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. INTERVENTIONS: Twelve weekly hatha yoga classes or education using The Back Pain Helpbook. MEASURES: Co-primary outcomes were changes from baseline at 12 weeks in back-related disability on the modified Roland Morris Disability Questionnaire and pain on the Defense & Veterans Pain Rating Scale. Secondary outcomes were global improvement, patient satisfaction, pain medication use, and post-traumatic stress symptoms. An intention-to-treat approach was used in primary analyses. RESULTS: One hundred twenty Veterans (mean age, 55.5 [SD = 16.9]; 11 [9%] women; mean number of chronic conditions, 5.5) were randomized to yoga (n = 62) and education (n = 58). At 12 weeks, reductions in back-related disability in yoga (mean difference [MD] = - 3.50, 95% CI: - 5.03, - 1.97) were not significantly different than education (MD = - 2.55, 95% CI: - 4.10, - 0.99; between-group difference: - 0.95 [95% CI: - 3.14, 1.23], p = 0.39). For pain, there was no significant difference between yoga (MD = - 1.01, 95% CI: - 1.67, - 0.35) and education (MD = - 0.81, 95% CI: - 1.36, - 0.27; between-group difference: - 0.20, 95% CI: - 1.06, 0.66, p = 0.65). More yoga than education participants reported being very much or extremely improved (39% vs 19%, OR = 3.71, 95% CI: 1.37, 10.02, p = 0.01) and very satisfied with treatment (60% vs 31%, OR = 4.28, 95% CI: 1.70, 10.77, p = 0.002). No differences in pain medication use or post-traumatic stress symptoms were observed at 12 weeks. No serious adverse events were reported in either group. CONCLUSION: Twelve weekly yoga classes were not more effective than an education intervention for improving pain or disability outcomes among mostly older male Veterans with cLBP and multiple comorbid health conditions. GOV IDENTIFIER: NCT02224183.

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. Cognitive appraisal was assessed with the Pain Self-Efficacy Questionnaire (PSEQ), Coping Strategies Questionnaire (CSQ), and Fear-Avoidance Beliefs Questionnaire (FABQ). Using multiple imputation and linear regression, we estimated within- and between-group changes in cognitive appraisal at 12 and 52 weeks, with baseline and the education group as references. RESULTS: Participants (mean age = 46 years) were majority female (64%) and majority Black (57%), and 54% had an annual household income <$30,000. All three groups showed improvements in PSEQ (range 0-60) at 12 weeks (yoga, mean difference [MD] = 7.0, 95% confidence interval [CI]: 4.9, 9.0; PT, MD = 6.9, 95% CI: 4.7 to 9.1; and education, MD = 3.4, 95% CI: 0.54 to 6.3), with yoga and PT improvements being clinically meaningful. At 12 weeks, improvements in catastrophizing (CSQ, range 0-36) were largest in the yoga and PT groups (MD = -3.0, 95% CI: -4.4 to -1.6; MD = -2.7, 95% CI: -4.2 to -1.2, respectively). Changes in FABQ were small. No statistically significant between-group differences were observed on PSEQ, CSQ, or FABQ at either time point. Many of the changes observed at 12 weeks were sustained at 52 weeks. CONCLUSION: All three interventions were associated with improvements in self-efficacy and catastrophizing among low-income, racially diverse adults with cLBP. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT01343927.

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. DESIGN: Post hoc analysis of the Lumbar Imaging with Reporting of Epidemiology cluster-randomized trial. PARTICIPANTS: A total of 170,680 patients aged ≥ 18 years from four healthcare systems who received thoracolumbar, lumbar, or lumbosacral spine imaging from 2013 to 2016 and had not received a prescription for non-opioid pain medication in the preceding 120 days. INTERVENTION: Text of age- and modality-specific epidemiologic benchmarks indicating the prevalence of common findings in people without back pain inserted into thoracolumbar, lumbar, or lumbosacral spine imaging reports at intervention clinics. MAIN MEASURES: Primary outcomes: any non-opioid prescription within 90 days after index imaging, overall, and by sub-class (skeletal muscle relaxants, NSAIDs, gabapentinoids, tricyclic antidepressants, benzodiazepines, duloxetine). SECONDARY OUTCOMES: count of non-opioid prescriptions within 90 days, overall, and by sub-class. KEY RESULTS: The intervention was not associated with the likelihood of patients receiving at least one prescription for new non-opioid pain-related medications, overall (adjusted OR, 1.02; 95% CI, 0.97-1.08) or by sub-class. The intervention was not associated with the number of prescriptions for any non-opioid medication (adjusted incidence rate ratio [IRR], 1.02; 95% CI, 0.99-1.04). However, the intervention was associated with more new prescriptions for NSAIDs (IRR, 1.12) and tricyclic antidepressants (IRR, 1.11). CONCLUSIONS: Inserting epidemiologic text in spine imaging reports had no effect on whether new non-opioid pain-related medications were prescribed but was associated with the number of new prescriptions for certain non-opioid sub-classes. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02015455.

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. DESIGN: Secondary analysis of a randomized controlled trial. SETTING: Academic safety net hospital and seven federally qualified community health centers. SUBJECTS: Adults with cLBP (N = 299). METHODS: We report patient characteristics that were predictors of response and/or modified treatment effect across three 12-week treatments: yoga, physical therapy [PT], and a self-care book. Using preselected characteristics, we used logistic regression to identify predictors of "response," defined as a ≥30% improvement in the Roland Morris Disability Questionnaire. Then, using "response" as our outcome, we identified baseline characteristics that were treatment effect modifiers by testing for statistical interaction (P < 0.05) across two comparisons: 1) yoga-or-PT vs self-care and 2) yoga vs PT. RESULTS: Overall, 39% (116/299) of participants were responders, with more responders in the yoga-or-PT group (42%) than the self-care (23%) group. There was no difference in proportion responding to yoga (48%) vs PT (37%, odds ratio [OR] = 1.5, 95% confidence interval = 0.88 - 2.6). Predictors of response included having more than a high school education, a higher income, employment, few depressive symptoms, lower perceived stress, few work-related fear avoidance beliefs, high pain self-efficacy, and being a nonsmoker. Effect modifiers included use of pain medication and fear avoidance beliefs related to physical activity (both P = 0.02 for interaction). When comparing yoga or PT with self-care, a greater proportion were responders among those using pain meds (OR = 5.3), which differed from those not taking pain meds (OR = 0.94) at baseline. We also found greater treatment response among those with lower (OR = 7.0), but not high (OR = 1.3), fear avoidance beliefs around physical activity. CONCLUSIONS: Our findings revealed important subgroups for whom referral to yoga or PT may improve cLBP outcomes.

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. METHODS: Forward and backward translations were conducted. The translated scale was then pretested in a small sample of English-speaking adults (n = 30), followed by cognitive interviews. Finally, consensus of the translated scale was achieved among an expert committee (n = 5), resulting in the Postural Awareness Scale-English Version (PAS-E). Psychometric properties of the PAS-E were investigated among a sample of individuals with chronic pain (n = 301) by evaluating factor structure, reliability, and construct validity. Analyses of variance were conducted to calculate differences in PAS-E scores between specific subgroups (pain conditions, sex, and history of mindfulness practice). Linear regression analyses investigated whether the scores on the PAS-E predicted levels of pain, stress, and mood. RESULTS: The results obtained from an exploratory factor analysis showed a two-factor solution and were supported by a confirmatory factor analysis. The scale demonstrated good internal consistency and satisfactory construct validity. No significant differences related to sex at birth or pain duration were found. CONCLUSION: PAS-E demonstrated good psychometric properties, and therefore, can and should be used both for research and clinical practice.

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.

Yoga, Physical Therapy, and Back Pain Education for Sleep Quality in Low-Income Racially Diverse Adults with Chronic Low Back Pain: a Secondary Analysis of a Randomized Controlled Trial.

BACKGROUND: Poor sleep is common among adults with chronic low back pain (cLBP), but the influence of cLBP treatments, such as yoga and physical therapy (PT), on sleep quality is under studied. OBJECTIVE: Evaluate the effectiveness of yoga and PT for improving sleep quality in adults with cLBP. DESIGN: Secondary analysis of a randomized controlled trial. SETTING: Academic safety-net hospital and 7 affiliated community health centers. PARTICIPANTS: A total of 320 adults with cLBP. INTERVENTION: Twelve weekly yoga classes, 1-on-1 PT sessions, or an educational book. MAIN MEASURES: Sleep quality was measured using the Pittsburgh Sleep Quality Index (PSQI) global score (0-21) at baseline, 12 weeks, and 52 weeks. Additionally, we also evaluated how the proportion of participants who achieved a clinically meaningful improvement in sleep quality (> 3-point reduction in PSQI) at 12 weeks varied by changes in pain and physical function at 6 weeks. KEY RESULTS: Among participants (mean age = 46.0, 64% female, 82% non-white), nearly all (92%) reported poor sleep quality (PSQI > 5) at baseline. At 12 weeks, modest improvements in sleep quality were observed among the yoga (PSQI mean difference [MD] = - 1.19, 95% confidence interval [CI] - 1.82, - 0.55) and PT (PSQI MD = - 0.91, 95% CI - 1.61, - 0.20) groups. Participants who reported a ≥ 30% improvement in pain or physical function at 6 weeks, compared with those who improved < 10%, were more likely to be a sleep quality responder at 12 weeks (odds ratio [OR] = 3.51, 95% CI 1.73, 7.11 and OR = 2.16, 95% CI 1.18, 3.95, respectively). Results were similar at 52 weeks. CONCLUSION: In a sample of adults with cLBP, virtually all with poor sleep quality prior to intervention, modest but statistically significant improvements in sleep quality were observed with both yoga and PT. Irrespective of treatment, clinically important sleep improvements at the end of the intervention were associated with mid-intervention pain and physical function improvements. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01343927.

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. METHODS: We used data from an assessor-blinded, parallel-group randomized controlled trial, which recruited predominantly low-income and racially diverse adults with cLBP. Participants (N = 320) were randomly assigned to 12 weeks of yoga, PT, or back pain education. We compared changes in the 10-item Perceived Stress Scale (PSS-10) from baseline to 12- and 52-week follow-up among yoga and PT participants with those receiving education. Subanalyses were conducted for participants with elevated pre-intervention perceived stress (PSS-10 score ≥17). We conducted sensitivity analyses using various imputation methods to account for potential biases in our estimates due to missing data. RESULTS: Among 248 participants (mean age = 46.4 years, 80% nonwhite) completing all three surveys, yoga and PT showed greater reductions in PSS-10 scores compared with education at 12 weeks (mean between-group difference = -2.6, 95% confidence interval [CI] = -4.5 to -0.66, and mean between-group difference = -2.4, 95% CI = -4.4 to -0.48, respectively). This effect was stronger among participants with elevated pre-intervention perceived stress. Between-group effects had attenuated by 52 weeks. Results were similar in sensitivity analyses. CONCLUSIONS: Yoga and PT were more effective than back pain education for reducing perceived stress among low-income adults with cLBP.

Impact of initiatives to reduce prescription opioid risks on medically attended injuries in people using chronic opioid therapy.

PURPOSE: The purpose of the study is to determine whether initiatives to improve the safety of opioid prescribing decreased injuries in people using chronic opioid therapy (COT). METHODS: We conducted an interrupted time series analysis using data from Group Health (GH), an integrated health care delivery system in the United States. In 2007, GH implemented initiatives which substantially reduced daily opioid dose and increased patient monitoring. Among GH members age 18 or older receiving COT between 2006 and 2014, we compared injury rates for patients in GH's integrated group practice (IGP; exposed to the initiatives) vs patients cared for by contracted providers (not exposed). Injuries were identified using a validated algorithm. We calculated injury incidence during the baseline (preintervention) period from 2006 to 2007; the dose reduction period, 2008 to 2010; and the risk stratification and monitoring period, 2010 to 2014. Using modified Poisson regression, we estimated adjusted relative risks (RRs) representing the relative change per year in injury rates. RESULTS: Among 21 853 people receiving COT in the IGP and 8260 in contracted care, there were 2679 injuries during follow-up. The baseline injury rate was 1.0% per calendar quarter in the IGP and 0.9% in contracted care. Risk reduction initiatives did not decrease injury rates: Within the IGP, the RR in the dose reduction period was 1.01 (95% CI, 0.95-1.07) and in the risk stratification and monitoring period, 0.99 (95% CI, 0.95-1.04). Injury trends did not differ between the two care settings. CONCLUSIONS: Risk reduction initiatives did not decrease injuries in people using COT.

Adaptation and Implementation of the STarT Back Risk Stratification Strategy in a US Health Care Organization: A Process Evaluation.

OBJECTIVE: To support implementation of effective treatments for back pain that can be delivered to a range of people, we summarize learnings from our process evaluation of the MATCH trial's implementation of an adaptation of the STarT Back risk-stratified care model. DESIGN: Our logic model-driven evaluation focused primarily on qualitative data sources. SETTING: This study took place in a US-based health care delivery system that had adapted and implemented the STarT Back stratified care approach. This was the first formal test of the strategy in a US setting. METHODS: Data collection included observation of implementation activities, staff/provider interviews, and post-training evaluation questionnaires. Data were analyzed using thematic analysis of qualitative data and descriptive statistics for questionnaire data. RESULTS: We found that both primary care teams and physical therapists at intervention clinics gave the training high scores on evaluation questionnaires and reported in the interviews that they found the training engaging and useful. However, there was significant variation in the extent to which the risk stratification strategy was incorporated into care. Some primary care providers reported that the intervention changed their conversations with patients and increased their confidence in working with patients with back pain. Providers using the STarT Back tool did not change referral rates for recommended matched treatments. CONCLUSIONS: These insights provide guidance for future efforts to adapt and implement the STarT Back strategy and other complex practice change interventions. They emphasize the need for primary care-based interventions to minimize complexity and the need for ongoing monitoring and feedback.

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.

Impact of Opioid Dose Reduction and Risk Mitigation Initiatives on Chronic Opioid Therapy Patients at Higher Risk for Opioid-Related Adverse Outcomes.

Objective: We aimed to determine if opioid risk reduction initiatives including dose reduction and risk mitigation strategies for chronic noncancer pain patients receiving chronic opioid therapy (COT) had a differential impact on average daily opioid doses of COT patients at higher risk for opioid-related adverse outcomes compared with lower-risk patients. Design: Interrupted time series. Setting: Group Health Cooperative (GH), a health care delivery system and insurance within Washington State, between 2006 and 2014. Population: GH enrollees on COT defined as receiving a supply of 70 or more days of opioids within 90 days using electronic pharmacy data for filled prescriptions. Methods: We compared the average daily morphine equivalent doses (MED) of COT patients with and without each of the following higher-risk characteristics: mental disorders, substance use disorders, sedative use, and male gender. Results: In all four pairwise comparisons, the higher-risk subgroup had a higher average daily MED than the lower-risk subgroup across the study period. Adjusted for covariates, modest differences in the annual rate of reduction in average daily MED were noted between higher- and lower-risk subgroups in three pairwise comparisons: those with mental disorders vs without (-8.2 mg/y vs -5.2 mg/y, P = 0.005), with sedative use vs without (-9.2 mg/y vs -5.8 mg/y, P = 0.004); mg), in men vs women (-8.8 mg/y vs -5.9 mg/y, P = 0.01). Conclusion: Using clinical policy initiatives in a health care system, dose reductions were achieved among COT patients at higher risk for opioid-related adverse outcomes that were at least as large as those among lower-risk patients.

Yoga, Physical Therapy, or Education for Chronic Low Back Pain: A Randomized Noninferiority Trial.

BACKGROUND: Yoga is effective for mild to moderate chronic low back pain (cLBP), but its comparative effectiveness with physical therapy (PT) is unknown. Moreover, little is known about yoga's effectiveness in underserved patients with more severe functional disability and pain. OBJECTIVE: To determine whether yoga is noninferior to PT for cLBP. DESIGN: 12-week, single-blind, 3-group randomized noninferiority trial and subsequent 40-week maintenance phase. (ClinicalTrials.gov: NCT01343927). SETTING: Academic safety-net hospital and 7 affiliated community health centers. PARTICIPANTS: 320 predominantly low-income, racially diverse adults with nonspecific cLBP. INTERVENTION: Participants received 12 weekly yoga classes, 15 PT visits, or an educational book and newsletters. The maintenance phase compared yoga drop-in classes versus home practice and PT booster sessions versus home practice. MEASUREMENTS: Primary outcomes were back-related function, measured by the Roland Morris Disability Questionnaire (RMDQ), and pain, measured by an 11-point scale, at 12 weeks. Prespecified noninferiority margins were 1.5 (RMDQ) and 1.0 (pain). Secondary outcomes included pain medication use, global improvement, satisfaction with intervention, and health-related quality of life. RESULTS: One-sided 95% lower confidence limits were 0.83 (RMDQ) and 0.97 (pain), demonstrating noninferiority of yoga to PT. However, yoga was not superior to education for either outcome. Yoga and PT were similar for most secondary outcomes. Yoga and PT participants were 21 and 22 percentage points less likely, respectively, than education participants to use pain medication at 12 weeks. Improvements in yoga and PT groups were maintained at 1 year with no differences between maintenance strategies. Frequency of adverse events, mostly mild self-limited joint and back pain, did not differ between the yoga and PT groups. LIMITATIONS: Participants were not blinded to treatment assignment. The PT group had disproportionate loss to follow-up. CONCLUSION: A manualized yoga program for nonspecific cLBP was noninferior to PT for function and pain. PRIMARY FUNDING SOURCE: National Center for Complementary and Integrative Health of the National Institutes of Health.

Using Natural Language Processing of Free-Text Radiology Reports to Identify Type 1 Modic Endplate Changes.

Electronic medical record (EMR) systems provide easy access to radiology reports and offer great potential to support quality improvement efforts and clinical research. Harnessing the full potential of the EMR requires scalable approaches such as natural language processing (NLP) to convert text into variables used for evaluation or analysis. Our goal was to determine the feasibility of using NLP to identify patients with Type 1 Modic endplate changes using clinical reports of magnetic resonance (MR) imaging examinations of the spine. Identifying patients with Type 1 Modic change who may be eligible for clinical trials is important as these findings may be important targets for intervention. Four annotators identified all reports that contained Type 1 Modic change, using N = 458 randomly selected lumbar spine MR reports. We then implemented a rule-based NLP algorithm in Java using regular expressions. The prevalence of Type 1 Modic change in the annotated dataset was 10%. Results were recall (sensitivity) 35/50 = 0.70 (95% confidence interval (C.I.) 0.52-0.82), specificity 404/408 = 0.99 (0.97-1.0), precision (positive predictive value) 35/39 = 0.90 (0.75-0.97), negative predictive value 404/419 = 0.96 (0.94-0.98), and F1-score 0.79 (0.43-1.0). Our evaluation shows the efficacy of rule-based NLP approach for identifying patients with Type 1 Modic change if the emphasis is on identifying only relevant cases with low concern regarding false negatives. As expected, our results show that specificity is higher than recall. This is due to the inherent difficulty of eliciting all possible keywords given the enormous variability of lumbar spine reporting, which decreases recall, while availability of good negation algorithms improves specificity.

Predictors of Persistent Disability and Back Pain in Older Adults with a New Episode of Care for Back Pain.

Objective: To identify predictors of persistent disability and back pain in older adults. Design: Prospective cohort study. Setting: Back pain outcomes using longitudinal data registry. Subjects: Five thousand two hundred twenty adults age 65 years and older with a new primary care visit for back pain. Methods: Baseline measurements included: demographics, health, and back pain characteristics. We abstracted imaging findings from 348 radiology reports. The primary outcomes were the Roland-Morris Disability Questionnaire (RMDQ) and back pain intensity. We defined persistent disability as RMDQ of 4/24 or higher at both six and 12 months and persistent back pain as pain 3/10 or higher at both six and 12 months. Results: There were 2,498 of 4,143 (60.3%) participants with persistent disability, and 2,099 of 4,144 (50.7%) had persistent back pain. Adjusted analyses showed the following characteristics most strongly predictive of persistent disability and persistent back pain: sex, race, worse baseline clinical characteristics of back pain, leg pain, back-related disability and duration of symptoms, smoking, anxiety symptoms, depressive symptoms, a history of falls, greater number of comorbidities, knee osteoarthritis, wide-spread pain syndromes, and an index diagnosis of lumbar spinal stenosis. Within the imaging data subset, central spinal stenosis was not associated with disability or pain. Conclusion: We found that many predictors in older adults were similar to those for younger populations.

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.

Changes in vitamin and mineral supplement use after breast cancer diagnosis in the Pathways Study: a prospective cohort study.

BACKGROUND: Vitamin and mineral supplement use after a breast cancer diagnosis is common and controversial. Dosages used and the timing of initiation and/or discontinuation of supplements have not been clearly described. METHODS: We prospectively examined changes in use of 17 vitamin/mineral supplements in the first six months following breast cancer diagnosis among 2,596 members (28% non-white) of Kaiser Permanente Northern California. We used multivariable logistic regression to examine demographic, clinical, and lifestyle predictors of initiation and discontinuation. RESULTS: Most women used vitamin/mineral supplements before (84%) and after (82%) diagnosis, with average doses far in excess of Institute of Medicine reference intakes. Over half (60.2%) reported initiating a vitamin/mineral following diagnosis, 46.3% discontinuing a vitamin/mineral, 65.6% using a vitamin/mineral continuously, and only 7.2% not using any vitamin/mineral supplement before or after diagnosis. The most commonly initiated supplements were calcium (38.2%), vitamin D (32.01%), vitamin B6 (12.3%) and magnesium (11.31%); the most commonly discontinued supplements were multivitamins (17.14%), vitamin C (15.97%) and vitamin E (45.62%). Higher education, higher intake of fruits/vegetables, and receipt of chemotherapy were associated with initiation (p-values <0.05). Younger age and breast-conserving surgery were associated with discontinuation (p-values <0.05). CONCLUSIONS: In this large cohort of ethnically diverse breast cancer patients, high numbers of women used vitamin/mineral supplements in the 6 months following breast cancer diagnosis, often at high doses and in combination with other supplements. The immediate period after diagnosis is a critical time for clinicians to counsel women on supplement use.

Menopausal quality of life: RCT of yoga, exercise, and omega-3 supplements.

OBJECTIVE: The purpose of this study was to determine the efficacy of 3 nonhormonal therapies for the improvement of menopause-related quality of life in women with vasomotor symptoms. STUDY DESIGN: We conducted a 12-week 3 × 2 randomized, controlled, factorial design trial. Peri- and postmenopausal women, 40-62 years old, were assigned randomly to yoga (n = 107), exercise (n = 106), or usual activity (n = 142) and also assigned randomly to a double-blind comparison of omega-3 (n = 177) or placebo (n = 178) capsules. We performed the following interventions: (1) weekly 90-minute yoga classes with daily at-home practice, (2) individualized facility-based aerobic exercise training 3 times/week, and (3) 0.615 g omega-3 supplement, 3 times/day. The outcomes were assessed with the following scores: Menopausal Quality of Life Questionnaire (MENQOL) total and domain (vasomotor symptoms, psychosocial, physical and sexual). RESULTS: Among 355 randomly assigned women who average age was 54.7 years, 338 women (95%) completed 12-week assessments. Mean baseline vasomotor symptoms frequency was 7.6/day, and the mean baseline total MENQOL score was 3.8 (range, 1-8 from better to worse) with no between-group differences. For yoga compared to usual activity, baseline to 12-week improvements were seen for MENQOL total -0.3 (95% confidence interval, -0.6 to 0; P = .02), vasomotor symptom domain (P = .02), and sexuality domain (P = .03) scores. For women who underwent exercise and omega-3 therapy compared with control subjects, improvements in baseline to 12-week total MENQOL scores were not observed. Exercise showed benefit in the MENQOL physical domain score at 12 weeks (P = .02). CONCLUSION: All women become menopausal, and many of them seek medical advice on ways to improve quality of life; little evidence-based information exists. We found that, among healthy sedentary menopausal women, yoga appears to improve menopausal quality of life; the clinical significance of our finding is uncertain because of the modest effect.

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.