Providing Epidemiological Data in Lumbar Spine Imaging Reports Did Not Affect Subsequent Utilization of Spine Procedures: Secondary Outcomes from a Stepped-Wedge Randomized Controlled Trial.

OBJECTIVE: To evaluate the effect of inserting epidemiological information into lumbar spine imaging reports on subsequent nonsurgical and surgical procedures involving the thoracolumbosacral spine and sacroiliac joints. DESIGN: Analysis of secondary outcomes from the Lumbar Imaging with Reporting of Epidemiology (LIRE) pragmatic stepped-wedge randomized trial. SETTING: Primary care clinics within four integrated health care systems in the United States. SUBJECTS: 238,886 patients ≥18 years of age who received lumbar diagnostic imaging between 2013 and 2016. METHODS: Clinics were randomized to receive text containing age- and modality-specific epidemiological benchmarks indicating the prevalence of common spine imaging findings in people without low back pain, inserted into lumbar spine imaging reports (the "LIRE intervention"). The study outcomes were receiving 1) any nonsurgical lumbosacral or sacroiliac spine procedure (lumbosacral epidural steroid injection, facet joint injection, or facet joint radiofrequency ablation; or sacroiliac joint injection) or 2) any surgical procedure involving the lumbar, sacral, or thoracic spine (decompression surgery or spinal fusion or other spine surgery). RESULTS: The LIRE intervention was not significantly associated with subsequent utilization of nonsurgical lumbosacral or sacroiliac spine procedures (odds ratio [OR] = 1.01, 95% confidence interval [CI] 0.93-1.09; P = 0.79) or any surgical procedure (OR = 0.99, 95 CI 0.91-1.07; P = 0.74) involving the lumbar, sacral, or thoracic spine. The intervention was also not significantly associated with any individual spine procedure. CONCLUSIONS: Inserting epidemiological text into spine imaging reports had no effect on nonsurgical or surgical procedure utilization among patients receiving lumbar diagnostic imaging.

Multi-site Pain Is Associated with Long-term Patient-Reported Outcomes in Older Adults with Persistent Back Pain.

OBJECTIVE: To estimate the prevalence of co-occurring pain sites among older adults with persistent back pain and associations of multisite pain with longitudinal outcomes. DESIGN: Secondary analysis of a cohort study. SETTING: Three integrated health systems in the United States. SUBJECTS: Eight hundred ninety-nine older adults with persistent back pain. METHODS: Participants reported pain in the following sites: stomach, arms/legs/joints, headaches, neck, pelvis/groin, and widespread pain. Over 18 months, we measured back-related disability (Roland Morris, scored 0-24), pain intensity (11-point numerical rating scale), health-related quality of life (EuroQol-5D [EQ-5D], utility from 0-1), and falls in the past three weeks. We used mixed-effects models to test the association of number and type of pain sites with each outcome. RESULTS: Nearly all (N = 839, 93%) respondents reported at least one additional pain site. There were 216 (24%) with one additional site and 623 (69%) with multiple additional sites. The most prevalent comorbid pain site was the arms/legs/joints (N = 801, 89.1%). Adjusted mixed-effects models showed that for every additional pain site, RMDQ worsened by 0.65 points (95% confidence interval [CI] = 0.43 to 0.86), back pain intensity increased by 0.14 points (95% CI = 0.07 to 0.22), EQ-5D worsened by 0.012 points (95% CI = -0.018 to -0.006), and the odds of falling increased by 27% (odds ratio = 1.27, 95% CI = 1.12 to 1.43). Some specific pain sites (extremity pain, widespread pain, and pelvis/groin pain) were associated with greater long-term disability. CONCLUSIONS: Multisite pain is common among older adults with persistent back pain. Number of pain sites was associated with all outcomes; individual pain sites were less consistently associated with outcomes.

Subsequent health-care utilization associated with early physical therapy for new episodes of low back pain in older adults.

BACKGROUND: The association between early physical therapy (PT) and subsequent health-care utilization following a new visit for low back pain is not clear, particularly in the setting of acute low back pain. PURPOSE: This study aimed to estimate the association between initiating early PT following a new visit for an episode of low back pain and subsequent back pain-specific health-care utilization in older adults. DESIGN/SETTING: This is a prospective cohort study. Data were collected at three integrated health-care systems in the United States through the Back Pain Outcomes using Longitudinal Data (BOLD) registry. PATIENT SAMPLE: We recruited 4,723 adults, aged 65 and older, presenting to a primary care setting with a new episode of low back pain. OUTCOME MEASURES: Primary outcome was total back pain-specific relative value units (RVUs), from days 29 to 365. Secondary outcomes included overall RVUs for all health care and use of specific health-care services including imaging (x-ray and magnetic resonance imaging [MRI] or computed tomography [CT]), emergency department visits, physician visits, PT, spinal injections, spinal surgeries, and opioid use. METHODS: We compared patients who had early PT (initiated within 28 days of the index visit) with those not initiating early PT using appropriate, generalized linear models to adjust for potential confounding variables. RESULTS: Adjusted analysis found no statistically significant difference in total spine RVUs between the two groups (ratio of means 1.19, 95% CI of 0.72-1.96, p=.49). For secondary outcomes, only the difference between total spine imaging RVUs and total PT RVUs was statistically significant. The early PT group had greater PT RVUs; the ratio of means was 2.56 (95% CI of 2.17-3.03, p<.001). The early PT group had greater imaging RVUs; the ratio of means was 1.37 (95% CI of 1.09-1.71, p=.01.) CONCLUSIONS: We found that in a group of older adults presenting for a new episode of low back pain, the use of early PT is not associated with any statistically significant difference in subsequent back pain-specific health-care utilization compared with patients not receiving early PT.

Effect of Comorbid Knee and Hip Osteoarthritis on Longitudinal Clinical and Health Care Use Outcomes in Older Adults With New Visits for Back Pain.

OBJECTIVE: To examine if a comorbid diagnosis of knee or hip osteoarthritis (OA) in older adults with new back pain visits is associated with long-term patient-reported outcomes and back-related health care use. DESIGN: Prospective cohort study. SETTING: Three integrated health systems forming the Back pain Outcomes using Longitudinal Data cohort. PARTICIPANTS: Participants (N=5155) were older adults (≥65y) with a new visit for back pain and a complete electronic health record data. INTERVENTIONS: Not applicable; we obtained OA diagnoses using diagnostic codes in the electronic health record 12 months prior to the new back pain visit. MAIN OUTCOME MEASURES: The Roland-Morris Disability Questionnaire (RDQ) and the EuroQol-5D (EQ-5D) were key patient-reported outcomes. Health care use, measured by relative-value units (RVUs), was summed for the 12 months after the initial visit. We used linear mixed-effects models to model patient-reported outcomes. We also used generalized linear models to test the association between comorbid knee or hip OA and total back-related RVUs. RESULTS: Of the 5155 participants, 368 (7.1%) had a comorbid knee OA diagnosis, and 94 (1.8%) had a hip OA diagnosis. Of the participants, 4711 (91.4%) had neither knee nor hip OA. In adjusted models, the 12-month RDQ score was 1.23 points higher (95% confidence interval [CI], 0.72-1.74) for patients with knee OA and 1.26 points higher (95% CI, 0.24-2.27) for those with hip OA than those without knee or hip OA, respectively. A lower EQ-5D score was found among participants with knee OA (.02 lower; 95% CI, -.04 to -.01) and hip OA diagnoses (.03 lower; 95% CI, -.05 to -.01) compared with those without knee or hip OA, respectively. Comorbid knee or hip OA was not significantly associated with total 12-month back-related resource use. CONCLUSIONS: Comorbid knee or hip OA in older adults with a new back pain visit was associated with modestly worse long-term disability and health-related quality of life.

Clinical outcomes of early and later physical therapist services for older adults with back pain.

BACKGROUND CONTEXT: The timing of physical therapy (PT) services and its association with later function and pain are not clear, especially in older adults. PURPOSE: The purpose of this study was to compare clinical outcomes of patients receiving early or later PT services with those not receiving PT among older adults presenting to primary care for a new visit for back pain. STUDY DESIGN/SETTING: Prospective cohort study using the Back Pain Outcomes Using Longitudinal Data registry. PATIENT SAMPLE: A total of 3,705 adults 65 years and older with a new visit for back pain were included. OUTCOME MEASURES: The outcome measures were Roland-Morris Disability Questionnaire (RMDQ), Pain Numerical Rating Scales, and EuroQol-5D. METHODS: We studied two phases of PT utilization: early (0-28 days) and later (3-6 months). At baseline, we selected the participants with complete 12 months of patient-reported outcomes and electronic medical record data. Early PT was defined as initiating PT less than or equal to 28 days from the index visit for back pain. The no early PT group consisted of patients with no PT, no injections, no surgery, and no chiropractic within 28 days. We restricted the later phase analysis to patients with pain greater than 2 of 10 and an RMDQ score greater than 4 to create a subsample of patients with continuing clinically important back pain. We defined later PT as initiating PT between 3 and 6 months after the index visit. The no later PT group consisted of patients without any PT during this time. We used propensity score matching followed by multiple linear regression to estimate the mean difference in outcome. Sensitivity analysis examined clinically important change and dose of PT use among the early PT group. RESULTS: The early PT group had better functional status with an adjusted mean RMDQ of 1.1 points less than the no early PT group (95% confidence interval: -2.2, -0.1) and less back pain of -0.5 (-0.9, -0.1) at 12 months. There was no difference between early PT groups at 3 and 6 months. The odds of a 30% improvement in function or pain were not different between these matched groups at 12 months, but the early PT group had increased odds of a 50% improvement in function at 12 months (odds ratio: 1.58, 95% confidence interval: 1.04, 2.40). There was no difference between later groups at 12 months. Greater dose of PT use within the early PT group was associated with better functional status (p= .01). CONCLUSIONS: We found that among older adults presenting to their primary care providers for a new episode of back pain, early referral to PT resulted in no or minimal differences in pain, function, or health-related quality at 3, 6, or 12 months compared with a matched group that did not receive early PT. Secondary analysis show that patients initiating early PT may be somewhat more likely to experience 50% improvement in function at 12 months.

The clinical course of pain and function in older adults with a new primary care visit for back pain.

OBJECTIVES: To report the clinical course of older adults presenting for a new primary care visit for back pain, no healthcare visit for back pain within the prior 6 months, by describing pain intensity, disability, pain interference, and resolution of back pain over 12 months. DESIGN: Prospective inception cohort study. SETTING: Primary care settings of three integrated healthcare systems in the United States that participated in the Back pain Outcomes using Longitudinal Data (BOLD) registry. PARTICIPANTS: Five thousand two hundred eleven (99.5%) of the 5,239 adults aged 65 and older who had reached their 12-month follow-up date. MEASUREMENTS: Baseline demographic characteristics, EQ-5D score, duration of back pain, expectation for recovery, depression, and anxiety. Participant-reported outcomes of back-related disability (Roland Morris Disability Questionnaire), numerical pain rating scale, pain interference, and resolution of back pain were collected at baseline and 3, 6, and 12 months. RESULTS: Most improvement occurred within the first 3 months. The number and proportion with 30% improvement in back pain increased from 1,950 (42.3%) at 3 months to 1,994 (44.8%) by 12 months, and 1,331 (28.8%) and 1,576 (35.4%) had 30% improvement in disability at 3 and 12 months. Only 23.0% reported that their back pain had resolved at 12 months. Improvements in disability and interference with activity over 12 months differed according to age, duration of back pain, symptoms of depression and anxiety, and expectation for recovery. CONCLUSION: The majority of older adults in primary care practice settings presenting with a new visit for back pain have persistent symptoms, disability, and interference over 12 months of follow-up. Future research is needed to identify risk factors for persistent symptoms and effective interventions.

Back pain in seniors: the Back pain Outcomes using Longitudinal Data (BOLD) cohort baseline data.

BACKGROUND: Back pain represents a substantial burden globally, ranking first in a recent assessment among causes of years lived with disability. Though back pain is widely studied among working age adults, there are gaps with respect to basic descriptive epidemiology among seniors, especially in the United States. Our goal was to describe how pain, function and health-related quality of life vary by demographic and geographic factors among seniors presenting to primary care providers with new episodes of care for back pain. METHODS: We examined baseline data from the Back pain Outcomes using Longitudinal Data (BOLD) registry, the largest inception cohort to date of seniors presenting to a primary care provider for back pain. The sample included 5,239 patients ≥ 65 years old with a new primary care visit for back pain at three integrated health systems (Northern California Kaiser-Permanente, Henry Ford Health System [Detroit], and Harvard Vanguard Medical Associates [Boston]). We examined differences in patient characteristics across healthcare sites and associations of patient sociodemographic and clinical characteristics with baseline patient-reported measures of pain, function, and health-related quality of life. RESULTS: Patients differed across sites in demographic and other characteristics. The Detroit site had more African-American patients (50%) compared with the other sites (7-8%). The Boston site had more college graduates (68%) compared with Detroit (20%). Female sex, lower educational status, African-American race, and older age were associated with worse functional disability as measured by the Roland-Morris Disability Questionnaire. Except for age, these factors were also associated with worse pain. CONCLUSIONS: Baseline pain and functional impairment varied substantially with a number of factors in the BOLD cohort. Healthcare site was an important factor. After controlling for healthcare site, lower education, female sex, African-American race, and older age were associated with worse physical disability and all of these factors except age were associated with worse pain. TRIAL REGISTRATION: Clinical Trials.gov NCT01776242; Registration date: June 13, 2012.

Health care utilization and costs associated with adherence to clinical practice guidelines for early magnetic resonance imaging among workers with acute occupational low back pain.

OBJECTIVE: To estimate health care utilization and costs associated with adherence to clinical practice guidelines for the use of early magnetic resonance imaging (MRI; within the first 6 weeks of injury) for acute occupational low back pain (LBP). DATA SOURCES: Washington State Disability Risk Identification Study Cohort (D-RISC), consisting of administrative claims and patient interview data from workers' compensation claimants (2002-2004). STUDY DESIGN: In this prospective, population-based cohort study, we compared health care utilization and costs among workers whose imaging was adherent to guidelines (no early MRI) to workers whose imaging was not adherent to guidelines (early MRI in the absence of red flags). DATA COLLECTION/EXTRACTION METHODS: We identified workers (age>18) with work-related LBP using administrative claims. We obtained demographic, injury, health, and employment information through telephone interviews to adjust for baseline differences between groups. We ascertained health care utilization and costs from administrative claims for 1 year following injury. PRINCIPAL FINDINGS: Of 1,770 workers, 336 (19.0 percent) were classified as nonadherent to guidelines. Outpatient and physical/occupational therapy utilization was 52-54 percent higher for workers whose imaging was not adherent to guidelines compared to workers with guideline-adherent imaging; utilization of chiropractic care was significantly lower (18 percent). CONCLUSIONS: Nonadherence to guidelines for early MRI was associated with increased likelihood of lumbosacral injections or surgery and higher costs for out-patient, inpatient, and nonmedical services, and disability compensation.

Study protocol: the Back Pain Outcomes using Longitudinal Data (BOLD) registry.

BACKGROUND: Back pain is one of the most important causes of functional limitation, disability, and utilization of health care resources for adults of all ages, but especially among older adults. Despite the high prevalence of back pain in this population, important questions remain unanswered regarding the comparative effectiveness of commonly used diagnostic tests and treatments in the elderly. The overall goal of the Back pain Outcomes using Longitudinal Data (BOLD) project is to establish a rich, sustainable registry to describe the natural history and evaluate prospectively the effectiveness, safety, and cost-effectiveness of interventions for patients 65 and older with back pain. METHODS/DESIGN: BOLD is enrolling 5,000 patients ≥ 65 years old who present to a primary care physician with a new episode of back pain. We are recruiting study participants from three integrated health systems (Kaiser-Permanente Northern California, Henry Ford Health System in Detroit and Harvard Vanguard Medical Associates/ Harvard Pilgrim Health Care in Boston). Registry patients complete validated, standardized measures of pain, back pain-related disability, and health-related quality of life at enrollment and 3, 6 and 12 months later. We also have available for analysis the clinical and administrative data in the participating health systems' electronic medical records. Using registry data, we will conduct an observational cohort study of early imaging compared to no early imaging among patients with new episodes of back pain. The aims are to: 1) identify predictors of early imaging and; 2) compare pain, functional outcomes, diagnostic testing and treatment utilization of patients who receive early imaging versus patients who do not receive early imaging. In terms of predictors, we will examine patient factors as well as physician factors. DISCUSSION: By establishing the BOLD registry, we are creating a resource that contains patient-reported outcome measures as well as electronic medical record data for elderly patients with back pain. The richness of our data will allow better matching for comparative effectiveness studies than is currently possible with existing datasets. BOLD will enrich the existing knowledge base regarding back pain in the elderly to help clinicians and patients make informed, evidence-based decisions regarding their care.

Factors associated with early magnetic resonance imaging utilization for acute occupational low back pain: a population-based study from Washington State workers' compensation.

STUDY DESIGN: A population-based, prospective cohort study. OBJECTIVE: To identify demographic, job-related, psychosocial, and clinical factors associated with the use of magnetic resonance imaging (MRI) within 6 weeks from injury (early MRI) among workers' compensation claimants with acute occupational low back pain (LBP). SUMMARY OF BACKGROUND DATA: Early MRI may be associated with increased use of services for treatment and costs. To understand utilization and most appropriately apply guidelines, it is important to identify factors associated with early imaging use for occupational LBP. METHODS: Workers (N = 1830) were interviewed 3 weeks (median) after submitting a workers' compensation claim for a back injury. Demographic, work, health, clinical, and injury characteristics were ascertained from interviews, medical records, and administrative data. Modified Poisson regression analyses identified factors associated with early MRI use. RESULTS: Among respondents, 362 (19.8%) received an early MRI. Multivariable regression showed that male workers were 43% more likely to receive an early MRI than female workers (incident rate ratio [IRR]: 1.43, 95% confidence interval [CI]: 1.12-1.82). Initial visit type with a surgeon was associated with 78% greater likelihood of receiving an early MRI than that with a primary care physician (IRR: 1.78, 95% CI: 1.08-2.92). Having a chiropractor as the initial provider was associated with a reduced likelihood of early MRI (IRR: 0.53, 95% CI: 0.42-0.66). Workers with elevated work fear-avoidance, higher Roland scores, or increased injury severity were more likely to receive early MRI than counterparts with lower levels or scores. CONCLUSION: Nearly 20% of the injured workers with LBP receive early MRI, a rate similar to that reported elsewhere. Early MRI may lead to greater subsequent interventions, potentially poorer outcomes, and increased health care expenditures. On the basis of the characteristics of patients with uncomplicated occupational LBP, providers may be able to provide tailored care, and providers and policy makers may better understand the utilization of imaging and adherence to clinical guidelines.

INvestigational Vertebroplasty Efficacy and Safety Trial (INVEST): a randomized controlled trial of percutaneous vertebroplasty.

BACKGROUND: The treatment of painful osteoporotic vertebral compression fractures has historically been limited to several weeks of bed rest, anti-inflammatory and analgesic medications, calcitonin injections, or external bracing. Percutaneous vertebroplasty (the injection of bone cement into the fractured vertebral body) is a relatively new procedure used to treat these fractures. There is increasing interest to examine the efficacy and safety of percutaneous vertebroplasty and to study the possibility of a placebo effect or whether the pain relief is from local anesthetics placed directly on the bone during the vertebroplasty procedure. METHODS/DESIGNS: Our goal is to test the hypothesis that patients with painful osteoporotic vertebral compression fractures who undergo vertebroplasty have less disability and pain at 1 month than patients who undergo a control intervention. The control intervention is placement of local anesthesia near the fracture, without placement of cement. One hundred sixty-six patients with painful osteoporotic vertebral compression fractures will be recruited over 5 years from US and foreign sites performing the vertebroplasty procedure. We will exclude patients with malignant tumor deposit (multiple myeloma), tumor mass or tumor extension into the epidural space at the level of the fracture. We will randomly assign participants to receive either vertebroplasty or the control intervention. Subjects will complete a battery of validated, standardized measures of pain, functional disability, and health related quality of life at baseline and at post-randomization time points (days 1, 2, 3, and 14, and months 1, 3, 6, and 12). Both subjects and research interviewers performing the follow-up assessments will be blinded to the randomization assignment. Subjects will have a clinic visit at months 1 and 12. Spine X-rays will be obtained at the end of the study (month 12) to determine subsequent fracture rates. Our co-primary outcomes are the modified Roland score and pain numerical rating scale at 1 month. DISCUSSION: Although extensively utilized throughout North America for palliation of pain, vertebroplasty still has not undergone rigorous study. The study outlined above represents the first randomized, controlled study that can account for a placebo effect in the setting of vertebroplasty. TRIAL REGISTRATION: Current Controlled Trials ISRCTN81871888.