Serum cortisol level to screen for significant hypothalamic-pituitary-adrenal axis suppression in patients receiving multiple steroid injections.

BACKGROUND: Morning serum cortisol level (mSCL) is a practical screening tool for hypothalamic-pituitary-adrenal (HPA) axis suppression and has been used to assess for duration of cortisol deficiency after epidural and peripheral glucocorticoid injections. More evidence is needed to establish the utility of mSCL in patients undergoing repeat injections with increasing cumulative glucocorticoid equivalent dose (CGED) that could place them at higher risk of HPA axis suppression. OBJECTIVES: To estimate the prevalence of spine injection candidates with significant HPA axis suppression (sigAS), to understand the correlation between 12 months of CGED and the presence of sigAS based on the timing of mSCL collection after the most recent glucocorticoid injection (within 6 weeks or between 6 weeks and 12 months), and to investigate demographic and clinical factors relating to sigAS. METHODS: Retrospective chart review of patients scheduled for spine injection who had an associated mSCL and documented histories of prior glucocorticoid injections. The steroid name, dose, type, and procedure location were recorded for each injection that occurred within 12 months before mSCL. CGED was calculated from standard glucocorticoid equivalent conversion factors. RESULTS: SigAS was present in 7.8% to 22% of the analysis cohorts. There was no association found between CGED and sigAS regardless of timing of mSCL. There was a trend toward lower mSCL and sigAS with increasing CGED. There were no significant relationships found between sigAS and overall demographic or clinical factors. CONCLUSIONS: A 3-fold reduction in the rate of sigAS was noted 6 weeks after the most recent steroid injection. Using mSCL provides a template to investigate the impact of CGED and the best timing for mSCL collection in order to define a more practical guideline to identify patients at higher risk of sigAS earlier and plan for future spine injections.

Feasibility and acceptability of a telemedicine triage model among Medicaid patients with low back pain referred to a spine center.

Background: The data for primary triage via telemedicine for spine related conditions are sparse but has potential to improve access, quality of care, and offer significant cost savings for Medicaid insured patients who have very limited access to care. The purpose of this study was to evaluate the feasibility and acceptability of implementing a telehealth triage framework using synchronous video conferencing appointments. Methods: This is a prospective cohort feasibility study conducted within an academic spine center in the United States. Participants include Medicaid insured patients referred to an academic spine center for low back pain. We collected demographic information, a spine red flag survey, a patient satisfaction survey and demand and implementation feasibility metrics. Participants completed a demographic and red-flag survey followed by a telehealth spine appointment with a physiatrist. Immediately after the appointment, the participant completed a satisfaction survey. Results: Nineteen patients met inclusion criteria but declined telehealth either due to preference for in-person appointment or lack of comfort with technology. Thirty-three participants enrolled and attended their initial telehealth appointment. Few participants reporting 1 or more red flag symptom also screened positive during their subsequent telehealth evaluation with the physician (n=7/28). Participant satisfaction was high across all domains including ease of scheduling, efficiency of virtual check in, ability to report their symptoms fully and accurately to the provider, imaging review, explanation of diagnosis and treatment plan. Most participants (n=19/20, 95%) would recommend an initial telehealth appointment. Conclusions: The telehealth framework used was feasible and provided an acceptable form of care for Medicaid patients who were interested and able to participate in this form of care. Our acceptability results are promising but should be interpreted with caution given the proportion of patients who declined to participate.

The utility of magnetic resonance imaging results in physician decision-making before initial lumbar spinal injection.

BACKGROUND CONTEXT: The need for advanced imaging before spinal intervention is an area of ongoing debate. Many studies have demonstrated the accuracy of magnetic resonance imaging (MRI) results in evaluating structural pathology in the lumbar spine, but few have addressed how frequently MRI findings change clinical management. A randomized controlled trial showed that viewing MRI results did not impact outcomes in patients with radiculopathy undergoing epidural steroid injection (ESI). The results suggested ESIs that correlated with both imaging and clinical findings experienced slightly more benefit than the blinded cohort, although statistically insignificantly. PURPOSE: Three related studies were conducted to (1) increase understanding of the opinions of interventional spine physicians regarding the utility of viewing imaging before injection and (2) evaluate the impact of viewing MRI results on injection planning (retrospective and prospective analyses). STUDY DESIGN: Survey, prospective, and retrospective analysis. PATIENT SAMPLE: Patients presenting to a university-based spine center for initial evaluation of back or leg pain who were candidates for spinal intervention. OUTCOME MEASURES: Self-reported measures from a clinical practice questionnaire distributed to interventional spine physicians to determine rates and rationale for utilization of MRI before spine injection, physiologic measures including MRI results, functional measures including physician decision-making regarding type and location of injection performed. METHODS: This study was funded by the University of Colorado Health and Welfare Trust. A survey was sent to interventional spine physicians to assess their utilization of MRI results before spine procedures. A retrospective analysis of patients who were candidates for ESI was conducted to evaluate how initial injection plan compared with the postviewing of MRI results on injection performed. In a prospective analysis, injection plans pre- and post-MRI were compared among patients presenting for initial evaluation of low back or leg pain. RESULTS: Survey responses showed that specialists order MRI studies to correlate with physical exam (91%) and to detect the presence of synovial cysts (68%), whereas tumor/infection (93%) was most likely to cause a change in their approach. In the retrospective review, the physician's planned approach before viewing the MRI was concordant with the actual procedure 49% of the time. A different type of procedure was performed in 15% of planned injections. In such cases, the initial treatment plan was altered (ie, same procedure at a different or additional level or side) in 35% of planned injections. In the prospective data collection, 43% of injections were different from the initial physician decision. The most common reasons for altering the injection was different level affected (36%), facet pathology (22%), and different nerve root affected (16%). CONCLUSIONS: In clinical practice, MRI before injection frequently changes management decisions in the planning and delivery of lumbar spine injections.

Effectiveness of Physical Therapy Combined With Epidural Steroid Injection for Individuals With Lumbar Spinal Stenosis: A Randomized Parallel-Group Trial.

OBJECTIVE: To examine the effectiveness of epidural steroid injection (ESI) and back education with and without physical therapy (PT) in individuals with lumbar spinal stenosis (LSS). DESIGN: Randomized clinical trial. SETTING: Orthopedic spine clinics. PARTICIPANTS: A total of 390 individuals were screened with 60 eligible and randomly selected to receive ESI and education with or without PT (N=54). INTERVENTIONS: A total of 54 individuals received 1-3 injections and education in a 10-week intervention period, with 31 receiving injections and education only (ESI) and 23 additionally receiving 8-10 sessions of multimodal PT (ESI+PT). MAIN OUTCOME MEASURES: Disability, pain, quality of life, and global rating of change were collected at 10 weeks, 6 months, and 1 year and analyzed using linear mixed model analysis. RESULTS: No significant difference was found between ESI and ESI+PT in the Oswestry Disability Index at any time point, although the sample had significant improvements at 10 weeks (P<.001; 95% confidence interval [CI], -18.01 to -5.51) and 1 year (P=.01; 95% CI, -14.57 to -2.03) above minimal clinically important difference. Significant differences in the RAND 36-Item Short Form Health Survey 1.0 were found for ESI+PT at 10 weeks with higher emotional role function (P=.03; 95% CI, -49.05 to -8.01), emotional well-being (P=.02; 95% CI, -19.52 to -2.99), and general health perception (P=.05; 95% CI, -17.20 to -.78). CONCLUSIONS: Epidural steroid injection plus PT was not superior to ESI alone for reducing disability in individuals with LSS. Significant benefit was found for the addition of PT related to quality of life factors of emotional function, emotional well-being, and perception of general health.

Clinical Course of Motor Deficits from Lumbosacral Radiculopathy Due to Disk Herniation.

BACKGROUND: The clinical course of motor deficits from lumbosacral radiculopathy appears to improve with or without surgery. Strength measurements have been confined to manual muscle testing (MMT) and have not been extensively followed and quantified in prior studies. OBJECTIVE: To determine if motor weakness and patient-reported outcomes related to lumbosacral radiculopathy improve without surgical intervention over the course of 12 months. DESIGN: Prospective observational cohort. SETTING: Outpatient academic spine practice. PARTICIPANTS: Adults with acute radicular weakness due to disk herniation. METHODS: Forty patients with radiculopathy and strength deficit were followed over a 12-month period. Objective strength and performance tests as well as survey-based measurements were collected at baseline and then every 3 months. Patients underwent comprehensive pain management and rehabilitation and/or surgical approaches as determined in coordination with the treating specialist. This study was approved by the institutional review board of Colorado. MAIN OUTCOME MEASUREMENTS: Testing of strength was through MMT, handheld dynamometer, and performance-based testing. Furthermore, visual analog scale, modified Oswestry Disability Index, and 36-Item Short Form Health Survey (SF-36) were used to measure pain and disability outcomes. RESULTS: Of the 40 patients, 33 (82.5%) did not have surgery; 7 (17.5%) had surgery. Twenty-four of the 33 patients (60%) did not undergo surgery and were followed for 12 months (Comprehensive Pain Management and Rehabilitation, Complete [CPM&R-C]), and 9 (22%) did not have surgery and lacked at least one follow-up evaluation (Comprehensive Pain Management and Rehabilitation, Incomplete [CPM&R-I]). No statistically significant differences were found on baseline measures of strength deficits and SF-36 domains between the CPM&R-C, Surgery, and CPM&R-I groups. Pain and disability scores in the Surgery group were significantly higher than in the CPM&R-C at baseline. There were statistically significant improvements in all areas of strength, pain, and function when comparing measurements at the 12-month follow-up to baseline in the CPM&R-C group. CONCLUSIONS: Individuals with motor deficits due to lumbosacral radiculopathy improve over time regardless of treatment choice. Most did not choose surgery, and almost all of these patients regained full strength at 1 year. Strength recovery typically occurred in the first 3 months, but there was ongoing recovery over the course of a year. LEVEL OF EVIDENCE: II.

Systemic effects of epidural steroid injections for spinal stenosis.

This analysis of the lumbar epidural steroid injections for spinal stenosis multicenter randomized controlled trial data identifies the degree of and risk factors for cortisol suppression after epidural steroid injections in older adults with spinal stenosis. Four hundred patients aged 50 years and older with back or leg pain and central lumbar spinal stenosis completed baseline demographic and psychosocial measures. Morning serum cortisol levels were measured at baseline and 3 weeks after initial injection. Patients were randomized to receive epidural injections of either local anesthetic with corticosteroid (n = 200) or local anesthetic only (n = 200). The specific corticosteroid was chosen at the treating physician's discretion (methylprednisolone, betamethasone, triamcinolone, or dexamethasone). Thirty-two patients (20.3%) treated with corticosteroid experienced cortisol reduction at 3 weeks of >50% compared with 10 patients (6.7%) treated with lidocaine only (adjusted treatment effect = 3.5, 95% confidence interval: 1.6-7.9, P = 0.002). The effect on 3-week cortisol changes did not differ by demographic or patient-level characteristics. Those treated with methylprednisolone or triamcinolone had an average 3-week cortisol reduction of 41.0% (P = 0.005) and 41.6% (P < 0.001) from baseline, respectively, whereas patients treated with betamethasone or dexamethasone were not significantly different than comparable patients in the lidocaine arm. The higher rates of cortisol suppression at 3 weeks in those receiving epidural corticosteroid injections, particularly with longer-acting insoluble corticosteroid formulations, are consistent with sustained systemic absorption of corticosteroid.

Reliability and Practicality of the Core Score: Four Dynamic Core Stability Tests Performed in a Physician Office Setting.

OBJECTIVE: Pilot study to determine the practicality and inter-rater reliability of the "Core Score," a composite measure of 4 clinical core stability tests. DESIGN: Repeated measures. SETTING: Academic hospital physician clinic. PARTICIPANTS: 23 healthy volunteers with mean age of 32 years (12 females, 11 males). ASSESSMENT OF VARIABLES: All subjects performed 4 core stability maneuvers under direct observation from 3 independent physicians in sequence. MAIN OUTCOME MEASURES: Inter-rater reliability and time necessary to perform examination. RESULTS: The Core Score scale is 0 to 12, with 12 reflecting the best core stability. The mean composite score of all 4 tests for all subjects was 9.54 (SD, 1.897; range, 4-12). The intraclass correlation coefficients (ICC 1,1) for inter-rater reliability for the composite Core Score and 4 individual tests were 0.68 (Core Score), 0.14 (single-leg squat), 0.40 (supine bridge), 0.69 (side bridge), and 0.46 (prone bridge). The time required for a single examiner to assess a given subject's core stability in all 4 maneuvers averaged 4 minutes (range, 2-6 minutes). CONCLUSIONS: Even without specialized equipment, a clinically practical and moderately reliable measure of core stability may be possible. Further research is necessary to optimize this measure for clinical application. CLINICAL RELEVANCE: Despite the known value of core stability to athletes and patients with low back pain, there is currently no reliable and practical means for rating core stability in a typical office-based practice. This pilot study provides a starting point for future reliability research on clinical core stability assessments.

Scoping review to develop common data elements for lumbar spinal stenosis.

BACKGROUND CONTEXT: Common data elements (CDE) represent an important tool for understanding and classifying health outcomes across settings. Although CDEs have been developed for a number of disorders, to date CDEs for lumbar spinal stenosis (LSS) have not been fully developed. To facilitate the identification of CDEs and measures to assess them, this technical study leverages the International Classification of Functioning, Disability and Health (ICF), peer-reviewed research, and a panel of experts to identify CDEs specific to LSS. PURPOSE: The study aimed to define CDEs for disease characteristics and outcomes of LSS using the World Health Organization's ICF taxonomy, and to facilitate the selection of assessment instruments for research and clinical care. DESIGN: This is a scoping review using a modified Delphi approach with a technical expert panel composed of clinicians and scientists representing the academia, policy and advocacy stakeholders, and professional associations with expertise in LSS. METHODS: This is a scoping review to identify measures that assess LSS symptoms. Thirty-one subject matter experts (SMEs) prioritized ICF codes and evaluated instruments measuring specific domains. We used a modified Delphi technique to evaluate item-level content and achieve consensus. RESULTS: SMEs prioritized 53 ICF codes; 3 received 100% endorsement, 27 received ≥90% endorsement, whereas the remaining 23 received ≥80% endorsement. Prioritized ICF codes represent diverse domains, including pain, activities and participation, and emotional well-being. The review yielded 58 instruments; we retained 24 for content analysis. CONCLUSIONS: The retained instruments adequately represent the ICFs activities and participation, and body function domains. Body structure and environmental factors were assessed infrequently. Adoption of these CDEs may guide clinical decision making and facilitate comparative effectiveness trials for interventions focused on LSS.

Long-Term Effects of Repeated Injections of Local Anesthetic With or Without Corticosteroid for Lumbar Spinal Stenosis: A Randomized Trial.

OBJECTIVE: To determine the overall long-term effectiveness of treatment with epidural corticosteroid injections for lumbar central spinal stenosis and the effect of repeat injections, including crossover injections, on outcomes through 12 months. DESIGN: Multicenter, double-blind, randomized controlled trial comparing epidural injections of corticosteroid plus lidocaine versus lidocaine alone. SETTING: Sixteen clinical sites. PARTICIPANTS: Participants with imaging-confirmed lumbar central spinal stenosis (N=400). INTERVENTIONS: Participants were randomized to receive either epidural injections with corticosteroid plus lidocaine or lidocaine alone with the option of blinded crossover after 6 weeks to receive the alternate treatment. Participants could receive 1 to 2 injections from 0 to 6 weeks and up to 2 injections from 6 to 12 weeks. After 12 weeks, participants received usual care. MAIN OUTCOME MEASURES: Primary outcomes were the Roland-Morris Disability Questionnaire (RDQ) (range, 0-24, where higher scores indicate greater disability) and leg pain intensity (range, 0 [no pain] to 10 [pain as bad as you can imagine]). Secondary outcomes included opioid use, spine surgery, and crossover rates. RESULTS: At 12 months, both treatment groups maintained initial observed improvements, with no significant differences between groups on the RDQ (adjusted mean difference, -0.4; 95% confidence interval [CI], -1.6 to 0.9; P=.55), leg pain (adjusted mean difference, 0.1; 95% CI, -0.5 to 0.7; P=.75), opioid use (corticosteroid plus lidocaine: 41.4% vs lidocaine alone: 36.3%; P=.41), or spine surgery (corticosteroid plus lidocaine: 16.8% vs lidocaine alone: 11.8%; P=.22). Fewer participants randomized to corticosteroid plus lidocaine (30%, n=60) versus lidocaine alone (45%, n=90) crossed over after 6 weeks (P=.003). Among participants who crossed over at 6 weeks, the 6- to 12-week RDQ change did not differ between the 2 randomized treatment groups (adjusted mean difference, -1.0; 95% CI, -2.6 to 0.7; P=.24). In both groups, participants crossing over at 6 weeks had worse 12-month trajectories compared with participants who did not choose to crossover. CONCLUSIONS: For lumbar spinal stenosis symptoms, epidural injections of corticosteroid plus lidocaine offered no benefits from 6 weeks to 12 months beyond that of injections of lidocaine alone in terms of self-reported pain and function or reduction in use of opioids and spine surgery. In patients with improved pain and function 6 weeks after initial injection, these outcomes were maintained at 12 months. However, the trajectories of pain and function outcomes after 3 weeks did not differ by injectate type. Repeated injections of either type offered no additional long-term benefit if injections in the first 6 weeks did not improve pain.

Descriptive Analysis of Spinal Neuroaxial Injections, Surgical Interventions, and Physical Therapy Utilization for Degenerative Lumbar Spondylolisthesis Within Medicare Beneficiaries from 2000 to 2011.

STUDY DESIGN: A retrospective, observational study. OBJECTIVE: The aim of this study was to determine the utilization of various treatment modalities in the management of degenerative spondylolisthesis within Medicare beneficiaries. SUMMARY OF BACKGROUND DATA: Degenerative lumbar spondylolisthesis is a condition often identified in symptomatic low back pain. A variety of treatment algorithms including physical therapy and interventional techniques can be used to manage clinically significant degenerative spondylolisthesis. METHODS: This study utilized the 5% national sample of Medicare carrier claims from 2000 through 2011. A cohort of beneficiaries with a new International Classification of Diseases 9th edition (ICD-9) diagnosis code for degenerative lumbar spondylolisthesis was identified. Current procedural terminology codes were used to identify the number of procedures performed each year by specialty on this cohort. RESULTS: A total of 95,647 individuals were included in the analysis. Average age at the time of initial diagnosis was 72.8 ±â€Š9.8 years. Within this study cohort, spondylolisthesis was more prevalent in females (69%) than males and in Caucasians (88%) than other racial demographics. Over 50% of beneficiaries underwent at least one injection, approximately one-third (37%) participated in physical therapy, one in five (21%) underwent spinal surgery, and one-third (36%) did not utilize any of these interventions. Greater than half of all procedures (124,280/216,088) occurred within 2 years of diagnosis. The ratio of focal interventions (transforaminal and facet interventions) to less selective (interlaminar) procedures was greater for the specialty of Physical Medicine and Rehabilitation than for the specialties of Anesthesiology, Interventional Radiology, Neurosurgery, and Orthopedic Surgery. The majority of physical therapy was dedicated to passive treatment modalities and range of motion exercises rather than active strengthening modalities within this cohort. CONCLUSION: Interventional techniques and physical therapy are frequently used treatment modalities for symptomatic degenerative spondylolisthesis. Understanding utilization of these techniques is important to determine relative clinical efficacies and to optimize future health care expenditures. LEVEL OF EVIDENCE: N/A.

Conservative Care in Lumbar Spine Surgery Trials: A Descriptive Literature Review.

OBJECTIVE: To evaluate the degree to which conservative care and failure were specifically defined in studies comparing nonoperative treatment versus surgery for low back pain (LBP) conditions in adults. DATA SOURCES: A comprehensive literature search was conducted by an experienced librarian using MEDLINE (PubMed), Embase, Google Scholar, and CENTRAL from January 2003 to June 2014. Endnote bibliographic management application was used to remove duplicates and organize the citations. STUDY SELECTION: Prospective, randomized, or cohort trials comparing surgery versus conservative intervention for patients with LBP conditions. Study selection was conducted by 2 independent reviewers. DATA EXTRACTION: Three independent reviewers extracted data from each article using a structured data extraction form. Data extracted included type of study, participant characteristics, sample size, description, and duration of conservative care and whether failed conservative care criterion was defined. DATA SYNTHESIS: A total of 852 unique records were screened for eligibility; of those, 72 articles were identified for further full-text review. Thirty-four full texts were excluded based on the exclusion criteria, and 38 articles, representing 20 unique studies, were included for qualitative synthesis. Fifteen of the 20 studies defined the duration of conservative care. Only 3 studies defined the dosage of physical therapy sessions, including total number of visits and visit duration. Two studies described medication usage, including the duration and type. No studies specifically defined what constituted failed conservative therapy. CONCLUSIONS: This literature review suggests conservative care is poorly defined in randomized trials, which can lead to ambiguity of research procedures and unclear guidelines for clinicians. Future studies should increase transparency and explicitly define conservative care.

Physical Medicine and Rehabilitation Resident Use of iPad Mini Mobile Devices.

BACKGROUND: Previous research on the use of tablet devices in residency programs has been undertaken in radiology and medicine or with standard-sized tablet devices. With new, smaller tablet devices, there is an opportunity to assess their effect on resident behavior. This prospective study attempts to evaluate resident behavior after receiving a smaller tablet device. OBJECTIVE: To evaluate whether smaller tablet computers facilitate residents' daily tasks. DESIGN: Prospective study that administered surveys to evaluate tablet computer use. SETTING: Residency program. PARTICIPANTS: Thirteen physical medicine and rehabilitation residents. METHODS: Residents were provided 16-GB iPad Minis and surveyed with Redcap to collect usage information at baseline, 3, and 6 months. Survey analysis was conducted using SAS (SAS, Cary, NC) for descriptive analysis. MAIN OUTCOME MEASUREMENTS: To evaluate multiple areas of resident education, the following tasks were selected: accessing e-mail, logging duty hours, logging procedures, researching clinical information, accessing medical journals, reviewing didactic presentations, and completing evaluations. Then, measurements were taken of: (1) residents' response to how tablet computers made it easier to access the aforementioned tasks; and (2) residents' response to how tablet computers affected the frequency they performed the aforementioned tasks. RESULTS: After being provided tablet computers, our physical medicine and rehabilitation residents reported significantly greater access to e-mail, medical journals, and didactic material. Also, receiving tablet computers was reported to increase the frequency that residents accessed e-mail, researched clinical information, accessed medical journals, reviewed didactic presentations, and completed evaluations. After receiving a tablet computer, residents reported an increase in the use of calendar programs, note-taking programs, PDF readers, online storage programs, and file organization programs. CONCLUSIONS: These physical medicine and rehabilitation residents reported tablet computers increased access to e-mail, presentation material, and medical journals. Tablet computers also were reported to increase the frequency residents were able to complete tasks associated with residency training.

A randomized trial of epidural glucocorticoid injections for spinal stenosis.

BACKGROUND: 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. METHODS: In a double-blind, multisite trial, we randomly assigned 400 patients who had lumbar central spinal stenosis and moderate-to-severe leg pain and disability to receive epidural injections of glucocorticoids plus lidocaine or lidocaine alone. The patients received one or two injections before the primary outcome evaluation, performed 6 weeks after randomization and the first injection. The primary outcomes were the score on the Roland-Morris Disability Questionnaire (RMDQ, in which scores range from 0 to 24, with higher scores indicating greater physical disability) and the rating of the intensity of leg pain (on a scale from 0 to 10, with 0 indicating no pain and 10 indicating "pain as bad as you can imagine"). RESULTS: At 6 weeks, there were no significant between-group differences in the RMDQ score (adjusted difference in the average treatment effect between the glucocorticoid-lidocaine group and the lidocaine-alone group, -1.0 points; 95% confidence interval [CI], -2.1 to 0.1; P=0.07) or the intensity of leg pain (adjusted difference in the average treatment effect, -0.2 points; 95% CI, -0.8 to 0.4; P=0.48). A prespecified secondary subgroup analysis with stratification according to type of injection (interlaminar vs. transforaminal) likewise showed no significant differences at 6 weeks. CONCLUSIONS: In the treatment of lumbar spinal stenosis, epidural injection of glucocorticoids plus lidocaine offered minimal or no short-term benefit as compared with epidural injection of lidocaine alone. (Funded by the Agency for Healthcare Research and Quality; ClinicalTrials.gov number, NCT01238536.).