[Show abstract][Hide abstract] ABSTRACT: Epidural glucocorticoid injections are widely used to treat symptoms of lumbar spinal stenosis, a common cause of pain and disability in older adults. However, rigorous data are lacking regarding the effectiveness and safety of these injections.
New England Journal of Medicine 07/2014; 371(1):11-21. · 54.42 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: 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.
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.
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.
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.
[Show abstract][Hide abstract] ABSTRACT: PURPOSE
To describe how pain, functional status and health related quality-of-life vary by demographic factors among seniors presenting to primary care providers with new episodes of low back pain.
METHOD AND MATERIALS
We enrolled patients ≥ 65 years old who presented to a primary care provider with a new episode of back pain. We recruited study participants from three integrated health systems (Kaiser-P N CA, Henry Ford-Detroit and Harvard Vanguard Med Assoc -Boston). Baseline measures included: 1) Roland-Morris Disability Questionnaire (RMDQ); 2) 0-10 pain numerical rating scales (NRS); 3) Brief Pain Inventory (BPI); 4) Patient Health Questionnaire (PHQ)-4; 5) EuroQol-5D (EQ5D); 6) Pain duration; 7) Patient expectations. We examined demographic characteristics, comparing the three recruitment sites. We used the chi-square test to compare categorical variables and unpaired t-tests to compare numerical variables and the Mann-Whitney U-test when appropriate.
We enrolled 5,288 patients. RMDQ had a small increase with age, from a mean (SD) of 9.1(6.6) at ages 65-69 to a mean of 10.7(6.1) for those greater than 85. The average pain duration also increased with age (32% of those 65-69 having had pain of more than a year compared with 44% >85). The oldest age group had slightly lower confidence (4.9(3.7) vs. 5.6(3.7)) that they would be pain-free or substantially improved by 3 months. African American (AA) patients were worse on most baseline measures of function and pain. Eg: the mean/median RMDQ scores were 12.1/13 in AAs compared with 8.8/8 for Caucasians. Because over 50% of AAs were at Detroit, confounding by site may be a factor. However, within a given site, AAs had worse scores than Caucasians by more than 1 point on the Roland scale There were substantial differences between sites with respect to potentially important prognostic demographic factors and baseline reported measures.
We observed substantial differences of our baseline measures between sites, emphasizing the need for caution when pooling results from a multicenter study. African-Americans appeared to have worse back-related health status in our cohort although confounding by site was present.
There is great heterogenity between sites with respect to baseline characteristics of seniors with back pain. Worse health status among African-Americans may be explained, in part, by site factors.
Radiological Society of North America 2013 Scientific Assembly and Annual Meeting; 12/2013
[Show abstract][Hide abstract] ABSTRACT: 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.
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.
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.
[Show abstract][Hide abstract] ABSTRACT: Lumbar spinal stenosis is one of the most common causes of low back pain among older adults and can cause significant disability. Despite its prevalence, treatment of spinal stenosis symptoms remains controversial. Epidural steroid injections are used with increasing frequency as a less invasive, potentially safer, and more cost-effective treatment than surgery. However, there is a lack of data to judge the effectiveness and safety of epidural steroid injections for spinal stenosis. We describe our prospective, double-blind, randomized controlled trial that tests the hypothesis that epidural injections with steroids plus local anesthetic are more effective than epidural injections of local anesthetic alone in improving pain and function among older adults with lumbar spinal stenosis.
We will recruit up to 400 patients with lumbar central canal spinal stenosis from at least 9 clinical sites over 2 years. Patients with spinal instability who require surgical fusion, a history of prior lumbar surgery, or prior epidural steroid injection within the past 6 months are excluded. Participants are randomly assigned to receive either ESI with local anesthetic or the control intervention (epidural injections with local anesthetic alone). Subjects receive up to 2 injections prior to the primary endpoint at 6 weeks, at which time they may choose to crossover to the other intervention.Participants complete validated, standardized measures of pain, functional disability, and health-related quality of life at baseline and at 3 weeks, 6 weeks, and 3, 6, and 12 months after randomization. The primary outcomes are Roland-Morris Disability Questionnaire and a numerical rating scale measure of pain intensity at 6 weeks. In order to better understand their safety, we also measure cortisol, HbA1c, fasting blood glucose, weight, and blood pressure at baseline, and at 3 and 6 weeks post-injection. We also obtain data on resource utilization and costs to assess cost-effectiveness of epidural steroid injection.
This study is the first multi-center, double-blind RCT to evaluate the effectiveness of epidural steroid injections in improving pain and function among older adults with lumbar spinal stenosis. The study will also yield data on the safety and cost-effectiveness of this procedure for older adults.