Eldrige, Jason S.

Background Lumbar facet arthropathy (LFA) is a degenerative, arthritic joint disorder and a common specific cause of axial low back pain and functional impairment. Currently, no disease-modifying therapies are available for symptomatic LFA. Mesenchymal stem/stromal cell (MSC)-based therapy represents an emerging regenerative treatment modality with the promise to target the underlying pathophysiology of LFA. Despite encouraging clinical evidence supporting the safety and efficacy of MSC therapy in other osteoarthritis, its therapeutic utility in LFA remains largely unexplored. We recently completed a prospective, single-arm, open-label phase I clinical trial that demonstrated a favourable safety profile and preliminary clinical benefit following intra-articular administration of bone marrow-derived MSCs (BMSCs) in patients with symptomatic LFA. Building on these findings, we present the protocol for CellKine II , a prospective, randomised, double-blind, placebo-controlled, cross-over phase II clinical trial to evaluate the safety and preliminary efficacy of intra-articular delivery of allogeneic, culture-expanded BMSCs in patients with painful LFA. Methods and analysis This study is a single-centre, randomised, double-blind, placebo-controlled, cross-over phase II trial with a target accrual of 40 patients. Eligible patients will be randomly assigned in a 1:1 ratio to receive a single intra-articular injection of either Arm A: BMSC or Arm B: Placebo (dimethyl sulfoxide). At the 6-month follow-up, all patients will be unblinded. Patients initially randomised to Arm A will continue follow-up for up to 12 months. Patients initially randomised to Arm B may cross over to receive the BMSC treatment, followed by an additional 12 months of post-BMSC treatment follow-up, or they may continue observation for another 6 months without BMSC treatment. Overall, each patient will be followed up to 12 months after BMSC treatment. The primary endpoints are back pain, functional outcomes and adverse events at 6 months post-randomisation. Ethics and dissemination This study will be conducted in compliance with U.S. federal regulations and Mayo Clinic institutional research policies and procedures. The protocol has been approved by the Mayo Clinic Institutional Review Board (IRB) and the Data Safety Monitoring Board (IRB No. 21-013278). The results of this trial will be disseminated through publication in peer-reviewed journals and on ClinicalTrials.gov. Trial registration number NCT06001853 .

Abstract Pain medicine triage plays a crucial role in ensuring patients receive timely and appropriate care by scheduling them to the most suitable treatment path. However, the absence of standardized triage protocols in pain medicine often leads to inefficiencies, including delay of care and wastage of healthcare resources. This study aims to develop a rule-based automated referral triage system leveraging information from patients' medical notes for scheduling patients to specific procedures in the pain medicine department. The proposed triage system, grounded in the knowledge and expertise of clinical providers, processed referral order comments and referring provider notes by iteratively refining the Natural Language Processing (NLP) rules and post-processing rules through intensively reviewing 76 patients. A post-processing regression model was incorporated to further enhance the accuracy. To ensure alignment with real-world practices, the system was integrated into an electronic health record (EHR) platform for real-time application, streamlining scheduling workflows and enhancing usability in daily clinical settings. After three iterations, the proposed NLP and post-processing rules improved accuracy from 76.3 to 80.3% compared to machine learning (ML) approaches in the preliminary study. The post-processing model further increased accuracy to 84.2%. The implementation accuracy of 200 cases for the first 3 months was consistent with our prediction at 83.5%, which concluded that the improvement over ML models (p-value = 0.018) was statistically significant at 95% significance level. This study demonstrates the feasibility and benefits of a knowledge-driven approach to referral triage in specialized medical fields. It lays a foundation for others in building similar triaging solutions to other specialties.

Objectives To identify Reddit users’ viewpoints and inquiries about spinal cord stimulation (SCS) for chronic back pain using Reddit databases. Methods We performed a qualitative analysis of public, anonymous threads and comments from targeted subreddits within the Reddit community. We used the Python Reddit API Wrapper to extract relevant data. A qualitative descriptive approach was employed, using natural language processing to identify and categorize common questions, concerns, and opinions shared by patients regarding SCS. Results Our analysis included 112 posts and 448 comments. The tone of comments was neutral (n=231), followed by negative (n=121) and positive (n=96). 13 users actively encouraged other users to try the procedure, while 25 advised against it. The main topics of discussions revolved around pain relief expectations and adverse events. Almost half of users commenting about pain relief expectations reported experiencing considerably lower improvement than anticipated. Pocket pain, lead fracture/migration, infection risk, and scars were common topics of discussion among users. Furthermore, users shared strategies to mitigate postoperative discomfort and offered insights into device selection based on MRI conditionality, reprogramming need, and charging prerequisites. Conclusion Our Reddit analysis identified potential targets for enhanced dialog between physicians and patients around anticipated pain relief, complications, and postoperative care. Reddit and other social media platforms may offer valuable opportunities for healthcare professionals to improve engagement with patients.

Introduction Epidural steroid injections and epidural blood patches commonly involve the injection of a small amount of radiocontrast media under fluoroscopy to properly identify the target tissue or anatomic space and prevent off-target or intravascular delivery of therapeutic or diagnostic drugs. Iodinated low osmolar non-ionic contrast media is the standard preparation used as it is considered safe and cost-effective, but gadolinium-based preparations have been used as an alternative for patients with an ‘iodine’-related or radiocontrast media allergy label to prevent hypersensitivity reactions. The risk of neurotoxic events when gadolinium is inadvertently injected into the intrathecal space has been reported in recent years, raising concerns when gadolinium-based contrast media is used in lieu of iodinated low osmolar non-ionic contrast media. Methods A retrospective review was conducted of patients who received gadolinium-based contrast media for procedures with risk of inadvertent intrathecal access from January 1, 2019 to May 1, 2022. Information on patient demographics, allergy label information, and procedure description was documented for all patients who received gadolinium-based contrast media for axial spine procedures (including epidural steroid injections, epidural blood patch procedures, and selective nerve root blocks), and all side effects reported within 1 month of the procedure were recorded. Saved fluoroscopy images of all procedures for which there was concern for possible gadolinium-based contrast media-related side effect were reviewed for evidence of inadvertent intrathecal gadolinium-based contrast media administration. Descriptive statistical analysis was performed using REDCap and IBM SPSS Statistics V.28. Results We identified 508 patients who received gadolinium-based contrast media during a fluoroscopically guided axial spine procedure. These patients underwent 697 epidural procedures and 23 patients were identified as experiencing an adverse event that could be consistent with possible, probable, or clear signs of exposure to intrathecal gadolinium. Our calculated adverse event rate was 3.3%. Ten patients required additional medical evaluation or treatment. Discussion Almost all patients in our cohort had an allergy label on their chart that guided the provider to switch to gadolinium-based contrast media, but most were incomplete, ill-defined, or related to allergy to iodine but not iodinated contrast media. Such practice is not recommended based on current guidelines. The current study raises concern regarding the use of gadolinium-based contrast media in axial spine procedures, with the risk of potential severe adverse events, without evidence-based need for avoiding iodinated contrast media.

Abstract Introduction Greater trochanteric pain syndrome may often mimic pain generated from other sources. However, it is most commonly caused by gluteus medius and gluteus minimus tendinopathy or tear. The purpose of this technical report was to: 1) describe the ultrasound-guided fascial plane block technique targeting the superior gluteal nerve in the plane between gluteus medius/gluteus minimus to treat moderate-to-severe, chronic, refractory greater trochanteric pain syndrome; 2) anatomically correlate the procedure with cadaveric dissections demonstrating the structures being imaged and the tissues along the needle trajectory; 3) demonstrate the feasibility of the technique with serial dissection of one cadaveric specimen following injection with color dye. Technique description The ultrasound-guided fascial plane block targeting the superior gluteal nerve to treat moderate-to-severe, chronic, refractory greater trochanteric pain syndrome has been outlined with supporting ultrasound scans and anatomical dissections. The cadaveric dissections are correlated to the ultrasound scans of a healthy volunteer and provide visualization of the tissues in the needle trajectory. The feasibility study in a cadaveric specimen showed adequate stain of the superior gluteal nerve without spread to the piriformis muscle belly, the sciatic nerve, or the inferior gluteal nerve. Conclusions This ultrasound-guided fascial plane block is a feasible option for blocking the superior gluteal nerve without inadvertent involvement of the sciatic and inferior gluteal nerves. Further randomized controlled clinical trials are necessary to assess the clinical efficacy of the gluteus medius/gluteus minimus fascial plane block to treat moderate-to-severe, chronic, refractory greater trochanteric pain syndrome.