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.

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.

Midwives and Liability: Results of the 2018 National Midwives and Liability Survey.

INTRODUCTION: This is the third national survey about the incidence of midwifery involvement in malpractice litigation, case outcome, methods of coping, and the influence of fear of liability or actual litigation on midwifery practice and professional liability insurance. Incidence of disciplinary action was also included. METHODS: A link to a web-based survey was sent to all American College of Nurse-Midwives members with an active email address in January 2018. Students and associate members were excluded from analysis. Logistic regression was used to identify predictors of involvement in lawsuit. RESULTS: Of 6199 email links sent, 880 midwives responded (14%). One-third of participants (n = 280, 32%) have been named in at least one lawsuit after a median of 7 years in practice. Claims most often involved intrapartum hospital-based care and resulted from fetal heart rate interpretation. The most common outcome of a case was settlement prior to court or arbitration (n = 117, 42%). Significant predictors of litigation included older age of the midwife and region of practice (increased in Northeastern states, decreased in Midwestern states). Midwives' most common source of emotional support was their attorney. Only 6% (n = 53) of participants experienced disciplinary action against their state license. Half of the actions by a state governing board were unrelated to a lawsuit. DISCUSSION: Midwives may experience litigation the longer they are in practice, but there has not been a significant change in the incidence since the previous survey in 2009. More resources and education are needed for midwives to provide adequate peer support to colleagues following adverse events or when named in a lawsuit. Continued education is also needed for midwives regarding types of professional liability insurance, affordability, and how policy terms and limits influence clinical practice.

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.

Empathy in Medicine Osteopathic and Allopathic Physician Interpersonal Manner, Empathy, and Communication Style and Clinical Status of Their Patients: A Pain Registry-Based Study.

CONTEXT: Comparisons of osteopathic physicians (ie, DOs) and allopathic physicians (ie, MDs) on interpersonal manner, including empathy and communication style, have been limited by such methodologic issues as self-assessment and a focus on medical students rather than practicing physicians. OBJECTIVE: To compare perceptions of the interpersonal manner, empathy, and communication style of DOs and MDs and corresponding clinical measures reported by their patients. METHODS: A cross-sectional study of adults with subacute or chronic low back pain was conducted within the PRECISION Pain Research Registry from April 2016 through December 2018. A total of 313 patients having their physician for 1 year or longer reported sociodemographic and clinical characteristics, including use of nonsteroidal anti-inflammatory drugs (NSAIDs) and opioids for low back pain. Using validated research instruments, they also reported perceptions of their physician's interpersonal manner, empathy, and communication style and clinical measures of pain catastrophizing, pain self-efficacy, low back pain intensity, back-related disability, and deficits in quality of life relating to sleep disturbance, pain interference with activities, anxiety, depression, and low energy/fatigue. RESULTS: Patients treated by DOs were less likely to be using NSAIDs (odds ratio [OR], 0.60; 95% CI, 0.36-0.997) or opioids (OR, 0.57; 95% CI, 0.32-0.998) than patients treated by MDs. Patients treated by DOs reported lesser pain catastrophizing (mean, 12.5; 95% CI, 10.1-15.0 for DOs vs 18.1; 95% CI, 16.3-19.9 for MDs; P<.001) and greater pain self-efficacy (mean, 39.5; 95% CI, 36.3-42.8 for DOs vs 35.3; 95% CI, 33.4-37.3 for MDs; P=.03). Correspondingly, patients treated by DOs reported lesser back-related disability (mean, 11.2; 95% CI, 9.9-12.5 for DOs vs 13.5; 95% CI, 12.8-14.3 for MDs; P=.002) and a trend toward lesser deficits in quality of life. Patients reported more favorable perceptions of DOs on interpersonal manner (mean, 4.3; 95% CI, 4.2-4.5 for DOs vs 4.0; 95% CI, 3.9-4.2 for MDs; P=.01) and empathy (mean, 41.2; 95% CI, 39.1-43.3 for DOs vs 38.0; 95% CI, 36.5-39.5 for MDs; P=.02). CONCLUSION: The mechanisms underlying lesser use of NSAIDs and opioids, superior clinical status measures, and more favorable perceptions of physician interpersonal manner and empathy reported by patients treated by DOs warrant further investigation.

A pilot mobile integrated healthcare program for frequent utilizers of emergency department services.

PURPOSE: To examine whether or not a mobile integrated health (MIH) program may improve health-related quality of life while reducing emergency department (ED) transports, ED admissions, and inpatient hospital admissions in frequent utilizers of ED services. METHODS: A small retrospective evaluation assessing pre- and post-program quality of life, ED transports, ED admissions, and inpatient hospital admissions was conducted in patients who frequently used the ED for non-emergent or emergent/primary care treatable conditions. RESULTS: Pre- and post-program data available on 64 program completers are reported. Of those with mobility problems (n=42), 38% improved; those with problems performing usual activities (N=45), 58% reported improvement; and of those experiencing moderate to extreme pain or discomfort (N=48), 42% reported no pain or discomfort after program completion. Frequency of ED transports decreased (5.34±6.0 vs. 2.08±3.3; p <0.000), as did ED admissions (9.66±10.2 vs. 3.30±4.6; p<0.000), and inpatient hospital admissions (3.11±5.5 vs. 1.38±2.5; p=0.003). CONCLUSION: Results suggest that MIH participation is associated with improved quality of life, reduced ED transports, ED admissions, and inpatient hospital admissions. The MIH program may have potential to improve health outcomes in patients who are frequent ED users for non-emergent or emergent/primary care treatable conditions by teaching them how to proactively manage their health and adhere to therapeutic regimens. Programmatic reasons for these improvements may include psychosocial bonding with participants who received in-home care, health coaching, and the MIH team's 24/7 availability that provided immediate healthcare access.

Recovery From Chronic Low Back Pain After Osteopathic Manipulative Treatment: A Randomized Controlled Trial.

CONTEXT: Little is known about recovery after spinal manipulation in patients with low back pain (LBP). OBJECTIVE: To assess recovery from chronic LBP after a short regimen of osteopathic manipulative treatment (OMT) in a responder analysis of the OSTEOPAThic Health outcomes In Chronic low back pain (OSTEOPATHIC) Trial. METHODS: A randomized double-blind, sham-controlled trial was conducted to determine the efficacy of 6 OMT sessions over 8 weeks. Recovery was assessed at week 12 using a composite measure of pain recovery (10 mm or less on a 100-mm visual analog scale) and functional recovery (2 or less on the Roland-Morris Disability Questionnaire for back-specific functioning). The RRs and numbers-needed-to-treat (NNTs) for recovery with OMT were measured, and corresponding cumulative distribution functions were plotted according to baseline LBP intensity and back-specific functioning. Multiple logistic regression was used to compute the OR for recovery with OMT while simultaneously controlling for potential confounders. Sensitivity analyses were performed to corroborate the primary results. RESULTS: There were 345 patients who met neither of the recovery criteria at baseline in the primary analyses and 433 patients who met neither or only 1 of these criteria in the sensitivity analyses. There was a large treatment effect for recovery with OMT (RR, 2.36; 95% CI, 1.31-4.24; P=.003), which was associated with a clinically relevant NNT (8.9; 95% CI, 5.4-25.5). This significant finding persisted after adjustment for potential confounders (OR, 2.92; 95% CI, 1.43-5.97; P=.003). There was also a significant interaction effect between OMT and comorbid depression (P=.02), indicating that patients without depression were more likely to recover from chronic LBP with OMT (RR, 3.21; 95% CI, 1.59-6.50; P<.001) (NNT, 6.5; 95% CI, 4.2-14.5). The cumulative distribution functions demonstrated optimal RR and NNT responses in patients with moderate to severe levels of LBP intensity and back-specific dysfunction at baseline. Similar results were observed in the sensitivity analyses. CONCLUSIONS: The OMT regimen was associated with significant and clinically relevant measures for recovery from chronic LBP. A trial of OMT may be useful before progressing to other more costly or invasive interventions in the medical management of patients with chronic LBP. (ClinicalTrials.gov number NCT00315120).

Targeting Patient Subgroups With Chronic Low Back Pain for Osteopathic Manipulative Treatment: Responder Analyses From a Randomized Controlled Trial.

CONTEXT: Osteopathic manipulative treatment (OMT) is often used to treat patients with low back pain (LBP). OBJECTIVE: To identify subgroups of patients with chronic LBP who achieve medium to large treatment effects with OMT based on responder analyses involving pain and functioning outcomes from the OSTEOPAThic Health outcomes In Chronic low back pain (OSTEOPATHIC) Trial. METHODS: This randomized, double-blind, sham-controlled trial involving 455 patients in Dallas-Fort Worth was conducted from 2006 to 2011. A 100-mm visual analog scale (VAS) for LBP intensity and the Roland-Morris Disability Questionnaire (RMDQ) for back-specific functioning were used to assess primary and secondary outcomes, respectively. Substantial improvement was defined as 50% or greater reduction at week 12 compared with baseline. Cumulative distribution functions for the RR and number-needed-to-treat (NNT) were used to assess response. RESULTS: Medium treatment effects for LBP intensity were observed overall (RR, 1.41; 95% CI, 1.13-1.76; P=.002; NNT, 6.9; 95% CI, 4.3-18.6). However, large treatment effects were observed in patients with baseline VAS scores of 35 mm or greater. Although OMT was not associated with overall substantial improvement in back-specific functioning, patients with baseline RMDQ scores of 7 or greater experienced medium effects, and patients with baseline scores 16 or greater experienced large effects that were significant. The OMT effects for LBP intensity and back-specific functioning were independent of baseline patient demographic characteristics, comorbid medical conditions, and medication use for LBP during the trial. CONCLUSIONS: Subgrouping according to baseline levels of chronic LBP intensity and back-specific functioning appears to be a simple strategy for identifying sizeable numbers of patients who achieve substantial improvement with OMT and may thereby be less likely to use more costly and invasive interventions. (ClinicalTrials.gov number NCT00315120).

Clinical response and relapse in patients with chronic low back pain following osteopathic manual treatment: results from the OSTEOPATHIC Trial.

Clinical response and relapse following a regimen of osteopathic manual treatment (OMT) were assessed in patients with chronic low back pain (LBP) within the OSTEOPATHIC Trial, a randomized, double-blind, sham-controlled study. Initial clinical response and subsequent stability of response, including final response and relapse status at week 12, were determined in 186 patients with high baseline pain severity (≥50 mm on a 100-mm visual analogue scale). Substantial improvement in LBP, defined as 50% or greater pain reduction relative to baseline, was used to assess clinical response at weeks 1, 2, 4, 6, 8, and 12. Sixty-two (65%) patients in the OMT group attained an initial clinical response vs. 41 (45%) patients in the sham OMT group (risk ratio [RR], 1.45; 95% confidence interval [CI], 1.11-1.90). The median time to initial clinical response to OMT in these patients was 4 weeks. Among patients with an initial clinical response prior to week 12, 13 (24%) patients in the OMT group vs. 18 (51%) patients in the sham OMT group relapsed (RR, 0.47; 95% CI, 0.26-0.83). Overall, 49 (52%) patients in the OMT group attained or maintained a clinical response at week 12 vs. 23 (25%) patients in the sham OMT group (RR, 2.04; 95% CI, 1.36-3.05). The large effect size for short-term efficacy of OMT was driven by stable responders who did not relapse.

Somatic dysfunction and use of osteopathic manual treatment techniques during ambulatory medical care visits: a CONCORD-PBRN study.

CONTEXT: Osteopathic manual treatment (OMT) of somatic dysfunction is a unique approach to medical care that may be studied within a practice-based research network. OBJECTIVE: To measure patient characteristics and osteopathic physician practice patterns within the Consortium for Collaborative Osteopathic Research Development-Practice-Based Research Network (CONCORD-PBRN). DESIGN: Cross-sectional card study. SETTING: Eleven member clinics within the CONCORD-PBRN coordinated by The Osteopathic Research Center. PATIENTS: A total of 668 patients seen between January and March 2013. MAIN STUDY MEASURES: Patient age and sex; primary diagnoses; somatic dysfunction as manifested by tenderness, asymmetry, restricted motion, or tissue texture changes; and use of 14 OMT techniques. Results were stratified by anatomical region and adjusted for clustering within member clinics. Clustering was measured by the intracluster correlation coefficient. RESULTS: Patient ages ranged from 7 days to 87 years (adjusted mean age, 49.2 years; 95% confidence interval [CI], 43.3-55.1 years). There were 450 females (67.4%) and 508 patient visits (76.0%) involved a primary diagnosis of disease of the musculoskeletal system and connective tissue. Structural examination was performed during 657 patient visits (98.4%), and 649 visits (97.2%) involved OMT. Restricted motion and tenderness were the most and least common palpatory findings, respectively. Cranial (1070 [14.5%]), myofascial release (1009 [13.7%]), muscle energy (1001 [13.6%]), and counterstrain (980 [13.3%]) techniques were most commonly used, accounting for more than one-half of the OMT provided. Pediatric patients were more likely than adults to receive OMT within the head (adjusted odds ratio [OR], 9.53; 95% CI, 1.28-71.14). Geriatric patients were more likely than adults to receive a structural examination (adjusted OR, 1.83; 95% CI, 1.09-3.07) and OMT (adjusted OR, 1.62; 1.02-2.59) within the lower extremity. Females were more likely than males to receive a structural examination (adjusted OR, 2.44; 95% CI, 1.44-4.16) and OMT (adjusted OR, 2.11; 95% CI, 1.26-3.52) within the sacrum and OMT within the pelvis (adjusted OR, 1.79; 95% CI, 1.12-2.88). Intracluster correlation coefficients for the 4 most commonly used OMT techniques ranged from 0.34 to 0.72. CONCLUSION: This study provides proof of concept of the feasibility of studying osteopathic medical practice on a national level by developing and growing the CONCORD-PBRN.

Prevention of progressive back-specific dysfunction during pregnancy: an assessment of osteopathic manual treatment based on Cochrane Back Review Group criteria.

CONTEXT: Back pain during pregnancy may be associated with deficits in physical functioning and disability. Research indicates that osteopathic manual treatment (OMT) slows the deterioration of back-specific functioning during pregnancy. OBJECTIVE: To measure the treatment effects of OMT in preventing progressive back-specific dysfunction during the third trimester of pregnancy using criteria established by the Cochrane Back Review Group. DESIGN: A randomized sham-controlled trial including 3 parallel treatment arms: usual obstetric care and OMT (UOBC+OMT), usual obstetric care and sham ultrasound therapy (UOBC+SUT), and usual obstetric care (UOBC). SETTING: The Osteopathic Research Center within the University of North Texas Health Science Center in Fort Worth. PARTICIPANTS: A total of 144 patients were randomly assigned and included in intention-to-treat analyses. MAIN OUTCOME MEASURES: Progressive back-specific dysfunction was defined as a 2-point or greater increase in the Roland-Morris Disability Questionnaire (RMDQ) score during the third trimester of pregnancy. Risk ratios (RRs) and 95% confidence intervals (CIs) were used to compare progressive back-specific dysfunction in patients assigned to UOBC+OMT relative to patients assigned to UOBC+SUT or UOBC. Numbers needed to treat (NNTs) and 95% CIs were also used to assess UOBC+OMT vs each comparator. Subgroup analyses were performed using median splits of baseline scores on a numerical rating scale for back pain and the RMDQ. RESULTS: Overall, 68 patients (47%) experienced progressive back-specific dysfunction during the third trimester of pregnancy. Patients who received UOBC+OMT were significantly less likely to experience progressive back-specific dysfunction (RR, 0.6; 95% CI, 0.3-1.0; P=.046 vs UOBC+SUT; and RR, 0.4; 95% CI, 0.2-0.7; P<.0001 vs UOBC). The effect sizes for UOBC+OMT vs UOBC+SUT and for UOBC+OMT vs UOBC were classified as medium and large, respectively. The corresponding NNTs for UOBC+OMT were 5.1 (95% CI, 2.7-282.2) vs UOBC+SUT; and 2.5 (95% CI, 1.8-4.9) vs UOBC. There was no statistically significant interaction between subgroups in response to OMT. CONCLUSION: Osteopathic manual treatment has medium to large treatment effects in preventing progressive back-specific dysfunction during the third trimester of pregnancy. The findings are potentially important with respect to direct health care expenditures and indirect costs of work disability during pregnancy.