Prevalence of weakness and factors mediating discrepancy between reported and observed leg weakness in people with sciatica.

PURPOSE: To establish the prevalence and agreement between reported and observed leg weakness in people with sciatica. To establish which factors mediate any identified difference between reported and observed leg weakness in people with sciatica. METHODS: 68 people with a clinical diagnosis of sciatica, records from spinal service, secondary care NHS Hospital, England, UK reviewed. Primary outcome measures were the sciatica bothersome index for reported leg weakness and the Medical Research Council scale for observed weakness. Agreement was established with Cohen's Kappa and intraclass correlation coefficient. Potential factors that may mediate a difference between reported and observed weakness included leg pain, sciatica bothersome index sensory subscale, age, hospital anxiety and depression subscale for anxiety. RESULTS: 85% of patients reported weakness but only 34% had observed weakness. Cohen's Kappa (0.066, 95% CI - 0.53, 0.186; p = 0.317)] and ICC 0.213 (95% CI - 0.26, 0.428, p = 0.040) both showed poor agreement between reported and observed weakness. The difference between reported and observed measures of weakness was mediated by the severity of leg pain (b = 0.281, p = 0.024) and age (b = 0.253, p = 0.042). CONCLUSION: There is a high prevalence of reported leg weakness in people with sciatica, which is not reflected in observed clinical measures of weakness. Differences between reported and observed weakness may be driven by the severity of leg pain and age. Further work needs to establish whether other objective measures can detect patient reported weakness.

Clinical pathways for the management of low back pain from primary to specialised care: a systematic review.

PURPOSE: Clinical pathways for low back pain (LBP) have potential to improve clinical outcomes and health service efficiency. This systematic review aimed to synthesise the evidence for clinical pathways for LBP and/or radicular leg pain from primary to specialised care and to describe key pathway components. METHODS: Electronic database searches (CINAHL, MEDLINE, Cochrane Library, EMBASE) from 2006 onwards were conducted with further manual and citation searching. Two independent reviewers conducted eligibility assessment, data extraction and quality appraisal. A narrative synthesis of findings is presented. RESULTS: From 18,443 identified studies, 28 papers met inclusion criteria. Pathways were developed primarily to address over-burdened secondary care services in high-income countries and almost universally used interface services with a triage remit at the primary-secondary care boundary. Accordingly, evaluation of healthcare resource use and patient flow predominated, with interface services associated with enhanced service efficiency through decreased wait times and appropriate use of consultant appointments. Low quality study designs, heterogeneous outcomes and insufficient comparative data precluded definitive conclusions regarding clinical- and cost-effectiveness. Pathways demonstrated basic levels of care integration across the primary-secondary care boundary. CONCLUSIONS: The limited volume of research evaluating clinical pathways for LBP/radicular leg pain and spanning primary and specialised care predominantly used interface services to ensure appropriate specialised care referrals with associated increased efficiency of care delivery. Pathways demonstrated basic levels of care integration across healthcare boundaries. Well-designed randomised controlled trials to explore the potential of clinical pathways to improve clinical outcomes, deliver cost-effective, guideline-concordant care and enhance care integration are required.

Percutaneous Transforaminal Endoscopic Lumbar Foraminotomy in Stable Degenerative Lumbar Isthmic Spondylolisthesis with Radicular Leg Pain: A Retrospective Study.

Objective: Endoscopic surgery is a minimally invasive option for effectively addressing lumbar degenerative diseases. This study aimed to describe the specific technology of percutaneous transforaminal endoscopic lumbar foraminotomy (PTELF) as a therapeutic intervention for managing radicular leg pain (RLP) resulting from stable degenerative lumbar isthmic spondylolisthesis (DLIS) and to present the associated clinical results. Methods: From March 2022 and April 2023, 25 patients were diagnosed with single-level stable DLIS with RLP and underwent PTELF. Clinical assessments utilized the visual analog scale (VAS), Oswestry Disability Index (ODI), and modified MacNab criteria. All endoscopic surgery videos were reviewed to interpret the pathology associated with DLIS. Results: The mean age of the cohort was 65.3 ± 11.0 years. The mean preoperative ODI score, VAS score for low back, and VAS score of the leg were 64.1 ± 8.2, 7.0 ± 0.7, and 7.3 ± 0.8, respectively. These scores significantly improved to 16.3 ± 10.4, 2.0 ± 0.6, and 1.7 ± 1.0 at the final follow-up, respectively (P<0.01). The modified MacNab criteria indicated "good" or "excellent" outcomes in 92.0% of cases. Analysis of 23 surgical videos revealed 15 patients with disc herniation, nine with lower vertebral endplate involvement, consistent presence of uneven bone spurs (at the proximal lamina stump and around the foramen), and accumulated scars. Two patients experienced postoperative dysesthesia, and one encountered a recurrence of RLP. Conclusion: PTELF emerges as a potentially safe and effective procedure for alleviating RLP in patients with stable DLIS. However, additional evidence and extended follow-up periods are imperative to evaluate the feasibility and potential risks associated with PTELF.

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. PURPOSE: The Discover 6603 study (NCT03607838) evaluated the efficacy and safety of a single-dose injection of SI-6603 (condoliase) vs sham for the treatment of radicular leg pain associated with LDH. STUDY DESIGN/SETTING: A randomized, double-blind, sham-controlled, phase 3 study conducted across 41 sites in the United States. PATIENT SAMPLE: Male and female participants (N=352; aged 30-70 years) with contained posterolateral LDH and unilateral radiculopathy/radicular leg pain for greater than 6 weeks. OUTCOME MEASURES: The primary endpoint was the change from baseline (CFB) in average worst leg pain score at 13 weeks, assessed using the 100-mm visual analogue scale. Key secondary endpoints were CFB in average worst leg pain score at 52 weeks, herniation volume at 13 weeks, and Oswestry Disability Index (ODI) score at 13 weeks. Safety evaluations included adverse events (AEs) and imaging findings. METHODS: Participants were randomized 1:1 to receive a single intradiscal injection of condoliase (1.25 units) or sham injection followed by 52 weeks of observation. The primary and key secondary endpoints were assessed using a mixed model for repeated measures (MMRM) analysis and a protocol-specified multiple imputation (MI) sensitivity analysis on the modified intention-to-treat (mITT) population. A prespecified serial gatekeeping algorithm was used for multiple comparisons. Safety endpoints included AEs, laboratory tests, vital signs, imaging (by X-ray and magnetic resonance imaging [MRI]), and occurrence of posttreatment lumbar surgery. RESULTS: Of the 352 randomized participants, 341 constituted the mITT population (condoliase n=169; sham n=172) and the safety population (condoliase n=167; sham n=174). For the primary endpoint, the condoliase group showed significantly greater improvement in CFB in worst leg pain at Week 13 (least squares mean [LSM] CFB: -41.7) compared with sham injection (-34.2; LSM difference: -7.5; 95% confidence interval [CI]: -14.1, -0.9; p=.0263) based on the MMRM analysis. CFB in worst leg pain at Week 52 favored condoliase vs sham, but the difference was not statistically significant (p=.0558), which halted the serial gatekeeping testing algorithm and dictated that the CFB in herniation volume and ODI scores at Week 13 would be considered nonsignificant, regardless of their p-values. Treatment group differences in CFB in herniation volume and ODI score favored the condoliase group vs sham at all timepoints. The MI sensitivity analysis showed differences in CFB in worst leg pain at Week 13 (p=.0223) and Week 52 (p=.0433) in favor of the condoliase group. Treatment-emergent AEs (TEAEs) were more common in the condoliase group (≥1 TEAE: 71.9%; ≥1 treatment-related TEAE: 28.1%) compared with the sham group (≥1 TEAE: 60.3%; ≥1 treatment-related TEAE: 10.3%). Of the TEAEs, spinal MRI abnormalities and back pain occurred most frequently. No treatment-related serious AEs occurred. CONCLUSIONS: Condoliase met its primary endpoint of significantly improving radicular leg pain at Week 13 and was generally well tolerated in patients with LDH. Chemonucleolysis with condoliase has the potential to provide a less invasive treatment option than surgery for those unresponsive to conservative treatment strategies.