Research objectives and general considerations for pragmatic clinical trials of pain treatments: IMMPACT statement.

Many questions regarding the clinical management of people experiencing pain and related health policy decision-making may best be answered by pragmatic controlled trials. To generate clinically relevant and widely applicable findings, such trials aim to reproduce elements of routine clinical care or are embedded within clinical workflows. In contrast with traditional efficacy trials, pragmatic trials are intended to address a broader set of external validity questions critical for stakeholders (clinicians, healthcare leaders, policymakers, insurers, and patients) in considering the adoption and use of evidence-based treatments in daily clinical care.

Yoga Versus Education for Veterans with Chronic Low Back Pain: a Randomized Controlled Trial.

Background: Yoga is effective for chronic low back pain (cLBP) in civilians but understudied among Veterans.

Objective: Determine whether yoga is more effective than an educational book for improving disability and pain among Veterans with cLBP.

Design, Setting, And Participants: Veterans diagnosed with cLBP at a VA medical center enrolled in a randomized controlled trial from March to December of 2015.

Theory of Planned Behavior and Mindfulness Intentions in Chronic Low Back Pain.

Objectives: Theory of planned of behavior (TPB) constructs have been linked to health behavior intentions. Intentions to try mindfulness-based stress reduction (MBSR), a first-line therapy for chronic low back pain (cLBP), have been less studied. This study aimed to identify which TPB constructs could inform strategies to improve adoption of MBSR.

Optimizing Narrowband UVB Phototherapy: Is It More Challenging for Your Older Patients?

Narrowband UVB (NB-UVB) phototherapy remains versatile, safe, and efficacious for multiple dermatologic conditions even with recent pharmacologic treatment advances. Polypharmacy contributes to prescribers pursuing phototherapy as a nonpharmacologic treatment, but some wonder if it is as effective and safe for older patients. This study aimed to determine if NB-UVB is equally effective in both older and younger adults treated with the same protocol and to examine the association between photosensitizing medications, clearance, and erythema rates in older vs younger adults.

Moderators and Nonspecific Predictors of Treatment Benefits in a Randomized Trial of Mindfulness-Based Stress Reduction vs Cognitive-Behavioral Therapy vs Usual Care for Chronic Low Back Pain.

Both mindfulness-based stress reduction (MBSR) and cognitive-behavioral therapy (CBT) are effective for chronic low back pain (CLBP), but little is known regarding who might benefit more from one than the other. Using data from a randomized trial comparing MBSR, CBT, and usual care (UC) for adults aged 20 to 70 years with CLBP (N = 297), we examined baseline characteristics that moderated treatment effects or were associated with improvement regardless of treatment. Outcomes included 8-week function (modified Roland Disability Questionnaire), pain bothersomeness (0-10 numerical rating scale), and depression (Patient Health Questionnaire-8).

An experimental study to inform adoption of mindfulness-based stress reduction in chronic low back pain.

Background: Chronic low back pain is a common and sometimes disabling condition, and mindfulness-based stress reduction is recommended as a first line of therapy. This study tested whether different descriptions of mindfulness training altered based on influential intervention characteristics increased adoption intentions.

Methods: People with chronic low back pain (n = 452) were randomized to review one of four mindfulness training descriptions in an online survey using a 2 × 2 factorial design.

"In Class We Were All One." A Qualitative Exploration of Yoga and Educational Interventions for Predominantly Low-Income and Minority Adults with Chronic Low Back Pain.

Chronic low back pain (cLBP) can be physically and psychologically debilitating and disproportionally afflicts vulnerable populations. Yoga and education are increasingly common interventions for cLBP yet are understudied in low-income and minority adults. The objective of this qualitative study was to understand the yoga and self-care experience of adults with cLBP from urban, underserved communities who were enrolled in a randomized controlled trial that included these treatments.

Do Physical Therapy and Yoga Improve Pain and Disability through Psychological Mechanisms? A Causal Mediation Analysis of Adults with Chronic Low Back Pain.

Objective: To investigate whether indirect effects via psychological mechanisms explain the effects of physical therapy (PT) or yoga versus education on back-related outcomes.

Design: Mediation analyses using data from a randomized controlled trial of PT, yoga, and education interventions for chronic low back pain.

Methods: Primary outcomes were changes in back-related pain on the 11-point numeric rating scale and disability on the modified 23-point Roland-Morris Disability Questionnaire, measured at 52 weeks after randomization.

An Exploratory Randomized Controlled Trial of a 12-Week Yoga Versus Educational Film Program for the Management of Restless Legs Syndrome: Feasibility and Acceptability.

The primary objectives of this pilot trial were to assess the study feasibility and acceptability of the 12-week yoga and educational film programs for the management of restless legs syndrome (RLS) in preparation for a future randomized controlled trial (RCT). This pilot, parallel-arm, randomized feasibility trial was conducted at two sites, Morgantown, WV and Columbus, OH. Yoga group participants attended 75-min Iyengar yoga classes, twice weekly for 4 weeks, then once a week for 8 weeks (16 total classes), and completed a 30-min homework routine on nonclass days.

How to design high quality acupuncture trials-a consensus informed by evidence.

An international panel including patients, clinicians, researchers, acupuncture and surgery trialists, statisticians, and experts in clinical epidemiology and methodology have developed new guidance for randomised controlled trials in acupuncture. It addresses the most prevalent and critical concerns of current acupuncture trials and will help funding agencies, trial registers, and journal editors to evaluate the relevance, importance, and quality of submitted trial proposals and completed trials

Interest in Mindfulness Training for Chronic Low-Back Pain: Results from a Vignette-driven, Web-based Survey of Patients.

Mindfulness-based stress reduction (MBSR) has been found effective for improving chronic low-back pain (cLBP). However, little data exist regarding how attractive this technique is to Americans as a therapy for cLBP. Survey of randomly selected persons with cLBP.

Changes in Pain Self-Efficacy, Coping Skills, and Fear-Avoidance Beliefs in a Randomized Controlled Trial of Yoga, Physical Therapy, and Education for Chronic Low Back Pain.

Objective: We evaluated exercise interventions for cognitive appraisal of chronic low back pain (cLBP) in an underserved population.

Methods: We conducted a secondary analysis of the Back to Health Trial, showing yoga to be noninferior to physical therapy (PT) for pain and function outcomes among adults with cLBP (n = 320) recruited from primary care clinics with predominantly low-income patients. Participants were randomized to 12 weeks of yoga, PT, or education.

Patient, Provider, and Clinic Characteristics Associated with Opioid and Non-Opioid Pain Prescriptions for Patients Receiving Low Back Imaging in Primary Care.

Background: To describe characteristics of patients, providers, and clinics associated with opioid or non-opioid pain medication prescribing patterns for patients who received lower spine imaging in primary care clinics.

Methods: In these secondary analyses of the Lumbar Imaging with Reporting of Epidemiology (LIRE) study, a randomized controlled trial conducted in 4 health systems in the United States, we evaluated characteristics associated with receipt of pain medication prescriptions. The outcomes were receipt of prescriptions for opioid or, separately, non-opioid pain medications within 90 days after imaging.

Translation, Cross-Cultural Adaptation, and Psychometric Validation of the English Version of the Postural Awareness Scale.

Purpose: The Postural Awareness Scale (PAS) was developed among a sample of German speakers to measure self-reported awareness of body posture. The first aim of this study was to conduct an English translation and cross-cultural adaptation of the PAS. The second aim was to assess psychometric properties of the English version of the PAS.

Expected Organizational Costs for Inserting Prevalence Information Into Lumbar Spine Imaging Reports.

Background: Modifying physician behavior to more closely align with guideline-based care can be challenging. Few effective strategies resulting in appropriate spine-related health care have been reported. The Lumbar Imaging With Reporting of Epidemiology (LIRE) intervention did not result in reductions in spine care but did in opioid prescriptions written.

Acupuncture Intervention Protocol: Consensus Process for a Pragmatic Randomized Controlled Trial of Acupuncture for Management of Chronic Low Back Pain in Older Adults: An NIH HEAL Initiative Funded Project.

Objective: The aim of this article is to describe the consensus process used to develop an acupuncture intervention protocol for an NIH-funded pragmatic randomized controlled trial (PRCT) of acupuncture for the management of chronic low back (cLBP) in older adults (BackInAction).

Background: CLBP is among leading causes of disability worldwide: almost 33% of US adults 65 and older experience LBP. Acupuncture is effective for cLBP but there is no specific data on older adults.

The Intersection of Dissemination Research and Acupuncture: Applications for Chronic Low Back Pain.

Dissemination research is the study of distributing information and intervention materials to a specific clinical practice or public health audience. Acupuncture, a healthcare practice involving the stimulation of certain body points, often with thin needles, is considered an evidence-based treatment for low back pain (LBP), but is underutilized in the United States. We will use the example of acupuncture for LBP to identify opportunities to leverage dissemination research to increase utilization of acupuncture.

Providing Epidemiological Data in Lumbar Spine Imaging Reports Did Not Affect Subsequent Utilization of Spine Procedures: Secondary Outcomes from a Stepped-Wedge Randomized Controlled Trial.

Objective: To evaluate the effect of inserting epidemiological information into lumbar spine imaging reports on subsequent nonsurgical and surgical procedures involving the thoracolumbosacral spine and sacroiliac joints.

Design: Analysis of secondary outcomes from the Lumbar Imaging with Reporting of Epidemiology (LIRE) pragmatic stepped-wedge randomized trial.

Setting: Primary care clinics within four integrated health care systems in the United States.

Effects of Including Epidemiologic Data in Lumbar Spine Imaging Reports on Prescribing Non-Opioid Medications for Pain.

Background: Information on the prevalence of common imaging findings among patients without back pain in spine imaging reports might affect pain medication prescribing for patients with back pain. Prior research on inserting this text suggested a small reduction in opioid prescribing.

Objective: To evaluate the effect of epidemiologic information in spine imaging reports on non-opioid pain medication prescribing for primary care patients with back pain.

Do the effects of acupuncture vary between acupuncturists? Analysis of the Acupuncture Trialists' Collaboration individual patient data meta-analysis.

Objectives: The degree to which the effects of acupuncture treatment vary between acupuncturists is unknown. We used a large individual patient dataset of trials of acupuncture for chronic pain to assess practitioner heterogeneity.

Methods: Individual patient data linked to identifiable acupuncturists were drawn from a dataset of 39 high-quality trials of acupuncture, where the comparators were either sham acupuncture or non-acupuncture controls, such as standard care or waitlist.

Which Chronic Low Back Pain Patients Respond Favorably to Yoga, Physical Therapy, and a Self-care Book? Responder Analyses from a Randomized Controlled Trial.

Purpose: To identify baseline characteristics of adults with chronic low back pain (cLBP) that predict response (i.e., a clinically important improvement) and/or modify treatment effect across three nonpharmacologic interventions.

Identifying patients with chronic pain who respond to acupuncture: results from an individual patient data meta-analysis.

Background: In a recent individual patient data meta-analysis, acupuncture was found to be superior to sham and non-sham controls in patients with chronic pain. It has been suggested that a subgroup of patients has an exceptional response to acupuncture. We hypothesized the presence of exceptional acupuncture responders would lead to a different distribution of pain scores in acupuncture versus control groups, with the former being skewed to the right.

Changes in Perceived Stress After Yoga, Physical Therapy, and Education Interventions for Chronic Low Back Pain: A Secondary Analysis of a Randomized Controlled Trial.

Objective: Perceived stress and musculoskeletal pain are common, especially in low-income populations. Studies evaluating treatments to reduce stress in patients with chronic pain are lacking. We aimed to quantify the effect of two evidence-based interventions for chronic low back pain (cLBP), yoga and physical therapy (PT), on perceived stress in adults with cLBP.