Is There an Association Between Lateralization of Chronic Pain in the Body and Depression?

Depression commonly co-occurs with chronic pain and can worsen pain outcomes. Recent theoretical work has hypothesized that pain localized to the left hemibody is a risk factor for worse depression due to overlap in underlying neural substrates. This hypothesis has not been tested a priori. Using a large sample of treatment-seeking adults with mixed-etiology chronic pain (N = 1,185), our cross-sectional study tested whether patients with left-sided pain endorse worse depressive symptoms. We also examined differences in other pain-related functioning measures. We tested 4 comparisons based on painful body areas using the CHOIR body map: 1) only left-sided (OL) versus any right-sided pain; 2) only right-sided (OR) versus any left-sided pain; 3) OL versus OR versus bilateral pain; and 4) more left-sided versus more right-sided versus equal-sided pain. Analysis of variance models showed OL pain was not associated with worse depression (F = 5.50, P = .019). Any left-sided pain was associated with worse depression, though the effect was small (F = 8.58, P = .003, Cohens d = .29). Bilateral pain was associated with worse depression (F = 8.05, P < .001, Cohens d = .24-.33). Regardless of pain location, more body areas endorsed was associated with greater depression. Although a more rigorous assessment of pain laterality is needed, our findings do not support the hypothesis that left-lateralized pain is associated with worse depression. PERSPECTIVE: Pain lateralized to the left side of the body has been hypothesized as a risk factor for worse depression in chronic pain, despite never being tested in a large, real-world sample of patients with chronic pain. Findings showed that more widespread pain, not pain laterality, was associated with worse depression.

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.

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.

Innovative treatment formats, technologies, and clinician trainings that improve access to behavioral pain treatment for youth and adults.

Chronic pain is prevalent across the life span and associated with significant individual and societal costs. Behavioral interventions are recommended as the gold-standard, evidence-based interventions for chronic pain, but barriers, such as lack of pain-trained clinicians, poor insurance coverage, and high treatment burden, limit patients' ability to access evidenced-based pain education and treatment resources. Recent advances in technology offer new opportunities to leverage innovative digital formats to overcome these barriers and dramatically increase access to high-quality, evidenced-based pain treatments for youth and adults. This scoping review highlights new advances. First, we describe system-level barriers to the broad dissemination of behavioral pain treatment. Next, we review several promising new pediatric and adult pain education and treatment technology innovations to improve access and scalability of evidence-based behavioral pain treatments. Current challenges and future research and clinical recommendations are offered.

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.

Association between history of childbirth and chronic, functionally significant back pain in later life.

BACKGROUND: Back pain is more prevalent among women than men. The association with sex could be related to pregnancy and childbirth, unique female conditions. This association has not been thoroughly evaluated. METHODS: Using a retrospective cohort design, we evaluated the relationship between history of childbirth on the prevalence and severity of functionally consequential back pain in 1069 women from a tertiary care pain management clinic. Interactions among preexisting, acute peripartum, and subsequent back pain were evaluated as secondary outcomes among the parous women using logistic and linear regression as appropriate. RESULTS: The women who had given birth had a higher risk for functionally significant back pain compared to women who had not given birth (85% vs 77%, p < 0.001, Risk Ratio 1.11 [1.04-1.17]). The association was preserved after correction for age, weight, and race. Back pain was also more slightly severe (Numerical Rating Score for Pain 7[5-8] vs 6[5-7] out of 10, p = 0.002). Women who recalled severe, acute postpartum back pain had a higher prevalence of current debilitating back pain (89% vs 75%, Risk Ratio 1.19 (1.08-1.31), p = 0.001). Twenty-eight percent of acute postpartum back pain never resolved and 40% reported incomplete resolution. CONCLUSIONS: A history of pregnancy and childbirth is a risk factor for chronic functionally significant back pain in women. Severe acute postpartum back pain is a risk factor for future disability suggesting that the peripartum period may provide an important opportunity for intervention. Early recognition and management may mitigate future disability. TRIAL REGISTRATION: The study was registered with clinicaltrials.gov as "Association Between Chronic Headache and Back Pain with Childbirth" (NCT04091321) on 16/09/2019 before it was initiated.

Emotional Awareness and Expression Interview: Examining Interview Content and Patient Experiences in Two Medical Samples.

A single session of Emotional Awareness and Expression Therapy (EAET)-the EAET Interview-was previously shown to lead to clinical benefits for patients with centralized somatic conditions in primary care (Ziadni et al. in Health Psychol 37(3):282-290, 2018) and tertiary care (Carty et al. in Pain Med 20(7):1321-1329, 2019) settings. There has yet to be an examination of patients' experiences of and reactions to the EAET Interview, which is crucial in evaluating possible clinical implementation of the interview. We conducted secondary analyses on 88 patients (M age = 41.32, 90.9% women) from the two prior trials (primary care N = 51; tertiary care N = 37). Analyses examined interview processes (stress disclosure themes, working alliance, and emotional processing) and patients' reactions to the interview (interview credibility and perceived value of the interview), comparing the two samples and examining correlations among these variables. All patients disclosed at least one stressful life experience, commonly interpersonal problems (89.2%) and childhood adversity (51.5%). Patients had moderately high levels of working alliance and emotional processing during the interview and reported high interview credibility and perceived value of the interview. More extensive emotional processing of stressors was associated with more positive patient reactions to the interview, including higher interview credibility (r = .23) and perceived value (r = .32). We conclude that the single-session EAET Interview was valued by most patients, and patients' emotional processing is particularly beneficial. Addressing the trauma and emotional conflicts of patients with centralized somatic conditions is both feasible and valuable in front-line medical settings.

"Pain, Stress, and Emotions": Uncontrolled trial of a single-session, telehealth, emotional awareness and expression therapy class for patients with chronic pain.

Objectives: Trauma- and emotion-focused chronic pain interventions, particularly Emotional Awareness and Expression Therapy (EAET), show much promise for reducing pain and improving functioning. We developed a novel, single-session, telehealth-delivered EAET class ("Pain, Stress, and Emotions"; PSE) and tested it on adults with chronic pain of mixed etiology. Methods: After an initial developmental phase, we conducted an uncontrolled trial, providing PSE to 74 individuals with chronic pain (63.5% female; 64.9% White; 60.8% with pain duration >5 years) in four class administrations. Participants completed self-report measures (primary outcomes: pain intensity and pain interference) at baseline and multiple follow-ups to 12 weeks. Linear mixed-models examined changes over time, and effect sizes were calculated on change from baseline to 4-week (primary endpoint) and 12-week follow-ups. The trial was registered with clinicaltrials.gov (NCT05014126). Results: Participants reported high satisfaction with the PSE class. Pain intensity showed a significant, medium reduction across time (p < .001; d = 0.60 at 4 weeks); one-quarter of participants had clinically meaningful pain reduction (≥30%). Pain interference had a large reduction (p < .001; d = 0.74). There were significant but smaller improvements in most secondary outcomes (ds = 0.15 to 0.55; ps < .01). Effects were generally maintained or increased at 12-week follow-up. Higher education and baseline ambivalence over emotional expression predicted greater pain reductions. Conclusions: People taking this EAET class had reduced pain severity and interference and improvements in other pain-related outcomes. The single-session, telehealth class holds promise as an easily delivered, efficient, and potentially impactful intervention for some patients with chronic pain, although controlled trials are needed.

"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.

Efficacy of a Single-Session "Empowered Relief" Zoom-Delivered Group Intervention for Chronic Pain: Randomized Controlled Trial Conducted During the COVID-19 Pandemic.

BACKGROUND: Cognitive behavioral therapy-pain is an evidence-based treatment for chronic pain that can have significant patient burden, including health care cost, travel, multiple sessions, and lack of access in remote areas. OBJECTIVE: The study aims to pilot test the efficacy of a single-session videoconference-delivered empowered relief (ER) intervention compared to waitlist control (WLC) conditions among individuals with chronic pain. We hypothesized that ER would be superior to WLC in reducing pain catastrophizing, pain intensity, and other pain-related outcomes at 1-3 months posttreatment. METHODS: We conducted a randomized controlled trial involving a web-based sample of adults (N=104) aged 18-80 years with self-reported chronic pain. Participants were randomized (1:1) to 1 of 2 unblinded study groups: ER (50/104, 48.1%) and WLC (54/104, 51.9%). Participants allocated to ER completed a Zoom-delivered class, and all participants completed follow-up surveys at 2 weeks and 1, 2, and 3 months posttreatment. All the study procedures were performed remotely and electronically. The primary outcome was pain catastrophizing 1-month posttreatment, with pain intensity, pain bothersomeness, and sleep disruption as secondary outcomes. We also report a more rigorous test of the durability of treatment effects at 3 months posttreatment. Data were collected from September 2020 to February 2021 and analyzed using intention-to-treat analysis. The analytic data set included participants (18/101, 17.8% clinic patients; 83/101, 82.1% community) who completed at least one study survey: ER (50/101, 49.5%) and WLC (51/104, 49%). RESULTS: Participants (N=101) were 69.3% (70/101) female, with a mean age of 49.76 years (SD 13.90; range 24-78); 32.7% (33/101) had an undergraduate degree and self-reported chronic pain for 3 months. Participants reported high engagement (47/50, 94%), high satisfaction with ER (mean 8.26, SD 1.57; range 0-10), and high satisfaction with the Zoom platform (46/50, 92%). For the between-groups factor, ER was superior to WLC for all primary and secondary outcomes at 3 months posttreatment (highest P<.001), and between-groups Cohen d effect sizes ranged from 0.45 to 0.79, indicating that the superiority was of moderate to substantial clinical importance. At 3 months, clinically meaningful pain catastrophizing scale (PCS) reductions were found for ER but not for WLC (ER: PCS -8.72, 42.25% reduction; WLC: PCS -2.25, 11.13% reduction). ER resulted in significant improvements in pain intensity, sleep disturbance, and clinical improvements in pain bothersomeness. CONCLUSIONS: Zoom-delivered ER had high participant satisfaction and very high engagement. Among adults with chronic pain, this single-session, Zoom-delivered, skills-based pain class resulted in clinically significant improvement across a range of pain-related outcomes that was sustained at 3 months. Web-based delivery of ER could allow greater accessibility of home-based pain treatment and could address the inconveniences and barriers faced by patients when attempting to receive in-person care. TRIAL REGISTRATION: ClinicalTrials.gov NCT04546685; https://clinicaltrials.gov/ct2/show/NCT04546685.

Classifying chronic pain using multidimensional pain-agnostic symptom assessments and clustering analysis.

Chronic pain conditions present in various forms, yet all feature symptomatic impairments in physical, mental, and social domains. Rather than assessing symptoms as manifestations of illness, we used them to develop a chronic pain classification system. A cohort of real-world treatment-seeking patients completed a multidimensional patient-reported registry as part of a routine initial evaluation in a multidisciplinary academic pain clinic. We applied hierarchical clustering on a training subset of 11,448 patients using nine pain-agnostic symptoms. We then validated a three-cluster solution reflecting a graded scale of severity across all symptoms and eight independent pain-specific measures in additional subsets of 3817 and 1273 patients. Negative affect­related factors were key determinants of cluster assignment. The smallest subset included follow-up assessments that were predicted by baseline cluster assignment. Findings provide a cost-effective classification system that promises to improve clinical care and alleviate suffering by providing putative markers for personalized diagnosis and prognosis.

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.

Comparative efficacy of a single-session "Empowered Relief" videoconference-delivered group intervention for chronic pain: study protocol for a randomized controlled trial.

BACKGROUND: Chronic pain is naturally aversive and often distressing for patients. Pain coping and self-regulatory skills have been shown to effectively reduce pain-related distress and other symptoms. In this trial, the primary goal is to pilot test the comparative efficacy of a single-session videoconference-delivered group pain education class to a waitlist control among patients with chronic pain. METHODS: Our study is a randomized clinical trial pilot testing the superiority of our 2-h single-session videoconference-delivered group pain education class against a waitlist control. We will enroll 120 adult patients with mixed etiology chronic pain and randomize 1:1 to one of the two study arms. We hypothesize superiority for the pain education class for bolstering pain and symptom management. Team researchers masked to treatment assignment will assess the outcomes up to 3 months post-treatment. DISCUSSION: This study aims to test the utility of a single-session videoconference-delivered group pain education class to improve self-regulation of pain and pain-related outcomes. Findings from our project have the potential to significantly reduce barriers to effective psychological treatment for pain, optimizing the delivery of increasingly vital online and remote-delivered intervention options. TRIAL REGISTRATION: ClinicalTrials.gov NCT04546685 . Registered on 04 September 2020.

Development and validation of the Collaborative Health Outcomes Information Registry body map.

INTRODUCTION: Critical for the diagnosis and treatment of chronic pain is the anatomical distribution of pain. Several body maps allow patients to indicate pain areas on paper; however, each has its limitations. OBJECTIVES: To provide a comprehensive body map that can be universally applied across pain conditions, we developed the electronic Collaborative Health Outcomes Information Registry (CHOIR) self-report body map by performing an environmental scan and assessing existing body maps. METHODS: After initial validation using a Delphi technique, we compared (1) pain location questionnaire responses of 530 participants with chronic pain with (2) their pain endorsements on the CHOIR body map (CBM) graphic. A subset of participants (n = 278) repeated the survey 1 week later to assess test-retest reliability. Finally, we interviewed a patient cohort from a tertiary pain management clinic (n = 28) to identify reasons for endorsement discordances. RESULTS: The intraclass correlation coefficient between the total number of body areas endorsed on the survey and those from the body map was 0.86 and improved to 0.93 at follow-up. The intraclass correlation coefficient of the 2 body map graphics separated by 1 week was 0.93. Further examination demonstrated high consistency between the questionnaire and CBM graphic (<10% discordance) in most body areas except for the back and shoulders (≈15-19% discordance). Participants attributed inconsistencies to misinterpretation of body regions and laterality, the latter of which was addressed by modifying the instructions. CONCLUSIONS: Our data suggest that the CBM is a valid and reliable instrument for assessing the distribution of pain.