Cervical Epidural Steroid Injection Research Articles

Cervical Epidural Steroid Injections Improves Cervicalgia Greater than Radiculopathy: Efficacy and Safety of Epidural Steroids in a Single-Center Retrospective Study

Cervical Epidural Steroid Injections Improves Cervicalgia Greater than Radiculopathy: Efficacy and Safety of Epidural Steroids in a Single-Center Retrospective Study

The effectiveness of cervical transforaminal epidural steroid injections for the treatment of cervical radicular pain: A prospective cohort study reporting 12-month outcomes

The effectiveness of cervical transforaminal epidural steroid injections for the treatment of cervical radicular pain: A prospective cohort study reporting 12-month outcomes

Long-term effectiveness of transforaminal anterolateral approach CT-guided cervical epidural steroid injections for cervical radiculopathy treatment

To evaluate the long-term clinical effectiveness of computed tomography (CT)-guided transforaminal cervical epidural steroid injection using an anterolateral approach for thetreatment of cervical radiculopathy (CR) using well-established robust clinical scoringsystems for neck pain and neck disability. Despite its widespread use, evidence to support the long-term benefit of routine cervical epidural steroid injection is currently very limited. This study included 113 patients with magnetic resonance imaging (MRI)-confirmed CR who underwent a steroid injection at a single cervical level via a unilateral transforaminal anterolateral approach. Pain was assessed quantitatively at pre-injection, 15 minutes post-injection, 1 month, 3 months, and at 1 year. Neck disability was assessed using the Oswestry Neck Disability Index (NDI) at pre-injection, 1 month, 3 months, and 1 year time points. Eighty patients completed the study. Sixty per cent reported reduced neck pain (mean pain reduction, 55%), which was clinically significant in 45% cases. Furthermore, 66% reported an improvement in neck disability (mean improvement, 51%), which was clinically significant for 56% patients. Clinically significant good outcomes in both neck pain and neck disability were evident from as early as 1-month, and importantly, were independent both of pre-treatment CR characteristics (including severity of pre-injection neck pain or disability) and of findings on pre-injection MRI imaging. Transforaminal anterolateral approach CT-guided epidural steroid injection resulted in a clinically significant long-term improvement in both neck pain and disability for half of the present cohort of patients with unilateral single-level CR. This improvement was independent of the severity of the initial symptoms and pre-injection MRI findings.

The effectiveness of cervical transforaminal epidural steroid injections for the treatment of cervical radicular pain: A prospective cohort study reporting 12-month outcomes

ObjectivesTo evaluate the effectiveness of cervical transforaminal epidural steroid injection (CTFESI) for the treatment of unilateral cervical radicular pain. DesignSingle-group prospective cohort study. MethodsOutcomes included ≥50% reductions in Numeric Rating Scale (NRS) for arm pain, ≥30% Neck Disability Index (NDI-5) improvement, health-related quality of life (EQ-5D), global improvement (PGIC), personal goal achievement (COMBI), Chronic Pain Sleep Index (CPSI), and healthcare utilization at one, three, six, and 12 months. Data analysis included descriptive statistics with the calculations of 95% confidence intervals (CIs), contingency table analysis, and multilevel logistic regression (LR) analysis, including a worst-case (WC) sensitivity analysis in which missing data were treated as treatment failure. Participants who were treated surgically were considered failures in the categorical analyses. Results33 consecutively enrolled participants (63.6% females, 51.2 ± 12.2 years of age, BMI 28.3 ± 4.5 kg/m2) were analyzed. Success rates for ≥50% reduction in NRS for arm pain at one, three, six and 12 months were 57.6% (95% CI 40.8–72.8%), 71.9% (95% CI 54.6–84.4%), 64.5% (95% CI 46.9–78.9%), and 64.5% (95% CI 46.9–78.9%). Success rates for ≥30% improvement in NDI-5 were 60.6% (95% CI 43.7–75.3%), 68.8% (95% CI 51.4–82.0%), 61.3% (95% CI 43.8–76.3%), and 71.0% (95% CI 53.4–83.9%). In WC analysis, success rates for ≥50% arm NRS and NDI-5 were 0–4.3% lower between 1 and 12 months. PGIC scores were at least “much improved” or “very much improved,” in 48.4–65.6% of participants between 1 and 12 months. 6.1%, 6.1%, and 3.0% had one, two, or three repeat injections, respectively. 18.2% of participants underwent surgery by 12 months. Participants showed significant improvements in arm NRS and NDI-5 after treatment (p < 0.05), multilevel logistic regression models showed no significant decline in improvements across the follow-up time points (p > 0.05). ConclusionStatistically significant and clinically meaningful improvements in pain and disability were observed after CTFESI for up to 12 months in individuals with unilateral cervical radicular pain.

Safety outcomes and improvement in pain scores after radiologist-performed fluoroscopy-guided interlaminar cervical epidural steroid injection.

Image-guided spine injections are an important tool in the management of patients with a variety of spinal pathologies. Our practice offers radiologist-performed fluoroscopy-guided interlaminar cervical epidural steroid injection (ESI) routinely performed in the outpatient setting. The purpose of this study was to evaluate clinical outcomes and improvement in pain scores after radiologist-performed cervical ESI. An institutional database was used to retrospectively identify cervical injections performed between October 2016 and October 2022. All injections were performed at the C7-T1 level utilizing 1.0mL of 10mg/mL dexamethasone without epidural anesthetic. The Numerical Rating Scale (NRS) was used to assess pain improvement. Cervical MRI was reviewed to assess pre-injection cervical disease severity. Patient charts were reviewed for any post-injection complications. A total of 251 cervical injections in 186 patients met our inclusion criteria with mean clinical follow up of 28.5months (range 0.2 - 73.0months). No patients experienced any major complications after injection. Post-injection pain scores were available for 218 of 251 injections (86.9%) with mean follow-up of 11.8days (range 6 - 57days). There was a significant improvement in pain scores from a mean pre-injection NRS score of 5.2/10 to 3.0/10 (p < .0001). 117 patients (53.7%) reported ≥ 50% improvement after injection. Patients who had prior injection were more likely to report ≥ 50% pain improvement after subsequent injection (p = .012). Radiologist-performed fluoroscopy-guided interlaminar cervical ESI at the C7-T1 level is a safe and effective tool in the management of patients with cervical pathology.

Benefit of pain and function after cervical transforaminal epidural steroid injections, an observational study

ObjectiveTo evaluate the improvement of pain and function after cervical transforaminal epidural steroid injections (CTFESI) for radicular pain. DesignThis is a retrospective observational study of patients receiving fluoroscopically-guided cervical transforaminal epidural steroid injections under a single provider at a tertiary referral center from December 2013 to December 2020. Primary outcome measures were Numeric Rating Scale (NRS), patient reported percent of pain relief, the Patient Health Questionnaire, the Patient Reported Outcome Measurement Information System (PROMIS) Global Health Physical and Mental Health score, and the Pain Disability Questionnaire. ResultsA total of 219 individual patients underwent 261 CTFESI and were included in the analyses. The average subject age was 51.9 years (SD = 11.3) and 50.9 % were male. Following the intervention, average pain relief by NRS at 3 months, 6 months, 1 year, and 2 years was −4.07, −3.82, −4.20, and −4.45, respectively. The average functional improvement with PROMIS-GH physical at 3-months, 6-months, 1- year, and 2-years was 2.23, 2.35, 3.15, and 3.29, respectively. ConclusionsOur results suggest that patients with cervical radiculopathy report significant pain relief and functional improvement following CTFESI. They can also report clinically important improvement in their health-related quality of life.

Epidural Catheters for Cervical Epidural Steroid Injections to Target Higher Cervical Pathology: Clinical Images in Practice

Epidural Catheters for Cervical Epidural Steroid Injections to Target Higher Cervical Pathology: Clinical Images in Practice

Epidural hematoma risks associated with ceasing vs maintaining anticoagulant and/or antiplatelet medications for cervical and thoracic interlaminar epidural steroid injections

BackgroundThere is a lack of substantiated evidence to support or refute the risks of ceasing vs maintaining anticoagulant and/or antiplatelet medications (ACAP) prior to cervical and thoracic interlaminar epidural steroid injections. The ACAP medication is frequently stopped pre-procedure due to concerns for potential bleeding complications, particularly epidural hematomas (EH). This article provides evidence regarding EH incidence in this population. MethodsData for this study was collected retrospectively on all patients from September 19, 2009–Jun 16, 2017 who were scheduled for an Interlaminar Cervical and/or Thoracic Epidural Steroid Injections (IL-CTESI) and were on an ACAP medication at the time a procedure was scheduled. All possible adverse outcomes were then retrospectively analyzed via extensive data mining of the electronic medical record system with special emphasis on EHs. Results591 IL-CTESI were performed on patients taking ACAP medications. In total, 351 patients ceased their ACAP medication prior to the procedure and 240 maintained ACAP medication. Our findings demonstrate that there were no clinically relevant incidents of EHs in either cohort. ConclusionsThis data gives critical insight into the post-procedural EH risk for patients who had continued or stopped taking their ACAP medications prior to their IL-CTESI. The results from this study suggest re-evaluating the potential post-procedural EH risks associated with continuing vs ceasing these medications.

Efficacy of Caudal Epidural Steroid Injections in Chronic Low Backache Patients.

Caudal epidural steroid injections are the popular treatment for patients with chronic low back aches (LBA) and radiculopathy, pain that radiates down the legs. These injections are typically given in the lower back, and their purpose is to reduce inflammation and pain caused by a herniated disc or other issues in the lumbosacral spine. Studies have generally found that caudal epidural steroid injections effectively manage chronic LBP, although they may not provide long-term relief in all cases. It is essential to remember that these injections should be combined with other forms of conservative management, such as physical therapy, before considering more invasive interventions. A prospective analysis is performed at the Orthopedics Department At The Hind Institute Of Medical Sciences In Sitapur, Uttar Pradesh, India, over two years. In the study, 80 patients with chronic low back pain and symptoms that did not improve with conservative therapies. The patients are clinically examined before and after receiving a cervical epidural steroid injection (CESI) based on their ability to perform daily activities and work using the Oswestry disability index (ODI) and visual analog scale (VAS). The experiment was conducted with 165 CESI administered to 120 patients. A single injection is given to 85 patients; two injections are given to 25 patients, and 10 patients receive three injections. Of the 120 patients, 50 were male, and 70 were female, all of whom had chronic LBA. Of the 120 cases of LBA, 37 were diagnosed with lumbar disc herniation, 11 with lumbar canal stenosis, and 22 with degenerative disc disease. The remaining 50 cases were classified as non-specific LBA. Follow-up evaluations were conducted 1 week, 1 month, and 3 months after that, till 12 months of treatment. The mean pre-CESI VAS score was 7.11, and the mean post-CESI VAS score was 4.82 after one year of treatment. The mean ODI score before CESI treatment was 59.12; after CESI treatment for a full year, it was 44.64. We observed excellent outcomes in 27.5% of patients, good outcomes in 38.33%, fair outcomes in 21.67%, and bad outcomes in 12.5% of patients. Patients who experience chronic function aches can dramatically reduce their discomfort with the help of CESIs.

Association between fatty infiltration in the cervical multifidus and treatment response following cervical interlaminar epidural steroid injection.

Recent attention has been directed towards fatty infiltration in the cervical extensor muscles for predicting clinical outcomes in several cervical disorders. This study aimed to investigate the potential association between fatty infiltration in the cervical multifidus and treatment response following cervical interlaminar epidural steroid injection (CIESI) in patients with cervical radicular pain. The data of patients with cervical radicular pain who received CIESIs between March 2021 and June 2022 were reviewed. A responder was defined as a patient with a numerical rating scale decrease of ≥ 50% from the baseline to three months after the procedure. The presence of fatty infiltration in the cervical multifidus was assessed, along with patient characteristics, and cervical spine disease severity. To assess cervical sarcopenia, fatty infiltration in the bilateral multifidus muscles was evaluated at the C5-C6 level using the Goutallier classification. Among 275 included patients, 113 (41.1%) and 162 (58.9%) were classified as non-responders and responders, respectively. The age, severity of disc degeneration, and grade of cervical multifidus fatty degeneration were significantly lower in responders. Multivariate logistic regression analysis revealed that pre-procedural symptoms (radicular pain with neck pain, odd ratio [OR] = 0.527, P = 0.024) and high-grade cervical multifidus fatty degeneration (Goutallier grade 2.5-4, OR = 0.320, P = 0.005) were significantly associated with an unsuccessful response to CIESI. These results suggest high-grade cervical multifidus fatty infiltration is an independent predictor of poor response to CIESI in patients with cervical radicular pain.

Clinical Image: Contrast-Induced Encephalopathy Mimicking Subarachnoid Hemorrhage

A 72-year-old female with a history of hypertension and hyperlipidemia presented to the ED from an outside hospital with acute confusion and global amnesia immediately following cervical epidural steroid injection with fluoroscopic guidance for radiculopathy relief. On exam, she was oriented to self, but disoriented to place and situation. Otherwise, she was neurologically intact with no deficits. Head CT revealed diffuse subarachnoid hyperdensities most prominent in the parafalcine region concerning for diffuse subarachnoid hemorrhage (SAH), and tonsillar herniation concerning for intracranial hypertension. CT angiograms of head and neck were negative for vascular abnormalities. Dual-energy head CT (DE-HCT) was subsequently performed four hours later without IV contrast. The 80 kV sequence revealed prominent diffuse hyperdensity throughout the CSF spaces in bilateral cerebral hemispheres, basal cisterns, and posterior fossa consistent with the initial CT, but these corresponding regions were relatively less dense on the 150 kV sequence. These findings were consistent with contrast material in the CSF spaces without evidence of intracranial hemorrhage or transcortical infarct. Three hours later, the patient's transient confusion resolved, and she was discharged home the next morning without any neurological deficit.

Assessment of epidural fat at C7-T1 with image review prior to cervical interlaminar epidural steroid injections.

Journal Article Accepted manuscript Assessment of epidural fat at C7-T1 with image review prior to cervical interlaminar epidural steroid injections Get access Paul M Kitei, MD, Paul M Kitei, MD Department of Rehabilitation Medicine, Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, PennsylvaniaDepartment of Physical Medicine & Rehabilitation, Rothman Orthopaedic Institute, Philadelphia, Pennsylvania Corresponding author (Paul M. Kitei, paul.kitei@rothmanortho.com). Search for other works by this author on: Oxford Academic PubMed Google Scholar David E Surrey, MD, David E Surrey, MD Department of Physical Medicine & Rehabilitation, Rothman Orthopaedic Institute, Philadelphia, Pennsylvania Search for other works by this author on: Oxford Academic PubMed Google Scholar David S Stolzenberg, DO, David S Stolzenberg, DO Department of Rehabilitation Medicine, Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, PennsylvaniaDepartment of Physical Medicine & Rehabilitation, Rothman Orthopaedic Institute, Philadelphia, Pennsylvania Search for other works by this author on: Oxford Academic PubMed Google Scholar Jeremy I Simon, MD Jeremy I Simon, MD Department of Rehabilitation Medicine, Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, PennsylvaniaDepartment of Physical Medicine & Rehabilitation, Rothman Orthopaedic Institute, Philadelphia, Pennsylvania Search for other works by this author on: Oxford Academic PubMed Google Scholar Pain Medicine, pnad050, https://doi.org/10.1093/pm/pnad050 Published: 22 April 2023 Article history Received: 04 April 2023 Revision received: 16 April 2023 Accepted: 18 April 2023 Published: 22 April 2023

Inter-rater reliability of MRI superior articular process angle measurement for use in the modified approach to cervical transforaminal epidural steroid injections

BackgroundUpper extremity radicular pain is commonly treated with a cervical transforaminal epidural steroid injection (CTFESI). Recently, a new technique, the modified approach CTFESI, has been developed with a theoretical safety advantage to avoid the neurovascular structures. This approach requires an angle measurement of the superior articular process (SAP) on MRI. The inter-rater reliability of this angle measurement among practicing physicians is yet to be investigated. ObjectiveThe purpose of this study was to determine the inter-rater reliability of SAP angle measurements on MRI. MethodsThree raters independently measured the SAP angle on 50 cervical MRIs. A two-way, mixed effects, absolute agreement, single rater statistical model was used to determine the intraclass correlation coefficient (ICC) between all three raters, as well as between each pair of raters. ResultsInter-rater reliability among all raters showed good reliability with an ICC ​= ​0.837709 (95% CI 0.75–0.9, p ​< ​0.001). Similarly, good inter-rater reliability was found between each of the pairs of raters. ConclusionThis study demonstrates good inter-rater reliability of MRI SAP angle measurement among clinicians for use in the modified CTFESI approach.

The Retrodural Space of Okada Accessed During a Fluoroscopic Cervical Transforaminal Epidural Steroid Injection

The Retrodural Space of Okada Accessed During a Fluoroscopic Cervical Transforaminal Epidural Steroid Injection

Comparison of Clinical Effectiveness between the Management of Cervical and Lumbar Disc Herniation with Percutaneous Laser Disc Decompression Followed by Interlaminar Cervical Epidural and Lumbar Transforaminal Epidural Steroid Injection Respectively

Background: Different treatments for discogenic axial back/neck pain or radicular pain to limbs are there from conservative therapies and minimally invasive therapies to open spine surgeries with lots of controversial outcomes. Percutaneous laser disc decompression (PLDD) is one of the minimally invasive therapies which is done under local anesthesia and has been successfully performed in many selected patients for their lumbar and cervical disc herniation problems. In PLDD, a part of the nucleus pulposus is vaporized with the help of laser energy to reduce the intradiscal pressure of the diseased discs causing nerve compression. In this case series after a 1-year follow-up, the clinical effectiveness of PLDD with epidural steroid injection is assessed in selected lumbar and cervical disc herniation cases. Materials and Methods: Ninety-six patients underwent the PLDD procedure at the cervical and lumbar disc with epidural steroid injections for their disc herniation causing radicular pain in the upper and lower limbs, respectively. The patients were followed at 8 weeks, 3 months, 6 months, and 1 year. The main outcome measures were done through the visual analog scores (VASs) and the Oswestry Disability Index (ODI) for upper and lower limb pain. Results: The primary outcome showed that there is a significant clinically relevant difference between the two groups at a 1-year follow-up. VAS and mean disability score based on the ODI were significantly lower in cervical disc herniation patients. The reoperation rate in the cervical group is also much less than the lumbar group. Conclusion: Like all other surgical modalities for disc herniation, PLDD has its own advantages and disadvantages. However, compared to lumbar disc herniation, it may give better results in cervical disc herniation. In selected cases, combined PLDD with epidural steroid injection can be chosen as a “first-choice-minimally-invasive-treatment,” when standard conservative therapies do not give satisfactory outcome.

The Effectiveness of Cervical Transforaminal Epidural Steroid Injections for the Treatment of Cervical Radicular Pain: A Prospective Cohort Study Reporting 12-month Outcomes

The Effectiveness of Cervical Transforaminal Epidural Steroid Injections for the Treatment of Cervical Radicular Pain: A Prospective Cohort Study Reporting 12-month Outcomes

Intramedullary Spinal Cord Hemorrhage Associated with Monoparesis after Transforaminal Cervical Epidural Steroid Injection

Intramedullary Spinal Cord Hemorrhage Associated with Monoparesis after Transforaminal Cervical Epidural Steroid Injection

Identification of cervical epidural space: A comparison study between contrast spread and loss of resistance techniques.

Early epidural space identification is critical to the efficacy and safety of cervical epidural steroid injections (CESI). Currently, the accepted method for epidural space recognition is the loss of resistance technique (LORT). I hypothesized that the contrast spread technique might recognize epidural space concurrently with or sooner than LORT and that smaller needles might be employed with the fluoroscopy only method but not with LORT. To test my hypotheses, I conducted a comparison study. The study participants were patients from my practice with a clinical diagnosis of cervical radiculitis divided into two groups of 20 each, who underwent CESI with either an 18 G or a 25 G Tuohy needle. All CESIs were performed utilizing the fluoroscopy only method. Then, LOR was tested using an Epidrum device that was observed for 30 s; if the Epidrum deflated, the result was positive. LOR was positive in 12 out of 20 patients in the 18 G group and 2 out of 20 in the 25 G group. The 95% confidence interval test for proportion revealed a statistically significantly lower rate for epidural space detection by LORT in both groups: [0.385, 0.815] in the 18 G and [-0.031, 0.231] in the 25 G group. Statistical significance of the difference between groups in LOR accuracy rate (60% vs. 10%) was confirmed by z-test for independent proportions: z = 3.31 (p < 0.001), Cohen's h = 1.13. Fluoroscopy only method might be a safer alternative to LORT as it employs a different concept, might recognize epidural space sooner, and favors smaller needles. NCT05260294.

Symptomatic Pneumorrhachis After Cervical Epidural Steroid Injection Resulting in a Transient Right-Sided Brachial Plexopathy: A Case Report

BACKGROUND: Cervical epidural steroid injection (CESI) is a commonly performed procedure for both the diagnostic and therapeutic management of various types of cervical spine pathology. Serious complications from this procedure are rare, but include dural puncture, epidural hematoma, and air embolism. Pneumorrhachis, the presence of air in the spinal canal, is hypothesized to be a common radiological finding following epidural anesthesia that is rarely symptomatic. CASE REPORT: We report the case of a 56-year-old woman who experienced right upper-extremity numbness and paralysis following interlaminar CESI, with subsequent imaging showing an air lesion in the epidural space from C6-T3. The patient’s symptoms resolved spontaneously after 12 hours of observation. CONCLUSIONS: This case demonstrates a previously unreported complication of CESI that is important for practitioners of ESI (epidural steroid injection) to be aware of. KEY WORDS: Case report, epidural steroid injection, injections, interlaminar, pneumorrhachis

25. Perioperative complications associated with epidural injections followed by cervical decompression and fusion

<h3>BACKGROUND CONTEXT</h3> Cervical epidural steroid injections (CESIs) are widely used to alleviate pain caused by degenerative diseases of the cervical spine. However, some data suggest a potential link between CESIs and infection rates following fusion surgeries. No prior studies have assessed the association between CESI and other postoperative outcomes such as hematomas, revision rates, or wound complications following anterior cervical discectomy and fusion (ACDF) and posterior cervical decompression and fusion (PCDF). Therefore, using a national dataset, we aimed to explore whether an association exists between preoperative CESIs and a variety of serious complications following ACDF and PCDF surgery. <h3>METHODS</h3> In this retrospective cohort study, we queried the IBM MarketScan national claims dataset (after IRB approval) and included adult patients who had undergone inpatient or outpatient ACDF or PCDF surgery due to disc herniation, stenosis, radiculopathy, spondylosis, or myelopathy from January 2014 to September 2017. Current procedural terminology codes were used to identify patients who received a CESI within one year prior to their surgery. Multivariable logistic regression measured the association between preoperative CESI and postoperative rates of 90-day infection, hematoma, wound complications, revision surgery, or combined complications (the former first three complications). We report odds ratios (OR) and 95% confidence intervals (CI). <h3>RESULTS</h3> Among 44,777 ACDF patients, 31.2% (n=13,950) received a preoperative CESI. For PCDF, 3,284 patients underwent the surgery of which 22.3% (n=734) received a preoperative CESI. The median time from most recent CESI to ACDF surgery is 76 days (interquartile range 41-144 days) and 95 days (interquartile range 49-176 days) for PCDF. Among ACDF patients, preoperative CESI was associated with lower odds of developing a hematoma following ACDF (OR 0.60; 95% CI 0.37-0.99; p=0.0453); no significant associations existed for the other outcomes including infection (OR 0.98; 95% CI 0.77-1.26; p=0.8846), revision surgery (OR 0.94; 95% CI 0.71-1.23; p=0.6300), wound complications (OR 0.92; 95% CI 0.71-1.17; p=0.4865) or combined complications (OR 0.88; 95% CI 0.73-1.07; p=0.1904). In the PCDF cohort, no significant associations existed between preoperative CESI and post-PCDF infection (OR 1.26; 95% CI 0.82-1.95; p=0.2962), revision surgery (OR 1.96; 95% CI 0.91-4.18; p=0.0842), wound complications (OR 1.11; 95% CI 0.71-1.72; p=0.6608) or combined complications (OR 1.14; 95% CI 0.78-1.68; p=0.4929). <h3>CONCLUSIONS</h3> Our study is the first to assess a broad complication profile that includes hematoma rates, infection rates, revision rates, and wound complications following ACDF and PCDF surgeries. We found no association between preoperative CESI and the aforementioned complications following ACDF and PCDF which supports first-hand clinical outcomes. Future work will aim to delineate the role of timing of CESI before ACDF and PCDF surgery, and the impact of quantity of CESIs on complication risks. <h3>FDA DEVICE/DRUG STATUS</h3> This abstract does not discuss or include any applicable devices or drugs.