) responder criteria. Individuals were considered satisfied unless they indicated somewhat dissatisfied or very dissatisfied for one or more of the four items on the Self-Administered Patient Satisfaction Scale. From the resulting quadrants: responder satisfied, nonresponder satisfied, nonresponder dissatisfied, responder dissatisfied, we identified men and women with a range of ages and invited them to participate (n = 85). The final sample (n = 40), consisted of 10 responder satisfied, nine nonresponder satisfied, eight nonresponder dissatisfied, and 13 responder dissatisfied; 71% were women, with a mean age of 71 ± 7 years and a mean time since TKA surgery of 17 ± 2 months (range 13 to 25 months). Interview transcripts were analyzed by looking for factors in the participants' narrative that appeared to underscore their level of satisfaction and attaching inductive (data-derived, rather than a priori derived) codes to relevant sections of text. Coded data from participants who reported high and low levels of satisfaction were compared/contrasted and emerging patterns were mapped into a conceptual model. Recruitment continued until no new information was uncovered in data analysis of subsequent interviews, signalling to the researchers that further interviews would not change the key themes identified and data collection could cease. RESULTS: In those with high satisfaction levels, satisfaction was conceptualized as an improvement in pain and function. In those with low satisfaction levels, rather than an improvement, satisfaction was conceptualized as completely resolving all symptoms and functional limitations. In addition, we identified three pathways through which participants reached different levels of low and high satisfaction: (1) The full-glass pathway, characterized by no or minimal ongoing symptoms and functional deficits, which consistently led to high levels of satisfaction; (2) the glass-half-full pathway, characterized by ongoing symptoms and functional limitations, which led to high satisfaction; and (3) the glass-half-empty pathway, also characterized by ongoing symptoms and functional limitations, which led to low satisfaction levels. The latter two pathways were mediated by three core mechanisms (recalibration, reframing valued activities, and reconceptualization) influenced either positively or negatively by (1) a persons' thoughts and feelings such as optimism, self-efficacy, pain catastrophizing, external locus of control; and (2) social and contextual factors such as fulfilment of social roles, therapeutic alliance, lack of family/social support. CONCLUSIONS: This qualitative study suggests that for preoperative patients in whom unrealistically high hopes for complete symptom resolution and restoration of functional capacity persists, it may be appropriate to direct them away from TKA due to the risk of low satisfaction. For postoperative patients troubled by ongoing symptoms or functional limitations, clinicians may improve levels of satisfaction by targeting the three core mechanisms (recalibration, reframing valued activities, and reconceptualization) through addressing modifiable negative thoughts and feelings in interventions such as psychology or psychotherapy; and negative social and contextual factors by promoting a strong therapeutic alliance and engagement in community activities. Given that these factors may be identifiable preoperatively, future research is needed to explore if and how addressing them preoperatively may improve satisfaction post-TKA. LEVEL OF EVIDENCE: Level IV, therapeutic study.

Cognitive functional therapy compared with a group-based exercise and education intervention for chronic low back pain: a multicentre randomised controlled trial (RCT).

BACKGROUND: One-size-fits-all interventions reduce chronic low back pain (CLBP) a small amount. An individualised intervention called cognitive functional therapy (CFT) was superior for CLBP compared with manual therapy and exercise in one randomised controlled trial (RCT). However, systematic reviews show group interventions are as effective as one-to-one interventions for musculoskeletal pain. This RCT investigated whether a physiotherapist-delivered individualised intervention (CFT) was more effective than physiotherapist-delivered group-based exercise and education for individuals with CLBP. METHODS: 206 adults with CLBP were randomised to either CFT (n=106) or group-based exercise and education (n=100). The length of the CFT intervention varied according to the clinical progression of participants (mean=5 treatments). The group intervention consisted of up to 6 classes (mean=4 classes) over 6-8 weeks. Primary outcomes were disability and pain intensity in the past week at 6 months and 12months postrandomisation. Analysis was by intention-to-treat using linear mixed models. RESULTS: CFT reduced disability more than the group intervention at 6 months (mean difference, 8.65; 95% CI 3.66 to 13.64; p=0.001), and at 12 months (mean difference, 7.02; 95% CI 2.24 to 11.80; p=0.004). There were no between-group differences observed in pain intensity at 6 months (mean difference, 0.76; 95% CI -0.02 to 1.54; p=0.056) or 12 months (mean difference, 0.65; 95% CI -0.20 to 1.50; p=0.134). CONCLUSION: CFT reduced disability, but not pain, at 6 and 12 months compared with the group-based exercise and education intervention. Future research should examine whether the greater reduction in disability achieved by CFT renders worthwhile differences for health systems and patients. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov registry (NCT02145728).

'My hip is damaged': a qualitative investigation of people seeking care for persistent hip pain.

OBJECTIVES: Clinicians who use the biopsychosocial approach to manage musculoskeletal pain disorders aim to understand how patients make sense of their symptoms. Treatment includes targeting the negative beliefs and coping responses that can lead to progressive pain and disability. We aimed to explore how people seeking care for persistent hip pain and disability make sense of their symptoms. METHODS: Cross-sectional qualitative study. People were eligible if they were aged ≥18 years, were consulting an orthopaedic surgeon for persistent hip pain and offered a non-surgical intervention. Data were collected through interviews that explored patients' beliefs about the identity (diagnosis), causes, consequences, timeline and controllability of their symptoms, their strategies to cope with pain and their experiences in seeking healthcare. Transcribed interview data were analysed thematically using a framework approach. RESULTS: Sixteen people (median age=51, range=33-73 years; median duration hip pain=3 years, range=3 months-20 years) participated. Most participants (10/16) believed their pain was caused by an exercise-related injury. Because of the results of imaging and interactions with healthcare professionals, all participants believed they had damaged hip structures. All described ineffective strategies to manage their pain and multiple failed treatments. For many (7/16), a lack of control over symptoms threatened their physical and mental health. CONCLUSIONS: The way participants with persistent hip pain and disability made sense of their symptoms contributed to them avoiding physical activity, and it impaired their sleep, emotional well-being and physical health.

What does best practice care for musculoskeletal pain look like? Eleven consistent recommendations from high-quality clinical practice guidelines: systematic review.

OBJECTIVES: To identify common recommendations for high-quality care for the most common musculoskeletal (MSK) pain sites encountered by clinicians in emergency and primary care (spinal (lumbar, thoracic and cervical), hip/knee (including osteoarthritis [OA] and shoulder) from contemporary, high-quality clinical practice guidelines (CPGs). DESIGN: Systematic review, critical appraisal and narrative synthesis of MSK pain CPG recommendations. ELIGIBILITY CRITERIA: Included MSK pain CPGs were written in English, rated as high quality, published from 2011, focused on adults and described development processes. Excluded CPGs were for: traumatic MSK pain, single modalities (eg, surgery), traditional healing/medicine, specific disease processes (eg, inflammatory arthropathies) or those that required payment. DATA SOURCES: Four scientific databases (MEDLINE, Embase, CINAHL and Physiotherapy Evidence Database) and four guideline repositories. RESULTS: 6232 records were identified, 44 CPGs were appraised and 11 were rated as high quality (low back pain: 4, OA: 4, neck: 2 and shoulder: 1). We identified 11 recommendations for MSK pain care: ensure care is patient centred, screen for red flag conditions, assess psychosocial factors, use imaging selectively, undertake a physical examination, monitor patient progress, provide education/information, address physical activity/exercise, use manual therapy only as an adjunct to other treatments, offer high-quality non-surgical care prior to surgery and try to keep patients at work. CONCLUSION: These 11 recommendations guide healthcare consumers, clinicians, researchers and policy makers to manage MSK pain. This should improve the quality of care of MSK pain.