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Background/Aims: Embedded pragmatic clinical trials are increasingly recommended for non-pharmacological pain care research due to their focus on examining intervention effectiveness within real-world settings. Engagement with patients, health care providers, and other partners is essential, yet there is limited guidance for how to use engagement to meaningfully inform the design of interventions to be tested in pain-related pragmatic clinical trials. This manuscript aims to describe the process and impacts of partner input on the design of two interventions (care pathways) for low back pain currently being tested in an embedded pragmatic trial in the Veterans Affairs health care system. Methods: Sequential cohort design for intervention development was followed. Engagement activities were conducted with 25 participants between November 2017 and June 2018. Participants included representatives from multiple groups: clinicians, administrative leadership, patients, and caregivers. Results: Partner feedback led to several changes in each of the care pathways to improve patient experience and usability. Major changes to the sequenced care pathway included transitioning from telephone-based delivery to a flexible telehealth model, increased specificity about pain modulation activities, and reduction of physical therapy visits. Major changes to the pain navigator pathway included transitioning from a traditional stepped care model to one that offers care in a feedback loop, increased flexibility regarding pain navigator provider type, and increased specificity for patient discharge criteria. Centering patient experience emerged as a key consideration from all partner groups. Conclusion: Diverse input is important to consider before implementing new interventions in embedded pragmatic trials. Partner engagement can increase acceptability of new care pathways to patients and providers and enhance uptake of effective interventions by health systems. Trial registration: NCT#04411420. Registered on 2 June 2020. [ABSTRACT FROM AUTHOR]

Objective Patients with chronic low back pain (CLBP) and comorbid depression or anxiety disorders are highly prevalent. Negative affect (NA) refers to a combination of negative thoughts, emotions, and behaviors. Patients with CLBP with high NA have greater pain, worse treatment outcomes, and greater prescription opioid misuse. We present the protocol for SYNNAPTIC (SYNergizing Negative Affect & Pain Treatment In Chronic pain). Design A randomized comparative-effectiveness study of antidepressants, fear-avoidance rehabilitation, or their combination in 300 patients with CLBP with high NA. In the antidepressant- or rehabilitation-only arms, SYNNAPTIC includes an adaptive design of re-randomization after 4 months for nonresponders. Setting A multisite trial conducted in routine pain clinical treatment settings: pain clinics and physical and occupational therapy treatment centers. Methods Inclusion criteria include CLBP with elevated depression and anxiety symptoms. Antidepressant and rehabilitation treatments follow validated and effective protocols for musculoskeletal pain in patients with high NA. Power and sample size are based on superior outcomes of combination therapy with these same treatments in a 71-subject 4-arm pilot randomized controlled trial. Conclusions SYNNAPTIC addresses the lack of evidence-based protocols for the treatment of the vulnerable subgroup of patients with CLBP and high NA. We hypothesize that combination therapy of antidepressants plus fear-avoidance rehabilitation will be more effective than each treatment alone. Trial registration ClinicalTrials.gov ID: NCT04747314. [ABSTRACT FROM AUTHOR]

• Mind-body exercise delivered by physical therapists consisted mostly of Pilates. • Overall, mind-body exercise was more effective than control for pain and disability. • Effects were moderated by type (non-exercise vs alternative exercise) of control. • Larger effect estimates were observed in studies with non-exercise controls. • Mind-body exercise treatment delivered by physical therapists is effective. To assess the effectiveness of mind-body (MB) exercise interventions provided by physical therapists for reducing pain and disability in people with low back pain (LBP). MEDLINE, Embase, CINAHL, and the Cochrane Library were searched for articles published in English between December 2010 and June 2020. Randomized controlled trials evaluating the effects of Pilates, yoga, and tai chi interventions performed by physical therapists on pain or disability outcomes in adults with musculoskeletal LBP were included. Data were extracted by 2 independent reviewers. Quality of evidence and risk of bias were assessed using the Grading of Recommendations Assessment, Development, and Evaluation framework and Cochrane risk of bias tools, respectively. 21,230 exercise trials were identified; 161 progressed to full-text review. Eight trials, 7 reporting on Pilates and 1 reporting on yoga, were included. Short-term outcomes for pain (SMD: -0.93; 95% confidence interval [CI]: -1.65 to -0.021) and disability (SMD: -0.74 95% CI: -1.36 to -0.012) indicated MB exercise was more effective than control intervention. Tests for subgroup differences between studies with exercise vs non-exercise control groups revealed a moderating effect on short-term outcomes where larger effects were observed in studies with non-exercise comparators. Long-term outcomes for pain (SMD: -0.60; 95% CI:-1.43 to 0.23) and disability (SMD: -1.05; 95% CI:-3.51 to 1.41) suggested that MB exercise is not more effective than control interventions for pain or disability. Quality of the evidence ranged from very low to low. Physical therapist-delivered MB exercise interventions, which overwhelmingly consisted of Pilates, were more effective than control in the short and long-term for pain and in the short-term for disability, with differences in the short-term effects lessened when compared with an active intervention. Pilates interventions delivered by physical therapists represent a viable tool for the clinical management of chronic LBP. [ABSTRACT FROM AUTHOR]

Therapeutic alliance (TA) has been positively correlated to improvements in patient outcomes. This study examined the Working Alliance Inventory (WAI) relationship with changes in disability and pain intensity for patients receiving physical therapy (PT) treatment for acute and chronic musculoskeletal pain conditions. Fifty participants were dichotomized into success or failure by the minimal clinically important difference (MCID) on region-specific patient-reported outcome measures (PROM) and Numeric Pain Rating Scale (NPRS). Regression and correlation statistics examined the relationship between WAI with change scores and quantity of PT. Independent t-tests compared WAI scores across categorical variables. WAI scores were higher for those meeting MCIDs on PROM and NPRS compared to those who did not. WAI scores were significantly correlated with improvement on region-specific outcome measures and NPRS. Regression analysis found the patient rating of the TA to be a positive predictor for improvement on regions specific outcome measures and NPRS. Patients who rated the TA higher were more likely to meet the MCID for region-specific disability and pain intensity. Patient ratings of the TA were associated with improved change scores on pain rating and standardized outcome measures during a course of treatment for musculoskeletal pain conditions. Patients' early rating of the therapeutic alliance (TA) is associated with improvements seen on pain and functional outcomes. Physical therapists should assess the TA and use strategies to enhance the alliance to optimize patient's experiences with physical therapy. [ABSTRACT FROM AUTHOR]

Objective High-impact chronic pain (HICP) is a term that characterizes the presence of a severe and troubling pain-related condition. To date, the prevalence of HICP in lumbar spine surgery recipients and their HICP transitions from before to after surgery are unexplored. The purpose was to define HICP prevalence, transition types, and outcomes in lumbar spine surgery recipients and to identify predictors of HICP outcomes. Methods In total, 43,536 lumbar surgery recipients were evaluated for HICP transition. Lumbar spine surgery recipients were categorized as having HICP preoperatively and at 3 months after surgery if they exhibited chronic and severe pain and at least one major activity limitation. Four HICP transition groups (Stable Low Pain, Transition from HICP, Transition to HICP, and Stable High Pain) were categorized and evaluated for outcomes. Multivariate multinomial modeling was used to predict HICP transition categorization. Results In this sample, 15.1% of individuals exhibited HICP preoperatively; this value declined to 5.1% at 3 months after surgery. Those with HICP at baseline and 3 months had more comorbidities and worse overall outcomes. Biological, psychological, and social factors predicted HICP transition or Stable High Pain; some of the strongest involved social factors of 2 or more to transition to HICP (OR = 1.43; 95% CI = 1.21–1.68), and baseline report of pain/disability (OR = 3.84; 95% CI = 3.20–4.61) and psychological comorbidity (OR = 1.78; 95% CI = 1.48–2.12) to Stable Stable High Pain. Conclusion The percentage of individuals with HICP preoperatively (15.1%) was low, which further diminished over a 3-month period (5.1%). Postoperative HICP groups had higher levels of comorbidities and worse baseline outcomes scores. Transition to and maintenance of HICP status was predicted by biological, psychological, and social factors. [ABSTRACT FROM AUTHOR]