EFFects of Exposure and Cognitive behavioral Therapy for chronic BACK pain ("EFFECT-BACK"): study protocol for a randomized controlled trial.

INTRODUCTION: Chronic back pain is a widespread medical condition associated with high socioeconomic costs and increasing prevalence. Despite the advanced implementation of multidisciplinary approaches, providing a satisfactory treatment offer for those affected is often not possible. Exposure therapy (EXP) promises to be an effective and economical form of treatment and in a previous pilot study showed to be superior to cognitive behavioral therapy (CBT) in reducing perceived limitations of movement. The current study aims to further compare the efficacy of both treatment methods and identify those patient groups that particularly benefit from EXP. METHODS: The general objective of this randomized multicenter clinical trial (targeted N = 380) is to improve and expand the range of treatments available to patients with chronic back pain. As the primary objective of the study, two different psychological treatments (EXP and CBT) will be compared. The primary outcome measure is a clinically significant improvement in pain-related impairment, measured by the QPBDS, from baseline to 6-month follow-up. Secondary outcome measures are absolute changes and clinically significant improvements in variables coping, psychological flexibility, depressiveness, catastrophizing, exercise avoidance and fear of exercise, and intensity of pain. Participants are recruited in five psychological and medical centers in Germany and receive ten sessions of manualized therapy by trained licensed CBT therapists or clinical psychologists, who are currently in their post-gradual CBT training. Potential predictors of each treatment's efficacy will be explored with a focus on avoidance and coping behavior. CONCLUSION: This study will be the first RCT to compare CBT and EXP in chronic back pain in a large sample, including patients from different care structures due to psychological and medical recruitment centers. By identifying and exploring potential predictors of symptom improvement in each treatment group, this study will contribute to enable a more individualized assignment to treatment modalities and thus improves the care situation for chronic back pain and helps to create a customized treatment program for subgroups of pain patients. If our findings confirm EXP to be an efficacious and efficient treatment concept, it should gain more attention and be further disseminated. TRIAL REGISTRATION: ClinicalTrials.gov NCT05294081. Registered on 02 March 2022.

Mechanisms of change in digital cognitive behavioral therapy for depression in patients with chronic back pain: A mediation analysis of a multicenter randomized clinical trial.

BACKGROUND: While there is evolving knowledge on change processes of digital cognitive behavioral therapy (CBT) in the treatment of depression, little is known about how these interventions produce therapeutic change in the comorbid constellation of chronic back pain (CBP). Here, we examined whether the effects of a digital intervention to treat depression in patients with CBP are mediated by three pain-related variables (i.e., pain self-efficacy, pain-related disability, pain intensity). METHODS: This study is a secondary analysis of a randomized clinical trial conducted in routine care at 82 orthopedic clinics across Germany. In total, 209 adults with CBP and diagnosed depression (SCID interview) were randomly assigned to the intervention (n = 104) or treatment-as-usual (n = 105). Cross-lagged mediation models were estimated to investigate longitudinal mediation effects of putative mediators with depression symptom severity (PHQ-9) as primary outcome at post-treatment. RESULTS: Longitudinal mediation effects were observed for pain self-efficacy (ß = -0.094, 95%-CI [-0.174, -0.014], p = 0.021) and pain-related disability (ß = -0.068, 95%-CI [-0.130, -0.001], p = 0.047). Furthermore, the hypothesized direction of the mediation effects was supported, reversed causation did not occur. Pain intensity did not reveal a mediation effect. CONCLUSIONS: The results suggest a relevant role of pain self-efficacy and pain-related disability as change processes in the treatment of depression for patients with CBP in routine care. However, further research is needed to disclose potential reciprocal relationships of mediators, and to extend and specify our knowledge of the mechanisms of change in digital CBT for depression.

Mediators of digital depression prevention in patients with chronic back pain: Findings from a multicenter randomized clinical trial.

OBJECTIVE: The mechanisms of change in digital interventions for the prevention of depression are largely unknown. Here, we explored whether five theoretically derived intervening variables (i.e., pain intensity, pain-related disability, pain self-efficacy, quality of life [QoL], and work capacity) were mediating the effectiveness of a digital intervention specifically designed to prevent depression in patients with chronic back pain (CBP). METHOD: This study is a secondary analysis of a pragmatic, observer-masked randomized clinical trial conducted at 82 orthopedic clinics in Germany. A total of 295 adults with a diagnosis of CBP and subclinical depressive symptoms were randomized to either the intervention group (n = 149) or treatment-as-usual (n = 146). Longitudinal mediation analyses were conducted with structural equation modeling and depression symptom severity as primary outcome (Patient Health Questionnaire-9 [PHQ-9]; 6 months after randomization) on an intention-to-treat basis. RESULTS: Beside the effectiveness of the digital intervention in preventing depression, we found a significant causal mediation effect for QoL as measured with the complete scale of Assessment of Quality of Life (AQoL-6D; axb: -0.234), as well as for the QoL subscales mental health (axb: -0.282) and coping (axb: -0.249). All other potential intervening variables were not significant. CONCLUSION: Our findings suggest a relevant role of QoL, including active coping, as change mechanism in the prevention of depression. Yet, more research is needed to extend and specify our knowledge on empirically supported processes in digital depression prevention. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Describing the nonsurgical, nonpharmacological interventions offered to adolescents with persistent back pain in randomized trials: A scoping review.

BACKGROUND AND OBJECTIVES: Persistent nonspecific back pain is now established as a biopsychosocial phenomenon that can be meaningfully affected by individuals' cognitions, emotions, lifestyle factors and family and social relationships. Recent guidelines for the treatment of adolescents with persistent nonspecific back pain, as well as those for youth with mixed chronic pain, strongly recommend interdisciplinary care in which adolescents receive treatment for both mind and body. The objective of this scoping review was to examine the interventions evaluated in randomized trials for adolescents with persistent back pain to determine whether they correspond to these guidelines and to reveal future research priorities. DATABASES AND DATA TREATMENT: The review protocol was registered in March 2022. We followed the PRISMA guidelines for scoping reviews. Twelve electronic databases were searched for relevant study reports. Data were charted on study characteristics, participant characteristics and intervention details using the Template for Intervention Description and Replication (TIDieR) checklist. RESULTS: The search yielded 1952 records, of which eight reports representing seven randomized trials were eligible. The most common interventions were exercise therapy (n = 6) and back education (n = 4). Five studies employed multiple intervention components, but none was multidisciplinary. Studies primarily targeted posture or biomechanical factors. One study included an intervention addressing participants' fears and beliefs about pain. CONCLUSIONS: Randomized trials for adolescents with persistent back pain have primarily relied upon an outdated, biomechanical explanation of persisting pain. Future randomized trials should align with current treatment recommendations and measure outcomes across multiple biopsychosocial domains. SIGNIFICANCE: This scoping review describes in detail the interventions included in randomized trials for adolescents with persistent, nonspecific back pain. The review is important because it reveals discrepancies between those interventions and the interventions recommended for this population.

[Multiprofessional treatment approach in chronic back pain]. / Multiprofessioneller Behandlungsansatz bei chronischen Rückenschmerzen.

International guidelines recommend involving various professions and disciplines at an early stage in the event of chronic back pain. In connection with this, terms such as multiprofessional or interprofessional interventions are often mentioned without a uniform idea of what they mean. This article is intended to provide an overview of multiprofessional interventions for patients with chronic back pain and the integration into a meaningful interdisciplinary and interprofessional multimodal treatment concept. This is illustrated in a biopsychosocial pillar model, which should be pursued for each patient individually.

The effectiveness of low-dosed outpatient biopsychosocial interventions compared to active physical interventions on pain and disability in adults with nonspecific chronic low back pain: A protocol for a systematic review with meta-analysis.

BACKGROUND: Best outpatient treatment of nonspecific chronic low back pain is high-dosed exercise that is maintained after therapy. Primary care biopsychosocial intervention (PCBI) is an outpatient multicomponent intervention that includes an active component (exercise, physical activity, or physiotherapy) and at least one psychological, social, or occupational component. Research has shown that PCBI can reduce pain intensity and disability. While scattered studies support low-dosed (<15 treatment hours) PCBI, there is no systematic review comparing the effectiveness of low-dosed PCBI treatment with traditional physical activity interventions in adults with nonspecific chronic low back pain (CLBP). INCLUSION CRITERIA: Randomised controlled trials that evaluate low-dosed outpatient biopsychosocial interventions compared to physical treatment with an active component such as exercise, physical activity or usual physiotherapy treatment for adult participants (18 years or older) who suffer from nonspecific CLBP will be included. METHODS: A comprehensive search of multiple databases will be used to find relevant studies. The databases will be searched from inception to December 2021, with English or German language restrictions imposed. Keywords and derivatives of "chronic back pain", "exercise intervention", "cognitive-behavioral therapy", "primary care" and "randomized controlled trials" will be used. Sources will include CINAHL, Cochrane Central Register of Controlled Trials (CENTRAL), Ovid Medline, Physiotherapy Evidence Database (PEDro), PubMed and Web of Science. DISCUSSION: To our knowledge, this will be the first systematic review and meta-analysis of narrowly defined low- dosed PCBI across populations with nonspecific chronic low back pain. The objective of this review is to evaluate the effectiveness of low-dosed outpatient biopsychosocial interventions versus physical active interventions on pain intensity and disability in adults with CLBP. This study will provide evidence that could improve treatment options for patients with nonspecific CLBP. TRAIL REGISTRATION: Systematic review registration number: PROSPERO 2022 CRD42022302771. https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42022302771.

Effect of Pain Reprocessing Therapy vs Placebo and Usual Care for Patients With Chronic Back Pain: A Randomized Clinical Trial.

Importance: Chronic back pain (CBP) is a leading cause of disability, and treatment is often ineffective. Approximately 85% of cases are primary CBP, for which peripheral etiology cannot be identified, and maintenance factors include fear, avoidance, and beliefs that pain indicates injury. Objective: To test whether a psychological treatment (pain reprocessing therapy [PRT]) aiming to shift patients' beliefs about the causes and threat value of pain provides substantial and durable pain relief from primary CBP and to investigate treatment mechanisms. Design, Setting, and Participants: This randomized clinical trial with longitudinal functional magnetic resonance imaging (fMRI) and 1-year follow-up assessment was conducted in a university research setting from November 2017 to August 2018, with 1-year follow-up completed by November 2019. Clinical and fMRI data were analyzed from January 2019 to August 2020. The study compared PRT with an open-label placebo treatment and with usual care in a community sample. Interventions: Participants randomized to PRT participated in 1 telehealth session with a physician and 8 psychological treatment sessions over 4 weeks. Treatment aimed to help patients reconceptualize their pain as due to nondangerous brain activity rather than peripheral tissue injury, using a combination of cognitive, somatic, and exposure-based techniques. Participants randomized to placebo received an open-label subcutaneous saline injection in the back; participants randomized to usual care continued their routine, ongoing care. Main Outcomes and Measures: One-week mean back pain intensity score (0 to 10) at posttreatment, pain beliefs, and fMRI measures of evoked pain and resting connectivity. Results: At baseline, 151 adults (54% female; mean [SD] age, 41.1 [15.6] years) reported mean (SD) pain of low to moderate severity (mean [SD] pain intensity, 4.10 [1.26] of 10; mean [SD] disability, 23.34 [10.12] of 100) and mean (SD) pain duration of 10.0 (8.9) years. Large group differences in pain were observed at posttreatment, with a mean (SD) pain score of 1.18 (1.24) in the PRT group, 2.84 (1.64) in the placebo group, and 3.13 (1.45) in the usual care group. Hedges g was -1.14 for PRT vs placebo and -1.74 for PRT vs usual care (P < .001). Of 151 total participants, 33 of 50 participants (66%) randomized to PRT were pain-free or nearly pain-free at posttreatment (reporting a pain intensity score of 0 or 1 of 10), compared with 10 of 51 participants (20%) randomized to placebo and 5 of 50 participants (10%) randomized to usual care. Treatment effects were maintained at 1-year follow-up, with a mean (SD) pain score of 1.51 (1.59) in the PRT group, 2.79 (1.78) in the placebo group, and 3.00 (1.77) in the usual care group. Hedges g was -0.70 for PRT vs placebo (P = .001) and -1.05 for PRT vs usual care (P < .001) at 1-year follow-up. Longitudinal fMRI showed (1) reduced responses to evoked back pain in the anterior midcingulate and the anterior prefrontal cortex for PRT vs placebo; (2) reduced responses in the anterior insula for PRT vs usual care; (3) increased resting connectivity from the anterior prefrontal cortex and the anterior insula to the primary somatosensory cortex for PRT vs both control groups; and (4) increased connectivity from the anterior midcingulate to the precuneus for PRT vs usual care. Conclusions and Relevance: Psychological treatment centered on changing patients' beliefs about the causes and threat value of pain may provide substantial and durable pain relief for people with CBP. Trial Registration: ClinicalTrials.gov Identifier: NCT03294148.

Estrategias de afrontamiento y alteraciones emocionales en pacientes con dolor crónico de la espalda: Cienfuegos 2020 (Cuba) / Coping strategies and emotional alterations in patients with chronic back pain. Cienfuegos 2020. (Cuba)

Introducción: El dolor crónico de la espalda forma parte de los síntomas que afectan la salud musculoesquelética. Las estrategias de afrontamiento van a determinar la experiencia del dolor actuando como mediador de las emociones. Objetivo General: Caracterizar las estrategias de afrontamiento y las alteraciones emocionales en pacientes con dolor crónico de la espalda, Cienfuegos 2020. Material y Método: Se realizó un estudio descriptivo, de serie de casos, en el Hospital Provincial Dr. Gustavo Aldereguía Lima de la provincia de Cienfuegos, Cuba, en los meses de septiembre de 2019 a enero de 2020. Se realizó un muestreo no probabilístico casual o a conveniencia de participantes voluntarios, con los pacientes que fueron atendidos en consulta de Ortopedia durante el periodo de investigación declarado. El análisis estadístico de la información se realizó en el paquete estadístico SPSS. Resultados: Se obtuvo un predominio de estrategias de afrontamiento pasivas, así como alteraciones emocionales donde predomina la ansiedad y la depresión en niveles moderado-alto, mientras que en la ira se obtuvieron valores inferiores. Conclusión: Las estrategias de afrontamiento utilizadas por los pacientes de estudio se caracterizan por ir dirigidas fundamentalmente a la modificación de las reacciones emocionales que genera el dolor, pero no a lograr una adaptación a las nuevas circunstancias impuestas por la enfermedad, ni a un control instrumental del mismo.

Introduction: Chronic back pain is one of the symptoms that affect musculoskeletal health. Coping strategies will determine the experience of pain acting as a mediator of emotions. General aim: To characterize coping strategies and the emotional alterations in patients with chronic back pain, Cienfuegos 2020. Material and method: It was carried out a descriptive study, series of cases, in the University Hospital "Dr. GustavoAldereguía Lima", Cienfuegos municipality, Cuba, from September, 2019 to January, of 2020. It was done a non-probabilistic sampling to convenience. The patients who were treated at the outpatient orthopedics consulting office and voluntarily accepted to participate in the study during the declared period of investigation were chosen. The statistical analysis of the information was carried out in the statistical package SPSS. Results: A prevalence of passive coping strategies was obtained, so much in the interview semiestructurada as in the Coping Reduced Questionnaire to the pain. Regarding the negatives emotional states prevailed the anxiety and depression in moderate-high levels, while in anger lower values were obtained. Conclusions: The most frequent coping strategies in the studied patients were the passive ones, aimed to regulate emotional states, but not to control pain.

Achievement of a Minimum Clinically Important Difference for Back Disability Is a Suitable Predictor of Patient Satisfaction Among Lumbar Fusion Patients.

OBJECTIVE: Meeting patient expectations is believed to impact satisfaction scores; however, the influence of achieving a minimum clinically important difference (MCID) is scarcely reported. This study aims to evaluate meeting patient expectations or MCID achievement for pain and disability as predictors of patient satisfaction. METHODS: A retrospective review of single or multilevel lumbar fusion patients was performed. Patients with missing preoperative Oswestry Disability Index (ODI) expectation questionnaires were excluded. Preoperative expectations and postoperative satisfaction scores for visual analog scale (VAS) back, VAS leg, and ODI were collected. Meeting expectations was defined as scores less than or equal to preoperative expectations. Achievement of MCID was evaluated. Improvement of all outcomes and correlations with satisfaction scores were evaluated using the Student's t-test and Pearson coefficient. Achievement of MCID or meeting expectations as predictors of satisfaction were evaluated and compared using linear regression and Suest test. RESULTS: The study included 144 patients. All outcomes significantly improved and demonstrated significant correlations with satisfaction scores (P < 0.001, all). Patients reported a mean expectation of 17.7 (ODI), 1.7 (VAS back), and 0.9 (VAS leg). The majority had their expectations met and achieved MCID. Meeting expectations and MCID achievement demonstrated significant associations with satisfaction scores for all outcomes and time points. Achievement of MCID was a stronger predictor of satisfaction for ODI and VAS back. CONCLUSIONS: Meeting preoperative expectations and achievement of an MCID for pain and disability measures was significantly associated with satisfaction. Achievement of MCID may be a more consistent and suitable replacement as a predictor of satisfaction over meeting patient expectations.

Influence of Baseline Kinesiophobia Levels on Treatment Outcome in People With Chronic Spinal Pain.

BACKGROUND: Pain neuroscience education (PNE) combined with cognition-targeted exercises is an effective treatment for people with chronic spinal pain (CSP). However, it is unclear why some patients benefit more from this treatment. We expect that patients with more pronounced maladaptive pain cognitions, such as kinesiophobia, might show poorer treatment responses. OBJECTIVE: The objective of this study was to assess the influence of baseline kinesiophobia levels on the treatment outcomes of PNE combined with cognition-targeted exercises in people with CSP. This study was a secondary analysis of a multicenter, double-blind, randomized controlled trial. METHODS: Outcome measures included a numeric rating scale for pain (NRS), the Pain Disability Index (PDI), quality of life (Medical Outcomes Study 36-Item Health Survey [SF-36]), Pain Catastrophizing Scale (PCS), and Pain Vigilance and Awareness Questionnaire (PVAQ). Regression models were built using treatment (PNE plus cognition-targeted exercises or neck/back school plus general exercises), baseline scores on the Tampa Scale for Kinesiophobia (TSK), and time (in months) as independent variables. RESULTS: A significant 3-way interaction effect was found for the models of PDI, PCS, PVAQ, and the SF-36 mental domain, with estimates of -0.01, -0.01, -0.01, and 0.07, respectively. A significant effect of baseline TSK scores was found for the physical domain of the SF-36 (estimate = -3.16). For the NRS, no significant effect of baseline TSK scores was found. CONCLUSION: Our findings indicate that PNE plus cognition-targeted exercises can successfully decrease the unfavorable influence of pretreatment kinesiophobia on disability, mental health, pain catastrophizing, and hypervigilance over time in people with CSP. Nevertheless, higher scores in pretreatment kinesiophobia might still be a key factor for the lack of improvement in pain catastrophizing and hypervigilance following treatment. Regardless of the followed treatment program, pretreatment kinesiophobia was also shown to significantly influence physical health in people with CSP. IMPACT: This study provides novel insight into the unfavorable influence of kinesiophobia on treatment outcomes in people with CSP, and how PNE plus cognition-targeted exercises can limit this impact. Because this is one of the first studies to research possible predictors of this experimental treatment, its findings motivate further exploration of other possible influencing factors for treatment success of PNE plus cognition-targeted exercises. LAY SUMMARY: People with chronic spinal pain and high levels of fear of movement were found to have worse treatment outcomes compared to people with low levels of fear of movement. However, our experimental treatment, which includes pain neuroscience education combined with exercise therapy that reintroduces specific movements patients might fear, can decrease this negative influence of fear of movement in these patients.

Cross-sectional study of psychosocial and pain-related variables among patients with chronic pain during a time of social distancing imposed by the coronavirus disease 2019 pandemic.

ABSTRACT: The COVID-19 pandemic has had a tremendous impact, including on individuals with chronic pain. The social distancing policies necessary to slow the spread of SARS-CoV-2 have involved increased levels of social isolation. This cross-sectional survey study examined pain severity and interference among individuals with chronic pain during an early phase of social distancing mandates and identified characteristics of individuals who were most impacted. Approximately 4 to 8 weeks after social distancing mandates commenced in the state of Massachusetts, 150 patients with fibromyalgia, chronic spine, and postsurgical pain completed demographic, pain, social distancing, and validated psychosocial questionnaires. Patients self-reported an overall significant increase in pain severity and pain interference, compared with before social distancing, although both pain severity and interference were quite variable among individuals under conditions of social distancing. Several demographic, socioeconomic, and psychosocial factors were associated with greater pain severity and interference during social distancing. Multivariable linear regression demonstrated that female sex, nonwhite race, lower education, disability, fibromyalgia, and higher pain catastrophizing were independently associated with greater pain severity, while female sex and pain catastrophizing were independently associated greater pain interference. The findings suggest that individual differences among patients with chronic pain should be considered in the planning, development, and prioritization of interventions to improve pain care and to prevent worsening of symptoms during the continuing COVID-19 pandemic.

Rates, costs and determinants of lumbar spine imaging in population-based women born in 1973-1978: Data from the Australian Longitudinal Study on Women's Health.

OBJECTIVE: There are concerns that lumbar spine imaging represents low value care. Our aim was to examine the use of lumbar spine imaging [radiography, computed tomography (CT), magnetic resonance imaging (MRI)] over 20 years, and costs and person-level characteristics of imaging in a large cohort of Australian women. METHODS: The Australian Longitudinal Study on Women's Health (ALSWH) is a longitudinal population-based survey of women randomly selected from national health insurance scheme (Medicare) database. This study examined 13458 women born in 1973-1978 who consented to link their ALSWH and Medical Benefits Scheme records. Self-reported data on demographics, body mass index, depression, physical and mental health, and back pain were collected in each survey performed in 1996, 2000, 2003, 2006, 2009, 2012, and 2015. Data on lumbar spine imaging from 1996 to 2015 were obtained from the Medical Benefits Scheme database. RESULTS: 38.9% of women underwent some form of lumbar spine imaging over 20 years. While radiography increased from 1996 to 2011 and decreased thereafter, CT and MRI continued to increase from 1996 to 2015. In women with self-reported back pain, depression and poorer physical health were associated with imaging, with no significant differences in types of imaging. Based on imaging rates in ALSWH, the estimated costs for Australian women aged 30-39 years were AU$51,735,649 over 2011-2015. CONCLUSIONS: Lumbar spine imaging was common in population-based Australian women, with rates increasing over 20 years. Depression and poor physical health were associated with lumbar spine imaging. Raising awareness of this in clinicians is likely to result in significant cost savings if clinical guidelines are followed, with the potential of freeing resources for high value care and health outcomes.

Discrimination Ability of Patient Reported Outcome Measurement Information System Pediatric Domains Compared With Scoliosis Research Society-22r and Legacy Patient Reported Outcome Measures in Juvenile and Adolescent Idiopathic Scoliosis.

STUDY DESIGN: Comparative cohort study. OBJECTIVE: To compare patient reported outcome measures (PROMs) in children and adolescents with varying extent of spinal deformity. SUMMARY OF BACKGROUND DATA: Several PROMs have been proposed to help assess health-related quality-of-life (HRQoL) in pediatric spinal deformity surgery and research, but it is unclear which are sensitive to deformity severity. METHODS: Pediatric patients diagnosed with spinal asymmetry or juvenile/adolescent idiopathic scoliosis completed the patient-reported outcomes management information system (PROMIS) pediatric computer adaptive test bank (Domains: Mobility, Pain Interference, Physical Activity, Physical Stress Experiences, Psychological Stress Experiences), Scoliosis Research Society-22r (SRS-22r), Hospital for Special Surgery Pediatric Functional Activity Brief Scale (HSS Pedi-FABS) activity scale, and Trunk Appearance Perception Scale. Patients were grouped as spinal asymmetry, mild deformity, and substantial deformity by major Cobb angle measuring less than 10°, between 10° and 40°, and greater than 40° respectively. One-way analysis of variance with a Tukey post-hoc correction was used to determine score differences between groups. RESULTS: Final analyses included 206 patients, of which 135 (66%) were female. The mean age was 13.0 ±â€Š2.2 years, and the mean major Cobb angle was 20.1 ±â€Š14.1° (range: 0-74.2°). Compared with both spinal asymmetry and mild deformity patients, patients with substantial deformity reported worse outcomes, including lower function, more pain, and decreased psychological health by legacy PROMs and PROMIS. PROMIS Physical Activity and Psychological Stress Experiences did not capture any significant differences between all groups. There were no significant differences in outcomes between the spinal asymmetry and mild deformity groups for all PROMs measured. CONCLUSION: Patients with substantial spinal deformity reported lower activity and function, more pain, and greater physical and psychological stress compared with patients without clinical spinal deformity by legacy PROMs and several PROMIS domains. As PROMIS Physical Activity and Psychological Stress Experiences did not capture these differences, these PROMs may measure different constructs than the legacy PROMs as they relate to spinal curvature and may be less relevant to measure HRQoL in this population.Level of Evidence 3.

Influence of Hand Grip Strength on Surgical Outcomes After Surgery for Adult Spinal Deformity.

STUDY DESIGN: A prospective observational study. OBJECTIVE: This study was done to examine the influence of hand grip strength (HGS) on surgical outcomes of adult spinal deformity (ASD) patients. SUMMARY OF BACKGROUND DATA: No study has investigated the relation between hand grip strength and treatment outcome of adult spinal deformity correction surgery. METHODS: A total of 78 consecutive patients who underwent adult spinal deformity correction surgery were included in this study. Patients were assigned to either the high HGS (≥ 26 kg for men and ≥ 18 kg for women, n = 26) or the low HGS (< 26 kg for men and < 18 kg for women, n = 52) based on their preoperative measurements. The Oswestry disability index (ODI), EQ-5D, and visual analog scale (VAS) for back pain were assessed preoperatively, and 3 months, 6 months, and 12 months postoperatively. The primary outcome measure was ODI scores 12 months after surgery. The secondary outcome measures included the overall ODI scores, EQ-5D, and VAS for back pain, assessed at each time point during the 12-months follow-up. RESULTS: The ODI score at 12 months after surgery was significantly lower in the high HGS group than the low HGS group (P < 0.001), which was best predicted by a multivariate regression model including age, gender, BMI, HGS, and preoperative ODI scores. The overall ODI score, EQ-5D, and VAS for back pain had better outcomes in the high HGS group across each follow-up assessment (P < 0.001 for all follow-ups), while they improved significantly with time after surgery in both groups. CONCLUSIONS: Patients with higher preoperative HGS displayed better surgical outcomes, in terms of disability and health-related quality of life at 12 months after reconstructive spinal surgery for ASD. LEVEL OF EVIDENCE: 2.

Better Outcomes for Older people with Spinal Trouble (BOOST) trial: statistical analysis plan for a randomised controlled trial of a combined physical and psychological intervention for older adults with neurogenic claudication.

BACKGROUND: Neurogenic claudication is a common spinal condition affecting older adults that has a major effect on mobility and implicitly independence. The effectiveness of conservative interventions in this population is not known. We describe the statistical analysis plan for the Better Outcomes for Older people with Spinal trouble (BOOST) randomised controlled trial. METHODS/DESIGN: BOOST is a pragmatic, multicentre, parallel, two-arm, randomised controlled trial. Participants are community-dwelling adults, 65 years or older, with neurogenic claudication, registered prospectively, and randomised 2:1 (intervention to control) to the combined physical and psychological BOOST group physiotherapy programme or best practice advice. The primary outcome is the Oswestry Disability Index at 12 months. Secondary outcomes include the Short Physical Performance Battery, Swiss Spinal Stenosis Scale, 6 Minute Walk Test, Fear Avoidance Beliefs Questionnaire, and Tilburg Frailty Indicator. Outcomes are measured at 6 and 12 months by researchers blinded to treatment allocation. The primary statistical analysis is by intention to treat. Further study design details are published in the BOOST protocol. DISCUSSION: The planned statistical analyses for the BOOST trial aim to reduce the risk of outcome reporting bias from prior data knowledge. Any changes or deviations from this statistical analysis plan will be described and justified in the final study report. TRIAL REGISTRATION: This study has been registered in the International Standard Randomised Controlled Trial Number registry, reference number ISRCTN12698674 . Registered on 10 November 2015.

Fear-avoidance beliefs: A predictor for postpartum lumbopelvic pain.

OBJECTIVE: To evaluate potential prognostic factors of self-reported lumbopelvic pain 6 months postpartum for pregnant women with and without lumbopelvic pain. METHODS: Questionnaires were answered at gestational weeks 34-37 and again at 6 months postpartum. Psychosocial determinants and lumbopelvic pain symptoms were investigated using a visual analogue scale to assess pain intensity, and further using the Disability Rating Index, the Nottingham Health Profile, the Pain Catastrophizing Scale and the Fear-Avoidance Beliefs Questionnaire. Logistic regression analysis was used to analyse the data. RESULTS: Of the 260 women who answered the questionnaires on both occasions, 186 did not suffer from lumbopelvic pain 6 months after pregnancy. The remaining 74 did. The results of the logistic regression analysis showed that fear-avoidance beliefs was a significant predictor of lumbopelvic pain 6 months postpartum, with an odds ratio of 1.060 (p ≤ .05). CONCLUSION: Women with high fear-avoidance beliefs at 34-37 weeks of gestation had a higher risk of having lumbopelvic pain at 6 months postpartum. We theorize that early lumbopelvic pain intervention postpartum may be important in avoiding chronicity. Women at risk can be identified through clinically relevant questions which may help the clinician to choose appropriate rehabilitation strategies.

Effectiveness of a Guided Web-Based Self-help Intervention to Prevent Depression in Patients With Persistent Back Pain: The PROD-BP Randomized Clinical Trial.

Importance: Depression is a frequent comorbid condition in patients with persistent back pain and is associated with substantial adverse consequences, including the risk of developing opioid use disorders. Shifting the focus from depression treatment to preventing depression might be a viable way to reduce the disease burden. Objective: To evaluate the effectiveness of a web-based self-help intervention to reduce the incidence of major depressive episode (MDE) in patients with persistent back pain. Design, Setting, and Participants: Prevention of Depression in Back Pain Patients (PROD-BP) was a pragmatic, observer-blinded randomized clinical trial with a parallel design conducted in Germany. Eligible adults with a diagnosis of persistent back pain and subclinical depressive symptoms, but who were depression free, were recruited either on-site or after discharge from 82 orthopedic clinics between October 1, 2015, and July 31, 2017. All analyses were conducted according to the intention-to-treat principle from October 31, 2018, to April 30, 2019. Interventions: The intervention group received an e-coach-guided, web-based self-help intervention that was based on cognitive behavioral therapy and tailored to the needs of patients with persistent back pain. The intervention included 6 obligatory modules and 3 optional modules to be completed by participants as well as feedback from e-coaches. Both the intervention and control groups had unrestricted access to treatment as usual. Main Outcomes and Measures: Primary outcome was time to onset of an MDE over a 12-month period as assessed by blinded diagnostic raters using the Structured Clinical Interview for DSM-5. Secondary outcomes included depression severity, quality of life, pain intensity, pain-related disability, pain self-efficacy, work capacity, and user satisfaction assessed with a variety of instruments. Results: A total of 295 participants (mean [SD] age, 52.8 [7.7] years; 184 women [62.4%]) were recruited and randomized to either the intervention group (n = 149) or control group (n = 146). The intervention reduced the risk of MDE onset by 52% (hazard ratio, 0.48; 95% CI, 0.28-0.81; P < .001). Twenty-one participants (14.1%) in the intervention group and 41 participants (28.1%) in the control group experienced an MDE over the 12-month period. The number needed to treat to prevent 1 new case of MDE was 2.84 (95% CI, 1.79-9.44). Conclusions and Relevance: Results of this trial showed that among patients with persistent back pain, depression can be prevented by a guided web-based self-help intervention in addition to treatment as usual. This finding suggests that using a scalable digital approach to integrate psychological treatment into routine pain management is feasible. Trial Registration: German Clinical Trials Register Identifier: DRKS00007960.

Self-Efficacy and Multisite Pain Predictors among Economically Disadvantaged Women with Back Pain.

BACKGROUND: Chronic low back pain (CLBP) prevalence is higher among women and those with low socioeconomic status. Without adequate self-efficacy and subsequent self-management, patients gradually develop chronic multisite pain after one year of having CLBP alone. AIM: This study investigated the predictors of self-efficacy and multisite pain among adult, economically disadvantaged women, where pain prevalence is higher. DESIGN: Cross-sectional, descriptive study. SETTING: Pain management center. SUBJECTS: Participants (n = 50) with primary diagnosis of chronic low back pain. METHODS: After Institutional Review Board approval, data collection was conducted using valid and reliable instruments measuring several variables. Controlling for age and race, multiple linear regression was used for analyses. RESULTS AND CONCLUSIONS: For all predictors of self-efficacy, a significant regression equation was identified (p < .01) with R2 of .413 and variance of .643. Pain catastrophizing was a significant individual predictor (p < .05). A significant regression equation was also found for all predictors of multisite pain (p < .001) with R2 of .528 and variance of .726. Individual predictors (p < .05) were age, physical function, and numbers of pain treatments and chronic medical conditions. Study findings suggest that significant predictors can be key to advancing pain research, education, practice, and healthcare policy toward improving pain management. Particularly among this population, pain catastrophizing needs to be targeted in pain management. To minimize development of multisite pain, further investigation of identified predictors including number of chronic medical conditions and pain treatments received are necessary. Multimodal, but targeted approaches addressing these predictors are recommended, instead of costly, indiscriminate multimodal therapy. Targeted interventions can help reduce pain care disparities among socioeconomically disadvantaged women, identify high risk groups for prompt intervention, facilitate better pain response to treatments, and minimize further disability.

Patient-reported Quality of Life Following Posterior Lumbar Interbody Fusion or Indirect Decompression Using Lateral Lumbar Interbody Fusion.

STUDY DESIGN: A retrospective review of prospectively collected data. OBJECTIVE: The aim of this study was to compare quality of life (QOL) outcomes of posterior lumbar interbody fusion (PLIF) with lateral lumbar interbody fusion (LLIF) using reports from patients obtained at the 2-year postoperative follow-up. SUMMARY OF BACKGROUND DATA: Indirect decompression with LLIF is used to treat degenerative lumbar diseases that require neural decompression. However, the difference in improvement in QOL following indirect decompression compared with direct neural decompression using PLIF is unclear. METHODS: We enrolled 284 consecutive patients with degenerative lumbar spondylolisthesis in the present study, 203 who underwent PLIF and 81 who underwent LLIF. All patients completed a minimum of 2 years of follow-up. We evaluated the effectiveness of surgery in each category of the Japanese Orthopaedic Association Back Pain Evaluation Questionnaire (JOABPEQ). RESULTS: The results of preoperative JOABPEQ and the severity of thecal sac stenosis were not significantly different between PLIF and LLIF, neither was the rate of perioperative complications (14.8% and 15.4% for the PLIF and LLIF groups, respectively; P = 0.91). The effectiveness at 2 years postoperatively was almost the same for all five domains of the JOABPEQ: 62.6% and 68.9% for pain-related disorders (P = 0.34), 38.3% and 42.7% for lumbar spine dysfunction (P = 0.51), 65.8% and 67.5% for gait disturbance (P = 0.79), 53.5% and 48.8% for social life dysfunction (P = 0.47), and 29.1% and 33.3% for psychological disorders (P = 0.48) following PLIF and LLIF, respectively. Visual analogue scale results for back and lower-limb pain and numbness of the lower limbs were almost the same for both groups. No significant differences were observed in terms of perioperative complications and radiographical outcomes. CONCLUSION: Indirect decompression using LLIF improves QOL and radiographical outcomes to a comparable degree as direct decompression via PLIF. LEVEL OF EVIDENCE: 4.

Sleep Disturbance in Patients With Lumbar Spinal Stenosis: Association With Disability and Quality of Life.

STUDY DESIGN: This was a cross-sectional cohort study. OBJECTIVE: The objective of this study was to identify the prevalence of sleep disturbance in patients with symptomatic lumbar spinal stenosis (LSS) and to establish the relationship between sleep disturbance and both functional disability and health-related quality of life in patients with symptomatic LSS. SUMMARY OF BACKGROUND DATA: Despite the possible association between LSS and poor sleep quality, there has been no study regarding the relationship between LSS and sleep disturbance. MATERIALS AND METHODS: A total of 148 patients with LSS were divided into the poor sleeper and nonpoor sleeper groups according to Global Pittsburgh Sleep Quality Index (PSQI) score. Demographic data, Visual Analog Scale (VAS) score for back and leg pain, Oswestry Disability Index (ODI), and EuroQol 5-dimension questionnaire (EQ-5D) were compared between both groups. Multiple regression analysis was performed with ODI or ODI without sleep component as the dependent variable and age, sex, PSQI, VAS for back pain, VAS for leg pain as independent variables. RESULTS: Of the 148 patients who participated in this study, 54 (36.5%) and 94 (63.5%) patients were classified into nonpoor sleeper and poor sleeper groups. Although there were no differences in demographic data or VAS for back or leg pain between the nonpoor sleeper and poor sleeper groups, poor sleepers demonstrated significantly higher ODI scores, and lower EQ-5D than nonpoor sleepers (P=0.003 and 0.004, respectively). There were significant correlations between the global PSQI score and both the ODI score and EQ-5D. Although the surgical treatment group showed significantly higher VAS for back pain, VAS for leg pain, ODI scores, and lower EQ-5D than the conservative treatment group, the ratio of poor to nonpoor sleepers was not different between both groups (P=0.733). In the surgical treatment group, the percent of poor sleeper decreased from 65.1% to 47.6% 6 months after surgery (P<0.001). CONCLUSIONS: The present study demonstrated that 'poor sleep quality' is a prevalent condition (63.5%) in patients with symptomatic LSS. Poor sleep quality has an adverse effect on functional disability and health-related quality of life in symptomatic LSS patients.