STRategies to Improve Pain and Enjoy life (STRIPE): results of a pragmatic randomized trial of pain coping skills training and opioid medication taper guidance for patients on long-term opioid therapy.

ABSTRACT: Because long-term opioid therapy (LtOT) for chronic pain has uncertain benefits and dose-dependent harms, safe and effective strategies for opioid tapering are needed. Adapting a promising pilot study intervention, we conducted the STRategies to Improve Pain and Enjoy life (STRIPE) pragmatic clinical trial. Patients in integrated health system on moderate-to-high dose of LtOT for chronic noncancer pain were randomized individually to usual care plus intervention (n = 79) or usual care only (n = 74). The intervention included pain coping skills training and optional support for opioid taper, delivered in 18 telephone sessions over a year, with pharmacologic guidance provided to participants' primary care providers by a pain physician. Coprimary outcomes were daily opioid dose (morphine milligram equivalent [MME]), calculated using pharmacy dispensing data, and the self-reported Pain, Enjoyment of Life and General Activity scale at 12 months (primary time point) and 6 months. Secondary outcomes included opioid misuse, opioid difficulties, opioid craving, pain self-efficacy, and global impression of change, depression, and anxiety. Only 41% randomized to the intervention completed all sessions. We did not observe significant differences between intervention and usual care for MME (adjusted mean difference: -2.3 MME; 95% confidence interval: -10.6, 5.9; P = 0.578), the Pain, Enjoyment of Life, General Activity scale (0.0 [95% confidence interval: -0.5, 0.5], P = 0.985), or most secondary outcomes. The intervention did not lower opioid dose or improve pain or functioning. Other strategies are needed to reduce opioid doses while improving pain and function for patients who have been on LtOT for years with high levels of medical, mental health, and substance use comorbidity.

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). There were differences in the effects of CBT versus MBSR on pain based on participant gender (P = .03) and baseline depressive symptoms (P = .01), but the only statistically significant moderator after Bonferroni correction was the nonjudging dimension of mindfulness. Scores on this measure moderated the effects of CBT versus MBSR on both function (P = .001) and pain (P = .04). Pain control beliefs (P <.001) and lower anxiety (P < .001) predicted improvement regardless of treatment. Replication of these findings is needed to guide treatment decision-making for CLBP. TRIAL REGISTRATION: The trial and analysis plan were preregistered in ClinicalTrials.gov (Identifier: NCT01467843). PERSPECTIVE: Although few potential moderators and nonspecific predictors of benefits from CBT or MBSR for CLBP were statistically significant after adjustment for multiple comparisons, these findings suggest potentially fruitful directions for confirmatory research while providing reassurance that patients could reasonably expect to benefit from either treatment.

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. SUBJECTS: 238,886 patients ≥18 years of age who received lumbar diagnostic imaging between 2013 and 2016. METHODS: Clinics were randomized to receive text containing age- and modality-specific epidemiological benchmarks indicating the prevalence of common spine imaging findings in people without low back pain, inserted into lumbar spine imaging reports (the "LIRE intervention"). The study outcomes were receiving 1) any nonsurgical lumbosacral or sacroiliac spine procedure (lumbosacral epidural steroid injection, facet joint injection, or facet joint radiofrequency ablation; or sacroiliac joint injection) or 2) any surgical procedure involving the lumbar, sacral, or thoracic spine (decompression surgery or spinal fusion or other spine surgery). RESULTS: The LIRE intervention was not significantly associated with subsequent utilization of nonsurgical lumbosacral or sacroiliac spine procedures (odds ratio [OR] = 1.01, 95% confidence interval [CI] 0.93-1.09; P = 0.79) or any surgical procedure (OR = 0.99, 95 CI 0.91-1.07; P = 0.74) involving the lumbar, sacral, or thoracic spine. The intervention was also not significantly associated with any individual spine procedure. CONCLUSIONS: Inserting epidemiological text into spine imaging reports had no effect on nonsurgical or surgical procedure utilization among patients receiving lumbar diagnostic imaging.

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.

Multi-site Pain Is Associated with Long-term Patient-Reported Outcomes in Older Adults with Persistent Back Pain.

OBJECTIVE: To estimate the prevalence of co-occurring pain sites among older adults with persistent back pain and associations of multisite pain with longitudinal outcomes. DESIGN: Secondary analysis of a cohort study. SETTING: Three integrated health systems in the United States. SUBJECTS: Eight hundred ninety-nine older adults with persistent back pain. METHODS: Participants reported pain in the following sites: stomach, arms/legs/joints, headaches, neck, pelvis/groin, and widespread pain. Over 18 months, we measured back-related disability (Roland Morris, scored 0-24), pain intensity (11-point numerical rating scale), health-related quality of life (EuroQol-5D [EQ-5D], utility from 0-1), and falls in the past three weeks. We used mixed-effects models to test the association of number and type of pain sites with each outcome. RESULTS: Nearly all (N = 839, 93%) respondents reported at least one additional pain site. There were 216 (24%) with one additional site and 623 (69%) with multiple additional sites. The most prevalent comorbid pain site was the arms/legs/joints (N = 801, 89.1%). Adjusted mixed-effects models showed that for every additional pain site, RMDQ worsened by 0.65 points (95% confidence interval [CI] = 0.43 to 0.86), back pain intensity increased by 0.14 points (95% CI = 0.07 to 0.22), EQ-5D worsened by 0.012 points (95% CI = -0.018 to -0.006), and the odds of falling increased by 27% (odds ratio = 1.27, 95% CI = 1.12 to 1.43). Some specific pain sites (extremity pain, widespread pain, and pelvis/groin pain) were associated with greater long-term disability. CONCLUSIONS: Multisite pain is common among older adults with persistent back pain. Number of pain sites was associated with all outcomes; individual pain sites were less consistently associated with outcomes.

Prevention and treatment of low back pain: evidence, challenges, and promising directions.

Many clinical practice guidelines recommend similar approaches for the assessment and management of low back pain. Recommendations include use of a biopsychosocial framework to guide management with initial non-pharmacological treatment, including education that supports self-management and resumption of normal activities and exercise, and psychological programmes for those with persistent symptoms. Guidelines recommend prudent use of medication, imaging, and surgery. The recommendations are based on trials almost exclusively from high-income countries, focused mainly on treatments rather than on prevention, with limited data for cost-effectiveness. However, globally, gaps between evidence and practice exist, with limited use of recommended first-line treatments and inappropriately high use of imaging, rest, opioids, spinal injections, and surgery. Doing more of the same will not reduce back-related disability or its long-term consequences. The advances with the greatest potential are arguably those that align practice with the evidence, reduce the focus on spinal abnormalities, and ensure promotion of activity and function, including work participation. We have identified effective, promising, or emerging solutions that could offer new directions, but that need greater attention and further research to determine if they are appropriate for large-scale implementation. These potential solutions include focused strategies to implement best practice, the redesign of clinical pathways, integrated health and occupational interventions to reduce work disability, changes in compensation and disability claims policies, and public health and prevention strategies.

Cost-effectiveness of Mindfulness-based Stress Reduction Versus Cognitive Behavioral Therapy or Usual Care Among Adults With Chronic Low Back Pain.

STUDY DESIGN: Economic evaluation alongside a randomized trial of cognitive-behavioral therapy (CBT) and mindfulness-based stress reduction (MBSR) versus usual care alone (UC) for chronic low back pain (CLBP). OBJECTIVE: To determine 1-year cost-effectiveness of CBT and MBSR compared to 33 UC. SUMMARY OF BACKGROUND DATA: CLBP is expensive in terms of healthcare costs and lost productivity. Mind-body interventions have been found effective for back pain, but their cost-effectiveness is unexplored. METHODS: A total of 342 adults in an integrated healthcare system with CLBP were randomized to receive MBSR (n = 116), CBT (n = 113), or UC (n = 113). CBT and MBSR were offered in 8-weekly 2-hour group sessions. Cost-effectiveness from the societal perspective was calculated as the incremental sum of healthcare costs and productivity losses over change in quality-adjusted life-years (QALYs). The payer perspective only included healthcare costs. This economic evaluation was limited to the 301 health plan members enrolled ≥180 days in the years pre-and postrandomization. RESULTS: Compared with UC, the mean incremental cost per participant to society of CBT was $125 (95% confidence interval, CI: -4103, 4307) and of MBSR was -$724 (CI: -4386, 2778)-that is, a net saving of $724. Incremental costs per participant to the health plan were $495 for CBT over UC and -$982 for MBSR, and incremental back-related costs per participant were $984 for CBT over UC and -$127 for MBSR. These costs (and cost savings) were associated with statistically significant gains in QALYs over UC: 0.041 (0.015, 0.067) for CBT and 0.034 (0.008, 0.060) for MBSR. CONCLUSION: In this setting CBT and MBSR have high probabilities of being cost-effective, and MBSR may be cost saving, as compared with UC for adults with CLBP. These findings suggest that MBSR, and to a lesser extent CBT, may provide cost-effective treatment for CLBP for payers and society. LEVEL OF EVIDENCE: 2.

A Prospective Study of Predictors of Long-term Opioid Use Among Patients With Chronic Noncancer Pain.

BACKGROUND: Chronic pain patients at increased risk of unfavorable pain and opioid misuse outcomes may be those most likely to use opioids long-term, but this has not been evaluated prospectively. OBJECTIVES: To ascertain whether pain prognostic risk, problem opioid use risk, and depression predict opioid use 1 year later among patients recently initiating opioid therapy with a moderate likelihood of long-term opioid use. MATERIALS AND METHODS: Self-report and electronic health record data were collected from patients aged 45+ years who recently initiated opioid therapy (N=762), in an integrated health care system. Logistic regression models tested whether baseline patient chronic pain prognostic risk, problem opioid use risk, depression, and expectations concerning continued opioid use independently predicted continuing use at 1 year (≥30 d supply in the prior 4 mo). RESULTS: At 1 year, 46% of participants continued to use opioids. Baseline problem opioid use risk score (adjusted odds ratio, 1.15; 95% confidence interval, 1.04-1.26) and expectations about continuing opioid use, but not pain prognostic risk score or depression, were significant predictors of 1-year opioid use. Compared with patients who thought continued opioid use unlikely, those who thought it was extremely or very likely had 4 times the odds of opioid use at 1 year (adjusted odds ratio, 4.05; 95% confidence interval, 2.59-6.31). DISCUSSION: The strongest predictors of long-term opioid use were not patient-related or medication-related factors, but expectations about using opioids in the future. Asking about such expectations may be the easiest way to identify patients likely to continue opioid use long-term.

Development and Validation of the EXPECT Questionnaire: Assessing Patient Expectations of Outcomes of Complementary and Alternative Medicine Treatments for Chronic Pain.

BACKGROUND: Patient expectations may be associated with outcomes of complementary and alternative medicine (CAM) treatments for chronic pain. However, a psychometrically sound measure of such expectations is needed. OBJECTIVES: The purpose of this study was to develop and evaluate a questionnaire to assess individuals' expectations regarding outcomes of CAM treatments for chronic low back pain (CLBP), as well as a short form of the questionnaire. METHODS: An 18-item draft questionnaire was developed through literature review, cognitive interviews with individuals with CLBP, CAM practitioners, and expert consultation. Two samples completed the questionnaire: (1) a community sample (n = 141) completed it via an online survey before or soon after starting a CAM treatment for CLBP, and (2) participants (n = 181) in randomized clinical trials evaluating CAM treatments for CLBP or fibromyalgia completed it prior to or shortly after starting treatment. Factor structure, internal consistency, test-retest reliability, and criterion validity were examined. RESULTS: Based on factor analyses, 10 items reflecting expectations (used to create a total score) and three items reflecting hopes (not scored) were selected for the questionnaire. The questionnaire had high internal consistency, moderate test-retest reliability, and moderate correlations with other measures of expectations. A three-item short form also had adequate reliability and validity. CONCLUSIONS: The Expectations for Complementary and Alternative Medicine Treatments (EXPECT) questionnaire can be used in research to assess individuals' expectations of treatments for chronic pain. It is recommended that the three hope questions are included (but not scored) to help respondents distinguish between hopes and expectations. The short form may be appropriate for clinical settings and when expectation measurement is not a primary focus.

Mindfulness-based stress reduction and cognitive behavioral therapy for chronic low back pain: similar effects on mindfulness, catastrophizing, self-efficacy, and acceptance in a randomized controlled trial.

Cognitive behavioral therapy (CBT) is believed to improve chronic pain problems by decreasing patient catastrophizing and increasing patient self-efficacy for managing pain. Mindfulness-based stress reduction (MBSR) is believed to benefit patients with chronic pain by increasing mindfulness and pain acceptance. However, little is known about how these therapeutic mechanism variables relate to each other or whether they are differentially impacted by MBSR vs CBT. In a randomized controlled trial comparing MBSR, CBT, and usual care (UC) for adults aged 20 to 70 years with chronic low back pain (N = 342), we examined (1) baseline relationships among measures of catastrophizing, self-efficacy, acceptance, and mindfulness and (2) changes on these measures in the 3 treatment groups. At baseline, catastrophizing was associated negatively with self-efficacy, acceptance, and 3 aspects of mindfulness (nonreactivity, nonjudging, and acting with awareness; all P values <0.01). Acceptance was associated positively with self-efficacy (P < 0.01) and mindfulness (P values <0.05) measures. Catastrophizing decreased slightly more posttreatment with MBSR than with CBT or UC (omnibus P = 0.002). Both treatments were effective compared with UC in decreasing catastrophizing at 52 weeks (omnibus P = 0.001). In both the entire randomized sample and the subsample of participants who attended ≥6 of the 8 MBSR or CBT sessions, differences between MBSR and CBT at up to 52 weeks were few, small in size, and of questionable clinical meaningfulness. The results indicate overlap across measures of catastrophizing, self-efficacy, acceptance, and mindfulness and similar effects of MBSR and CBT on these measures among individuals with chronic low back pain.

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.

A qualitative study of changes in expectations over time among patients with chronic low back pain seeking four CAM therapies.

BACKGROUND: The relationship between patient expectations about a treatment and the treatment outcomes, particularly for Complementary and Alternative Medicine (CAM) therapies, is not well understood. Using qualitative data from a larger study to develop a valid expectancy questionnaire for use with participants starting new CAM therapies, we examined how participants' expectations of treatment changed over the course of a therapy. METHODS: We conducted semi-structured qualitative interviews with 64 participants initiating one of four CAM therapies (yoga, chiropractic, acupuncture, massage) for chronic low back pain. Participants just starting treatment were interviewed up to three times over a period of 3 months. Interviews were transcribed verbatim and analyzed using a qualitative mixed methods approach incorporating immersion/crystallization and matrix analysis for a decontexualization and recontextualization approach to understand changes in thematic emphasis over time. RESULTS: Pre-treatment expectations consisted of conjecture about whether or not the CAM therapy could relieve pain and improve participation in meaningful activities. Expectations tended to shift over the course of treatment to be more inclusive of broader lifestyle factors, the need for long-term pain management strategies and attention to long-term quality of life and wellness. Although a shift toward greater acceptance of chronic pain and the need for strategies to keep pain from flaring was observed across participants regardless of therapy, participants varied in their assessments of whether increased awareness of the need for ongoing self-care and maintenance strategies was considered a "positive outcome". Regardless of how participants evaluated the outcome of treatment, participants from all four therapies reported increased awareness, acceptance of the chronic nature of pain, and attention to the need to take responsibility for their own health. CONCLUSIONS: The shift in treatment expectations to greater acceptance of pain and the need for continued self-care suggests that future research should explore how CAM practitioners can capitalize on these shifts to encourage feelings of empowerment rather than disappointment surrounding realizations of the need for continued engagement with self-care.

New perspectives on patient expectations of treatment outcomes: results from qualitative interviews with patients seeking complementary and alternative medicine treatments for chronic low back pain.

BACKGROUND: Positive patient expectations are often believed to be associated with greater benefits from complementary and alternative medicine (CAM) treatments. However, clinical studies of CAM treatments for chronic pain have not consistently supported this assumption, possibly because of differences in definitions and measures of expectations. The goal of this qualitative paper is to provide new perspectives on the outcome expectations of patients prior to receiving CAM therapies for chronic low back pain. METHODS: We conducted semi-structured interviews with 64 individuals receiving massage, chiropractic, acupuncture or yoga for chronic low back pain. Interviews were recorded and transcribed. Transcripts were analyzed by a team of experienced qualitative researchers using an immersion/crystallization approach to coding and analysis. RESULTS: Overall, participants' expectations of treatment outcomes tended to cluster in four key domains: pain relief, improved function (including an increase in ability to engage in meaningful activities), improved physical fitness, and improved overall well-being (including mental well-being). Typically, patients had modest expectations for outcomes from treatment. Furthermore, outcome expectations were complex on several levels. First, the concept of expectations overlapped with several related concepts; in particular, hopes. Participants sometimes used expectations and hopes interchangeably and at other times made clear distinctions between these two terms depending on context. A related finding was that participants were cautious about stating that they expected positive outcomes. Finally, participants articulated strong interrelationships among the four key domains and often discussed how changes in one domain might affect other domains. CONCLUSIONS: Overall, these findings contribute to a growing body of literature exploring the role of expectations in patient outcomes. This paper provides important guidance that may help refine the way treatment expectations are studied in the future. In particular, participants' statements indicate that standardized measures of patient expectations should include items that capture hesitancy to articulate overly optimistic outcomes as well as interrelationships among different outcomes.

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.

Back pain in seniors: the Back pain Outcomes using Longitudinal Data (BOLD) cohort baseline data.

BACKGROUND: Back pain represents a substantial burden globally, ranking first in a recent assessment among causes of years lived with disability. Though back pain is widely studied among working age adults, there are gaps with respect to basic descriptive epidemiology among seniors, especially in the United States. Our goal was to describe how pain, function and health-related quality of life vary by demographic and geographic factors among seniors presenting to primary care providers with new episodes of care for back pain. METHODS: We examined baseline data from the Back pain Outcomes using Longitudinal Data (BOLD) registry, the largest inception cohort to date of seniors presenting to a primary care provider for back pain. The sample included 5,239 patients ≥ 65 years old with a new primary care visit for back pain at three integrated health systems (Northern California Kaiser-Permanente, Henry Ford Health System [Detroit], and Harvard Vanguard Medical Associates [Boston]). We examined differences in patient characteristics across healthcare sites and associations of patient sociodemographic and clinical characteristics with baseline patient-reported measures of pain, function, and health-related quality of life. RESULTS: Patients differed across sites in demographic and other characteristics. The Detroit site had more African-American patients (50%) compared with the other sites (7-8%). The Boston site had more college graduates (68%) compared with Detroit (20%). Female sex, lower educational status, African-American race, and older age were associated with worse functional disability as measured by the Roland-Morris Disability Questionnaire. Except for age, these factors were also associated with worse pain. CONCLUSIONS: Baseline pain and functional impairment varied substantially with a number of factors in the BOLD cohort. Healthcare site was an important factor. After controlling for healthcare site, lower education, female sex, African-American race, and older age were associated with worse physical disability and all of these factors except age were associated with worse pain. TRIAL REGISTRATION: Clinical Trials.gov NCT01776242; Registration date: June 13, 2012.

Cognitive interviews guide design of a new CAM patient expectations questionnaire.

BACKGROUND: No consistent relationship exists between pre-treatment expectations and therapeutic benefit from various complementary and alternative medicine (CAM) therapies in clinical trials. However, many different expectancy measures have been used in those studies, with no validated questionnaires clearly focused on CAM and pain. We undertook cognitive interviews as part of a process to develop and validate such a questionnaire. METHODS: We reviewed questions about expectations of benefits of acupuncture, chiropractic, massage, or yoga for pain. Components of the questions - verbs, nouns, response options, terms and phrases describing back pain - were identified. Using seven different cognitive interview scripts, we conducted 39 interviews to evaluate how individuals with chronic low back pain understood these individual components in the context of expectancy questions for a therapy they had not yet received. Chosen items were those with the greatest agreement and least confusion among participants, and were closest to the meanings intended by the investigators. RESULTS: The questionnaire drafted for psychometric evaluation had 18 items covering various domains of expectancy. "Back pain" was the most consistently interpreted descriptor for this condition. The most understandable response options were 0-10 scales, a structure used throughout the questionnaire, with 0 always indicating no change, and 10 anchored with an absolute descriptor such as "complete relief". The use of words to describe midpoints was found to be confusing. The word "expect" held different and shifting meanings for participants. Thus paired items comparing "hope" and "realistically expect" were chosen to evaluate 5 different aspects of treatment expectations (back pain; back dysfunction and global effects; impact of back pain on specific areas of life; sleep, mood, and energy; coping). "Impact of back pain" on various areas of life was found to be a consistently meaningful concept, and more global than "interference". CONCLUSIONS: Cognitive interviews identified wordings with considerable agreement among both participants and investigators. Some items widely used in clinical studies had different meanings to participants than investigators, or were confusing to participants. The final 18-item questionnaire is undergoing psychometric evaluation with goals of streamlining as well as identifying best items for use when questionnaire length is constrained.

Chronic opioid therapy risk reduction initiative: impact on urine drug testing rates and results.

BACKGROUND: In response to epidemic levels of prescription opioid overdose, abuse, and diversion, routine urine drug tests (UDTs) are recommended for patients receiving chronic opioid therapy (COT) for chronic pain. However, UDT ordering for COT patients is inconsistent in primary care, and little is known about how to increase UDT ordering or the impact of increased testing on rates of aberrant results. OBJECTIVE: To compare rates and results of UDTs for COT patients before versus after implementation of an opioid risk reduction initiative in a large healthcare system. DESIGN: Pre-post observational study. PATIENTS: Group Health patients on COT October 2008-September 2009 (N = 4,821), October 2009-September 2010 (N = 5,081), and October 2010-September 2011 (N = 5,498). INTERVENTION: Multi-faceted opioid risk reduction initiative. MAIN MEASURES: Annual rates of UDTs and UDT results. KEY RESULTS: Half of COT patients received at least one UDT in the year after the initiative was implemented, compared to only 7 % 2 years prior. The adjusted odds of COT patients having at least one UDT in the first year of the opioid initiative were almost 16 times (adjusted OR = 15.79; 95 % CI: 13.96-17.87) those 2 years prior. The annual rate of UDT detection of marijuana and illicit drugs did not change (12.6 % after initiative implementation), and largely reflected marijuana use (detected in 11.1 % of all UDTs in the year after initiative implementation). In the year after initiative implementation, 10.7 % of UDTs were negative for opioids. CONCLUSIONS: The initiative appeared to dramatically increase urine drug testing of COT patients in the healthcare system without impacting rates of aberrant results. The large majority of aberrant results reflected marijuana use or absence of opioids in the urine. The utility of increased urine drug testing for COT patient safety and prevention of diversion remains uncertain.