A phase 3, randomized, double-blind, sham-controlled trial of SI-6603 (condoliase) in patients with radicular leg pain associated with lumbar disc herniation.

Background Context: SI-6603 (condoliase) is a chemonucleolytic agent approved in Japan in 2018 for the treatment of lumbar disc herniation (LDH) associated with radicular leg pain. Condoliase, a mucopolysaccharidase with high substrate specificity for glycosaminoglycans (GAGs), offers a unique mechanism of action through the degradation of GAGs in the nucleus pulposus. As LDH management is currently limited to conservative approaches and surgical intervention, condoliase could offer a less invasive treatment option than surgery for patients with LDH.

Intraosseous basivertebral nerve ablation: Pooled long-term outcomes from two prospective clinical trials.

Background: Vertebrogenic pain is an established source of anterior column chronic low back pain (CLBP) resulting from damaged vertebral endplates with pain signals transmitted by the basivertebral nerve (BVN). Type 1 or Type 2 Modic changes on magnetic resonance imaging (MRI) are objective biomarkers for vertebrogenic pain. Radiofrequency ablation of the BVN (BVNA) has demonstrated both efficacy and effectiveness for the treatment of vertebrogenic pain in two randomized trials.

The Relationship Between Patient Demographic and Clinical Characteristics and Successful Treatment Outcomes After Basivertebral Nerve Radiofrequency Ablation: A Pooled Cohort Study of Three Prospective Clinical Trials.

Objective: Multiple studies have demonstrated the safety and effectiveness of basivertebral nerve radiofrequency ablation (BVN RFA) for improving low back pain related to the vertebral endplate. However, the influence of patient demographic and clinical characteristics on treatment outcome is unknown.

Design: Pooled cohort study of three clinical trials of patients with vertebral endplate pain identified by Type 1 and/or Type 2 Modic changes and a correlating presentation of anterior spinal element pain.

Long-term outcomes following intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 5-year treatment arm results from a prospective randomized double-blind sham-controlled multi-center study.

Background: Damaged or degenerated vertebral endplates are a significant cause of vertebrogenic chronic low back pain (CLBP). Modic changes are one objective MRI biomarker for these patients. Prior data from the treatment arm of a sham-controlled, RCT showed maintenance of clinical improvements at 2 years following ablation of the basivertebral nerve (BVN).

Intra-Articular Sacroiliac Joint Injection: Technical Guide.

Sacroiliac (SI) joint pathology has been an increasingly discussed pathology as a potential etiology for significant low back and lower extremity pain. While patient history and examination maneuvers can assist with identifying the SI joint as a potential cause of pain, an intra-articular SI joint injection is critical to properly diagnose the SI joint as a clinically relevant pain generator. In addition to the diagnostic information from the injection, SI joint intra-articular injections can be performed for therapeutic benefit as part of a multi-modal, conservative treatment approach for SI joint pathology.

A prospective, open-label, single-arm, multi-center study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain.

Purpose: A prospective, single-arm, open-label study to evaluate the effectiveness of intraosseous radio frequency (RF) ablation of the basivertebral nerve (BVN) for the treatment of vertebrogenic-related chronic low back pain (CLBP) in typical spine practice settings using permissive criteria for study inclusion.

Methods: Consecutive patients with CLBP of at least 6 months duration and with Modic Type 1 or 2 vertebral endplate changes between L3 and S1 were treated with RF ablation of the BVN in up to four vertebral bodies. The primary endpoint was patient-reported change in Oswestry Disability Index (ODI) from baseline to 3 months post-procedure.

Selective nerve root injections can predict surgical outcome for lumbar and cervical radiculopathy: comparison to magnetic resonance imaging.

Objective: Diagnostic selective nerve root injection (SNI) results were analyzed in 101 patients who underwent lumbar or cervical decompression for radiculopathy and compared to surgical outcome 1 year postoperatively. A comparison of surgical outcomes was also examined between magnetic resonance imaging (MRI) and SNI results.

Results: Of the 101 patients, 91 (90%) had positive and 10 had negative SNI results at the level operated.