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"Darnall, Beth D"
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Association between concurrent use of prescription opioids and benzodiazepines and overdose: retrospective analysis
by
Baker, Laurence C
,
Humphreys, Keith
,
Mackey, Sean
in
Adolescent
,
Adult
,
Analgesics, Opioid - adverse effects
2017
Objectives To identify trends in concurrent use of a benzodiazepine and an opioid and to identify the impact of these trends on admissions to hospital and emergency room visits for opioid overdose.Design Retrospective analysis of claims data, 2001-13.Setting Administrative health claims database.Participants 315 428 privately insured people aged 18-64 who were continuously enrolled in a health plan with medical and pharmacy benefits during the study period and who also filled at least one prescription for an opioid.Interventions Concurrent benzodiazepine/opioid use, defined as an overlap of at least one day in the time periods covered by prescriptions for each drug. Main outcome measures Annual percentage of opioid users with concurrent benzodiazepine use; annual incidence of visits to emergency room and inpatient admissions for opioid overdose.Results 9% of opioid users also used a benzodiazepine in 2001, increasing to 17% in 2013 (80% relative increase). This increase was driven mainly by increases among intermittent, as opposed to chronic, opioid users. Compared with opioid users who did not use benzodiazepines, concurrent use of both drugs was associated with an increased risk of an emergency room visit or inpatient admission for opioid overdose (adjusted odds ratio 2.14, 95% confidence interval 2.05 to 2.24; P<0.001) among all opioid users. The adjusted odds ratio for an emergency room visit or inpatient admission for opioid overdose was 1.42 (1.33 to 1.51; P<0.001) for intermittent opioid users and 1.81 (1.67 to 1.96; P<0.001) chronic opioid users. If this association is causal, elimination of concurrent benzodiazepine/opioid use could reduce the risk of emergency room visits related to opioid use and inpatient admissions for opioid overdose by an estimated 15% (95% confidence interval 14 to 16).Conclusions From 2001 to 2013, concurrent benzodiazepine/opioid use sharply increased in a large sample of privately insured patients in the US and significantly contributed to the overall population risk of opioid overdose.
Journal Article
An 8-Week Self-Administered At-Home Behavioral Skills-Based Virtual Reality Program for Chronic Low Back Pain: Double-Blind, Randomized, Placebo-Controlled Trial Conducted During COVID-19
2021
Chronic low back pain is the most prevalent chronic pain condition worldwide and access to behavioral pain treatment is limited. Virtual reality (VR) is an immersive technology that may provide effective behavioral therapeutics for chronic pain.
We aimed to conduct a double-blind, parallel-arm, single-cohort, remote, randomized placebo-controlled trial for a self-administered behavioral skills-based VR program in community-based individuals with self-reported chronic low back pain during the COVID-19 pandemic.
A national online convenience sample of individuals with self-reported nonmalignant low back pain with duration of 6 months or more and with average pain intensity of 4 or more/10 was enrolled and randomized 1:1 to 1 of 2 daily (56-day) VR programs: (1) EaseVRx (immersive pain relief skills VR program); or (2) Sham VR (2D nature content delivered in a VR headset). Objective device use data and self-reported data were collected. The primary outcomes were the between-group effect of EaseVRx versus Sham VR across time points, and the between-within interaction effect representing the change in average pain intensity and pain-related interference with activity, stress, mood, and sleep over time (baseline to end-of-treatment at day 56). Secondary outcomes were global impression of change and change in physical function, sleep disturbance, pain self-efficacy, pain catastrophizing, pain acceptance, pain medication use, and user satisfaction. Analytic methods included intention-to-treat and a mixed-model framework.
The study sample was 179 adults (female: 76.5%, 137/179; Caucasian: 90.5%, 162/179; at least some college education: 91.1%, 163/179; mean age: 51.5 years [SD 13.1]; average pain intensity: 5/10 [SD 1.2]; back pain duration ≥5 years: 67%, 120/179). No group differences were found for any baseline variable or treatment engagement. User satisfaction ratings were higher for EaseVRx versus Sham VR (P<.001). For the between-groups factor, EaseVRx was superior to Sham VR for all primary outcomes (highest P value=.009), and between-groups Cohen d effect sizes ranged from 0.40 to 0.49, indicating superiority was moderately clinically meaningful. For EaseVRx, large pre-post effect sizes ranged from 1.17 to 1.3 and met moderate to substantial clinical importance for reduced pain intensity and pain-related interference with activity, mood, and stress. Between-group comparisons for Physical Function and Sleep Disturbance showed superiority for the EaseVRx group versus the Sham VR group (P=.022 and .013, respectively). Pain catastrophizing, pain self-efficacy, pain acceptance, prescription opioid use (morphine milligram equivalent) did not reach statistical significance for either group. Use of over-the-counter analgesic use was reduced for EaseVRx (P<.01) but not for Sham VR.
EaseVRx had high user satisfaction and superior and clinically meaningful symptom reduction for average pain intensity and pain-related interference with activity, mood, and stress compared to sham VR. Additional research is needed to determine durability of treatment effects and to characterize mechanisms of treatment effects. Home-based VR may expand access to effective and on-demand nonpharmacologic treatment for chronic low back pain.
ClinicalTrials.gov NCT04415177; https://clinicaltrials.gov/ct2/show/NCT04415177.
RR2-10.2196/25291.
Journal Article
Efficacy of a Single-Session “Empowered Relief” Zoom-Delivered Group Intervention for Chronic Pain: Randomized Controlled Trial Conducted During the COVID-19 Pandemic
2021
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.
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.
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%).
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.
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.
ClinicalTrials.gov NCT04546685; https://clinicaltrials.gov/ct2/show/NCT04546685.
Journal Article
Durability of the Treatment Effects of an 8-Week Self-administered Home-Based Virtual Reality Program for Chronic Low Back Pain: 6-Month Follow-up Study of a Randomized Clinical Trial
by
Louis, Robert
,
Castro, Carina
,
Birckhead, Brandon
in
Backache
,
Care and treatment
,
Clinical trials
2022
We previously reported the efficacy of an 8-week home-based therapeutic immersive virtual reality (VR) program in a double-blind randomized placebo-controlled study. Community-based adults with self-reported chronic low back pain were randomized 1:1 to receive either (1) a 56-day immersive therapeutic pain relief skills VR program (EaseVRx) or (2) a 56-day sham VR program. Immediate posttreatment results revealed the superiority of therapeutic VR over sham VR for reducing pain intensity; pain-related interference with activity, mood, and stress (but not sleep); physical function; and sleep disturbance. At 3 months posttreatment, therapeutic VR maintained superiority for reducing pain intensity and pain-related interference with activity, stress, and sleep (new finding). This study assessed between-group and within-group treatment effects 6 months posttreatment to determine the extended efficacy, magnitude of efficacy, and clinical importance of home-based therapeutic VR. E-surveys were deployed at pretreatment, end-of-treatment, and posttreatment months 1, 2, 3, and 6. Self-reported data for 188 participants were analyzed in a mixed-model framework using a marginal model to allow for correlated responses across the repeated measures. Primary outcomes were pain intensity and pain-related interference with activity, mood, stress, and sleep at 6 months posttreatment. Secondary outcomes were Patient-Reported Outcome Measurement Information System (PROMIS) sleep disturbance and physical function. Therapeutic VR maintained significant and clinically meaningful effects 6 months posttreatment and remained superior to sham VR for reducing pain intensity and pain-related interference with activity, stress, and sleep (ds=0.44-0.54; P<.003). Between-group comparisons for physical function and sleep disturbance showed superiority of EaseVRx over sham VR (ds=0.34; P=.02 and ds=0.46; P<.001, respectively). Participants were encouraged to contact study staff with any problems experienced during treatment; however, no participants contacted study staff to report adverse events of any type, including nausea and motion sickness. Our 8-week home-based VR pain management program caused important reductions in pain intensity and interference up to 6 months after treatment. Additional studies are needed in diverse samples.
Journal Article
Protocol for research examination of individual suicides occurring in chronic pain: A qualitative approach to psychological autopsy methodology
by
Leal, Ashley S.
,
Dwivedi, Yogesh
,
Patton, Carla Stumpf
in
Adult
,
Aircraft
,
Analgesics, Opioid - adverse effects
2025
In the United States, taper and discontinuation of opioids prescribed for long-term pain have emerged as statistical correlates of suicidal events. Suicide is a complex and multidetermined event reflecting a combination of risks occurring over time in a particular narrative context. Prevention of suicides should be informed by a detailed understanding of life events, pain-related and other risk factors contributing to these tragedies. To date, there have been no efforts to qualitatively profile these suicides through interview of bereaved survivors or review of medical records. This method is usually termed \"psychological autopsy.\".
This paper summarizes the protocol for the Clinical Context of Suicide Following Opioid Transitions (CSI:OPIOIDs) study. The study seeks to qualitatively characterize patient and clinical context factors associated with suicide among persons who died by suicide in the context of opioid stoppage or reduction, and to compare findings between Veteran and non-Veteran decedents.
In the United States, there is no master list for suicide deaths linked to an antemortem health care event. For this reason, recruitment requires public advertising followed by screening of bereaved individuals who wish to participate. Data collection and interpretation are guided by the Social-Ecological Model for suicide. The study involves a collaboration of persons with lived experience and disciplinary experts in suicide, primary care, pain, health services, and medical anthropology.
This study aims to deliver the first in-depth analysis of suicide events occurring in persons with chronic pain who died by suicide in the context of a prescription opioid reduction or stoppage. The results should provide insights that can guide alterations to care by health systems and by individual practitioners.
Journal Article
Differential treatment response to virtual reality in high-impact chronic pain: secondary analysis of a randomized trial
by
Linde-Zwirble, Walter
,
Ffrench, Kelsey
,
Bonakdar, Robert
in
692/308/409
,
692/700/565/411
,
Adult
2025
High-impact chronic pain (HICP) affects 8.5% of the population and is associated with higher healthcare utilization and costs. Sparse data exist on pain treatment response differences between HICP vs. lower-impact chronic pain (LICP). We conducted a secondary analysis of a randomized controlled trial in a diverse community sample (N = 1067) with chronic low back pain who were demographically diverse (female: 77%; non-Caucasian: 32%; high school or less education: 19%; mean age: 50.8) and clinically severe (baseline pain intensity = 6.6, baseline pain interference = 6.2, and 42% severe/completely disabled). We compared HICP vs. LICP treatment responses for an 8-week Skills-Based Virtual Reality program at end-of-treatment and at 12-months for pain intensity and pain interference (multi-primary outcomes). MMRM analysis (multiplicity corrected) revealed significantly larger reductions (and clinically meaningful reductions) for HICP than LICP for both primary outcomes at both post-treatment time points. End-of-treatment reduction in pain interference among HICP reclassified 70% of them as LICP, and this improvement held at 12-months (67%). Significantly larger reductions were found for HICP vs LICP for the secondary outcomes Sleep Disturbance and the Oswestry Disability Index, but not for Depression. No differences were found for HICP vs. LICP for device engagement or usability scores.
Trial registration:
ClinicalTrials.govNCT05263037
.
Journal Article
The impact of COVID-19 on patients with chronic pain seeking care at a tertiary pain clinic
by
Cramer, Eric M.
,
Anderson, Steven R.
,
You, Dokyoung S.
in
692/699/255/2514
,
692/700/784
,
Anxiety - epidemiology
2022
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.
Journal Article
Online 1-session Empowered Relief in Marfan syndrome and related diseases: a single-arm feasibility and pilot efficacy study
2026
Marfan syndrome is a rare and often painful genetic disorder that affects connective tissue, and multiple organs and systems. We conducted a non-randomized feasibility and efficacy study of Empowered Relief, an evidence-based 1-session pain relief skills class, delivered online to a single national cohort of individuals with Marfan and related diseases. Adults in the United States with chronic pain and a self-reported diagnosis of Marfan or related diseases were recruited via The Marfan Foundation. Data were collected at baseline; immediately post-treatment; and at follow-up months 1–3. Symptom changes from baseline were estimated using mixed effects model for repeated measurements regression modeling. Participants (
N
= 92) were: 69(75%) female; with a mean age of 48 years (SD = 15); 78(85%) White. Attendance (80.7%) and treatment appraisal ratings (80%) supported feasibility for large group treatment. At 3 months, pain intensity and pain interference (primary outcomes) were significantly improved; as well as all secondary outcomes (e.g., pain catastrophizing, anxiety, and other variables) (p-values either < 0.05 or < 0.001). Limitations include a single-arm design and an 85% White sample. Multidimensional symptom reduction at 3 months justifies a future randomized trial. Results suggest promise for large size, online, brief behavioral pain care for people with Marfan and other rare disease.
ClinicalTrials.gov #
: NCT05980104.
Journal Article
Establishing the interpretability and utility of the 4-item BriefPCS
2023
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.
Journal Article
Correction: Protocol for research examination of individual suicides occurring in chronic pain: A qualitative approach to psychological autopsy methodology
2025
[This corrects the article DOI: 10.1371/journal.pone.0329874.].
Journal Article