Correlation Between Abdominal Wall Stimulation and Spinal Cord Stimulator Tip Location: A Nonrandomized Clinical Trial.

OBJECTIVES: This study aimed to investigate the correlation between the vertebral level of paddle placement and abdominal wall stimulation (AWS) after differential target multiplexed spinal cord stimulation (SCS) to improve the safety and effectiveness of SCS for patients with chronic pain, particularly those with low back pain (LBP). MATERIALS AND METHODS: The Correlation Between Abdominal Wall Stimulation and Spinal Cord Stimulator Tip Location study was a nonrandomized clinical trial that included 24 patients with SCS for persistent spinal pain syndrome (PSPS) type 2 (trial ID: NCT05565469). The intervention involved increasing stimulation amplitude to a maximum tolerable value and obtaining numerical rating scores for AWS. The primary outcome measure was the association between AWS, the neurostimulator tip, and conus medullaris location, whereas the secondary outcome was the pre-postinterventional difference in proportion of patients experiencing AWS. Patient demographics and postoperative imaging were assessed. Statistical analyses involved descriptive statistics, a descriptive logistic regression, and a McNemar test. RESULTS: The results of the study showed that seven (29%) of the 24 patients experienced AWS either previously or during interventional stimulation. However, there was no significant correlation found between AWS and the location of the neurostimulator tip or conus medullaris, and there was no difference in the pre-postinterventional proportion of patients experiencing AWS. CONCLUSIONS: The study concludes that a relatively high proportion of patients who received SCS for PSPS type 2 experienced or previously experienced AWS. There was no significant correlation found between the location of the neurostimulator tip and the occurrence of AWS. This suggests that AWS may not be solely dependent on the stimulation itself and emphasizes the need to consider other factors. Nonetheless, this study provides important insights into the occurrence of AWS in patients receiving SCS for PSPS type 2 and highlights the need for further research in this area. CLINICAL TRIAL REGISTRATION: The Clinicaltrials.gov registration number for the study is NCT05565469.

Temporal profile of care following mild traumatic brain injury: predictors of hospital admission, follow-up referral and six-month outcome.

OBJECTIVE: To investigate the clinical management and medical follow-up of patients with mild traumatic brain injury (mTBI) presenting to emergency departments (EDs). METHODS: Overall, 168 adult patients with mTBI from the prospective, multicentre Transforming Research and Clinical Knowledge in TBI (TRACK-TBI) Pilot study with Glasgow Coma Scale (GCS) 13-15, no polytrauma and alive at six months were included. Predictors for hospital admission, three-month follow-up referral and six-month functional disability (Glasgow Outcome Scale-Extended (GOSE) ≤ 6) were analysed using multivariable regression. RESULTS: Overall, 48% were admitted to hospital, 22% received three-month referral and 27% reported six-month functional disability. Intracranial pathology on ED head computed tomography (multivariable odds ratio (OR) = 81.08, 95% confidence interval (CI) [10.28-639.36]) and amnesia (>30-minutes: OR = 5.27 [1.75-15.87]; unknown duration: OR = 4.43 [1.26-15.62]) predicted hospital admission. Older age (per-year OR = 1.03 [1.01-1.05]) predicted three-month referral, while part-time/unemployment predicted lack of referral (OR = 0.17 [0.06-0.50]). GCS < 15 (OR = 2.46 [1.05-5.78]) and prior history of seizures (OR = 3.62 [1.21-10.89]) predicted six-month functional disability, while increased education (per-year OR = 0.86 [0.76-0.97]) was protective. CONCLUSIONS: Clinical factors modulate triage to admission, while demographic/socioeconomic elements modulate follow-up care acquisition; six-month functional disability associates with both clinical and demographic/socioeconomic variables. Improving triage to acute and outpatient care requires further investigation to optimize resource allocation and outcome after mTBI. ClinicalTrials.gov registration: NCT01565551.

Transforaminal epidural steroid injection for radiculopathy and the evolution to surgical treatment: a pragmatic prospective observational multicenter study.

Aim: The aim of this study is to analyze the real-world outcomes of transforaminal epidural steroid injections (TFESIs) in all patients with radiculopathy and their long-term outcomes. Methods: Patients with radiculopathy and failure of conservative treatment were included in a prospective, multicenter, observational cohort study. Results: In total, 117 patients were treated with one or two TFESIs. The mean duration of follow-up was 116 (±14) weeks. In total 19,6% (95% CI: 12.9-28.0%) patients were treated with surgery after insufficient symptom improvement. The evolution to surgery was not associated with etiology, symptom duration or previous spine surgery. Conclusion: Real-world data confirms that TFESIs is an effective treatment with satisfactory results in about 80% of patients for a period of 2 years.

This study focusses on evaluating the real-world effectiveness of transforaminal epidural steroid injections (TFESIs) in treating radiculopathy, a condition characterized by back and leg pain due to compressed spinal nerves. This nerve compression can originate from different problems.A total of 117 patients with radiating leg pain were included in this study. The infiltrations were administered, and the primary outcome was the need for spinal surgery within 2 years. The findings revealed that approximately 20% of patients eventually required surgery due to unsatisfactory results after injections. However, for patients with satisfactory outcomes, there was a notable reduction in back and leg pain, disability and pain medication usage, along with an improved quality of life.Importantly, the results suggested that TFESIs could be considered as a treatment option in daily clinical practice, also after a prolonged duration of symptoms.Despite certain limitations, such as the absence of a control group undergoing immediate surgical treatment, the real-world data supported the effectiveness of TFESIs in treating radiculopathy. This information provides valuable insights for spine surgeons and pain physicians in understanding the prognosis of TFESIs across diverse patient scenarios.

Twiddler's syndrome after dorsal root ganglion stimulation: A case report.

Dorsal root ganglion stimulation (DRG-S) is a promising therapy for chronic neuropathic pain, but complications of this therapy are poorly understood. Twiddler's syndrome, a rare complication characterized by lead displacement and coiling of wires, has been reported in other neuromodulation devices, but has not been described in the context of DRG-S. Here, we present a first-of-a-kind case report of Twiddler's syndrome occurring after 8 months of DRG-S. This case report highlights the importance of considering Twiddler's syndrome as a potential complication in patients undergoing DRG-S, especially in those with significant weight loss history.

Extreme Lateral Interbody Fusion as a Feasible Treatment for Thoracolumbar Spondylodiscitis: A Multicenter Belgian Case-Series.

BACKGROUND: Spondylodiscitis is, after tissue sampling, initially managed with intravenous antibiotics. In patients with treatment failure, surgical debridement and stabilization is considered. An anterior or posterior approach has already been reported as a successful surgical access, but is associated with a large exposure and a significant morbidity. METHODS: We present a multicenter Belgian case-series on the use of a minimally invasive extreme lateral interbody fusion procedure with add-on percutaneous pedicle screw fixation for patients with a need for surgical debridement and tissue samples or intractable back pain due to spondylodiscitis. Patient characteristics, microbiology results, antibiotic treatment, pre- and postoperative Visual Analogue Pain Score (VAS) scores, time to bony consolidation, complications and duration of the hospital stay were collected. RESULTS: Seven patients with one level spondylodiscitis were included. The mean age 64 years with a mean preoperative VAS score of 8.86 ( ± 0.90). Postoperative VAS score significantly decreased to 2.57 (-70.3%, P < 0.001). Mean antibiotic treatment duration was 8 weeks. Median duration of the hospital stay was 14 days. Patients were followed for 1 year. Complete bony consolidation was observed in 6 out of 7 patients after 1 year. One patient had a stable pseudarthrosis. CONCLUSIONS: These results indicate that extreme lateral interbody fusion topped off with a percutaneous pedicle screw fixation might be a feasible, safe and valuable choice to surgically treat patients with spondylodiscitis with fast and important improvement in VAS. Further prospective research might strengthen the sparsely existing literature of minimally invasive surgery for spondylodiscitis to provide the best possible care.

Lateral Lumbar Interbody Fusion (Direct Lateral Interbody Fusion/Extreme Lateral Interbody Fusion) versus Posterior Lumbar Interbody Fusion Surgery in Spinal Degenerative Disease: A Systematic Review.

BACKGROUND: Degenerative diseases of the lumbar spine are often treated with posterior interbody fusion surgery (posterior lumbar interbody fusion [PLIF]) for spinal instability or intractable back pain with neurologic impairment. Several lateral, less invasive procedures have recently been described (lateral lumbar interbody fusion [LLIF]/direct lateral interbody fusion/extreme lateral interbody fusion [XLIF]). The aim of this systematic review is to compare structural and functional outcomes of lateral surgical approaches to PLIF. METHODS: We conducted a MEDLINE (PubMed), Web of Science, ScienceDirect, and Cochrane Library search for studies focusing on outcomes and complications comparing LLIF (direct lateral interbody fusion/XLIF) and PLIF. The systematic review was reported using the PRISMA criteria. RESULTS: In total, 1000 research articles were identified, of which 5 studies were included comparing the outcomes and complications between the lateral and posterior approach. Three studies found significantly less perioperative blood loss with a lateral approach. Average hospital stay was shorter in populations who underwent the lateral approach compared with PLIF. Functional outcomes (visual analog scale score/Oswestry Disability Index) were similar or better with LLIF. In most of the included studies, complication rates did not differ between the posterior and lateral approach. Most of the neurologic deficits with XLIF/LLIF were temporary and healed completely within 1 year follow-up. CONCLUSIONS: A lateral approach (XLIF/LLIF) is a good and safe alternative for PLIF in single-level degenerative lumbar diseases, with comparable functional outcomes, shorter hospital stays, and less blood loss. Future prospective studies are needed to establish the role of lateral minimally invasive approaches in spinal degenerative surgery.

Patient profiling and outcome assessment in spinal cord stimulation for chronic back and/or leg pain (the PROSTIM study): a study protocol.

Spinal cord stimulation (SCS) is a well-established treatment option in the multidisciplinary approach to chronic back and leg pain. Nevertheless, careful patient selection remains crucial to provide the most optimal treatment and prevent treatment failure. We report the protocol for the PROSTIM study, an ongoing prospective, multicentric and observational clinical study (NCT05349695) that aims to identify different patient clusters and their outcomes after SCS. Patients are recruited in different centers in Europe. Analysis focuses on identifying significant patient clusters based on different health domains and the changes in biopsychosocial variables 6 weeks, 3 and 12 months after implantation. This study is the first to include a biopsychosocial cluster analysis to identify significant patient groups and their response to treatment with SCS.

What is the study about? Spinal cord stimulation (SCS) is a treatment for chronic back and leg pain, in which an electrical stimulation is delivered to the spinal cord in order to reduce pain experience. It is important to choose the right patients to make sure the treatment works well. The PROSTIM study is a research project in which we study patients selected to be treated with SCS. We want to understand how different groups of patients selected for this treatment do after getting SCS. The study includes patients in different European centers, following them for 6 weeks, 3 months and 1 year after getting SCS. This study is the first one to use a cluster analysis to group patients based on different aspects of their psychological and physical health and see how they respond differently to SCS treatment. Clinical Trial Registration: NCT05349695 (ClinicalTrials.gov).

Common Data Elements: Critical Assessment of Harmonization between Current Multi-Center Traumatic Brain Injury Studies.

Standardization and harmonization of data collection in studies on traumatic brain injury (TBI) is of paramount importance for meta-analyses across studies. Nearly 10 years ago, the first set of Common Data Elements for TBI (TBI-CDEs v1) were introduced to achieve these goals. The TBI-CDEs version 2 were developed in 2012 to broaden the approach to all ages, injury severity, and phases of recovery. We aimed to quantify the degree of harmonization of these data elements in three large, prospective multi-center studies conducted within the International Initiative for TBI Research (InTBIR). Data variables of the Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury (CENTER-TBI; adult and pediatric patients in Europe and Israel), Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI; adult and pediatric patients in the U.S.), and Approaches and Decisions in Acute Pediatric TBI (ADAPT; international study on severe pediatric TBI) studies were indexed and matched to the second version of the TBI CDEs. We focused on the CDE sub-categories of "Acute Hospitalized" (AH) and "Moderate/Severe TBI: Rehabilitation (Rehab). All "Core" and "Basic" level CDEs were considered. Closely related elements were reduced to one variable to prevent over-representation. Categorical elements and text elements for the same variable were likewise merged to one element for analysis. Following reduction and merging of related elements, 21 Core, 46 Basic AH, and 50 Basic Rehab elements were deemed harmonizable across studies. Gaps in global applicability were identified for four of the TBI CDEs and many of the outcome instruments, which are only available in the English language. Agreements of Core and Basic study CDEs for the AH domain with the TBI CDEs were respectively 81% and 91% for CENTER-TBI, 76% and 93% for TRACK-TBI, and 85% in ADAPT for both domains. For the domain Rehab, agreement with Basic TBI CDEs was 84% for CENTER-TBI, 94% for TRACK-TBI, and 71% for ADAPT. Non-harmonization was largely caused by absence of the elements in the studies. For elements present, the compatibility of coding with TBI CDEs was 90-99%. The degree of harmonization was greatest between CENTER-TBI and TRACK-TBI with 81-87% overlap within the TBI CDE sub-categories. The high degree of harmonization of study variables among these studies demonstrates the importance and utility of common data elements in TBI research. It also confirms the potential for future meta-analyses across these large studies, especially for CENTER TBI and TRACK TBI. The global applicability of the TBI CDEs needs to be improved for them to become a global standard for TBI research. CENTER-TBI, TRACK-TBI, and ADAPT, along with other studies within the InTBIR Initiative, provide a platform to inform further refinement and internationalization for the next version of the TBI CDEs.