Impact of Shared Decision-Making on Opioid Prescribing Among Patients With Chronic Pain: A Retrospective Cohort Study.

Shared decision-making (SDM) involving patient and physician is a desirable goal that is recommended in chronic pain management guidelines. This study measured whether SDM affects opioid prescribing frequency for chronic low back pain. A retrospective cohort study involving 1,478 participants was conducted within a national pain research registry. The patient participation and patient orientation (PPPO) scale of the Communication Behavior Questionnaire was used to measure SDM, including the classification of greater SDM (PPPO scale score ≥ 80) or lesser SDM (PPPO scale score < 80). Opioid prescribing frequency was measured at quarterly intervals from enrollment through 12 months. Baseline and longitudinal covariates were collected to adjust for potential confounding using generalized estimating equations. The mean age of participants was 53.1 (SD, 13.2) years, and 1,098 (74.3%) were female. A total of 473 (32.0%) participants were prescribed opioids at baseline. Participants completed 5,968 encounters wherein multivariable analyses demonstrated that PPPO scale scores were associated with more frequent opioid prescribing (ß = .013; 95% CI, .005-.021; P < .001). Greater SDM was associated with more frequent opioid prescribing than lesser SDM (ß = .441; 95% CI, .160-.722; P = .002). Opioids were prescribed in 34.3% versus 25.2% of encounters with greater versus lesser SDM (OR, 1.55; 95% CI, 1.17-2.06). SDM remained associated with more frequent opioid prescribing in a series of sensitivity analyses. Although SDM is desirable in chronic pain management, complex issues and challenging patient conversations may arise during serial assessments of the appropriateness of opioid therapy. Physicians need better education and training to address such difficult situations. PERSPECTIVE: The more frequent use of opioid therapy among patients who reported greater SDM with their physicians underscores the need for better medical education and training in dealing with the complex issues and challenges pertaining to serial assessments of the appropriateness of opioid therapy for chronic pain.

Physician Empathy and Chronic Pain Outcomes.

Importance: Empathy is an aspect of the patient-physician relationship that may be particularly important in patients with chronic pain. Objective: To measure the association of physician empathy with pain, function, and health-related quality of life (HRQOL) among patients with chronic low back pain. Design, Setting, and Participants: This cohort study included adult enrollees from the Pain Registry for Epidemiological, Clinical, and Interventional Studies and Innovation national pain research registry. Study dates were from April 1, 2016, to July 25, 2023, with up to 12 months of follow-up. Exposure: Physician empathy was assessed with the Consultation and Relational Empathy measure and dichotomized to yield very empathic physician and slightly empathic physician groups. Main Outcomes and Measures: Main outcomes were patient-reported pain, function, and HRQOL measured with a numerical rating scale for low back pain intensity, the Roland-Morris Disability Questionnaire for back-related disability, and the Patient-Reported Outcomes Measurement Information System for HRQOL deficits pertaining to anxiety, depression, fatigue, sleep disturbance, and pain interference. Data were collected at 5 quarterly encounters from registry enrollment through 12 months and analyzed with generalized estimating equations, including multivariable models to measure temporal trends and to adjust for baseline and longitudinal covariates. Results: Among the 1470 patients, the mean (SD) age was 53.1 (13.2) years, and 1093 (74.4%) were female. Patients completed 5943 encounters in which multivariable analyses demonstrated that greater physician empathy was inversely associated with pain intensity (ß = -0.014; 95% CI, -0.022 to -0.006; P < .001), back-related disability (ß = -0.062; 95% CI, -0.085 to -0.040; P < .001), and HRQOL deficits on each measure (eg, pain interference: ß = -0.080; 95% CI, -0.111 to -0.049; P < .001). Correspondingly, compared with the slightly empathic physician group, the very empathic physician group reported lower mean pain intensity (6.3; 95% CI, 6.1-6.5 vs 6.7; 95% CI, 6.5-6.9; P < .001), less mean back-related disability (14.9; 95% CI, 14.2-15.6 vs 16.8; 95% CI, 16.0-17.6; P < .001), and fewer HRQOL deficits on each measure (eg, fatigue: 57.3; 95% CI, 56.1-58.5 vs 60.4; 95% CI, 59.0-61.7; P < .001). All physician empathy group differences were clinically relevant, with Cohen d statistics ranging from 0.21 for pain intensity to 0.30 for back-related disability, fatigue, and pain interference. Physician empathy was associated with more favorable outcomes than non-pharmacological treatments, opioid therapy, and lumbar spine surgery. Conclusions and Relevance: In this cohort study of adult patients with chronic pain, physician empathy was associated with better outcomes over 12 months. Greater efforts to cultivate and improve physician empathy appear warranted.

Pain catastrophizing and risk of progression to widespread pain among patients with chronic low back pain: A retrospective cohort study.

BACKGROUND: Chronic low back pain often progresses to widespread pain. Although many factors are associated with progression, their roles in contributing to chronic widespread pain (CWP) are often unclear. OBJECTIVE: To determine if pain catastrophizing is an independent risk factor for CWP. DESIGN: Retrospective cohort study within a national pain research registry from April 2016 through August 2022. METHODS: A total of 1111 participants with chronic low back pain, but without CWP, were included. Participants were followed at quarterly intervals for up to 48 months to measure CWP risk. Survival analyses involved Kaplan-Meier plots and the Cox proportional hazards model to measure CWP risk according to pain catastrophizing and subscale scores for rumination, magnification, and helplessness. RESULTS: Crude CWP risks for moderate pain catastrophizing (HR, 2.13; 95% CI, 1.54-2.95; P < 0.001) and high pain catastrophizing (HR, 3.98; 95% CI, 2.95-5.35; P < 0.001) were each elevated in comparison with low pain catastrophizing. Adjusted CWP risks for moderate pain catastrophizing (HR, 1.80; 95% CI, 1.27-2.53; P < 0.001) and high pain catastrophizing (HR, 2.82; 95% CI, 1.98-4.02; P < 0.001) remained elevated in analyses that controlled for potential confounders. Corresponding results were observed in the survival analyses involving rumination, magnification, and helplessness. CONCLUSIONS: Pain catastrophizing appears to be an independent risk factor for progression to CWP among patients with chronic low back pain. These findings provide a rationale for interventions aimed at reducing pain catastrophizing, including rumination, magnification, and helplessness, among patients with chronic low back pain.

Effectiveness of Long-Term Opioid Therapy for Chronic Low Back Pain.

PURPOSE: Clinical trials generally have not assessed efficacy of long-term opioid therapy (LTOT) beyond 6 months because of methodological barriers and ethical concerns. We aimed to measure the effectiveness of LTOT for up to 12 months. METHODS: We conducted a retrospective cohort study among adults with chronic low back pain (CLBP) from April 2016 through August 2022. Participants reporting LTOT (>90 days) were matched to opioid nonusers with propensity scores. Primary outcomes involved low back pain intensity, back-related disability, and pain impact measured with a numerical rating scale, the Roland-Morris Disability Questionnaire, and the Patient-Reported Outcomes Measurement Information System, respectively. Secondary outcomes involved minimally important changes in primary outcomes. RESULTS: The mean age of 402 matched participants was 55.4 years (S.D., 11.9 years), and 297 (73.9%) were female. There were 119 (59.2%) LTOT users who took opioids continuously for 12 months. The mean daily morphine milligram equivalent dosage at baseline was 36.7 (95% CI, 32.8 to 40.7). There were no differences between LTOT and control groups in mean pain intensity (6.06, 95% CI, 5.80-6.32 vs 5.92, 95% CI, 5.68-6.17), back-related disability (15.32, 95% CI, 14.55-16.09 vs 14.81, 95% CI, 13.99-15.62), or pain impact (32.51, 95% CI, 31.33-33.70 vs 31.22, 95% CI, 30.00 to 32.43). Correspondingly, LTOT users did not report greater likelihood of minimally important changes in any outcome. CONCLUSIONS: Using LTOT for up to 12 months is not more effective in improving CLBP outcomes than treatment without opioids. Clinicians should consider tapering opioid dosage among LTOT users in accordance with clinical practice guidelines.

Racial Disparities in Opioid Use and Lumbar Spine Surgery for Chronic Pain and in Pain and Function Over 3 Years: A Retrospective Cohort Study.

This study aims to compare treatments and outcomes among Black and White patients with chronic low back pain in the United States. A retrospective cohort study was conducted within a pain research registry, including 1,443 participants with up to 3 years of follow-up. Pain treatments were measured at quarterly research encounters using reported current opioid use and prior lumbar spine surgery. Pain intensity and functional disability were also measured quarterly with a numerical rating scale and the Roland-Morris Disability Questionnaire, respectively. Longitudinal data were analyzed with generalized estimating equations, including multivariable models to measure temporal trends and adjust for potential confounders. The mean baseline age of participants was 53.5 years (SD, 13.1 years); 1,074 (74.4%) were female, and 260 (18.0%) were Black. In longitudinal multivariable analyses, Black participants reported more frequent current opioid use (odds ratio, 1.40; 95% confidence interval [CI], 1.03-1.91; P = .03) and less frequent lumbar spine surgery (odds ratio, .45; 95% CI, .28-.72; P < .001). Black participants also reported greater pain intensity (mean, 6.6; 95% CI, 6.3-6.9 vs mean, 5.6; 95% CI, 5.4-5.8; P < .001) and functional disability (mean, 15.3; 95% CI, 14.6-16.0 vs mean, 13.8; 95% CI, 13.2-14.3; P = .002). Racial disparities were clinically important (risk ratio = 1.28 and risk ratio = .49, respectively, for opioid use and surgery; and d = .46 and d = .24, respectively, for pain and function). Racial disparities in pain and function also widened over time. Thus, barriers to guideline-adherent and specialized pain care among Black patients may affect pain and function outcomes. Greater efforts are needed to address the observed racial disparities. PERSPECTIVE: Widening racial disparities in pain and function over time indicate that new approaches to chronic pain management are needed in the United States. Considering race as a social framework represents an emerging strategy for planning and improving pain treatment services for Black patients.

The process and outcomes of chronic low back pain treatment provided by osteopathic and allopathic physicians: a retrospective cohort study.

CONTEXT: Osteopathic physicians are trained to treat patients with musculoskeletal symptoms, to treat somatic dysfunction with osteopathic manipulative treatment (OMT), and to avoid unnecessarily prescribing drugs such as opioids. It is also generally believed that osteopathic physicians provide a unique patient-centered approach to medical care that involves effective communication and empathy. Such training and characteristics of osteopathic medical care (OMC) may enhance clinical outcomes among patients with chronic pain. OBJECTIVES: The objectives of this study were to measure and compare the process and longitudinal outcomes of chronic low back pain (CLBP) treatment provided by osteopathic and allopathic physicians and to identify mediators of the treatment effects of OMC. METHODS: This retrospective cohort study was conducted utilizing adult participants with CLBP within the Pain Registry for Epidemiological, Clinical, and Interventional Studies and Innovation (PRECISION) from April 2016 through December 2022. Participants having an osteopathic or allopathic physician for at least 1 month prior to registry enrollment were included and followed at quarterly intervals for up to 12 months. Physician communication and physician empathy were measured at registry enrollment. Opioid prescribing and effectiveness and safety outcomes were measured at registry enrollment and for up to 12 months and were analyzed with generalized estimating equations to compare participants treated by osteopathic vs. allopathic physicians. Multiple mediator models, including physician communication, physician empathy, opioid prescribing, and OMT, with covariate adjustments, were utilized to identify mediators of OMC treatment effects. RESULTS: A total of 1,079 participants and 4,779 registry encounters were studied. The mean (SD) age of participants at enrollment was 52.9 (13.2) years, 796 (73.8 %) were female, and 167 (15.5 %) reported having an osteopathic physician. The mean physician communication score for osteopathic physicians was 71.2 (95 % CI, 67.6-74.7) vs. 66.2 (95 % CI, 64.8-67.7) for allopathic physicians (p=0.01). The respective mean scores for physician empathy were 41.6 (95 % CI, 39.9-43.2) vs. 38.3 (95 % CI, 37.6-39.1) (p<0.001). There was no significant difference in opioid prescribing for low back pain between osteopathic and allopathic physicians. Although participants treated by osteopathic physicians reported less severe nausea and vomiting as adverse events potentially attributable to opioids in a multivariable model, neither result was clinically relevant. OMC was associated with statistically significant and clinically relevant outcomes pertaining to low back pain intensity, physical function, and health-related quality of life (HRQOL) over 12 months. Physician empathy was a significant mediator of OMC treatment effects in each of the three outcome domains; however, physician communication, opioid prescribing, and OMT were not mediators. CONCLUSIONS: The study findings indicate that osteopathic physicians provide a patient-centered approach to CLBP treatment, particularly involving empathy, that yields significant and clinically relevant outcomes pertaining to low back pain intensity, physical function, and HRQOL over 12 months of follow-up.

Patient Satisfaction With Medical Care for Chronic Low Back Pain: A Pain Research Registry Study.

PURPOSE: The process and outcomes of delivering medical care for chronic low back pain might affect patient satisfaction. We aimed to determine the associations of process and outcomes with patient satisfaction. METHODS: We conducted a cross-sectional study of patient satisfaction among adult participants with chronic low back pain in a national pain research registry using self-reported measures of physician communication, physician empathy, current physician opioid prescribing for low back pain, and outcomes pertaining to pain intensity, physical function, and health-related quality of life. We used simple and multiple linear regression models to measure factors associated with patient satisfaction, including a subgroup of participants having both chronic low back pain and the same treating physician for >5 years. RESULTS: Among 1,352 participants, only physician empathy (standardized ß, 0.638; 95% CI, 0.588-0.688; t = 25.14; P < .001) and physician communication (standardized ß, 0.182; 95% CI, 0.133-0.232; t = 7.22; P < .001) were associated with patient satisfaction in the multivariable analysis that controlled for potential confounders. Similarly, in the subgroup of 355 participants, physician empathy (standardized ß, 0.633; 95% CI, 0.529-0.737; t = 11.95; P < .001) and physician communication (standardized ß, 0.208; 95% CI, 0.105-0.311; t = 3.96; P < .001) remained associated with patient satisfaction in the multivariable analysis. CONCLUSIONS: Process measures, notably physician empathy and physician communication, were strongly associated with patient satisfaction with medical care for chronic low back pain. Our findings support the view that patients with chronic pain highly value physicians who are empathic and who make efforts to more clearly communicate treatment plans and expectations.

Osteopathic manipulative treatment of patients with chronic low back pain in the United States: a retrospective cohort study.

CONTEXT: The practice of osteopathic manipulative treatment (OMT) varies substantially across nations. Much of this variability may be attributed to disparate international educational, licensing, and regulatory environments that govern the practice of osteopathy by nonphysicians. This is in contrast with the United States, where osteopathic physicians are trained to integrate OMT as part of comprehensive patient management. OBJECTIVES: This study will analyze the factors associated with OMT use and its outcomes when integrated within the overall medical care for chronic low back pain (CLBP) provided by osteopathic physicians in the United States. METHODS: A retrospective cohort study was conducted within the Pain Registry for Epidemiological, Clinical, and Interventional Studies and Innovation (PRECISION) from April 2016 through April 2022 to study the effectiveness of OMT integrated within medical care provided by osteopathic physicians. The outcome measures, which included pain intensity, pain impact, physical function, and health-related quality of life, were assessed with the National Institutes of Health Minimum Dataset, Patient-Reported Outcomes Measurement Information System, and Roland-Morris Disability Questionnaire. RESULTS: A total of 1,358 adults with CLBP entered the cohort (mean age, 53.2 years; 74.4% female), 913 completed the final quarterly encounter, 348 were in various stages of follow-up, and 97 had withdrawn. Blacks (odds ratio [OR], 0.36; 95% confidence interval [CI], 0.21-0.63; p<0.001), cigarette smokers (OR, 0.56; 95% CI, 0.33-0.93; p=0.02), and nonsteroidal anti-inflammatory drug users (OR, 0.59; 95% CI, 0.43-0.81; p=0.001) were less likely to have utilized OMT in the multivariable analysis. Mean between-group differences among 753 participants with no OMT crossover and complete follow-up favored OMT: 1.02 (95% CI, 0.63-1.42; p<0.001) for pain intensity; 5.12 (95% CI, 3.09-7.16; p<0.001) for pain impact; 3.59 (95% CI, 2.23-4.95; p<0.001) for physical function, and 2.73 (95% CI, 1.19-4.27; p<0.001) for health-related quality of life. Analyses involving propensity-score adjustment and inclusion of participants with missing data yielded similar conclusions. None of 12 prespecified participant characteristics demonstrated an OMT interaction effect. CONCLUSIONS: OMT integrated within medical care provided by osteopathic physicians for CLBP was associated with improved pain and related outcomes. Its use may be facilitated by the growing osteopathic physician workforce in the United States and adherence to relevant clinical practice guidelines.

The effect of long-term opioid use on back-specific disability and health-related quality of life in patients with chronic low back pain.

CONTEXT: Opioids are commonly utilized for the treatment of chronic pain. However, research regarding the long-term (≥12 months) outcomes of opioid therapy remains sparse. OBJECTIVES: This study aims to evaluate the effects of long-term opioid therapy on measures of back-specific disability and health-related quality of life in patients with chronic low back pain. METHODS: In this retrospective cohort study, patients with chronic low back pain who reported consistent opioid use or abstinence for at least 12 months while enrolled in the Pain Registry for Epidemiological, Clinical, and Interventional Studies and Innovation Pain Research Registry were classified as long-term opioid users or nonusers, respectively. For comparison, intermediate-term and short-term opioid users and nonusers were also identified. Multiple linear regression analysis was performed to compare back-specific disability (Roland-Morris Disability Questionnaire [RMDQ]) and health-related quality of life (29-item Patient-Reported Outcomes Measurement Information System [PROMIS]) between opioid users and nonusers while controlling for pain intensity, depression, age, body mass index (BMI), and eight common comorbid conditions (herniated disc, sciatica, osteoporosis, osteoarthritis, heart disease, hypertension, diabetes, and asthma). Statistically significant findings were assessed for clinical relevance. RESULTS: There were 96 long-term opioid users and 204 long-term opioid nonusers. After controlling for potential confounders, long-term opioid use was a predictor of worse back-specific disability (adjusted mean difference=2.85, p<0.001), physical function (adjusted mean difference=-2.90, p=0.001), fatigue (adjusted mean difference=4.32, p=0.001), participation in social roles (adjusted mean difference=-4.10, p<0.001), and pain interference (adjusted mean difference=3.88, p<0.001) outcomes. Intermediate-term opioid use was a predictor of worse back-specific disability (adjusted mean difference=2.41, p<0.001), physical function (adjusted mean difference=-2.26, p=0.003), fatigue (adjusted mean difference=3.70, p=0.002), and sleep disturbance outcomes (adjusted mean difference=3.03, p=0.004), whereas short-term opioid use was a predictor of worse back-specific disability (adjusted mean difference=2.42, p<0.001) and physical function outcomes (adjusted mean difference=-1.90, p<0.001). CONCLUSIONS: The findings of this study are largely consistent with existing literature regarding the outcomes of long-term opioid therapy. Taken in conjunction with the well-established risks of opioid medications, these findings draw into question the utility of long-term opioid therapy for chronic low back pain.

Optimizing chronic pain management through patient engagement with quality of life measures: a randomized controlled trial.

CONTEXT: Health-related quality of life (HRQOL) represents a new approach for guiding chronic pain management because it is patient-centered and more likely to be understood and accepted by patients. OBJECTIVES: To assess the value and utility of an eHealth intervention for patients with chronic low back pain (CLBP) that was primarily based on HRQOL measures and to measure the clinical outcomes associated with its use. METHODS: A randomized controlled trial was conducted within the Pain Registry for Epidemiological, Clinical, and Interventional Studies and Innovation (PRECISION Pain Research Registry) using participants screened from November 2019 through February 2021. A total of 331 registry participants within the 48 contiguous states and the District of Columbia met the eligibility criteria, which included having CLBP and HRQOL deficits. Almost three-fourths of the participants were enrolled after onset of the COVID-19 pandemic. The participants were randomized to an eHealth intervention for HRQOL or wait list control. The primary outcome measures involved HRQOL based on the Patient-Reported Outcomes Measurement Information System (PROMIS), including the SPADE cluster (Sleep disturbance, Pain interference with activities, Anxiety, Depression, and low Energy/fatigue) and each of its five component scales. Secondary outcome measures involved low back pain intensity and back-related functioning. Changes over time for each outcome measure reported by participants in each treatment group were compared utilizing the student's t-test for statistical significance and Cohen's d statistic for clinical importance. Outcomes were reported as between-group differences in change scores and the d statistic, with positive values favoring the experimental treatment group. RESULTS: There were no significant differences between the experimental and control treatment groups for changes over time in any primary outcome measure. The d statistic (95% confidence interval) for the difference between the experimental and control treatment groups on the SPADE cluster was 0.04 (-0.18-0.25). The corresponding d statistics for the SPADE scales ranged from -0.06 (-0.27 to 0.16) for anxiety to 0.11 (-0.10 to 0.33) for sleep disturbance. There were also no significant or clinically important differences between the experimental and control treatment groups on the secondary outcome measures. Additionally, in subgroup analyses involving participants treated by osteopathic vs allopathic physicians, no significant interaction effects were observed. CONCLUSIONS: The eHealth intervention studied herein did not achieve statistically significant or clinically important improvements in any of the primary or secondary outcome measures. However, the validity and generalizability of the findings may have been limited by the unforeseen onset and impact of the COVID-19 pandemic shortly after beginning the trial.

Pain and functional recovery from chronic low back pain over 12 months: implications for osteopathic medicine.

CONTEXT: Although low back pain is a common medical condition that often progresses to become a chronic problem, little is known about the likelihood of recovery from chronic low back pain (CLBP). OBJECTIVES: This study aimed to measure the risk of recovery from CLBP based on low back pain intensity and back-related functioning measures reported by participants within a pain research registry over 12 months of observation and to consider the implications for osteopathic medicine. METHODS: A total of 740 participants with CLBP in the Pain Registry for Epidemiological, Clinical, and Interventional Studies and Innovation in the United States were studied between April 2016 and October 2021. Inception cohorts for pain recovery and functional recovery were assembled from the participants who did not meet the recovery criteria at registry enrollment. The pain recovery criterion was having a score of ≤1/10 on a numerical rating scale for low back pain intensity, and the functional recovery criterion was having a score of ≤4/24 on the Roland-Morris Disability Questionnaire. A total of 737 and 692 participants were included in the inception cohorts for pain recovery and functional recovery, respectively. Participants provided follow-up data at quarterly encounters over 12 months to determine if they achieved and maintained a pain or functional recovery from CLBP over the entire period of observation. Logistic regression was utilized to identify factors associated with recovery. RESULTS: The mean age of the participants at baseline was 52.9 years (SD, 13.1 years) and 551 (74.5%) were female. No participant reported a pain recovery that was maintained over all four quarterly encounters, whereas 16 participants (2.3%; 95% CI, 1.2-3.4%) maintained a functional recovery. Having high levels of pain self-efficacy (OR, 17.50; 95% CI, 2.30-133.23; p=0.006) and being Hispanic (OR, 3.55; 95% CI, 1.11-11.37; p=0.03) were associated with functional recovery, and high levels of pain catastrophizing (OR, 0.15; 95% CI, 0.03-0.65; p=0.01) and having chronic widespread pain (OR, 0.23; 95% CI, 0.08-0.66; p=0.007) were inversely associated with functional recovery. The findings for pain self-efficacy and Hispanic ethnicity remained significant in the multivariate analysis that adjusted for potential confounders. CONCLUSIONS: The absence of pain recovery and the low likelihood of functional recovery observed in our study suggests that osteopathic physicians should embrace a biopsychosocial approach to CLBP management and work with patients to set realistic expectations based on more pragmatic outcome measures, such as those that address health-related quality of life. The findings also suggest the potential importance of patient education and counseling to enhance pain self-efficacy.

Nonadherence to Clinical Practice Guidelines for Opioid Prescribing in Patients with Chronic Low Back Pain: A Pain Research Registry-Based Study.

INTRODUCTION: This study measured the prevalence and impact of nonadherence to clinical practice guidelines (CPGs) that recommend using nonpharmacological and nonopioid treatments such as nonsteroidal anti-inflammatory drugs (NSAIDs) before considering opioids in patients with chronic low back pain. METHODS: Participants within the PRECISION Pain Research Registry provided data during the period from April 2016 through October 2021. The prevalence of nonadherence to CPGs was based on current or prior use of 6 common nonpharmacological treatments, NSAIDs, and opioids for low back pain. The primary outcome measures were low back pain intensity, back-related disability, and pain impact on health-related quality of life. RESULTS: The prevalence of nonadherence to CPGs was 68 (18.0%) participants among the 378 participants currently using opioids. Participants having some post-high school education (OR, 0.41; 95% CI, 0.22-0.74) or at least a college education (OR, 0.26; 95% CI, 0.12-0.56) were at decreased risk of treatment that was nonadherent to CPGs in a multivariate analysis. Participants whose treatment was nonadherent to CPGs reported significantly worse clinical outcomes across all 3 measures (P ≤ .001; Cohen's d range, 0.41 to 0.62). CONCLUSION: Up to one-fifth of patients with chronic low back pain may be prescribed opioids in a manner that is not adherent to CPGs, thereby placing them at risk for poor outcomes.

Analysis of the Patient-Physician Relationship, Race, and Pain Control and Physical Function Among Adults With Chronic Low Back Pain.

Importance: Racial and ethnic disparities in pain outcomes are widely reported in the United States. However, the impact of the patient-physician relationship on such outcomes remains unclear. Objective: To determine whether the patient-physician relationship mediates the association of race with pain outcomes. Design, Setting, and Participants: This cross-sectional study uses data from the Pain Registry for Epidemiological, Clinical, and Interventional Studies and Innovation, collected from April 2016 to December 2021. All registry enrollees who identified as Black or White with chronic low back pain who had a regular physician who provided pain care were included. Data were analyzed during December 2021. Exposures: Participant-reported aspects of their patient-physician relationship, including physician communication, physician empathy, and satisfaction with physician encounters. Main Outcomes and Measures: The primary outcomes included low back pain intensity, measured with a numerical rating scale and physical function, measured with the Roland-Morris Disability Questionnaire. Mediator variables were derived from the Communication Behavior Questionnaire, Consultation and Relational Empathy measure, and Patient Satisfaction Questionnaire. Results: Among 1177 participants, the mean (SD) age was 53.5 (13.1) years, and there were 876 (74.4%) women. A total of 217 participants (18.4%) were Black, and 960 participants (81.6%) were White. The only difference between Black and White participants in the patient-physician relationship involved effective and open physician communication, which favored Black participants (mean communication score, 72.1 [95% CI, 68.8-75.4] vs 67.9 [95% CI, 66.2-69.6]; P = .03). Black participants, compared with White participants reported worse outcomes for pain intensity (mean pain score, 7.1 [95% CI, 6.8-7.3] vs 5.8 [95% CI, 5.7-6.0]; P < .001) and back-related disability (mean disability score, 15.8 [95% CI, 15.1-16.6] vs 14.1 [95% CI, 13.8-14.5]; P < .001). In mediation analyses that controlled for potential confounders using disease risk scores, virtually none of the associations of race with each outcome was mediated by the individual or combined factors of physician communication, physician empathy, and patient satisfaction. Similarly, no mediation was observed in sensitivity analyses that included only participants with both chronic low back pain and the same treating physician for more than 5 years. Conclusions and Relevance: These findings suggest that factors other than the patient-physician relationship were important to pain disparities experienced by Black participants. Additional research on systemic factors, such as access to high-quality medical care, may be helpful in identifying more promising approaches to mitigating racial pain disparities.

Preventing progression from chronic to widespread pain and its impact on health-related quality of life: a historical cohort study of osteopathic medical care.

CONTEXT: It is generally acknowledged that osteopathic physicians take a holistic approach to patient care. This style may help prevent the progression of painful musculoskeletal conditions, particularly if combined with osteopathic manipulative treatment (OMT). OBJECTIVES: The study aimed to determine if osteopathic medical care lowers the risk of progression from localized chronic low back pain to widespread pain and lessens the impact of pain on health-related quality of life. METHODS: A historical cohort study was conducted within the Pain Registry for Epidemiological, Clinical, and Interventional Studies and Innovation (PRECISION Pain Research Registry) using data acquired from April 2016 through March 2021. Registry participants aged 21-79 years with chronic low back pain at the baseline encounter were potentially eligible for inclusion if they had a treating physician, completed all four quarterly follow-up encounters, and did not report physician crossover at the final 12-month encounter. Eligible participants were classified according to the type of physician provider at baseline and thereby into osteopathic or allopathic medical care groups. Participants were also classified according to prior use of OMT at the final encounter. Widespread pain was measured at baseline and each quarterly encounter to determine the period prevalence rate of widespread pain and its severity over 12 months using the Minimum Dataset for Chronic Low Back Pain recommended by the National Institutes of Health. Participants who reported "not being bothered at all" by widespread pain during each encounter were classified as not having widespread pain, whereas those who were bothered "a little" or "a lot" at any quarterly encounter were classified as having widespread pain. The severity of widespread pain was measured by summing participant responses at each encounter. The Patient-Reported Outcomes Measurement Information System was used at each encounter to measure health-related quality-of-life (HRQOL) scores for physical function, anxiety, depression, fatigue, sleep disturbance, participation in social roles and activities, and pain interference with activities. RESULTS: A total of 462 participants were studied, including 101 (21.9%) in the osteopathic medical care group and 73 (15.8%) who used OMT. The mean age of participants at baseline was 52.7 ± 13.2 years (range, 22-79 years) and 336 (72.7%) were female. A lower period prevalence rate of widespread pain was observed in the osteopathic medical care group (OR, 0.47; 95% CI, 0.27-0.81; p=0.006) and in the OMT group (OR, 0.40; 95% CI, 0.21-0.75; p=0.004), although the latter finding did not persist after adjustment for potential confounders. The osteopathic medical care and OMT groups both reported lower widespread pain severity. The osteopathic medical care group also reported better age- and sex-adjusted outcomes for each of the seven HRQOL dimensions throughout the study. The OMT group reported better outcomes in five of the HRQOL dimensions. CONCLUSIONS: This study supports the view that osteopathic physicians practice a holistic approach to medical care that manifests itself through a lower risk of progression from chronic low back pain to widespread pain, lower widespread pain severity, and lesser deficits in HRQOL. Similar findings were generally associated with OMT use.

Patient-centered care or osteopathic manipulative treatment as mediators of clinical outcomes in patients with chronic low back pain.

CONTEXT: Patient-centered care is often considered a characteristic of osteopathic medicine, in addition to the use of osteopathic manipulative treatment (OMT) in such musculoskeletal conditions as low back pain. OBJECTIVES: This study aimed to determine if patient-centered care or OMT are mediators of the clinical outcomes of osteopathic medicine in patients with chronic low back pain. METHODS: A comparative effectiveness study was conducted within the Pain Registry for Epidemiological, Clinical, and Interventional Studies and Innovation (PRECISION Pain Research Registry). Eligible patients met the diagnostic criteria recommended by the National Institutes of Health Task Force on Research Standards for Chronic Low Back Pain and completed four consecutive quarterly encounters between April 2016 and November 2020. The Consultation and Relational Empathy instrument for patient-centered care was used at the baseline encounter and OMT use was measured at the final encounter. The clinical outcome measures included low back pain intensity on a numerical rating scale (NRS) from 0 to 10, back-related functioning on the Roland-Morris Disability Questionnaire (RMDQ), and pain impact on the National Institutes of Health Minimum Dataset for Chronic Low Back Pain (NIH-MDS). A parallel multiple mediator model was used to compute the direct and indirect effects of osteopathic medicine in achieving each of the three clinical outcomes. RESULTS: The 404 study patients had a mean age of 52.2 years (standard deviation, 13.1 years) and 288 (71.3%) were female. The 88 (21.8%) patients treated by osteopathic physicians reported more favorable scores for patient-centered care (mean, 41.3; 95% CI 39.0-43.5) than patients treated by allopathic physicians (mean, 38.0; 95% CI 36.8-39.3) (p=0.02). Fifty-six (63.6%) patients treated by osteopathic physicians used OMT. The age- and sex-adjusted outcomes for patients of osteopathic vs. allopathic physicians across all four encounters were: mean, 5.4; 95% CI 5.0-5.7 vs. mean, 5.9; 95% CI 5.7-6.1 on the NRS for pain intensity (p=0.01); mean, 11.3; 95% CI 10.1-12.6 vs. mean, 14.0; 95% CI 13.3-14.7 on the RMDQ for back-related disability (p<0.001); and mean, 26.8; 95% CI 24.9-28.7 vs. mean, 30.1; 95% CI 29.1-31.1 on the NIH-MDS for pain impact (p=0.002). Patient-centered care did not mediate any outcome of osteopathic medicine, whereas OMT mediated better outcomes in low back pain intensity. CONCLUSIONS: This appears to be the first study to simultaneously address both patient-centered care and OMT as potential mediators of the effect of osteopathic medicine in treating chronic pain. Patient-centered care did not mediate the effects of osteopathic medicine and OMT only mediated outcomes relating to low back pain intensity. More research is needed to identify other aspects of osteopathic medicine that mediate its beneficial effects in patients with chronic low back pain.

Impact of COVID-19 on utilization of nonpharmacological and pharmacological treatments for chronic low back pain and clinical outcomes.

CONTEXT: The novel coronavirus 2019 (COVID-19) pandemic has impacted the delivery of health care services throughout the United States, including those for patients with chronic pain. OBJECTIVES: To measure changes in patients' utilization of nonpharmacological and pharmacological treatments for chronic low back pain and related outcomes during the COVID-19 pandemic. METHODS: A pre-post study was conducted within the Pain Registry for Epidemiological, Clinical, and Interventional Studies and Innovation (PRECISION Pain Research Registry) using data in the 3 months before and 3-6 months after the declaration of a national emergency related to COVID-19. Participants 21-79 years old with chronic low back pain were included in the study and provided self reported data at relevant quarterly encounters. Use of exercise therapy, yoga, massage therapy, spinal manipulation, acupuncture, cognitive behavioral therapy, nonsteroidal antiinflammatory drugs, and opioids for low back pain was measured. The primary outcomes were low back pain intensity and back related functioning measured with a numerical rating scale and the Roland Morris Disability Questionnaire, respectively. Secondary outcomes included health related quality of life scales measured with the Patient Reported Outcomes Measurement Information System, including scales for physical function, anxiety, depression, low energy/fatigue, sleep disturbance, participation in social roles and activities, and pain interference with activities. RESULTS: A total of 476 participants were included in this study. The mean age of participants at baseline was 54.0 years (standard deviation, ±13.2 years; range, 22-81 years). There were 349 (73.3%) female participants and 127 (26.7%) male participants in the study. Utilization of exercise therapy (odds ratio [OR], 0.37; 95% confidence interval [CI], 0.23-0.57), massage therapy (OR, 0.46; 95% CI, 0.25-0.83), and spinal manipulation (OR, 0.53; 95% CI, 0.29-0.93) decreased during the pandemic. A reduction in NSAID use was also observed (OR, 0.67; 95% CI, 0.45-0.99). Participants reported a significant, but not clinically relevant, improvement in low back pain intensity during the pandemic (mean improvement, 0.19; 95% CI, 0.03-0.34; Cohen's d, 0.11). However, White participants reported a significant improvement in low back pain intensity (mean improvement, 0.28; 95% CI, 0.10-0.46), whereas Black participants did not (mean improvement, -0.13; 95% CI, -0.46 to 0.19; p for interaction=0.03). Overall, there was a significant and clinically relevant improvement in pain interference with activities (mean improvement, 1.11; 95% CI, 0.20-2.02; Cohen's d, 0.20). The use of NSAIDs during the pandemic was associated with marginal increases in low back pain intensity. CONCLUSIONS: Overall, decreased utilization of treatments for chronic low back pain did not adversely impact pain and functioning outcomes during the first 6 months of the pandemic. However, Black participants experienced significantly worse pain outcomes than their White counterparts.

Demographic Characteristics Associated With Utilization of Noninvasive Treatments for Chronic Low Back Pain and Related Clinical Outcomes During the COVID-19 Pandemic in the United States.

INTRODUCTION: This study was conducted to determine if limited access to health care during the COVID-19 pandemic impacted utilization of recommended nonpharmacological treatments, nonsteroidal anti-inflammatory drugs, and opioids by patients with chronic low back pain and affected clinical outcomes relating to pain intensity and disability. METHODS: Participants within the Pain Registry for Epidemiological, Clinical, and Interventional Studies and Innovation were eligible if they provided encounter data in the 3 months immediately before and after the national emergency proclamation date (NEPD). RESULTS: The mean age of the 528 study participants was 53.9 years and 74.1% were women. Utilization of exercise therapy, massage therapy, and spinal manipulation decreased during the pandemic. Increasing age was associated with decreased utilization of all nonpharmacological treatments except exercise therapy, and with increased opioid use during the pandemic. African American participants reported decreased utilization of yoga and spinal manipulation during the pandemic. Overall, mean change scores for pain intensity and disability before and after the NEPD were not significant. However, African American participants consistently reported worse pain intensity and disability outcomes during the pandemic. Marginally worse outcomes were observed less consistently for pain intensity with increasing age and for disability among women. DISCUSSION: Social distancing during the pandemic impacted the uptake of recommended nonpharmacological treatments for chronic low back pain that require visiting community-based facilities or interacting closely with providers. CONCLUSIONS: The pandemic threatens to exacerbate the impact of chronic low back pain, particularly among African American patients and the older population, by impeding access to guideline-informed noninvasive treatments.

Feasibility Trial of an eHealth Intervention for Health-Related Quality of Life: Implications for Managing Patients with Chronic Pain during the COVID-19 Pandemic.

PURPOSE: This study was conducted to determine the feasibility of providing an eHealth intervention for health-related quality of life (HRQOL) to facilitate patient self-management. METHODS: A randomized controlled trial was conducted from 2019-2020 within the Pain Registry for Epidemiological, Clinical, and Interventional Studies and Innovation. Eligible patients included those with chronic low back pain and a SPADE (sleep disturbance, pain interference with activities, anxiety, depression, and low energy/fatigue) cluster score ≥ 55 based on the relevant scales from the Patient-Reported Outcomes Measurement Information System instrument with 29 items (PROMIS-29). Patients were randomized to the eHealth treatment group, which received a tailored HRQOL report and interpretation guide, or to a wait-list control group. The primary outcome was change in the SPADE cluster score, including its five component scales, over 3 months. Secondary outcomes were changes in low back pain intensity and back-related disability. Treatment effects were measured using the standardized mean difference (SMD) in change scores between groups. The eHealth intervention was also assessed by a survey of the experimental treatment group 1 month following randomization. RESULTS: A total of 102 patients were randomized, including 52 in the eHealth treatment group and 50 in the wait-list control group, and 100 (98%) completed the trial. A majority of patients agreed that the HRQOL report was easy to understand (86%), provided new information (79%), and took actions to read or learn more about self-management approaches to improve their HRQOL (77%). Although the eHealth intervention met the criteria for a small treatment effect in improving the overall SPADE cluster score (SMD = 0.24; p= 0.23) and anxiety (SMD = 0.24; p = 0.23), and for a small-to-medium treatment effect in improving depression (SMD = 0.37; p = 0.06) and back-related disability (SMD = 0.36; p = 0.07), none of these results achieved statistical significance because of limited sample size. CONCLUSION: Given the feasibility of rapid online deployment, low cost, and low risk of adverse events, this eHealth intervention for HRQOL may be useful for patients with chronic pain during the COVID-19 pandemic.