Spinal Diagnostics and Treatment Center

Aim: The availability of long-term (>2years) safety outcomes of spinal cord stimulation (SCS) remains limited. We evaluated safety in a global SCS registry for chronic pain. Methods: Participants were prospectively enrolled globally at 79 implanting centers and followed out to 3yearsafter device implantation. Results: Of 1881 participants enrolled, 1289 received a permanent SCS implant(1776completed trial). The annualized rate of device explant was 3.5% (all causes), and 1.1% due to inadequate pain relief. Total incidence of device explantation >3years was 7.6% (n=98). Of these, 32subjects (2.5%) indicated inadequate pain relief as cause for removal. Implantsite infection (11 events) was the most common device-related serious adverse event(<1%). Conclusion: This prospective, global, real-world study demonstrates a high-level of safety for SCS with low rate of explant/serious adverse events. Clinical Trial Registration: NCT01719055 (ClinicalTrials.gov).

An institutional, prospective clinical data analysis. To evaluate the safety and efficacy of a new navigable percutaneous disc decompression device (L'DISQ) in patients with lumbar disc herniation with radicular pain. We performed disc decompressions using L'DISQ on 27 patients with persistent disabling back and leg pain for 1 month or longer (average 6.48 months) due to a herniated lumbar intervertebral disc. Baseline data were prospectively gathered before the index procedure and at 1, 4, 12, and 24 weeks post-procedure. Data included pain intensity (visual analog scale [VAS]), measure of disability (Oswestry Disability Index [ODI] and Rolando-Morris Questionnaire [RM]), health-related quality of life (Bodily Pain Scale of Short Form-36 version 2 [SF-36 BP]), and passive straight leg raising test (SLR). The VAS fell from 7.08±1.22 to 1.84±0.99 scores at 24 weeks post-procedure. At 24 weeks, the ODI had fallen from 41.88±10.61 to 16.66±8.55% and the RM from 11.52±3.91 to 2.68±1.97 points. The SF-36 BP dropped significant improvement from 32.89±5.83 to 49.57±4.96 scales. In the SLR test, the angular change of 24 weeks showed considerable improvement from 60.20±20.02 to 83.00±14.29 degrees. No major complication occurred, although two cases developed a disc reherniation 1 month post-procedure. The L'DISQ device is specifically designed to remove herniated disc using a wand that can be navigated into a disc protrusion or extrusion. Following decompression, we measured clinically significant pain improvement and decreased disability for patients with both radicular and axial pain caused by protruded and extruded discs.

The purpose of this study was to document particulate size in commonly used corticosteroid preparations. Inadvertent injection of particulate corticosteroids into a vertebral or foraminal artery can cause brain and spinal cord embolic infarcts and the size of the particles could be directly related to the chance that a clinically significant infarct would occur. One might assume that corticosteroids with particles significantly smaller than red blood cells might be safer. The following four types of corticosteroid preparations were used in various solutions and evaluated under light microscopy: dexamethasone sodium phosphate injection, triamcinolone acetonide injectable suspension, betamethasone sodium phosphate and betamethasone acetate injectable suspension, and methylprednisolone acetate injectable suspension. Dexamethasone sodium phosphate particle size was approximately 10 times smaller than red blood cells and the particles did not appear to aggregate; even mixed with 1% lidocaine HCl solution and with contrast dye, the size of the particles were unchanged. Triamcinolone acetonide and betamethasone sodium phosphate showed variable sizes; some particles were larger than red blood cells, and aggregation of particles was evident. Methylprednisolone acetate showed uniformity in size and the majority were smaller than red blood cells which were not aggregated, but the particles were densely packed. Compared with the particulate steroid solutions, dexamethasone sodium phosphate had particles that were significantly smaller than red blood cells, had the least tendency to aggregation, and had the lowest density. These characteristics should significantly reduce the risk of embolic infarcts or prevent them from occurring after intra-arterial injection. Until shown otherwise in clinical studies, interventionalists might consider using dexamethasone or another corticosteroid preparation with similar high solubility and negligible particle size when performing epidural injections.

The authors examined the effect of psychological and emotional status on the outcome in patients with suspected chronic discogenic low-back pain (LBP) who have undergone lumbar fusion. The authors retrospectively analyzed the medical records, including the results of the 36-item Short Form (SF-36), of 57 consecutive patients (mean age 42.7 years) who underwent single-level lumbar reconstructive surgery between 1994 and 2000. The SF-36 physical component summary (PCS) and mental component summary (MCS) domains were evaluated. Data were sorted into the following categories: excellent, good, fair, same, and worse. Scores greater than 40 for MCS and PCS were defined as "normal" according to US general population data provided by the Medical Outcomes Trust. Of 57 patients, 47 completed postoperative SF-36 surveys at 1 year and 36 completed the 2-year follow-up surveys. Analysis showed that preoperative MCS scores exhibited a significant, direct correlation with PCS score improvements at 1 (r = 0.584, p = 0.000) and 2 (r = 0.623, p = 0.000) years after surgery. In patients in whom preoperative MCS scores reflected normal status, outcomes were excellent or good in 60% at 1-year (18 of 30 cases) and 2-year (15 of 25 cases) follow-up intervals. Patients in whom MCS scores represented abnormal status had less satisfactory outcomes, with excellent or good outcome in only two (18.2%) of all patients at the 2-year follow-up study. Analysis of the data suggests that psychological and emotional distress may negatively affect postoperative outcome in patients with chronic discogenic LBP. The SF-36 may be easily and effectively used to measure both preoperative psychosocial distress and postoperative outcome.