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1.  Prediction of chronic disability in work-related musculoskeletal disorders: a prospective, population-based study 
Background
Disability associated with work-related musculoskeletal disorders is an increasingly serious societal problem. Although most injured workers return quickly to work, a substantial number do not. The costs of chronic disability to the injured worker, his or her family, employers, and society are enormous. A means of accurate early identification of injured workers at risk for chronic disability could enable these individuals to be targeted for early intervention to promote return to work and normal functioning. The purpose of this study is to develop statistical models that accurately predict chronic work disability from data obtained from administrative databases and worker interviews soon after a work injury. Based on these models, we will develop a brief instrument that could be administered in medical or workers' compensation settings to screen injured workers for chronic disability risk.
Methods
This is a population-based, prospective study. The study population consists of workers who file claims for work-related back injuries or carpal tunnel syndrome (CTS) in Washington State. The Washington State Department of Labor and Industries claims database is reviewed weekly to identify workers with new claims for work-related back injuries and CTS, and these workers are telephoned and invited to participate. Workers who enroll complete a computer-assisted telephone interview at baseline and one year later. The baseline interview assesses sociodemographic, employment-related, biomedical/health care, legal, and psychosocial risk factors. The follow-up interview assesses pain, disability, and work status. The primary outcome is duration of work disability over the year after claim submission, as assessed by administrative data. Secondary outcomes include work disability status at one year, as assessed by both self-report and work disability compensation status (administrative records). A sample size of 1,800 workers with back injuries and 1,200 with CTS will provide adequate statistical power (0.96 for low back and 0.85 for CTS) to predict disability with an alpha of .05 (two-sided) and a hazard ratio of 1.2. Proportional hazards regression models will be constructed to determine the best combination of predictors of work disability duration at one year. Regression models will also be developed for the secondary outcomes.
doi:10.1186/1471-2474-5-14
PMCID: PMC428578  PMID: 15157280
2.  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.
doi:10.1186/1471-2474-13-64
PMCID: PMC3403933  PMID: 22554166
Low back pain; Registry; Cohort studies; Aged; Primary health care
3.  Study Protocol- Lumbar Epidural Steroid Injections for Spinal Stenosis (LESS): a double-blind randomized controlled trial of epidural steroid injections for lumbar spinal stenosis among older adults 
Background
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.
Methods
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.
Discussion
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.
Trial Registration
Clinicaltrials.gov NCT01238536
doi:10.1186/1471-2474-13-48
PMCID: PMC3349603  PMID: 22458343
4.  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
doi:10.1186/1471-2474-8-126
PMCID: PMC2257946  PMID: 18096050
5.  Towards standardized measurement of adverse events in spine surgery: conceptual model and pilot evaluation 
Background
Independent of efficacy, information on safety of surgical procedures is essential for informed choices. We seek to develop standardized methodology for describing the safety of spinal operations and apply these methods to study lumbar surgery. We present a conceptual model for evaluating the safety of spine surgery and describe development of tools to measure principal components of this model: (1) specifying outcome by explicit criteria for adverse event definition, mode of ascertainment, cause, severity, or preventability, and (2) quantitatively measuring predictors such as patient factors, comorbidity, severity of degenerative spine disease, and invasiveness of spine surgery.
Methods
We created operational definitions for 176 adverse occurrences and established multiple mechanisms for reporting them. We developed new methods to quantify the severity of adverse occurrences, degeneration of lumbar spine, and invasiveness of spinal procedures. Using kappa statistics and intra-class correlation coefficients, we assessed agreement for the following: four reviewers independently coding etiology, preventability, and severity for 141 adverse occurrences, two observers coding lumbar spine degenerative changes in 10 selected cases, and two researchers coding invasiveness of surgery for 50 initial cases.
Results
During the first six months of prospective surveillance, rigorous daily medical record reviews identified 92.6% of the adverse occurrences we recorded, and voluntary reports by providers identified 38.5% (surgeons reported 18.3%, inpatient rounding team reported 23.1%, and conferences discussed 6.1%). Trained observers had fair agreement in classifying etiology of 141 adverse occurrences into 18 categories (kappa = 0.35), but agreement was substantial (kappa ≥ 0.61) for 4 specific categories: technical error, failure in communication, systems failure, and no error. Preventability assessment had moderate agreement (mean weighted kappa = 0.44). Adverse occurrence severity rating had fair agreement (mean weighted kappa = 0.33) when using a scale based on the JCAHO Sentinel Event Policy, but agreement was substantial for severity ratings on a new 11-point numerical severity scale (ICC = 0.74). There was excellent inter-rater agreement for a lumbar degenerative disease severity score (ICC = 0.98) and an index of surgery invasiveness (ICC = 0.99).
Conclusion
Composite measures of disease severity and surgery invasiveness may allow development of risk-adjusted predictive models for adverse events in spine surgery. Standard measures of adverse events and risk adjustment may also facilitate post-marketing surveillance of spinal devices, effectiveness research, and quality improvement.
doi:10.1186/1471-2474-7-53
PMCID: PMC1562418  PMID: 16787537
6.  A prospective cohort study of surgical treatment for back pain with degenerated discs; study protocol 
Background
The diagnosis of discogenic back pain often leads to spinal fusion surgery and may partly explain the recent rapid increase in lumbar fusion operations in the United States. Little is known about how patients undergoing lumbar fusion compare in preoperative physical and psychological function to patients who have degenerative discs, but receive only non-surgical care.
Methods
Our group is implementing a multi-center prospective cohort study to compare patients with presumed discogenic pain who undergo lumbar fusion with those who have non-surgical care. We identify patients with predominant low back pain lasting at least six months, one or two-level disc degeneration confirmed by imaging, and a normal neurological exam. Patients are classified as surgical or non-surgical based on the treatment they receive during the six months following study enrollment.
Results
Three hundred patients discogenic low back pain will be followed in a prospective cohort study for two years. The primary outcome measure is the Modified Roland-Morris Disability Questionnaire at 24-months. We also evaluate several other dimensions of outcome, including pain, functional status, psychological distress, general well-being, and role disability.
Conclusion
The primary aim of this prospective cohort study is to better define the outcomes of lumbar fusion for discogenic back pain as it is practiced in the United States. We additionally aim to identify characteristics that result in better patient selection for surgery. Potential predictors include demographics, work and disability compensation status, initial symptom severity and duration, imaging results, functional status, and psychological distress.
doi:10.1186/1471-2474-6-24
PMCID: PMC1180446  PMID: 15913458
7.  Randomized clinical trial of surgery versus conservative therapy for carpal tunnel syndrome [ISRCTN84286481] 
Background
Conservative treatment remains the standard of care for treating mild to moderate carpal tunnel syndrome despite a small number of well-controlled studies and limited objective evidence to support current treatment options. There is an increasing interest in the usefulness of wrist magnetic resonance imaging could play in predicting who will benefit for various treatments.
Method and design
Two hundred patients with mild to moderate symptoms will be recruited over 3 1/2 years from neurological surgery, primary care, electrodiagnostic clinics. We will exclude patients with clinical or electrodiagnostic evidence of denervation or thenar muscle atrophy.
We will randomly assign patients to either a well-defined conservative care protocol or surgery. The conservative care treatment will include visits with a hand therapist, exercises, a self-care booklet, work modification/ activity restriction, B6 therapy, ultrasound and possible steroid injections. The surgical care would be left up to the surgeon (endoscopic vs. open) with usual and customary follow-up. All patients will receive a wrist MRI at baseline.
Patients will be contacted at 3, 6, 9 and 12 months after randomization to complete the Carpal Tunnel Syndrome Assessment Questionnaire (CTSAQ). In addition, we will compare disability (activity and work days lost) and general well being as measured by the SF-36 version II. We will control for demographics and use psychological measures (SCL-90 somatization and depression scales) as well as EDS and MRI predictors of outcomes.
Discussion
We have designed a randomized controlled trial which will assess the effectiveness of surgery for patients with mild to moderate carpal tunnel syndrome. An important secondary goal is to study the ability of MRI to predict patient outcomes.
doi:10.1186/1471-2474-6-2
PMCID: PMC546190  PMID: 15656907

Results 1-7 (7)