The effectiveness of intradiscal biologic treatments for discogenic low back pain: a systematic review.

BACKGROUND CONTEXT: There are limited treatments for discogenic low back pain. Intradiscal injections of biologic agents such as platelet-rich plasma (PRP) or stem cells (SC) are theorized to have regenerative properties and have gained increasing interest as a possible treatment, but the evidence supporting their use in clinical practice is not yet well-defined. PURPOSE: Determine the effectiveness of intradiscal biologics for treating discogenic low back pain. STUDY DESIGN: PRISMA-compliant systematic review. PATIENT SAMPLE: Patients with discogenic low back pain confirmed by provocation discography or clinical and imaging findings consistent with discogenic pain. OUTCOME MEASURES: The primary outcome was the proportion of individuals with ≥50% pain relief after intradiscal biologic injection at 6 months. Secondary outcomes included ≥2-point pain score reduction on NRS; patient satisfaction; functional improvement; decreased use of other health care, including analgesics and surgery; and structural disc changes on MRI. METHODS: Comprehensive literature search performed in 2018 and updated in 2020. Interventions included were biologic therapies including mesenchymal stem cells, platelet rich plasma, microfragmented fat, amniotic membrane-based injectates, and autologous conditioned serum. Any other treatment (sham or active) was considered for comparative studies. Studies were independently reviewed. RESULTS: The literature search yielded 3,063 results, 37 studies were identified for full-text review, and 12 met established inclusion criteria for review. The quality of evidence on effectiveness of intradiscal biologics was very low. A single randomized controlled trial evaluating platelet-rich plasma reported positive outcomes but had significant methodological flaws. A single trial that evaluated mesenchymal stem cells was negative. Success rates for platelet-rich plasma injectate in aggregate were 54.8% (95% Confidence Interval: 40%-70%). For mesenchymal stem cells, the aggregate success rate at six months was 53.5% (95% Confidence Interval: 38.6%-68.4%), though using worst-case analysis this decreased to 40.7% (95% Confidence Interval: 28.1%-53.2%). Similarly, ≥30% functional improvement was achieved in 74.3% (95% Confidence Interval: 59.8%-88.7%) at six months but using worst-case analysis, this decreased to 44.1% (95% Confidence Interval: 28.1%-53.2%). CONCLUSION: Limited observational data support the use of intradiscal biologic agents for the treatment of discogenic low back pain. According to the Grades of Recommendation, Assessment, Development and Evaluation System, the evidence supporting use of intradiscal mesenchymal stem cells and platelet-rich plasma is very low quality.

Synovial Cysts Confounding Access to the Dorsal S1 Neural Foramen in Transforaminal Epidural Steroid Injections.

OBJECTIVES: The S1 dorsal foramen is the route for 30% of lumbar transforaminal epidural injections; it is therefore important to identify structures impeding S1 foraminal access. The study objective was to characterize the imaging findings, prevalence, and anatomic origin of synovial cysts presenting within the S1 neural foramen. METHODS: A case series (N = 14) established imaging characteristics of S1 synovial cysts. Imaging studies of 400 patients undergoing epidural injections were reviewed for lesions compromising S1 foraminal access. Cadaveric dissections defined the relationship of the inferior recess of the L5-S1 facet to the S1 dorsal foramen. RESULTS: Elderly patients (mean age = 76) exhibited S1 synovial cysts. Synovial cysts were typically 1-2 cm in diameter, hyperintense on sagittal T2 weighted magnetic resonance images (MRIs), fluid-density on computed tomography, and dorsal to the S1 spinal nerve. Sixty percent of cysts exhibited complex MRI signal characteristics (thick wall, internal structure). Tarlov cysts, in contrast, were larger, lobular, and exhibited pure fluid intensity. Lesions impeded access to the S1 dorsal foramina in 5% of reviewed imaging studies (16 Tarlov cysts, three synovial cysts, one conjoint S1-S2 nerve root). The multifidus muscle was interposed between the L5-S1 facet inferior recess and the S1 dorsal foramen on dissection specimens; severe atrophy of the ipsilateral multifidus was noted on imaging in 17/18 synovial cysts. CONCLUSIONS: The S1 neural foramina should be inspected on sagittal MRI, when available, for confounding lesions before performing S1 epidural injections. Tarlov cysts are more common than synovial cysts; the latter are seen in elderly patients with severe multifidus atrophy.

Quantitative Knee Arthrography in a Large Animal Model of Osteoarthritis Using Photon-Counting Detector CT.

OBJECTIVE: The aim of this study was to grade cartilage damage in a swine model of osteoarthritis using a whole-body photon-counting detector (PCD) CT. MATERIALS AND METHODS: A multienergy phantom containing gadolinium (Gd) (2, 4, 8, and 16 mg/mL) and hydroxyapatite (200 and 400 mg/cc) was scanned using a PCD-CT system (48 × 0.25 mm collimation, 80 kV, 800 mAs, D50 reconstruction kernel) to serve as calibration for material decomposition and to assess quantification accuracy. Osteoarthritis was induced in Yucatan miniswine (n = 8) using 1.2 mg monoiodoacetate (MIA) injected into a randomized knee, whereas the contralateral control knee received saline. Twenty-one days later, a contrast bolus (gadoterate meglumine, 4 mL/knee) was intra-articularly administered into both knees. The knees were simultaneously scanned on the PCD-CT system (48 × 0.25 mm collimation, 80 kV, 800 mAs). Multienergy images were reconstructed with a sharp "V71" kernel and a quantitative "D50" kernel. Image denoising was applied to the V71 images before grading cartilage damage, and an iterative material decomposition technique was applied to D50 images to generate the Gd maps. Two radiologists blinded to the knee injection status graded the cartilage integrity based on a modified International Cartilage Repair Society scoring system. Histology was performed on excised cartilage using methylene blue/basic fuchsin. Statistical analysis of grade distribution was performed using an exact test of omnibus symmetry with P < 0.05 considered significant. RESULTS: Material decomposed images from the multienergy phantom scan showed delineation and quantification of Gd and hydroxyapatite with a root-mean-squared error of 0.3 mg/mL and 18.4 mg/cc, respectively. In the animal cohort, the radiologists reported chondromalacia in the MIA knees with International Cartilage Repair Society scores ranging from grade 1 (cartilage heterogeneity, n = 4 knees) to grade 3 (up to 100% cartilage loss, n = 4 knees). Grade 1 was characterized by cartilage heterogeneity and increased joint space in the patellofemoral compartment, whereas grade 3 was characterized by cartilage erosion and bone-on-bone articulation in the patellofemoral compartment. All control knees were scored as grade 0 (normal cartilage). Significant difference (P = 0.004) was observed in the grade distribution between the MIA and control knees. Gross examination of the excised knees showed cartilage lesions in the grade 3 MIA knees. The Gd maps from material decomposition showed lower contrast levels in the joint space of the MIA knee compared with the contralateral control knee due to joint effusion. Histology revealed chondrocyte loss in the MIA knee cartilage confirming the chondrotoxic effects of MIA on cartilage matrix. CONCLUSIONS: We demonstrated a high-resolution and quantitative PCD-CT arthrography technique for grading cartilage damage in a large animal model of osteoarthritis. Photon-counting detector CT offers simultaneous high-resolution and multienergy imaging capabilities that allowed morphological assessment of cartilage loss and quantification of contrast levels in the joint as a marker of joint disease. Cartilage damage in the MIA knees was graded using PCD-CT images, and the image-based findings were further confirmed using histology and gross examination of the excised knees.

Low-Pressure Lumbar Provocation Discography According to Spine Intervention Society/International Association for the Study of Pain Standards Does Not Cause Acceleration of Disc Degeneration in Patients With Symptomatic Low Back Pain: A 7-Year Matched Cohort Study.

STUDY DESIGN: Retrospective matched cohort study. OBJECTIVE: To determine if low-pressure lumbar provocation discography (PD) results in long-term accelerated disc degeneration, internal disc disruption, or disc herniation in patients with symptomatic low back pain (LBP). SUMMARY OF BACKGROUND DATA: Study of subjects without clinically-significant LBP suggests that high-pressure PD may accelerate disc degeneration. METHODS: Consecutive patients with symptomatic LBP who underwent magnetic resonance imaging (MRI), PD, and repeat MRI more than 7 years later, but did not undergo subsequent spinal fusion surgery, were included. Punctured discs were matched (1:2 to 1:4) to corresponding discs in a control cohort by age, BMI, Pfirrmann score (±2), and presence of disc herniation; control cohort inclusion required MRIs for symptomatic LBP, separated by more than 7 years. The primary outcome of the study was a progression in Pfirrmann score category (I-II, III-IV, V). MRI disc-to-CSF T2 signal-intensity ratio, disc height, disc herniations, high intensity zones (HIZs), and Modic changes were assessed. RESULTS: Baseline and follow-up MRIs were available for 77 discs exposed to PD, and for 260 discs in the matched control cohort. There was no difference in the proportion of punctured discs that advanced in Pfirrmann score category in the PD group (17%, 95% CI 9-27%) compared with corresponding discs in the Control group (21%, 95% CI 17-27%), P = 0.3578, or in non-punctured discs in the PD group (35%, 95% CI 21-51%) compared with corresponding discs in the Control group (34%, 95% CI 27-42%), P = 0.1169. There were no differences in disc-to-CSF T2 signal-intensity ratio, presence of disc herniations, HIZs, or Modic changes following puncture in the PD versus matched cohort discs or in the non-punctured PD cohort discs versus corresponding control cohort discs (P > 0.05). CONCLUSION: Patients with symptomatic LBP who underwent low-pressure PD, but who did not undergo a subsequent spinal fusion surgery, developed disc degeneration and new disc herniations at a similar rate to corresponding discs in matched control patients. LEVEL OF EVIDENCE: 3.

Human interleukin-10 delivered intrathecally by self-complementary adeno-associated virus 8 induces xenogeneic transgene immunity without clinical neurotoxicity in swine.

INTRODUCTION: Intrathecal interleukin (IL)-10 delivered by plasmid or viral gene vectors has been proposed for clinical testing because it is effective for chronic pain in rodents, is a potential therapeutic for various human diseases, and was found to be nontoxic in dogs, when the human IL-10 ortholog was tested. However, recent studies in swine testing porcine IL-10 demonstrated fatal neurotoxicity. The present study aimed to deliver vector-encoded human IL-10 in swine, measure expression of the transgene in cerebrospinal fluid and monitor animals for signs of neurotoxicity. RESULTS: Human IL-10 levels peaked 2 weeks after vector administration followed by a rapid decline that occurred concomitant with the emergence of anti-human IL-10 antibodies in the cerebrospinal fluid and serum. Animals remained neurologically healthy throughout the study period. CONCLUSIONS: The findings of the present study suggest that swine are not idiosyncratically sensitive to intrathecal IL-10 because, recapitulating previous reports in dogs, they suffered no clinical neurotoxicity from the human ortholog. These results strongly infer that toxicity of intrathecal IL-10 in large animal models was previously overlooked because of a species mismatch between transgene and host. The present study further suggests that swine were protected from interleukin-10 by a humoral immune response against the xenogeneic cytokine. Future safety studies of IL-10 or related therapeutics may require syngeneic large animal models.

Fatal Meningitis in Swine after Intrathecal Administration of Adeno-associated Virus Expressing Syngeneic Interleukin-10.

Interleukin-10 (IL-10) delivered by intrathecal (i.t.) gene vectors is a candidate investigational new drug (IND) for several chronic neurological disorders such as neuropathic pain. We performed a preclinical safety study of IL-10. A syngeneic large animal model was used delivering porcine IL-10 (pIL-10) to the i.t. space in swine by adeno-associated virus serotype 8 (AAV8), a gene vector that was previously found to be nontoxic in the i.t. space. Unexpectedly, animals became ill, developing ataxia, seizures, and an inability to feed and drink, and required euthanasia. Necropsy demonstrated lymphocytic meningitis without evidence of infection in the presence of normal laboratory findings for body fluids and normal histopathology of peripheral organs. Results were replicated in a second animal cohort by a team of independent experimenters. An extensive infectious disease and neuropathology workup consisting of comprehensive testing of tissues and body fluids in a specialized research veterinary pathology environment did not identify a pathogen. These observations raise the concern that i.t. IL-10 therapy may not be benign, that previously used xenogeneic models testing the human homolog of IL-10 may not have been sensitive enough to detect toxicity, and that additional preclinical studies may be needed before clinical testing of IL-10 can be considered.

Imaging Determinants of Clinical Effectiveness of Lumbar Transforaminal Epidural Steroid Injections.

OBJECTIVE: To examine associations between imaging characteristics of compressive lesions and patient outcomes after lumbar transforaminal epidural steroid injections (TFESIs) stratified by steroid formulation (solution versus suspension). DESIGN/SUBJECTS: Retrospective observational study, academic radiology practice. A 516-patient sample was selected from 2,634 consecutive patients receiving lumbar TFESI for radicular pain. METHODS: The advanced imaging study(s) preceding sampled TFESI were reviewed. Compressive lesions were described by a) nature of the lesion [disc herniation, fixed stenosis, synovial cyst, epidural fibrosis, no lesion] b) degree of neural compression [4 part scale], and c) presence of a tandem lesion. Associations between 2-month categorical outcomes (responder rates for pain, functional recovery) and imaging characteristics, stratified by steroid formulation, were examined with chi-squared tests of categorical outcomes and multivariable logistic regression models. RESULTS: Disc herniation patients had more responders for functional recovery than patients with fixed lesions (54% versus 38%, P = 0.01). Patients with fixed lesions receiving steroid solution (dexamethasone) had more responders for pain relief, with a similar trend for functional recovery, than patients receiving suspensions (59% versus 40%, P = 0.01). Outcomes for patients with fixed lesions treated with dexamethasone were not statistically different from those for disc herniation patients. Patients with single compressive lesions had more responders than those with tandem lesions (55% versus 41%, P = 0.03). CONCLUSION: In the entire sample, outcomes for disc herniations were more favorable than for fixed lesions. However, fixed lesions treated with dexamethasone had outcomes indistinguishable from disc herniations. Single lesions had better outcomes than tandem lesions.

Uncommon Manifestations of Intervertebral Disk Pathologic Conditions.

Beyond the familiar disk herniations with typical clinical features, intervertebral disk pathologic conditions can have a wide spectrum of imaging and clinical manifestations. The goal of this review is to illustrate and discuss unusual manifestations of intervertebral disk pathologic conditions that radiologists may encounter, including disk herniations in unusual locations, those with atypical imaging features, and those with uncommon pathophysiologic findings. Examples of atypical disk herniations presented include dorsal epidural, intradural, symptomatic thoracic (including giant calcified), extreme lateral (retroperitoneal), fluorine 18 fluorodeoxyglucose-avid, acute intravertebral (Schmorl node), and massive lumbar disk herniations. Examples of atypical pathophysiologic conditions covered are discal cysts, fibrocartilaginous emboli to the spinal cord, tiny calcified disks or disk-level spiculated osteophytes causing spinal cerebrospinal fluid (CSF) leak and intracranial hypotension, and pediatric acute calcific discitis. This broad gamut of disease includes a variety of sizes of disk pathologic conditions, from the tiny (eg, the minuscule calcified disks causing high-flow CSF leaks) to the extremely large (eg, giant calcified thoracic intradural disk herniations causing myelopathy). A spectrum of clinical acuity is represented, from hyperacute fibrocartilaginous emboli causing spinal cord infarct, to acute Schmorl nodes, to chronic intradural herniations. The entities included are characterized by a range of clinical courses, from the typically devastating cord infarct caused by fibrocartilaginous emboli, to the usually spontaneously resolving pediatric acute calcific discitis. Several conditions have important differential diagnostic considerations, and others have relatively diagnostic imaging findings. The pathophysiologic findings are well understood for some of these entities and poorly defined for others. Radiologists' knowledge of this broad scope of unusual disk disease is critical for accurate radiologic diagnoses. Online supplemental material is available for this article. (©)RSNA, 2016.

Increased 99mTc MDP activity in the costovertebral and costotransverse joints on SPECT-CT: is it predictive of associated back pain or response to percutaneous treatment?

PURPOSE: Pain related to costovertebral and costotransverse joints is likely an underrecognized and potentially important cause of thoracic back pain. On combined single-photon emission computed tomography and computed tomography (SPECT-CT), increased technetium-99m methylene diphosphonate (99mTc MDP) activity at these articulations is not uncommon. We evaluated whether this activity corresponds with thoracic back pain and whether it predicts response to percutaneous injection. METHODS: All 99mTc MDP SPECT-CT spine examinations completed at our institution from March 2008 to March 2014 were retrospectively reviewed to identify those with increased 99mTc MDP activity in the costovertebral or costotransverse joints. The presence of corresponding thoracic back pain, percutaneous injection performed at the relevant joint(s), and response to injection were recorded. RESULTS: A total of 724 99mTc MDP SPECT-CT examinations were identified. Increased 99mTc MDP activity at costovertebral or costotransverse joints was reported in the examinations of 55 patients (8%). Of these, 25 (45%) had corresponding thoracic back pain, and nine of 25 patients (36%) underwent percutaneous injection of the joint(s) with increased activity. At clinical follow-up two days to 12 weeks after injection, one patient (11%) had complete pain relief, two (22%) had partial pain relief, and six (67%) had no pain relief. CONCLUSION: The findings suggest that increased activity in costovertebral and costotransverse joints on 99mTc MDP SPECT-CT is only variably associated with the presence and location of thoracic back pain; it does not predict pain response to percutaneous injection.

Efficacy of intervertebral disc regeneration with stem cells - a systematic review and meta-analysis of animal controlled trials.

Management of intervertebral disc (IVD) degenerative disease is challenging, as it is accompanied by irreversible loss of IVD cells. Stem cell transplantation to the disc has shown promise in decelerating or arresting the degenerative process. Multiple pre-clinical animal trials have been conducted, but with conflicting outcomes. To assess the effect of stem cell transplantation, a systematic review and meta-analysis was performed. A comprehensive literature search was conducted through Week 3, 2015. Inclusion criteria consisted of controlled animal trials. Two reviewers screened abstracts and full texts. Disagreements were resolved by a third reviewer. Random effects models were constructed to pool standardized mean difference (SMD). Twenty two studies were included; nine of which were randomized. Statistically significant differences were found with the stem cell group exhibiting increased disc height index (SMD=3.64, 95% confidence interval (CI): 2.49, 4.78; p<0.001), increased MRI T2 signal intensity (SMD=2.28, 95% CI: 1.48, 3.08; p<0.001), increased Type II collagen mRNA expression (SMD=3.68, 95% CI: 1.66, 5.70; p<0.001), and decreased histologic disc degeneration grade (SMD=-2.97, 95% CI: -3.97, -1.97; p<0.001). There was statistical heterogeneity between studies that could not be explained with pre-planned subgroup analyses based on animal species, study designs, and transplanted cell types. Stem cells transplanted to the IVD in quadruped animals decelerate or arrest the IVD degenerative process. Further studies in human clinical trials will be needed to understand if such benefit can be translated to bipedal humans.

Minimally invasive convection-enhanced delivery of biologics into dorsal root ganglia: validation in the pig model and prospective modeling in humans. Technical note.

Dorsal root ganglia (DRG) are critical anatomical structures involved in nociception. Intraganglionic (IG) drug delivery is therefore an important route of administration for novel analgesic therapies. Although IG injection in large animal models is highly desirable for preclinical biodistribution and toxicology studies of new drugs, no method to deliver pharmaceutical agents into the DRG has been reported in any large species. The present study describes a minimally invasive technique of IG agent delivery in domestic swine, one of the most common large animal models. The technique utilizes CT guidance for DRG targeting and a custom-made injection assembly for convection enhanced delivery (CED) of therapeutic agents directly into DRG parenchyma. The DRG were initially visualized by CT myelography to determine the optimal access route to the DRG. The subsequent IG injection consisted of 3 steps. First, a commercially available guide needle was advanced to a position dorsolateral to the DRG, and the dural root sleeve was punctured, leaving the guide needle contiguous with, but not penetrating, the DRG. Second, the custom-made stepped stylet was inserted through the guide needle into the DRG parenchyma. Third, the stepped stylet was replaced by the custom-made stepped needle, which was used for the IG CED. Initial dye injections performed in pig cadavers confirmed the accuracy of DRG targeting under CT guidance. Intraganglionic administration of adeno-associated virus in vivo resulted in a unilateral transduction of the injected DRG, with 33.5% DRG neurons transduced. Transgene expression was also found in the dorsal root entry zones at the corresponding spinal levels. The results thereby confirm the efficacy of CED by the stepped needle and a selectivity of DRG targeting. Imaging-based modeling of the procedure in humans suggests that IG CED may be translatable to the clinical setting.

99mTc-MDP SPECT/CT of the spine and sacrum at a multispecialty institution: clinical use, findings, and impact on patient management.

OBJECTIVE: The use of technetium-99m methylene diphosphonate single-photon emission tomography/computed tomography (99mTc-MDP SPECT/CT) of the spine and sacrum has increased over the past years; however, there is little information about the optimal clinical role and true clinical impact of this modality. METHODS: All 99mTc-MDP SPECT/CT examinations of the spine and sacrum performed at our large multispecialty institution between 1 January 2008 and 12 April 2012 were identified. The indications, findings, clinical context, and impact on patient management were identified through a retrospective chart review. RESULTS: Of the 212 99mTc-MDP SPECT/CT examinations of the spine and sacrum identified, 191 (90%) were for pain evaluation, 14 (7%) were to assess infection, and seven (3%) were to evaluate a potential malignancy. The most common specific indication was evaluation of facet joint pain in 70/191 (37%) patients, and the most common finding was facet joint activity in 106/212 (50%) patients. Several findings were reported, although facet joint activity was the most frequent. The other findings included costovertebral joint activity, pars interarticularis defects, an osteoid osteoma, a lumbosacral pseudoarticulation, and a postoperative pseudoarthrosis. A resultant change in clinical management was documented in 168/212 (79%) patients. Ninety-two of the 212 (44%) patients had undergone an MRI of the same region for any indication within ±6 months. CONCLUSION: 99mTc-MDP SPECT/CT of the spine and sacrum is most frequently used for the diagnosis and management of pain. It helps identify several potential pain generators, is often used in patients who have a near-contemporaneous MRI, and has an impact on the procedural and/or conservative management in most patients. In addition, several areas in need of future research to establish the optimal clinical role of this modality were identified.

Clinical effectiveness of single lumbar transforaminal epidural steroid injections.

OBJECTIVES: To assess the clinical effectiveness of single lumbar transforaminal epidural steroid injections (TFESIs) in subjects with radicular pain with or without radiculopathy. DESIGN: Retrospective observational series. SETTING: Single academic radiology pain management practice. SUBJECTS: Two thousand twenty-four subjects undergoing single lumbar TFESIs at the L4-5, L5-S1, or S1 neural foramina. METHODS / OUTCOME MEASURES: Subjects were assessed with a pain numerical rating scale (NRS, 0-10) and Roland-Morris disability questionnaire (R-M, 23-point Deyo modification) prior to TFESI and at 2 weeks and 2 months follow-up. Successful pain relief (responders) was defined as either ≥50% reduction in NRS or pain 0/10; functional success was defined as ≥40% reduction in R-M score. RESULTS: There were statistically significant (P < 0.0001) reductions in mean NRS and R-M scores at 2 weeks and 2 months postinjection. For NRS, 40.9% were responders at 2 weeks and 45.6% at 2 months. For R-M, 31.9% were responders at 2 weeks and 41.3% at 2 months. The proportion of responders for NRS and R-M was higher when there was <3 months of pain (odds ratio 2-month NRS = 2.42 [95% confidence interval: 1.82, 3.24], odds ratio 2-month R-M = 2.61 [1.96, 3.48]). For subjects with <3 months of pain, the proportion of responders was 62.4% (56.5, 68.3%) for NRS and 59.3% (53.3, 65.3%) for R-M scores. CONCLUSIONS: This retrospective observational study suggests TFESIs are clinically effective in the treatment of lumbar radicular pain. Subjects with a shorter duration of pain are more likely to achieve a successful outcome.

An audit of transforaminal epidural steroid injections without sedation: low patient dissatisfaction and low vasovagal rates.

OBJECTIVE: To assess frequency of sedation in transforaminal epidural steroid injections (TFESI) and to analyze patient dissatisfaction and vasovagal rates. DESIGN: Retrospective audit over a 6-year period, January 1, 2006-December 31, 2011. SETTING: Single academic center radiology pain management practice. SUBJECTS: Four thousand four hundred thirty-two patients undergoing 6,878 consecutive TFESI. OUTCOME MEASURES: Frequency of sedation for TFESI was assessed. Vasovagal and patient dissatisfaction rates were assessed, the latter by patients' responses to two follow-up survey questions at 2 weeks postprocedure. RESULTS: Six thousand eight hundred seventy-eight TFESI were performed, of which only 0.1% (N = 7) were performed with sedation. Only 0.4% (N = 28) of TFESI were complicated by vasovagal reaction. Seventy-two percent (N = 4,980) of nonsedated patients responded to the survey. Overall medical care in the nonsedated was rated as: excellent 51%, very good 30%, good 15%, fair 3%, and poor 1%. Ninety-five percent confidence interval (CI) for the 3.9% of the nonsedated patients who rated their care at best "fair" was (3.3, 4.4%). Likelihood of referring friends/family members in nonsedated patients was: definitely 53%, probably 28%, uncertain 16%, probably not 3%, definitely not 0.2%. Ninety-five percent CI for the 3.2% of the nonsedated patients who would at best "probably not refer" their friends/family was (2.7, 3.7%). CONCLUSIONS: In our radiology pain management practice, sedation was rarely utilized for TFESI. A small minority of nonsedated patients rated their care at best fair and would at best probably not refer friends/family members. TFESI can be performed without sedation with low patient dissatisfaction and low vasovagal rates.

Video fluoroscopic analysis of the effects of three commonly-prescribed off-the-shelf orthoses on vertebral motion.

STUDY DESIGN: Fluoroscopic assessment of the effects of commercially available spinal orthotics on lumbar vertebral motion as subjects performed flexion and extension maneuvers. OBJECTIVE: To quantitate the effects of 3 commonly available, off-the-shelf, soft, and semirigid spinal orthoses on lumbar spinal motion. SUMMARY OF BACKGROUND DATA: Commercially available soft and semirigid orthoses are widely prescribed for patients with low back pain and, at times, following surgery. Despite this use, surprisingly little is known about the magnitude of their effects on lumbar vertebral motion. METHODS: Ten subjects (6 men and 4 women) with an average age of 27.0 +/- 5.3 years, underwent videofluoroscopic imaging as they performed a full flexion/extension cycle. Assessments, during which the subjects were unbraced or wearing either a soft lumbrosacral orthosis (LSO), a semirigid LSO, or a semirigid thoracolumbrosacral orthosis (TLSO) were performed in random order. Images were obtained at a rate of 3.75 Hz and digitally processed to determine the sagittal rotation of the L3-L5 vertebral bodies. RESULTS: Each of the braces produced a statistically significant reduction in overall lumbar motion during the flexion maneuver (P = 0.007) but none had a detectable effect during extension. Relative effectiveness varied by vertebral level. At the L3-L4 level, only the TLSO had a statistically significant effect on intervertebral flexion movement (32%, P = 0.003). At the L4-L5 level all the orthoses were effective (and statistically indistinguishable) in their ability to reduce intervertebral flexion movements ranging from 48% for the semirigid TLSO to about 15% to 20% for the 2 LSOs. No effects were noted for any of the orthoses at the L5-S1 level. CONCLUSION: Commercially available soft and semirigid orthotics can have significant effects on lumbar vertebral body motion at the L3-L4 and L4-L5 levels.

Percutaneous image-guided biopsy in an elderly population.

PURPOSE: To evaluate the safety, accuracy, and clinical use of image-guided biopsy results in an elderly (age >/=80 years) patient population. MATERIALS AND METHODS: Image-guided biopsy results of 722 elderly patients were obtained from our image-guided biopsy database over a 5-year period. This retrospective study of the data yielded 616 cases. The accuracy and complication rates for the elderly population were compared with the remaining patients in the database who were younger than 80 years of age (n= 13,012). In addition, use of biopsy results for treatment was also evaluated against a group of randomly selected younger patients who were matched for type and location of biopsy. RESULTS: Image-guided biopsy in both patient groups was characterized by a high accuracy rate (95% for the elderly patients vs 96.5% for others), but the accuracy rate was significantly higher in the nonelderly group (P = .0247). Image-guided biopsy in elderly patients did not carry a greater complication rate compared with younger patients for any major complication. Use of malignant biopsy results (ie, initiating any therapy) was significantly less common in elderly patients (58% underwent therapy) than in younger age groups. In patients aged 60-70 y, 100% initiated therapy; in patients aged 70-80 y, 95% underwent therapy. CONCLUSIONS: Image-guided biopsy in elderly patients is a safe and accurate procedure. There is no greater risk of complication in elderly patients. Malignant diagnoses achieved by image-guided biopsy in elderly patients resulted less frequently in the initiation of therapy for malignancy.