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.

"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.

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.

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.

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.

Negative Affect-Related Factors Have the Strongest Association with Prescription Opioid Misuse in a Cross-Sectional Cohort of Patients with Chronic Pain.

OBJECTIVE: Increased opioid prescription to relieve pain among patients with chronic pain is associated with increased risk for misuse, potentially leading to substance use disorders and overdose death. We aimed to characterize the relative importance and identify the most significant of several potential risk factors for the severity of self-reported prescribed opioid misuse behaviors. METHODS: A sample of 1,193 patients (mean age ± SD = 50.72 ± 14.97 years, 64.04% female) with various chronic pain conditions completed a multidimensional registry assessing four pain severity measures and 14 physical, mental, and social health status factors using the National Institutes of Health's Patient-Reported Outcomes Measurement Information System (PROMIS). A validated PROMIS measure of medication misuse was completed by 692 patients who endorsed currently taking opioid medication. Patients taking opioid medications were compared across all measures with those who do not take opioid medications. Subsequently, a data-driven regression analysis was used to determine which measures best explained variability in severity of misuse. We hypothesized that negative affect-related factors, namely anxiety, anger, and/or depression, would be key predictors of misuse severity due to their crucial role in chronic pain and substance use disorders. RESULTS: Patients taking opioid medications had significantly greater impairment across most measures. Above and beyond demographic variables, the only and most significant predictors of prescribed opioid misuse severity were as follows: anxiety (ß = 0.15, P = 0.01), anger (ß = 0.13, P = 0.02), Pain Intensity-worst (ß = 0.09, P = 0.02), and depression (ß = 0.13, P = 0.04). CONCLUSIONS: Findings suggest that anxiety, anger, and depression are key factors associated with prescribed opioid misuse tendencies in patients with chronic pain and that they are potential targets for therapeutic intervention.

Hyperalgesia after a Drinking Episode in Young Adult Binge Drinkers: A Cross-Sectional Study.

AIMS: Rodent studies propose potential mechanisms linking excessive drinking and pain hypersensitivity (hyperalgesia), such that stress hormones (i.e. epinephrine and cortisol) mediate induction and maintenance of alcohol withdrawal-induced hyperalgesia. The first aim of this study was to examine whether hyperalgesia would occur within 48 h after a drinking episode in healthy young adult binge drinkers. The second was to examine whether stress hormones and negative effect would be associated with binge drinking or alcohol withdrawal-associated hyperalgesia. METHODS: A cross-sectional experiment was conducted in five groups with naturally occurring drinking (mean age = 19.6, range 18-29 years): abstainers (n = 43, 54% female), moderate drinkers with (n = 50, 50% female) or without recent drinking (i.e. within 48 h, n = 23, 26% female) and binge drinkers with (n = 36, 58% female) or without recent drinking (n = 25, 44% female). All types of drinkers endorsed drinking about 2-3 times a month and 2-3 years of drinking history. RESULTS: Muscle pressure pain thresholds were significantly lower in the binge group with recent drinking compared to other groups, but cutaneous mechanical and heat pain thresholds were not significantly different across the five groups. Basal epinephrine levels were significantly higher in binge groups regardless of recent drinking, but cortisol and negative effect were not significantly different across the five groups. CONCLUSIONS: This is the first study to show that alcohol withdrawal-associated muscle hyperalgesia may occur in healthy episodic binge drinkers with only 2-3 years of drinking history, and epinephrine may play a role in binge drinking-associated hyperalgesia.

Evaluation of Candidate Items for Severe PTSD Screening for Patients With Chronic Pain: Pilot Data Analysis With the IRT Approach.

OBJECTIVES: Post-traumatic stress disorder (PTSD) commonly co-occurs with chronic pain. Although PTSD symptoms are associated with negative health outcomes in patients with chronic pain, PTSD is typically under-detected and under-treated in outpatient pain settings. There is a need for rapid, brief screening tools to identify those at greatest risk for severe PTSD symptoms. To achieve that goal, our aim was to use item response theory (IRT) to identify the most informative PTSD symptoms characterizing severe PTSD in patients with chronic pain. METHODS: Fifty-six patients (71% female, 61% White) with mixed etiology chronic pain completed the PTSD Checklist-Civilian Version (PCL-C) as part of their appointment with a pain psychologist at a tertiary outpatient pain clinic. We used an IRT approach to evaluate each item's discriminant (a) and severity (b) parameters. RESULTS: Findings revealed that "feeling upset at reminders" (a = 3.67, b = 2.44) and "avoid thinking or talking about it" (a = 3.61, b = 2.17) as being highly discriminant for severe PTSD. CONCLUSIONS: We identified 2 candidate items for a brief PTSD screener as they were associated with severe PTSD symptoms. These 2 items may provide clinical utility in outpatient pain treatment settings to identify those suffering from severe PTSD, enabling physicians to refer them to trauma-specific evaluation or therapy. Future research is needed to further validate and confirm these candidate PTSD items in a larger clinic sample. LAY SUMMARY: The current study used the IRT approach to identify candidate items for a brief screener for severe PTSD. We examined 17 items of the PCL-C, and identified 2 items that were highly discriminant for severe PTSD. The 2 items were "feeling upset at reminders" and "avoid thinking or talking about it." These 2 items may provide clinical utility, since they may enable physicians to screen and make a referral for further assessment or treatment for PTSD.

Cumulative Childhood Adversity as a Risk Factor for Common Chronic Pain Conditions in Young Adults.

OBJECTIVE: Multiple and specific types of childhood adverse events are risk factors for chronic pain conditions. Although both can covary, no study has evaluated one aspect while controlling for the other. Therefore, the current study examined whether more adverse events would be a risk factor for common chronic pain conditions and pain medication use in young adults after controlling for different adversity types such as physical, emotional, and sexual traumatic events or vice versa. METHODS: This cross-sectional study recruited 3,073 undergraduates (72% female, mean age = 18.8 years, SD = 1.4 years) who completed the survey for current health status and early life traumatic events. RESULTS: More adverse events were associated with a 1.2-1.3-fold increase in the odds of any chronic pain, chronic back pain, headache, and dysmenorrhea with adjusting for adversity types, but they were not associated with the risk of comorbid pain conditions and use of pain medications. In contrast, specific adversity types were unrelated to chronic pain conditions when controlling for the number of adverse events. CONCLUSIONS: Cumulative childhood adverse events may be a more relevant risk factor for chronic pain conditions than the experience of a specific type of adverse event. Clinicians and researchers need to evaluate cumulative childhood adversity when assessing its link to chronic pain.

Childhood Adversity and Pain Facilitation.

OBJECTIVE: This study investigated whether childhood adversity would be associated with hypersensitivity on two measures of central pain facilitation: area of secondary allodynia and temporal summation of second pain (TSSP), and whether pain facilitation would be explained by adult posttraumatic stress disorder (PTSD) symptoms. METHOD: Participants endorsing high (n = 31) and low (n = 31) childhood adversity underwent capsaicin-induced secondary allodynia and TSSP testing. The tests were conducted a week apart with test order counterbalanced. RESULTS: Larger areas of secondary allodynia were observed in the high adversity group compared with the low adversity group (F(1,60) = 4.81, p = .032). This group difference was largely (62%) explained by greater PTSD symptoms in the high adversity group. Although no overall difference was found in TSSP slopes (p = .886), this was attributed to an order by group interaction (F(1,58) = 5.07, p = .028) and low power. Subsequent analyses revealed positive TSSP slopes in the high adversity group when TSSP testing was performed first, and this order effect was associated with blunted sympathetic responses to TSSP on the first visit. The two facilitation measures were unrelated (p = .631). CONCLUSIONS: Larger areas of secondary allodynia were observed in the high adversity group, which was explained largely by PTSD symptoms. This suggests that adversity-related changes in pain facilitation may underlie the association between childhood adversity and generalized widespread pain. Although TSSP was affected by previous testing, adversity-related pain facilitation was observed when TSSP testing occurred first. Finally, adversity was not associated with a consistent pattern of hypersensitivity across the two measures of central pain facilitation.

Generalized Pain Sensitization and Endogenous Oxytocin in Individuals With Symptoms of Migraine: A Cross-Sectional Study.

OBJECTIVE: The current study examined pain and neurogenic inflammation responses to topical capsaicin during the interictal period (between headache) and their relationship with plasma oxytocin in individuals with migraine. BACKGROUND: Individuals with migraine can experience generalized (extracephalic) hyperalgesia, which can persist even between headache attacks. Elevated levels of plasma and cerebrospinal fluid oxytocin have been observed during migraine attacks, oxytocin levels being positively associated with the intensity of migraine symptoms. However, whether oxytocin plays a role in the mechanisms of generalized pain sensitization and neurogenic inflammation during the interictal period has not been studied yet. Understanding migraineurs' interictal pain phenotype and endogenous oxytocin might help identify individuals who would benefit from intranasal oxytocin treatment. METHODS: Thirty-two subjects with migraine and 26 healthy controls underwent pain testing. The current study compared capsaicin-induced pain, central sensitization (areas of secondary mechanical allodynia and hyperalgesia), and neurogenic inflammation (capsaicin-induced flare) responses on the nondominant volar forearm between migraineurs and healthy controls. Additionally, we studied plasma oxytocin levels and their relationship to migraine symptoms, experimental pain and affect. RESULTS: The results indicated a significant group effect (P = .019): Migraineurs reported greater capsaicin-induced pain unpleasantness (M = 1.2, SD = 1.4) on a 0-10 scale and showed larger areas of flare (LnM = 2.8, SD = 0.4) than healthy controls (M = 0.5, SD = 0.8; LnM = 2.6, SD = 0.4; ps < .032). In a subgroup analysis, enhanced capsaicin-induced pain unpleasantness was found in the chronic (P = .007), but not the episodic (Ps > .200), migraineurs. The oxytocin levels were elevated in migraineurs and accounted for 18% of the group difference in capsaicin-induced pain unpleasantness. Within migraineurs, interictal oxytocin levels were negatively associated with psychological distress (Ps < .030). However, during the interictal period, pain sensitivity in extracephalic regions and plasma oxytocin levels were unrelated to migraine symptom parameters (Ps > .074). Lastly, the results found no group difference in areas of secondary mechanical allodynia and hyperalgesia (Ps >.298). CONCLUSION: The current study revealed that individuals with migraine exhibit enhanced extracephalic capsaicin-induced pain unpleasantness and flare responses during interictal periods. In addition, migraineurs, especially those with chronic migraine, had slightly elevated interictal oxytocin levels compared to controls, which was associated with their affective component of experimental pain. Therefore, treatment targeting affective pain during the interictal period may help to reduce generalized pain in migraine. Furthermore, endogenous increases in oxytocin may be a compensatory mechanism that may help decrease affective distress in migraineurs. The therapeutic effects of intranasal oxytocin may benefit migraineurs by reducing their affective distress.

Diagnostic Efficiency of Caregiver Report on the SCARED for Identifying Youth Anxiety Disorders in Outpatient Settings.

This study investigated the diagnostic and clinical utility of the parent-rated Screen for Child Anxiety Related Emotional Disorders (SCARED-P) for detecting youth anxiety disorders. Youth ages 6 to 12 years, 11 months were recruited from 9 outpatient mental health clinics (N = 707). Consensus diagnoses were based on semistructured interviews (Schedule for Affective Disorders and Schizophrenia for School-Age Children) with youth and caregivers; 31% were diagnosed with at least one anxiety disorder. Caregivers completed the SCARED-P to describe youth anxiety levels. SCARED-P scores were not considered during the consensus diagnoses. Areas under the curve (AUCs) from receiver operating characteristic analyses and diagnostic likelihood ratios (DLRs) quantified performance of the SCARED-P total score and subscale scores (generalized anxiety disorder and separation anxiety disorder). SCARED-P total scores had variable efficiency (AUCs = .69-.88), and Generalized Anxiety Disorder and Separation Anxiety subscale scores were excellent (AUCs = .86-.89) for identifying specific anxiety disorders. Optimal subscale cutoff scores were computed to help rule in (DLRs = 2.7-5.4) or rule out (DLRs < 1.0) anxiety disorders among youth. Results suggest that the Generalized Anxiety Disorder and Separation Anxiety SCARED-P subscales accurately identify their respective matched diagnoses. DLRs may aid clinicians in screening for youth anxiety disorders and improve accuracy of diagnosis.

Comparing the Diagnostic Accuracy of Five Instruments for Detecting Posttraumatic Stress Disorder in Youth.

The purpose of the study was to compare diagnostic accuracy of five posttraumatic stress disorder (PTSD) measures in a large outpatient sample of youths 11-18 years of age. Index tests included a parent report (a rationally derived scale from the Child Behavioral Checklist), a teacher report (the Teacher Report Form), and three youth reports-a PTSD scale from the Youth Self Report (YSR), Child PTSD Symptom Scale, and Child and Adolescent Trauma Survey. Interviews with the youth and caregiver using Schedule for Affective Disorders and Schizophrenia for School-Age Children generated criterion diagnoses of PTSD. Diagnoses were blind to scores on the index tests. Based on consensus diagnoses (N = 458), 10% of youth had PTSD. Area under the curve (AUC) from receiver operating characteristic analyses and multilevel likelihood ratios evaluated test performance. All youth reports (AUCs .67-.73) outperformed the teacher report (AUCs .42-.48) at identifying PTSD. The YSR outperformed the caregiver reports (AUCs .57-.58). Combining tests did not improve prediction of PTSD. The YSR predicted PTSD even after controlling for a self-reported traumatic event, but checklist ratings of traumatic events had no incremental value after controlling for YSR scores. When a youth endorsed few symptoms, the likelihood of the youth having PTSD was low. Very high scores on the YSR were associated with a moderate increase in the likelihood of PTSD diagnosis. The YSR appeared to be a useful diagnostic aid for youth PTSD and could facilitate differential diagnosis of youth PTSD in outpatient settings.

Association Between Borderline Personality Features and Temporal Summation of Second Pain: A Cross-Sectional Study.

Individuals with greater borderline personality features may be vulnerable to chronic pain. Because pain is an unpleasant sensory and emotional experience, affect dysregulation as the core personality feature may be linked to pain hypersensitivity. Studies have found that greater borderline features are associated with increased intensity in clinical and experimental pain, and that depression mediates this increase. The current study further examined the association between borderline features and heat pain sensitivity, the contribution of affect dysregulation and the other borderline personality factors (identity problems, negative relationships, self-harming/impulsivity) to the association, and depression as a mediator. Additionally, we examined whether blunted sympathetic responses mediate the association between borderline features and temporal summation of second pain (TSSP). Thermal pain threshold, thermal TSSP and aftersensations pain were assessed in 79 healthy individuals with varying degrees of borderline features. TSSP is a proxy measure for central sensitization and refers to the gradual increase in pain to repeated nociceptive stimuli. A regression analysis showed that greater borderline features predicted greater TSSP (ß = .22, p = .050, R2 = .05). Borderline features were unrelated to pain threshold and TSSP decay. A stepwise regression showed greater TSSP in individuals with greater borderline features was accounted for by the negative relationships factor rather than the affect dysregulation factor. The results of mediational analyses showed depression and blunted sympathetic skin conductance responses mediated the positive association between TSSP and borderline features.

Enhanced Area of Secondary Hyperalgesia in Women with Multiple Stressful Life Events: A Pilot Study.

OBJECTIVE: Stressful life events are associated with increased pain severity and chronicity. However, the mechanism underlying this association remains disputed. Recent animal studies suggest that chronic stress increases pain sensitivity and persistence by enhancing peripheral and central sensitization mechanisms. To test this hypothesis in humans, the authors examined whether sensitization is enhanced in healthy women reporting more stressful life events using the topical capsaicin test. METHODS: Thirty-two healthy young women reporting varying levels of stressful life events were invited for laboratory pain testing. Capsaicin was applied topically to the volar forearm. Measurements included capsaicin-induced spontaneous pain and area of secondary hyperalgesia in the region surrounding capsaicin application. Physiological (heart rate and skin conductance) and self-reported affective (emotional valence and arousal) states were also measured. RESULTS: The results indicate that more stressful life events predicted a linear increase in the area of secondary hyperalgesia (ß = 0.40, p = 0.023, R2 = 0.16), but not the intensity of secondary hyperalgesia nor capsaicin-induced spontaneous pain. These findings suggest that life stressors may be associated with heightened central sensitization manifested by an increased area of secondary hyperalgesia. Additionally, life stressors were related to greater sympathetic cardiac, but not to affective responses to capsaicin-induced pain. CONCLUSION: This study shows that women reporting more stressful life events show a larger area of secondary mechanical hyperalgesia. These preliminary findings suggest that life stressors may facilitate pain processing by enhancing central sensitization.

Effect of written emotional disclosure on secondary hyperalgesia in women with trauma history.

OBJECTIVE: This study investigated the effects of written emotional disclosure on a model of chronic pain in healthy women with and without trauma history. METHOD: Participants were prescreened for their trauma history (N = 78) and randomized to a disclosure or a control writing condition. Pain testing occurred either 1 day or 1 month after disclosure. Capsaicin was applied to the forearm to evoke spontaneous burning pain at the application site and mechanical secondary hyperalgesia in the surrounding untreated skin. RESULTS: As hypothesized, the effect of disclosure on the area and intensity of secondary hyperalgesia depended on trauma history and time of testing (F(1,69) ≥ 7.37, p = .008). Disclosure increased secondary hyperalgesia in participants with trauma history compared with those without trauma when testing occurred 1 day after writing (F(1,69) ≥ 5.27, p ≤ .025), whereas the opposite pattern was observed 1 month later (F(1,69) ≥ 4.88, p ≤ .031). Of the participants with trauma history in the disclosure condition, secondary hyperalgesia was reduced at 1 month compared with 1 day after writing (p = .001). Moreover, greater use of positive emotional words predicted reduced secondary hyperalgesia at 1 month (ß = -0.71, p = .022). In contrast, disclosure had no effect on spontaneous pain. CONCLUSIONS: Disclosure modulates secondary hyperalgesia observed in women with trauma history, producing a short-term enhancement and a long-term reduction. This suggests that disclosure has a long-term protective effect that reduces sensitization of pain, which may explain the therapeutic effects of disclosure in patients with chronic pain.

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.

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.

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.

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.