Getting cozy with causality: Advances to the causal pathway diagramming method to enhance implementation precision.

Background: Implementation strategies are theorized to work well when carefully matched to implementation determinants and when factors-preconditions, moderators, etc.-that influence strategy effectiveness are prospectively identified and addressed. Existing methods for strategy selection are either imprecise or require significant technical expertise and resources, undermining their utility. This article outlines refinements to causal pathway diagrams (CPDs), a method for articulating the causal process through which implementation strategies work and offers illustrations of their use. Method: CPDs are a visualization tool to represent an implementation strategy, its mechanism(s) (i.e., the processes through which a strategy is thought to operate), determinants it is intended to address, factors that may impede or facilitate its effectiveness, and the series of outcomes that should be expected if the strategy is operating as intended. We offer principles for constructing CPDs and describe their key functions. Results: Applications of the CPD method by study teams from two National Institute of Health-funded Implementation Science Centers and a research grant are presented. These include the use of CPDs to (a) match implementation strategies to determinants, (b) understand the conditions under which an implementation strategy works, and (c) develop causal theories of implementation strategies. Conclusions: CPDs offer a novel method for implementers to select, understand, and improve the effectiveness of implementation strategies. They make explicit theoretical assumptions about strategy operation while supporting practical planning. Early applications have led to method refinements and guidance for the field.

Advances to the Causal Pathway Diagramming Method to Enhance Implementation Precision Plain Language Summary Implementation strategies often fail to produce meaningful improvements in the outcomes we hope to impact. Better tools for choosing, designing, and evaluating implementation strategies may improve their performance. We developed a tool, causal pathway diagrams (CPD), to visualize and describe how implementation strategies are expected to work. In this article, we describe refinements to the CPD tool and accompanying approach. We use real illustrations to show how CPDs can be used to improve how to match strategies to barriers, understand the conditions in which those strategies work best, and develop generalizable theories describing how implementation strategies work. CPDs can serve as both a practical and scientific tool to improve the planning, deployment, and evaluation of implementation strategies. We demonstrate the range of ways that CPDs are being used, from a highly practical tool to improve implementation practice to a scientific approach to advance testing and theorizing about implementation strategies.

A Randomized Controlled Trial of Animal-assisted Activities for Pediatric Oncology Patients: Psychosocial and Microbial Outcomes.

INTRODUCTION: Evidence about the effectiveness and safety of dog visits in pediatric oncology is limited. METHOD: We conducted a randomized controlled trial (n=26) of dog visits versus usual care among pediatric oncology inpatients. Psychological functioning and microbial load from hand wash samples were evaluated. Parental anxiety was a secondary outcome. RESULTS: We did not observe a difference in the adjusted mean present functioning score (-3.0; 95% confidence interval [CI], -12.4 to 6.4). The difference in microbial load on intervention versus control hands was -0.04 (95% CI, -0.60 to 0.52) log10 CFU/mL, with an upper 95% CI limit below the prespecified noninferiority margin. Anxiety was lower in parents of intervention versus control patients. DISCUSSION: We did not detect an effect of dog visits on functioning; however, our study was underpowered by low recruitment. Visits improved parental anxiety. With hand sanitization, visits did not increase hand microbial levels. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov NCT03471221.

Kinless Older Adults With Dementia: Qualitative Analysis of Data From the Adult Changes in Thought Study.

OBJECTIVES: To examine the circumstances and needs of older adults who were "kinless," defined as having no living spouse or children, when they developed dementia. METHODS: We conducted a secondary analysis of information from the Adult Changes in Thought study. Among 848 participants diagnosed with dementia between 1994 and 2016, we identified 64 who had no living spouse or child at dementia onset. We then conducted a qualitative analysis of administrative documents pertaining to these participants: handwritten comments recorded after each study visit, and medical history documents containing clinical chart notes from participants' medical records. RESULTS: In this community-dwelling cohort of older adults diagnosed with dementia, 8.4% were kinless at dementia onset. Participants in this sample had an average age of 87 years old, half lived alone, and one third lived with unrelated persons. Through inductive content analysis, we identified 4 themes that describe their circumstances and needs: (1) life trajectories, (2) caregiving resources, (3) care needs and gaps, and (4) turning points in caregiving arrangements. DISCUSSION: Our qualitative analysis reveals that the life trajectories that led members of the analytic cohort to be kinless at dementia onset were quite varied. This research highlights the importance of nonfamily caregivers and participants' own roles as caregivers. Our findings suggest that clinicians and health systems may need to work with other parties to directly provide dementia caregiving support rather than rely on family, and address factors such as neighborhood affordability that particularly affect older adults who have limited family support.

Effects of the COVID-19 Pandemic on Animal-Assisted Activities in Pediatric Hospitals.

INTRODUCTION: The goal of this study was to document current hospital-based animal-assisted activities (AAA) practices. METHOD: We contacted 20 hospitals and asked about their AAA programs, including COVID-19 precautions. RESULTS: Eighteen of 20 hospitals responded. Before 2020, all offered either in-person only (n = 17) or both in-person and virtual AAA visits (n = 1). In early 2022, 13 provided in-person visits; the five hospitals that had not resumed in-person visits planned to restart. Most hospitals stopped group visits. Most required that patients and handlers be free of COVID-19 symptoms and that handlers be vaccinated and wear masks and eye protection. Most did not require COVID-19 vaccination for patients. None required handlers to test negative for COVID-19. DISCUSSION: The COVID-19 pandemic impacted hospital-based pediatric AAA. Future studies should assess the effectiveness of virtual AAA and of precautions to prevent COVID-19 transmission between patients and AAA volunteers.

Optimizing Implementation in Cancer Control (OPTICC): protocol for an implementation science center.

BACKGROUND: Evidence-based interventions (EBIs) could reduce cervical cancer deaths by 90%, colorectal cancer deaths by 70%, and lung cancer deaths by 95% if widely and effectively implemented in the USA. Yet, EBI implementation, when it occurs, is often suboptimal. This manuscript outlines the protocol for Optimizing Implementation in Cancer Control (OPTICC), a new implementation science center funded as part of the National Cancer Institute Implementation Science Consortium. OPTICC is designed to address three aims. Aim 1 is to develop a research program that supports developing, testing, and refining of innovative, efficient methods for optimizing EBI implementation in cancer control. Aim 2 is to support a diverse implementation laboratory of clinical and community partners to conduct rapid, implementation studies anywhere along the cancer care continuum for a wide range of cancers. Aim 3 is to build implementation science capacity in cancer control by training new investigators, engaging established investigators in cancer-focused implementation science, and contributing to the Implementation Science Consortium in Cancer. METHODS: Three cores serve as OPTICC's foundation. The Administrative Core plans coordinates and evaluates the Center's activities and leads its capacity-building efforts. The Implementation Laboratory Core (I-Lab) coordinates a network of diverse clinical and community sites, wherein studies are conducted to optimize EBI implementation, implement cancer control EBIs, and shape the Center's agenda. The Research Program Core conducts innovative implementation studies, measurement and methods studies, and pilot studies that advance the Center's theme. A three-stage approach to optimizing EBI implementation is taken-(I) identify and prioritize determinants, (II) match strategies, and (III) optimize strategies-that is informed by a transdisciplinary team of experts leveraging multiphase optimization strategies and criteria, user-centered design, and agile science. DISCUSSION: OPTICC will develop, test, and refine efficient and economical methods for optimizing EBI implementation by building implementation science capacity in cancer researchers through applications with our I-Lab partners. Once refined, OPTICC will disseminate its methods as toolkits accompanied by massive open online courses, and an interactive website, the latter of which seeks to simultaneously accumulate knowledge across OPTICC studies.

The Benefits of T'ai Chi for Older Adults with Chronic Back Pain: A Qualitative Study.

Objective: To determine the perceived benefits of t'ai chi in older adults with chronic low-back pain (cLBP). Design: A qualitative analysis from a randomized controlled feasibility trial. Subjects: Eighteen participants (65+ years old) with cLBP of at least moderate intensity. Intervention: A 36-week intervention beginning with twice weekly classes for 12 weeks, weekly classes for 6 weeks, biweekly classes for 6 weeks, and monthly classes for 12 weeks. Participants were asked to practice at home on nonclass days and videos were provided to assist in that process. Outcome Measures: Participants in the focus groups were asked to provide feedback on their experiences with the study as well as the benefits of their t'ai chi practice. We used demographic and class attendance data to describe the sample. Results: Regarding the benefits of t'ai chi practice, five major themes were identified: functional benefits, pain reduction/pain relief, psychospiritual benefits, the importance of social support in learning t'ai chi, and the integration of t'ai chi into daily activities. The most common functional benefits were improvements in balance, flexibility, leg strength, and posture. Some reported pain reduction or pain relief, but others did not. Increased relaxation, mindfulness, and a sense of connectedness were subthemes that emerged from psychospiritual benefits. Social support benefits included motivation to attend class and group support while learning a new skill. Finally, improved body awareness allowed participants to integrate t'ai chi skills into their daily activities. Conclusions: This qualitative analysis demonstrates the multifaceted benefits of t'ai chi for older adults living with cLBP.

T'ai Chi for Chronic Low Back Pain in Older Adults: A Feasibility Trial.

Objectives: T'ai chi (TC) has been found effective for improving chronic low back pain (cLBP). However, such studies did not include adults over 65 years of age. This study was designed to evaluate the feasibility and acceptability of TC in this population compared with Health Education (HE) and with Usual Care (UC). Design: Feasibility randomized controlled trial. Settings/Location: Participants were recruited from Kaiser Permanente Washington and classes took place in a Kaiser facility. Patients: Adults 65 years of age and older with cLBP. Interventions: Twenty-eight participants were randomized to 12 weeks of TC followed by a 24-week tapered TC program, 12 were assigned to a 12-week HE intervention and 17 were assigned to UC only. Outcome Measures: Feasibility and acceptability were determined by recruitment, retention and 12-, 26-, and 52-week follow-up rates, instructor adherence to protocol, class attendance, TC home practice, class satisfaction, and adverse events. Results: Fifty-seven participants were enrolled in two cohorts of 28 and 29 during two 4-month recruitment periods. Questionnaire follow-up completion rates ranged between 88% and 93%. Two major class protocol deviations were noted in TC and none in HE. Sixty-two percent of TC participants versus 50% of HE participants attended at least 70% of the classes during the 12-week initial intervention period. Weekly rates of TC home practice were high among class attendees (median of 4.2 days) at 12 weeks, with fewer people practicing at 26 and 52 weeks. By 52 weeks, 70% of TC participants reported practicing the week before, with a median of 3 days per week and 15 min/session. TC participants rated the helpfulness of their classes significantly higher than did HE participants, but the groups were similarly likely to recommend the classes. Conclusion: The TC intervention is feasible in this population, while the HE group requires modifications in delivery.

Previsit Screening for Parental Vaccine Hesitancy: A Cluster Randomized Trial.

OBJECTIVE: To evaluate the effect of vaccine hesitancy screening on childhood vaccine uptake. METHODS: We conducted a cluster randomized controlled trial in pediatric primary care clinics in Washington state. Vaccine-hesitant parents (VHPs) with a healthy newborn receiving health supervision at participating clinics were eligible. VHPs were identified by using a 4-item version of the validated Parent Attitudes About Childhood Vaccines Survey (PACV). Before their child's 2- and 6-month health supervision visits, VHPs at intervention clinics completed the 15-item PACV embedded in a survey containing placebo items. Intervention providers received a summary of parents' 15-item PACV responses and interpretation of their PACV score; discretion was given to providers regarding how they acted on this information. VHPs at control clinics completed only the placebo survey items, and their child's provider received a summary of their responses; control providers remained blinded to parent VHP status. Our outcome was child immunization status at 8 months of age expressed as percent of days underimmunized. We compared outcomes in control and intervention participants using t test and linear mixed-effects regression. RESULTS: We enrolled 24 clinics (12 in each arm) and 156 parents (65 in the intervention arm). Parent characteristics were similar across arms except more intervention (versus control) parents had a first-born child (60.9% vs 44%; P = .04). No significant difference in outcome was detected between arms (25.2% [95% confidence interval: 16.0% to 34.5%] vs 19.1% [95% confidence interval: 12.0% to 26.3%] mean days underimmunized in the intervention and control arms, respectively). CONCLUSION: Vaccine hesitancy screening was not significantly associated with days underimmunized.

Effect of Low Back Pain Risk-Stratification Strategy on Patient Outcomes and Care Processes: the MATCH Randomized Trial in Primary Care.

BACKGROUND: The STarT Back strategy for categorizing and treating patients with low back pain (LBP) improved patients' function while reducing costs in England. OBJECTIVE: This trial evaluated the effect of implementing an adaptation of this approach in a US setting. DESIGN: The Matching Appropriate Treatments to Consumer Healthcare needs (MATCH) trial was a pragmatic cluster randomized trial with a pre-intervention baseline period. Six primary care clinics were pair randomized, three to training in the STarT Back strategy and three to serve as controls. PARTICIPANTS: Adults receiving primary care for non-specific LBP were invited to provide data 2 weeks after their primary care visit and follow-up data 2 and 6 months (primary endpoint) later. INTERVENTIONS: The STarT Back risk-stratification strategy matches treatments for LBP to physical and psychosocial obstacles to recovery using patient-reported data (the STarT Back Tool) to categorize patients' risk of persistent disabling pain. Primary care clinicians in the intervention clinics attended six didactic sessions to improve their understanding LBP management and received in-person training in the use of the tool that had been incorporated into the electronic health record (EHR). Physical therapists received 5 days of intensive training. Control clinics received no training. MAIN MEASURES: Primary outcomes were back-related physical function and pain severity. Intervention effects were estimated by comparing mean changes in patient outcomes after 2 and 6 months between intervention and control clinics. Differences in change scores by trial arm and time period were estimated using linear mixed effect models. Secondary outcomes included healthcare utilization. KEY RESULTS: Although clinicians used the tool for about half of their patients, they did not change the treatments they recommended. The intervention had no significant effect on patient outcomes or healthcare use. CONCLUSIONS: A resource-intensive intervention to support stratified care for LBP in a US healthcare setting had no effect on patient outcomes or healthcare use. TRIAL REGISTRATION: National Clinical Trial Number NCT02286141.

Patient Perspectives on Communication with Primary Care Physicians about Chronic Low Back Pain.

OBJECTIVES: Chronic low back pain (CLBP) is a common health problem with challenges for providing satisfactory care. This study was undertaken to identify opportunities to improve key aspects of physicians' communications with CLBP-affected patients. METHODS: A series of 3 focus groups, each with 7 to 11 patients with CLBP, were recruited from primary care settings and grouped by risk level of reduced function resulting from back pain, to elicit perspectives about interactions with their primary care physicians. Analysis of focus group transcripts used an iterative process based on a thematic approach and a priori concepts. RESULTS: A total of 28 patients participated in the focus groups. Patient comments about communicating with physicians around CLBP fit into themes of listening and empathy, validating pain experiences, conducting effective CLBP assessment, providing clear diagnosis and information, and collaboratively working on treatment. Patients shared that physicians can foster positive interactions with CLBP-affected patients by sharing personal experiences of chronic pain, being truthful about not having all the answers and being clear about how patients can benefit from referrals, reviewing the patient's previous treatments before beginning conversations about treatment options, providing follow-up instructions, giving patients a diagnosis beyond "chronic pain," and explaining the role of imaging in their care. CONCLUSION: This study provides specific steps that physicians in the US can take to improve physician-patient interactions during primary care visits pertaining to CLBP. The findings could inform physician training, development of educational materials for patients, and future research.

Pilot Study of Therapy Dog Visits for Inpatient Youth With Cancer.

This study assessed the feasibility of studying animal-assisted activities (AAA) in inpatient pediatric oncology and collected preliminary data on potential benefits of AAA for this population. Patients at a large pediatric hospital were identified using electronic medical records and approached with physician approval. Patients completed surveys before and after a therapy dog visit in their private hospital room. Data on infections were ascertained by electronic medical record review. Provider surveys were placed in provider common areas and distributed through a link in an e-mail. We summarized resultsusing descriptive statistics and estimated mean changes in pre- and postintervention distress and conducted hypothesis tests using the paired t test. The study population (mean age = 12.9 years) consisted of 9 females and 10 males. Following the therapy dog visit, patients had lower distress and significant decreases in worry, tiredness, fear, sadness, and pain. Providers were generally supportive of the intervention. Eight patients developed infections during the 14 days after the dog visit but none could be clearly attributed to the therapy dog visit. The study's primary limitation was that there was no control group. However, results support the feasibility of and need for future studies on AAA in pediatric oncology.

Evaluation of a risk-stratification strategy to improve primary care for low back pain: the MATCH cluster randomized trial protocol.

BACKGROUND: Despite numerous options for treating back pain and the increasing healthcare resources devoted to this problem, the prevalence and impact of back pain-related disability has not improved. It is now recognized that psychosocial factors, as well as physical factors, are important predictors of poor outcomes for back pain. A promising new approach that matches treatments to the physical and psychosocial obstacles to recovery, the STarT Back risk stratification approach, improved patients' physical function while reducing costs of care in the United Kingdom (UK). This trial evaluates implementation of this strategy in a United States (US) healthcare setting. METHODS: Six large primary care clinics in an integrated healthcare system in Washington State were block-randomized, three to receive an intensive quality improvement intervention for back pain and three to serve as controls for secular trends. The intervention included 6 one-hour training sessions for physicians, 5 days of training for physical therapists, individualized and group coaching of clinicians, and integration of the STarT Back tool into the electronic health record. This prognostic tool uses 9 questions to categorize patients at low, medium or high risk of persistent disabling pain with recommendations about evidence-based treatment options appropriate for each subgroup. Patients at least 18 years of age, receiving primary care for non-specific low back pain, were invited to provide data 1-3 weeks after their primary care visit and follow-up data 2 months and 6 months (primary endpoint) later. The primary outcomes are back-related physical function and pain severity. Using an intention to treat approach, intervention effects on patient outcomes will be estimated by comparing mean changes at the 2 and 6 month follow-up between the pre- and post-implementation periods. The inclusion of control clinics permits adjustment for secular trends. Differences in change scores by intervention group and time period will be estimated using linear mixed models with random effects. Secondary outcomes include healthcare utilization and adherence to clinical guidelines. DISCUSSION: This trial will provide the first randomized trial evidence of the clinical effectiveness of implementing risk stratification with matched treatment options for low back pain in a United States health care delivery system. TRIAL REGISTRATION: NCT02286141. Registered November 5, 2014.

Effect of Mindfulness-Based Stress Reduction vs Cognitive Behavioral Therapy or Usual Care on Back Pain and Functional Limitations in Adults With Chronic Low Back Pain: A Randomized Clinical Trial.

IMPORTANCE: Mindfulness-based stress reduction (MBSR) has not been rigorously evaluated for young and middle-aged adults with chronic low back pain. OBJECTIVE: To evaluate the effectiveness for chronic low back pain of MBSR vs cognitive behavioral therapy (CBT) or usual care. DESIGN, SETTING, AND PARTICIPANTS: Randomized, interviewer-blind, clinical trial in an integrated health care system in Washington State of 342 adults aged 20 to 70 years with chronic low back pain enrolled between September 2012 and April 2014 and randomly assigned to receive MBSR (n = 116), CBT (n = 113), or usual care (n = 113). INTERVENTIONS: CBT (training to change pain-related thoughts and behaviors) and MBSR (training in mindfulness meditation and yoga) were delivered in 8 weekly 2-hour groups. Usual care included whatever care participants received. MAIN OUTCOMES AND MEASURES: Coprimary outcomes were the percentages of participants with clinically meaningful (≥30%) improvement from baseline in functional limitations (modified Roland Disability Questionnaire [RDQ]; range, 0-23) and in self-reported back pain bothersomeness (scale, 0-10) at 26 weeks. Outcomes were also assessed at 4, 8, and 52 weeks. RESULTS: There were 342 randomized participants, the mean (SD) [range] age was 49.3 (12.3) [20-70] years, 224 (65.7%) were women, mean duration of back pain was 7.3 years (range, 3 months-50 years), 123 (53.7%) attended 6 or more of the 8 sessions, 294 (86.0%) completed the study at 26 weeks, and 290 (84.8%) completed the study at 52 weeks. In intent-to-treat analyses at 26 weeks, the percentage of participants with clinically meaningful improvement on the RDQ was higher for those who received MBSR (60.5%) and CBT (57.7%) than for usual care (44.1%) (overall P = .04; relative risk [RR] for MBSR vs usual care, 1.37 [95% CI, 1.06-1.77]; RR for MBSR vs CBT, 0.95 [95% CI, 0.77-1.18]; and RR for CBT vs usual care, 1.31 [95% CI, 1.01-1.69]). The percentage of participants with clinically meaningful improvement in pain bothersomeness at 26 weeks was 43.6% in the MBSR group and 44.9% in the CBT group, vs 26.6% in the usual care group (overall P = .01; RR for MBSR vs usual care, 1.64 [95% CI, 1.15-2.34]; RR for MBSR vs CBT, 1.03 [95% CI, 0.78-1.36]; and RR for CBT vs usual care, 1.69 [95% CI, 1.18-2.41]). Findings for MBSR persisted with little change at 52 weeks for both primary outcomes. CONCLUSIONS AND RELEVANCE: Among adults with chronic low back pain, treatment with MBSR or CBT, compared with usual care, resulted in greater improvement in back pain and functional limitations at 26 weeks, with no significant differences in outcomes between MBSR and CBT. These findings suggest that MBSR may be an effective treatment option for patients with chronic low back pain. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01467843.

Animal-Assisted Activities: Results From a Survey of Top-Ranked Pediatric Oncology Hospitals.

Animal-assisted activities (AAA) are increasingly common, yet little is known about practices in pediatric oncology. To address this gap, we surveyed the top 20 pediatric oncology hospitals in the United States in May and June of 2014. Questionnaires were sent via e-mail and generally returned by e-mail or postal mail. Among the 19 responding hospitals, the 18 that offered AAA to pediatric patients formed the basis of our analysis. All sites had written AAA policies. Most programs were restricted to dogs. At 11 hospitals, children with cancer could participate in AAA activities. Outpatient waiting rooms and individual inpatient rooms were the most common locations for AAA with pediatric oncology patients. Safety precautions varied by hospital, but all required hand sanitation after visits and that animals receive an annual health examination, be on a leash or in a carrier, be ≥1 year old, and not be directly from a shelter. Our findings reveal consistencies and variations in practice that may help other hospitals develop their own programs and researchers identify areas of future study.

Comparison of complementary and alternative medicine with conventional mind-body therapies for chronic back pain: protocol for the Mind-body Approaches to Pain (MAP) randomized controlled trial.

BACKGROUND: The self-reported health and functional status of persons with back pain in the United States have declined in recent years, despite greatly increased medical expenditures due to this problem. Although patient psychosocial factors such as pain-related beliefs, thoughts and coping behaviors have been demonstrated to affect how well patients respond to treatments for back pain, few patients receive treatments that address these factors. Cognitive-behavioral therapy (CBT), which addresses psychosocial factors, has been found to be effective for back pain, but access to qualified therapists is limited. Another treatment option with potential for addressing psychosocial issues, mindfulness-based stress reduction (MBSR), is increasingly available. MBSR has been found to be helpful for various mental and physical conditions, but it has not been well-studied for application with chronic back pain patients. In this trial, we will seek to determine whether MBSR is an effective and cost-effective treatment option for persons with chronic back pain, compare its effectiveness and cost-effectiveness compared with CBT and explore the psychosocial variables that may mediate the effects of MBSR and CBT on patient outcomes. METHODS/DESIGN: In this trial, we will randomize 397 adults with nonspecific chronic back pain to CBT, MBSR or usual care arms (99 per group). Both interventions will consist of eight weekly 2-hour group sessions supplemented by home practice. The MBSR protocol also includes an optional 6-hour retreat. Interviewers masked to treatment assignments will assess outcomes 5, 10, 26 and 52 weeks postrandomization. The primary outcomes will be pain-related functional limitations (based on the Roland Disability Questionnaire) and symptom bothersomeness (rated on a 0 to 10 numerical rating scale) at 26 weeks. DISCUSSION: If MBSR is found to be an effective and cost-effective treatment option for patients with chronic back pain, it will become a valuable addition to the limited treatment options available to patients with significant psychosocial contributors to their pain. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT01467843.

Five-week outcomes from a dosing trial of therapeutic massage for chronic neck pain.

PURPOSE: This trial was designed to evaluate the optimal dose of massage for individuals with chronic neck pain. METHODS: We recruited 228 individuals with chronic nonspecific neck pain from an integrated health care system and the general population, and randomized them to 5 groups receiving various doses of massage (a 4-week course consisting of 30-minute visits 2 or 3 times weekly or 60-minute visits 1, 2, or 3 times weekly) or to a single control group (a 4-week period on a wait list). We assessed neck-related dysfunction with the Neck Disability Index (range, 0-50 points) and pain intensity with a numerical rating scale (range, 0-10 points) at baseline and 5 weeks. We used log-linear regression to assess the likelihood of clinically meaningful improvement in neck-related dysfunction (≥5 points on Neck Disability Index) or pain intensity (≥30% improvement) by treatment group. RESULTS: After adjustment for baseline age, outcome measures, and imbalanced covariates, 30-minute treatments were not significantly better than the wait list control condition in terms of achieving a clinically meaningful improvement in neck dysfunction or pain, regardless of the frequency of treatments. In contrast, 60-minute treatments 2 and 3 times weekly significantly increased the likelihood of such improvement compared with the control condition in terms of both neck dysfunction (relative risk = 3.41 and 4.98, P = .04 and .005, respectively) and pain intensity (relative risk = 2.30 and 2.73; P = .007 and .001, respectively). CONCLUSIONS: After 4 weeks of treatment, we found multiple 60-minute massages per week more effective than fewer or shorter sessions for individuals with chronic neck pain. Clinicians recommending massage and researchers studying this therapy should ensure that patients receive a likely effective dose of treatment.

Dosing study of massage for chronic neck pain: protocol for the dose response evaluation and analysis of massage [DREAM] trial.

BACKGROUND: Despite the growing popularity of massage, its effectiveness for treating neck pain remains unclear, largely because of the poor quality of research. A major deficiency of previous studies has been their use of low "doses" of massage that massage therapists consider inadequate. Unfortunately, the number of minutes per massage session, sessions per week, or weeks of treatment necessary for massage to have beneficial or optimal effects are not known. This study is designed to address these gaps in our knowledge by determining, for persons with chronic neck pain: 1) the optimal combination of number of treatments per week and length of individual treatment session, and 2) the optimal number of weeks of treatment. METHODS/DESIGN: In this study, 228 persons with chronic non-specific neck pain will be recruited from primary health care clinics in a large health care system in the Seattle area. Participants will be randomized to a wait list control group or 4 weeks of treatment with one of 5 different dosing combinations (2 or 3 30-min treatments per week or 1, 2, or 3 60-min treatments per week). At the end of this 4-week primary treatment period, participants initially receiving each of the 5 dosing combinations will be randomized to a secondary treatment period of either no additional treatment or 6 weekly 60-min massages. The primary outcomes, neck-related dysfunction and pain, will be assessed by blinded telephone interviewers 5, 12, and 26 weeks post-randomization. To better characterize the trajectory of treatment effects, these interview data will be supplemented with outcomes data collected by internet questionnaire at 10, 16, 20 and 39 weeks. Comparisons of outcomes for the 6 groups during the primary treatment period will identify the optimal weekly dose, while comparisons of outcomes during the secondary treatment period will determine if 10 weeks of treatment is superior to 4 weeks. DISCUSSION: A broad dosing schedule was included in this trial. If adherence to any of these doses is poor, those doses will be discontinued. TRIAL REGISTRATION: This trial is registered in ClinicalTrials.gov, with the ID number of NCT01122836

A randomized trial comparing yoga, stretching, and a self-care book for chronic low back pain.

BACKGROUND: Chronic low back pain is a common problem lacking highly effective treatment options. Small trials suggest that yoga may have benefits for this condition. This trial was designed to determine whether yoga is more effective than conventional stretching exercises or a self-care book for primary care patients with chronic low back pain. METHODS: A total of 228 adults with chronic low back pain were randomized to 12 weekly classes of yoga (92 patients) or conventional stretching exercises (91 patients) or a self-care book (45 patients). Back-related functional status (modified Roland Disability Questionnaire, a 23-point scale) and bothersomeness of pain (an 11-point numerical scale) at 12 weeks were the primary outcomes. Outcomes were assessed at baseline, 6, 12, and 26 weeks by interviewers unaware of treatment group. RESULTS: After adjustment for baseline values, 12-week outcomes for the yoga group were superior to those for the self-care group (mean difference for function, -2.5 [95% CI, -3.7 to -1.3]; P < .001; mean difference for symptoms, -1.1 [95% CI, -1.7 to -0.4]; P < .001). At 26 weeks, function for the yoga group remained superior (mean difference, -1.8 [95% CI, -3.1 to -0.5]; P < .001). Yoga was not superior to conventional stretching exercises at any time point. CONCLUSION: Yoga classes were more effective than a self-care book, but not more effective than stretching classes, in improving function and reducing symptoms due to chronic low back pain, with benefits lasting at least several months. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00447668.

Comparison of yoga versus stretching for chronic low back pain: protocol for the Yoga Exercise Self-care (YES) trial.

BACKGROUND: Back pain, one of the most prevalent conditions afflicting American adults, is the leading reason for using complementary and alternative medicine (CAM) therapies. Yoga is an increasingly popular "mind-body" CAM therapy often used for relieving back pain and several small studies have found yoga effective for this condition. This study will assess whether yoga is effective for treating chronic low back pain compared with self care and exercise and will explore the mechanisms responsible for any observed benefits. METHODS/DESIGN: A total of 210 participants with low back pain lasting at least 3 months will be recruited from primary care clinics of a large healthcare system based in Seattle. They will be randomized in a 2:2:1 ratio to receive 12 weekly yoga classes, 12 weekly conventional therapeutic exercise classes of comparable physical exertion, or a self-care book. Interviewers masked to participants' treatment group will assess outcomes at baseline and 6, 12 and 26 weeks after randomization. Primary outcomes will be back-related dysfunction and symptom bothersomeness. In addition, data will be collected on physical measurements (e.g., flexion) at baseline and 12 weeks and saliva samples will be obtained at baseline, 6 and 12 weeks. Information will be collected on specific physical, psychological, and physiological factors to allow exploration of possible mechanisms of action through which yoga could relieve back pain and dysfunction. The effectiveness of yoga will be assessed using analysis of covariance (using general estimating equations - GEE) within an intention-to-treat context. If yoga is found effective, further analyses will explore whether yoga's benefits are attributable to physical, psychological and/or physiological factors. CONCLUSIONS: This study will provide the clearest evidence to date about the value of yoga as a therapeutic option for treating chronic back pain, and if the results are positive, will help focus future, more in-depth, research on the most promising potential mechanisms of action identified by this study.