Feasibility of Web-Based Single-Session Empowered Relief in Patients With Chronic Pain Taking Methadone or Buprenorphine: Protocol for a Single-Arm Trial.

BACKGROUND: Chronic pain affects tens of millions of US adults and continues to rise in prevalence. Nonpharmacologic behavioral pain treatments are greatly needed and yet are often inaccessible, particularly in settings where medication prescribing is prioritized. OBJECTIVE: This study aims to test the feasibility of a live-instructor, web-based 1-session pain relief skills class in an underserved and potentially at-risk population: people with chronic pain prescribed methadone or buprenorphine either solely for pain or for comorbid opioid use disorder (OUD). METHODS: This is a national, prospective, single-arm, uncontrolled feasibility trial. The trial is untethered from medical care; to enhance participants' willingness to join the study, no medical records or drug-monitoring records are accessed. At least 45 participants will be recruited from outpatient pain clinics and from an existing research database of individuals who have chronic pain and are taking methadone or buprenorphine. Patient-reported measures will be collected at 6 time points (baseline, immediately post treatment, 2 weeks, and months 1-3) via a web-based platform, paper, or phone formats to include individuals with limited internet or computer access and low literacy skills. At baseline, participants complete demographic questions and 13 study measures (Treatment Expectations, Body Pain Map, Medication Use, Pain Catastrophizing Scale [PCS], Patient-Reported Outcomes Measurement Information System [PROMIS] Measures, and Opioid Craving Scale). Immediately post treatment, a treatment satisfaction and acceptability measure is administered on a 0 (very dissatisfied) to 10 (completely satisfied) scale, with 3 of these items being the primary outcome (perceived usefulness, participant satisfaction, and likelihood of using the skills). At each remaining time point, the participants complete all study measures minus treatment expectations and satisfaction. Participants who do not have current OUD will be assessed for historical OUD, with presence of OUD (yes or no), and history of OUD (yes or no) reported separately. Feasibility threshold is set as an overall group treatment satisfaction rating of 8 of 10. In-depth qualitative interviews will be conducted with about 10 participants to obtain additional data on patient perceptions, satisfactions, needs, and wants. To assess preliminary efficacy, we will examine changes in pain catastrophizing, pain intensity, pain bothersomeness, sleep disturbance, pain interference, depression, anxiety, physical function, global impression of change, and opioid craving at 1 month post treatment. RESULTS: This project opened to enrollment in September 2021 and completed the recruitment in October 2023. The data collection was completed in February 2024. Results are expected to be published in late 2024. CONCLUSIONS: Results from this trial will inform the feasibility and preliminary efficacy of Empowered Relief in this population and will inform the design of a future randomized controlled trial testing web-based Empowered Relief in chronic pain and comorbid OUD. TRIAL REGISTRATION: ClinicalTrials.gov NCT05057988; https://clinicaltrials.gov/study/NCT05057988. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/53784.

Utilizing a learning health system to capture real-world patient data: Application of the reliable change index to evaluate and improve the outcome of a pain rehabilitation program.

BACKGROUND AND OBJECTIVES: The learning healthcare system (LHS) has been developed to integrate patients' clinical data into clinical decisions and improve treatment outcomes. Having little guidance on this integration process, we aim to explain (a) an applicable analytic tool for clinicians to evaluate the clinical outcomes at a group and an individual level and (b) our quality improvement (QI) project, analyzing the outcomes of a new outpatient pain rehabilitation program ("Back-in-Action": BIA) and applying the analysis results to modify our clinical practice. METHODS: Through our LHS (CHOIR; https://choir.stanford.edu), we administered the Pain Catastrophizing Scale (PCS), Chronic Pain Acceptance Questionnaire (CPAQ), and Patient-Reported Outcomes Measures (PROMIS)® before and after BIA. After searching for appropriate analytic tools, we decided to use the Reliable Change Index (RCI) to determine if an observed change in the direction of better (improvement) or worse (deterioration) would be beyond or within the measurement error (no change). RESULTS: Our RCI calculations revealed that at least a 9-point decrease in the PCS scores and 10-point increase in the CPAQ scores would indicate reliable improvement. RCIs for the PROMIS measures ranged from 5 to 8 T-score points (i.e., 0.5-0.8 SD). When evaluating change scores of the PCS, CPAQ, and PROMIS measures, we found that 94% of patients showed improvement in at least one domain after BIA and 6% showed no reliable improvement. CONCLUSIONS: Our QI project revealed RCI as a useful tool to evaluate treatment outcomes at a group and an individual level, and RCI could be incorporated into the LHS to generate a progress report automatically for clinicians. We further explained how clinicians could use RCI results to modify a clinical practice, to improve the outcomes of a pain program, and to develop individualized care plans. Lastly, we suggested future research areas to improve the LHS application in pain practice.

Empowered Relief, cognitive behavioral therapy, and health education for people with chronic pain: a comparison of outcomes at 6-month Follow-up for a randomized controlled trial.

Introduction: We previously conducted a 3-arm randomized trial (263 adults with chronic low back pain) which compared group-based (1) single-session pain relief skills intervention (Empowered Relief; ER); (2) 8-session cognitive behavioral therapy (CBT) for chronic back pain; and (3) single-session health and back pain education class (HE). Results suggested non-inferiority of ER vs. CBT at 3 months post-treatment on an array of outcomes. Methods: Here, we tested the durability of treatment effects at 6 months post-treatment. We examined group differences in primary and secondary outcomes at 6 months and the degree to which outcomes eroded or improved from 3-month to 6-month within each treatment group. Results: Empowered Relief remained non-inferior to CBT on most outcomes, whereas both ER and CBT remained superior to HE on most outcomes. Outcome improvements within ER did not decrease significantly from 3-month to 6-month, and indeed ER showed additional 3- to 6-month improvements on pain catastrophizing, pain bothersomeness, and anxiety. Effects of ER at 6 months post-treatment (moderate term outcomes) kept pace with effects reported by participants who underwent 8-session CBT. Conclusions: The maintenance of these absolute levels implies strong stability of ER effects. Results extend to 6 months post-treatment previous findings documenting that ER and CBT exhibit similarly potent effects on outcomes.

Trends in Patient Representation in Low Back Pain Pharmacological Randomized Clinical Trials, 2011 to 2020: A Systematic Review.

Low back pain (LBP) significantly affects global health, with associated detrimental outcomes such as physical impairment, emotional distress, and exacerbated mental health symptoms. This study evaluated the representation of marginalized groups, including racialized, gender minority, pregnant/lactating, and elderly individuals in randomized controlled trials for pharmacological interventions treating LBP from 2011 to 2020. We searched Embase, MEDLINE, and CINAHL in December 2021, and 139 studies were eligible. Most trials (n = 113, 81%) reported participant sex; however, no study collected data on sexual and gender minorities, and the majority (n = 99, 71%) excluded pregnant/lactating individuals. Most trials (n = 105, 76%) reported no data on participant race or ethnicity. We limited within-country analyses of race and ethnicity to US-based trials because US-based trials were more likely to report race and/or ethnicity (48%) compared to non-US-based trials (8%). Black participants were the only racialized group whose composition was comparable to US Census estimates. About half (n = 73, 53%) of all trials had an upper age limit for eligibility (range: 40-85 years old) and 24% (n = 33) excluded adults aged >65 years. Our findings confirm that trials for pharmacological LBP interventions underreport demographic data, and the trials that include this data have unrepresentative samples. There is an urgent need for more inclusive and representative patient samples to ensure generalizability and equitable benefits. Standardizing demographic data reporting and integrating community-based participatory research methods can help foster inclusive research practices. This review was registered with prospective register of systematic reviews (PROSPERO), ID 296017. PERSPECTIVE: This systematic review investigates patient representation in pharmacological-based clinical trials for low back pain, LBP, the most prevalent pain condition worldwide. Improvements in reporting demographic data and recruiting diverse participant populations-across different racialized, gender and sexual minority, and age groups-will help clinical research generalizability and provide equitable benefits.

Establishing the interpretability and utility of the 4-item BriefPCS.

To reduce the patient burden associated with completing the 13-item Pain Catastrophizing Scale (PCS), the 4-item "BriefPCS" was developed. To date, no crosswalk has been developed that associates scores on the BriefPCS with PCS scores. Further, no study has compared the use of BriefPCS and PCS scores in a randomized clinical trial (RCT). We aimed to: (1) establish the interpretability of BriefPCS scores in reference to PCS scores, (2) compare the concurrent validity between the BriefPCS and PCS, and (3) asssess the use of BriefPCS in an RCT. First, we conducted equipercentile linking, created a crosswalk that associated scores of BriefPCS with PCS, and calculated differences between PCS and crosswalked PCS scores. Secondly, we compared Bootstrap correlation coefficients between PCS and self-reported measures of other domains. Lastly, we compared results from an RCT using BriefPCS scores versus PCS scores. Findings indicated that the correlation coefficient estimates with the BriefPCS and PCS scores were not significantly different. BriefPCS and PCS scores had similar ability to detect treatment-related changes. The BriefPCS scores validly, reliably, and accurately distinguish levels of pain catastrophizing. Additionally, the BriefPCS scores are sensitive to changes after behavioral interventions, with less respondent burden compared to the PCS scores.

A Longitudinal Investigation of the Impact of COVID-19 on Patients With Chronic Pain.

The COVID-19 pandemic prompted unexpected changes in the healthcare system. This current longitudinal study had 2 aims: 1) describe the trajectory of pandemic-associated stressors and patient-reported health outcomes among patients receiving treatment at a tertiary pain clinic over 2 years (May 2020 to June 2022); and 2) identify vulnerable subgroups. We assessed changes in pandemic-associated stressors and patient-reported health outcome measures. The study sample included 1270 adult patients who were predominantly female (74.6%), White (66.2%), non-Hispanic (80.6%), married (66.1%), not on disability (71.2%), college-educated (59.45%), and not currently working (57.9%). We conducted linear mixed effect modeling to examine the main effect of time with controlling for a random intercept. Findings revealed a significant main effect of time for all pandemic-associated stressors except financial impact. Over time, patients reported increased proximity to COVID-19, but decreased pandemic-associated stressors. A significant improvement was also observed in pain intensity, pain catastrophizing, and PROMIS-pain interference, sleep, anxiety, anger, and depression scores. Demographic-based subgroup analyses for pandemic-associated stressors revealed that younger adults, Hispanics, Asians, and patients receiving disability compensation were vulnerable groups either during the initial visit or follow-up visits. We observed additional differential pandemic effects between groups based on participant sex, education level, and working status. In conclusion, despite unanticipated changes in pain care services during the pandemic, patients receiving pain treatments adjusted to pandemic-related stressors and improved their health status over time. As the current study observed differential pandemic impacts on patient subgroups, future studies should investigate and address the unmet needs of vulnerable subgroups. PERSPECTIVE: Over a 2-year timeframe, the pandemic did not adversely influence physical and mental health among treatment-seeking patients with chronic pain. Patients reported small but significant improvements across indices of physical and psychosocial health. Differential impacts emerged among groups based on ethnicity, age, disability status, gender, education level, and working status.

Spontaneous self-affirmation: an adaptive coping strategy for people with chronic pain.

OBJECTIVES: Self-affirmation may be a promising treatment strategy for improving clinical outcomes. This study examined the association between self-affirmation and self-reported health status among people with chronic pain. METHODS: In this cross-sectional study, 768 treatment seeking people (female 67.2%, mean age=50.4 years with SD of 17.1, White/Caucasian 59.9%) completed surveys using a learning healthcare system. Measures included spontaneous self-affirmation (SSA) items, PROMIS® outcome measures, and Pain Catastrophizing Scale (PCS). Multiple regressions were conducted to examine if strength-based SSA, value-based SSA, and their interaction would predict perceived health status and pain coping strategy. Sensitivity analysis was done by performing additional regressions with covariates (age, sex, race/ethnicity, and education). Lastly, exploratory analysis examined if average SSA scores would have a linear relationship with perceived health status. RESULTS: The strength x value-based SSA interaction significantly predicted the PROMIS-depression, anxiety, and social isolation T-scores (ps≤0.007), but not anger T-scores (p=0.067). Specifically, greater tendency to use both SSA styles predicted less symptoms of depression, anxiety and social isolation. This interaction remained significant when controlling for the covariates. The two SSA styles and their interaction did not significantly predict pain interference, sleep disturbance, fatigue, average pain rating and PCS scores (ps≥0.054). Exploratory analysis revealed SSA average scores did not have a significant linear relationship with perceived health status. CONCLUSIONS: The current study showed self-affirmation as being associated with better psychosocial health, but not associated with physical health and pain catastrophizing among patients with chronic pain. Our findings suggested the potential benefit of incorporating strength- and value-based affirmations in pain intervention approaches.

Emotion regulation strategies moderate the impact of negative affect induction on alcohol craving in college drinkers: an experimental paradigm.

Objectives: Observational studies suggest emotion regulation (ER) as a potential treatment target for problematic college drinking. The primary aim of this laboratory study was to determine whether trait ER strategies would moderate the impact of negative affect induction on alcohol craving in college drinkers. Methods: Participants were randomly assigned to a neutral (n = 74) or a negative affect induction (n = 76) and reported their craving after the affect inductions. Results: Greater use of drinking to cope and less use of cognitive reappraisal predicted greater alcohol craving after the negative affect induction, but not after the neutral condition. In contrast, emotion suppression did not predict alcohol craving in either condition. Conclusion: Our results highlight the role of ER tendencies-particularly the benefits of cognitive reappraisal-on alcohol craving when experiencing emotional distress. Therefore, ER strategies may be an important target for college drinkers to prevent and reduce problematic drinking.

Patient Responses to the Term Pain Catastrophizing: Thematic Analysis of Cross-sectional International Data.

Pain catastrophizing is understood as a negative cognitive and emotional response to pain. Researchers, advocates and patients have reported stigmatizing effects of the term in clinical settings and the media. We conducted an international study to investigate patient perspectives on the term pain catastrophizing. Open-ended electronic patient and caregiver proxy surveys were promoted internationally by collaborator stakeholders and through social media. 3,521 surveys were received from 47 countries (77.3% from the U.S.). The sample was mainly female (82.1%), with a mean age of 41.62 (SD 12.03) years; 95% reported ongoing pain and pain duration > 10 years (68.4%). Forty-five percent (n = 1,295) had heard of the term pain catastrophizing; 12% (n = 349) reported being described as a 'pain catastrophizer' by a clinician with associated high levels of feeling blamed, judged, and dismissed. We present qualitative thematic data analytics for responses to open-ended questions, with 32% of responses highlighting the problematic nature of the term. We present the patients' perspective on the term pain catastrophizing, its material effect on clinical experiences, and associations with negative gender stereotypes. Use of patient-centered terminology may be important for favorably shaping the social context of patients' experience of pain and pain care. PERSPECTIVE: Our international patient survey found that 45% had heard of the term pain catastrophizing, about one-third spontaneously rated the term as problematic, and 12% reported the term was applied to them with most stating this was a negative experience. Clinician education on patient-centered terminology may improve care and reduce stigma.

"My Surgical Success": Feasibility and Impact of a Single-Session Digital Behavioral Pain Medicine Intervention on Pain Intensity, Pain Catastrophizing, and Time to Opioid Cessation After Orthopedic Trauma Surgery-A Randomized Trial.

BACKGROUND: Behavioral pain treatments may improve postsurgical analgesia and recovery; however, effective and scalable options are not widely available. This study tested a digital perioperative behavioral medicine intervention in orthopedic trauma surgery patients for feasibility and efficacy for reducing pain intensity, pain catastrophizing, and opioid cessation up to 3 months after surgery. METHODS: A randomized controlled clinical trial was conducted at an orthopedic trauma surgery unit at a major academic hospital to compare a digital behavioral pain management intervention ("My Surgical Success" [MSS]) to a digital general health education (HE) intervention (HE; no pain management skills). The enrolled sample included 133 patients; 84 patients were randomized (MSS, n = 37; HE, n = 47) and completed study procedures. Most patients received their assigned intervention within 3 days of surgery (85%). The sample was predominantly male (61.5%), White (61.9%), and partnered (65.5%), with at least a bachelor's degree (69.0%). Outcomes were collected at 1-3 months after intervention through self-report e-surveys and electronic medical record review; an intention-to-treat analytic framework was applied. Feasibility was dually determined by the proportion of patients engaging in their assigned treatment and an application of an 80% threshold for patient-reported acceptability. We hypothesized that MSS would result in greater reductions in pain intensity and pain catastrophizing after surgery and earlier opioid cessation compared to the digital HE control group. RESULTS: The engagement rate with assigned interventions was 63% and exceeded commonly reported rates for fully automated Internet-based e-health interventions. Feasibility was demonstrated for the MSS engagers, with >80% reporting treatment acceptability. Overall, both groups improved in the postsurgical months across all study variables. A significant interaction effect was found for treatment group over time on pain intensity, such that the MSS group evidenced greater absolute reductions in pain intensity after surgery and up to 3 months later (treatment × time fixed effects; F [215] = 5.23; P = .024). No statistically significant between-group differences were observed for time to opioid cessation or for reductions in pain catastrophizing ( F [215] = 0.20; P = .653), although the study sample notably had subclinical baseline pain catastrophizing scores (M = 14.10; 95% confidence interval, 11.70-16.49). CONCLUSIONS: Study findings revealed that a fully automated behavioral pain management skills intervention (MSS) may be useful for motivated orthopedic trauma surgery patients and reduce postsurgical pain up to 3 months. MSS was not associated with reduced time to opioid cessation compared to the HE control intervention.

Comparing Perceived Pain Impact Between Younger and Older Adults With High Impact Chronic Pain: A Cross-Sectional Qualitative and Quantitative Survey.

High impact chronic pain (HICP) is a recently proposed concept for treatment stratifying patients with chronic pain and monitoring their progress. The goal is to reduce the impact of chronic pain on the individual, their family, and society. The US National Pain Strategy defined HICP as the chronic pain associated with substantial restrictions on participation in work, social, and self-care activities for at least 6 months. To understand the meaning and characteristics of HICP from the younger (<65 years old) and older adults (≥65 years old) with chronic pain, our study examined patients' perceived pain impact between the two age groups. We also characterize the degree of pain impact, assessed with the Patient-Reported Outcomes Measurement Information System (PROMIS) pain interference (PI), between adults and older adults with HICP. We recruited patients at a tertiary pain clinic. The survey included open-ended questions about pain impact, the Graded Chronic Pain Scale-Revised to identify patients' meeting criteria for HICP, and the Patient-Reported Outcomes Measurement Information System (PROMIS®) 8-item PI short form (v.8a). A total of 55 younger adults (65.5% women, 72.7% HICP, mean age = 55.0 with SD of 16.2) and 28 older adults (53.6% women, 64.3% HICP, mean age = 72.6 with SD of 5.4) with chronic pain participated in this study. In response to an open-ended question in which participants were asked to list out the areas of major impact pain, those with HICP in the younger group most commonly listed work, social activity, and basic physical activity (e.g., walking and standing); for those in the older group, basic physical activity, instrumental activity of daily living (e.g., housework, grocery shopping), and participating in social or fun activity for older adults with HICP were the most common. A 2 × 2 ANOVA was conducted using age (younger adults vs. older adults) and HICP classification (HICP vs. No HICP). A statistically significant difference was found in the PROMIS-PI T-scores by HICP status (HICP: M = 58.4, SD = 6.3; No HICP: M = 67.8, SD = 6.3), but not by age groups with HICP. In conclusion, perceived pain impacts were qualitatively, but not quantitatively different between younger and older adults with HICP. We discuss limitations and offer recommendations for future research.

The impact of COVID-19 on patients with chronic pain seeking care at a tertiary pain clinic.

Empirical data on the health impacts of the COVID-19 pandemic remain scarce, especially among patients with chronic pain. We conducted a cross-sectional study matched by season to examine patient-reported health symptoms among patients with chronic pain pre- and post-COVID-19 pandemic onset. Survey responses were analyzed from 7535 patients during their initial visit at a tertiary pain clinic between April 2017-October 2020. Surveys included measures of pain and pain-related physical, emotional, and social function. The post-COVID-19 onset cohort included 1798 initial evaluations, and the control pre-COVID-19 cohort included 5737 initial evaluations. Patients were majority female, White/Caucasian, and middle-aged. The results indicated that pain ratings remained unchanged among patients after the pandemic onset. However, pain catastrophizing scores were elevated when COVID-19 cases peaked in July 2020. Pain interference, physical function, sleep impairment, and emotional support were improved in the post-COVID-19 cohort. Depression, anxiety, anger, and social isolation remained unchanged. Our findings provide evidence of encouraging resilience among patients seeking treatment for pain conditions in the face of the COVID-19 pandemic. However, our findings that pain catastrophizing increased when COVID-19 cases peaked in July 2020 suggests that future monitoring and consideration of the impacts of the pandemic on patients' pain is warranted.

Clinical Utility of CAT Administered PROMIS Measures to Track Change for Pediatric Chronic Pain.

Patient Reported Outcomes (PROs) are utilized in clinical registries and trials, necessitating development of benchmarks to enhance interpretability. This study aimed to 1) examine if PROMIS measures administered via computer adaptive testing (CAT) were responsive to change, and 2) highlight one method of assessing clinically significant change for youth seen in a tertiary pain clinic. Clinically significant change was achieved if patients had significantly reliable pre-to-post-changes greater than Reliable Change Index (RCI) value and reported decreased symptoms by at least one severity level (e.g., moderate to mild). Participants were 328 youth (8-17 years old) seen in a tertiary pediatric pain management clinic. Small to moderate effect sizes were noted across PROMIS measures (except Peer Relations). Reliable magnitudes of change were estimated for this sample as approximately 6 point reduction for Pain Interference and Mobility, 9 for Fatigue, and 11 for Anxiety and Depression. Depending on the measure, 10 to 24% were categorized as improved, 3 to 6% as deteriorated, and 68 to 81% were either not clinically elevated at baseline or remained unchanged at 3 months. Overall, PROMIS CAT measures demonstrated responsiveness to change over time. Estimation of clinically significant change offers preliminary yet rigorous benchmarks for evaluating treatment response and sets the stage for understanding treatment effects. PERSPECTIVE: This study assesses responsiveness of CAT administered PROMIS measures and highlights one methodological approach of presenting clinical significance for assessing treatment outcomes in pediatric chronic pain. These benchmarks will allow clinicians and researchers to evaluate treatment response utilizing PROs while allowing for a deeper understanding of treatment effects.

Lack of Premeditation Predicts Aberrant Behaviors Related to Prescription Opioids in Patients with Chronic Pain: A Cross-Sectional Study.

OBJECTIVE: In light of the opioid epidemic, there is a need to identify factors that predict aberrant opioid behaviors including misuse and abuse. Impulsivity has been extensively studied in addiction literature, but not in the context of opioid misuse. Hence, this study aimed to identify which of the impulsivity facets (negative urgency, positive urgency, sensation seeking, lack of perseverance, and lack of premeditation) would predict current aberrant opioid-related behaviors in patients with chronic pain. METHODS: Data were collected through an online survey from patients with chronic pain who visited a tertiary pain clinic. Patients were predominately female (74%), middle aged (M = 55 years), and White/Caucasian (84%). Upon consent, they completed a series of surveys including UPPS-P Impulsive Behavior Scale, the Current Opioid misuse Measure, Pain Catastrophizing Scale, PROMIS-anxiety, depression, and physical function, and a 0-10 numerical pain rating scale. Ordinal regression analyses were conducted to test study hypotheses. RESULTS: Contrary to expectations, only lack of premeditation predicted higher odds of aberrant opioid-related behaviors in the past 30 days, after controlling for known covariates, and explained 26% of variance. Interestingly, lack of premeditation together with pain catastrophizing as a covariate explained 56% of the variance in aberrant opioid-related behaviors. DISCUSSION: The current study is the first to identify a potential role of lack of premeditation as an impulsivity facet predicting aberrant opioid-related behaviors among patients with chronic pain.

Comparison of a Single-Session Pain Management Skills Intervention With a Single-Session Health Education Intervention and 8 Sessions of Cognitive Behavioral Therapy in Adults With Chronic Low Back Pain: A Randomized Clinical Trial.

Importance: Chronic low back pain (CLBP), the most prevalent chronic pain condition, imparts substantial disability and discomfort. Cognitive behavioral therapy (CBT) reduces the effect of CLBP, but access is limited. Objective: To determine whether a single class in evidence-based pain management skills (empowered relief) is noninferior to 8-session CBT and superior to health education at 3 months after treatment for improving pain catastrophizing, pain intensity, pain interference, and other secondary outcomes. Design, Setting, and Participants: This 3-arm randomized clinical trial collected data from May 24, 2017, to March 3, 2020. Participants included individuals in the community with self-reported CLBP for 6 months or more and an average pain intensity of at least 4 (range, 0-10, with 10 indicating worst pain imaginable). Data were analyzed using intention-to-treat and per-protocol approaches. Interventions: Participants were randomized to (1) empowered relief, (2) health education (matched to empowered relief for duration and format), or (3) 8-session CBT. Self-reported data were collected at baseline, before treatment, and at posttreatment months 1, 2, and 3. Main Outcomes and Measures: Group differences in Pain Catastrophizing Scale scores and secondary outcomes at month 3 after treatment. Pain intensity and pain interference were priority secondary outcomes. Results: A total of 263 participants were included in the analysis (131 women [49.8%], 130 men [49.4%], and 2 other [0.8%]; mean [SD] age, 47.9 [13.8] years) and were randomized into 3 groups: empowered relief (n = 87), CBT (n = 88), and health education (n = 88). Empowered relief was noninferior to CBT for pain catastrophizing scores at 3 months (difference from CBT, 1.39 [97.5% CI, -∞ to 4.24]). Empowered relief and CBT were superior to health education for pain catastrophizing scores (empowered relief difference from health education, -5.90 [95% CI, -8.78 to -3.01; P < .001]; CBT difference from health education, -7.29 [95% CI, -10.20 to -4.38; P < .001]). Pain catastrophizing score reductions for empowered relief and CBT at 3 months after treatment were clinically meaningful (empowered relief, -9.12 [95% CI, -11.6 to -6.67; P < .001]; CBT, -10.94 [95% CI, -13.6 to -8.32; P < .001]; health education, -4.60 [95% CI, -7.18 to -2.01; P = .001]). Between-group comparisons for pain catastrophizing at months 1 to 3 were adjusted for baseline pain catastrophizing scores and used intention-to-treat analysis. Empowered relief was noninferior to CBT for pain intensity and pain interference (priority secondary outcomes), sleep disturbance, pain bothersomeness, pain behavior, depression, and anxiety. Empowered relief was inferior to CBT for physical function. Conclusions and Relevance: Among adults with CLBP, a single-session pain management class resulted in clinically significant improvements in pain catastrophizing, pain intensity, pain interference, and other secondary outcomes that were noninferior to 8-session CBT at 3 months. Trial Registration: ClinicalTrials.gov Identifier: NCT03167086.

Effectiveness of a multidisciplinary rehabilitation program in real-world patients with chronic back pain: A pilot cohort data analysis.

BACKGROUND: Randomized clinical trials (RCT) suggest a multidisciplinary approach to pain rehabilitation is superior to other active treatments in improving pain intensity, function, disability, and pain interference for patients with chronic pain, with small effect size (ds= 0.20-0.36) but its effectiveness remains unknown in real-world practice. OBJECTIVE: The current study examined the effectiveness of a multidisciplinary program to a cognitive and behavioral therapy (pain-CBT) in real-world patients with chronic back pain. METHODS: Twenty-eight patients (M𝑎𝑔𝑒= 57.6, 82.1% Female) completed a multidisciplinary program that included pain psychology and physical therapy. Eighteen patients (M𝑎𝑔𝑒= 58.9, 77.8% Female) completed a CBT-alone program. Using a learning healthcare system, the Pain Catastrophizing Scale, 0-10 Numerical Pain Rating Scale, and Patient-Reported Outcomes Measurement Information System® measures were administered before and after the programs. RESULTS: We found significant improvement in mobility and pain behavior only after a multidisciplinary program (p's < 0.031; d= 0.69 and 0.55). We also found significant improvement in pain interference, fatigue, depression, anxiety, social role satisfaction, and pain catastrophizing after pain-CBT or multidisciplinary programs (p's < 0.037; ds = 0.29-0.73). Pain ratings were not significantly changed by either program (p's > 0.207). CONCLUSIONS: The effect of a multidisciplinary rehabilitation program observed in RCT would be generalizable to real-world practice.

Customizing CAT Administration of the PROMIS Misuse of Prescription Pain Medication Item Bank for Patients with Chronic Pain.

OBJECTIVE: The 22-item PROMIS®-Rx Pain Medication Misuse item bank (Bank-22) imposes a high response burden. This study aimed to characterize the performance of the Bank-22 in a computer adaptive testing (CAT) setting based on varied stopping rules. METHODS: The 22 items were administered to 288 patients. We performed a CAT simulation using default stopping rules (CATPROMIS). In 5 other simulations, a "best health" response rule was added to decrease response burden. This rule stopped CAT administration when a participant selected "never" to a specified number of initial Bank-22 items (2-6 in this study, designated CATAlt2-Alt6). The Bank-22 and 7-item short form (SF-7) scores were compared to scores based on CATPROMIS, and the 5 CAT variations. RESULTS: Bank-22 scores correlated highly with the SF-7 and CATPROMIS, Alt5, Alt6 scores (r=0.87-0.95) and moderately with CATAlt2- Alt4 scores (r=0.63-0.74). In all CAT conditions, the greatest differences with Bank-22 scores were at the lower end of misuse T-scores. The smallest differences with Bank-22 and CATPROMIS scores were observed with CATAlt5 and CATAlt6. Compared to the SF-7, CATAlt5 and CATAlt6 reduced overall response burden by about 42%. Finally, the correlations between PROMIS-Rx Misuse and Anxiety T-scores remained relatively unchanged across the conditions (r=0.31-0.43, Ps < .001). CONCLUSIONS: Applying a stopping rule based on number of initial "best health" responses reduced response burden for respondents with lower levels of misuse. The tradeoff was less measurement precision for those individuals, which could be an acceptable tradeoff when the chief concern is in discriminating higher levels of misuse.

A Brief Screening Tool for Opioid Use Disorder: EMPOWER Study Expert Consensus Protocol.

Growing concerns about the safety of long-term opioid therapy and its uncertain efficacy for non-cancer pain have led to relatively rapid opioid deprescribing in chronic pain patients who have been taking opioid for years. To date, empirically supported processes for safe and effective opioid tapering are lacking. Opioid tapering programs have shown high rates of dropouts and increases in patient distress and suicidal ideation. Therefore, safe strategies for opioid deprescribing that are more likely to succeed are urgently needed. In response to this demand, the EMPOWER study has been launched to examine the effectiveness of behavioral medicine strategies within the context of patient-centered opioid tapering in outpatient settings (https://empower.stanford.edu/). The EMPOWER protocol requires an efficient process for ensuring that collaborative opioid tapering would be offered to the most appropriate patients while identifying patients who should be offered alternate treatment pathways. As a first step, clinicians need a screening tool to identify patients with Opioid Use Disorder (OUD) and to assess for OUD severity. Because such a tool is not available, the study team composed of eight chronic pain and/or addiction experts has extended a validated screening instrument to develop a brief and novel consensus screening tool to identify OUD and assess for OUD severity for treatment stratification. Our screening tool has the potential to assist busy outpatient clinicians to assess OUD among patients receiving long-term opioid therapy for chronic pain.

Perceived Injustice Mediates the Relationship Between Perceived Childhood Neglect and Current Function in Patients with Chronic Pain: A Preliminary Pilot Study.

Cumulative evidence supports the association between perceived childhood neglect and adulthood psychological and physical health. To date, pathways mediating this association remain largely unknown, though other evidence suggests that negative patterns of appraisal, including injustice perception related to pain, may be shaped by prior adverse social experiences. Consequently, the current study examined perceived injustice about chronic pain as a possible factor connecting childhood neglect and pain-related outcomes, given its relevance for both adaptation to chronic pain and to prior adverse life experiences. Patients (n = 742) visiting a tertiary pain clinic completed a survey administered via the Collaborative Health Outcomes Information Registry. Path modeling analyses were used to examine perceived injustice as a mediator of the relationships between childhood neglect and affective distress and physical function, after controlling for pain intensity and pain catastrophizing. Patients endorsing childhood neglect reported higher levels of perceived injustice and worse affective distress and physical function. Further, inclusion of perceived injustice as a mediator fully accounted for the relationship between neglect and current levels of physical function, and accounted for a significant proportion of the relationship between neglect and current levels of affective distress. These preliminary findings suggest that perceived injustice appears to be a more proximal factor by which prior experiences of neglect may adversely affect adaptation to chronic pain. Given the single-item assessment of childhood neglect and cross-sectional nature of the current findings, further research may focus on replicating these findings in longitudinal studies with validated measures and examining other adverse social experiences (e.g., abuse, social disparities) that may contribute to injustice perception and poor pain-related outcomes.

Emotions matter: The role of emotional approach coping in chronic pain.

BACKGROUND: Emotional approach coping (EAC) is a potentially adaptive emotion-focused coping style that involves understanding or processing one's emotions and expressing them appropriately. Although EAC has been studied in various populations, little is known about this construct among people with chronic pain, including potential mediators such as negative affect, which might link EAC to pain-related variables, and moderators of these relationships. METHODS: Participants (N = 670; 76% women; 30% older adults-age 60 or over) with chronic pain completed online the Emotional Approach Coping Scale and measures of pain severity, pain interference and negative affect. Analyses correlated EAC to pain severity and interference and tested whether gender and age group (older adults versus young/middle-age adults) moderated the mediated relationships of EAC with pain-related variables through negative affect. RESULTS: Findings reveal that higher EAC was associated with lower pain intensity through lower negative affect in the young/middle-age portion of the sample, but not older adults. Also, higher EAC was associated with lower pain interference through lower negative affect among women in the sample, but not men. The associations of EAC to pain intensity and interference are small in magnitude, however, and should be considered preliminary. CONCLUSION: EAC is associated with lower pain intensity in young/middle-age adults and lower pain interference in women, and lower negative affect mediates these relationships. These results suggest the potential value of assessing and bolstering emotional approach coping processes in some people with chronic pain.