Microbiological Evaluation of the Extension Wire and Percutaneous Epidural Lead Anchor Site Following a "2-Stage Cut-Down" Spinal Cord Stimulator Procedure.

OBJECTIVES: There are concerns regarding bacterial colonization of the temporary extension leads and subsequent infection risk using the 2-stage cut-down approach in spinal cord stimulation (SCS). We sought to quantify the extent of bacterial colonization of the temporary extension wire and percutaneous epidural lead anchor site. MATERIALS AND METHODS: We conducted a cross-sectional observational study recruiting a pragmatic sample of 25 consecutive patients listed for a cut-down trial of SCS. We excluded patients undergoing revision procedures and those who had previously received a spinal cord stimulator. The primary outcome measure was the rate and type of colonization of the extension wires and lead anchor site. RESULTS: No surgical site infections were recorded in any of the patients and no late infections subsequent to insertion of the implantable pulse generator. Overall, 24% of patients grew organisms from the temporary extension wire. Five patients grew coagulase-negative Staphylococcus aureus, and 1 patient grew Enterococcus faecalis. There were no positive wound cultures from the anchor site of the epidural lead. CONCLUSIONS: Despite the high colonization rate of the temporary extension wire, there were no surgical site infections. We conclude that provided appropriate strategies for the management of surgical site infections are implemented, the 2-stage cut-down procedure is a safe approach that is not associated with a higher incidence of infection.

Toward Shared Decision-Making in Degenerative Cervical Myelopathy: Protocol for a Mixed Methods Study.

BACKGROUND: Health care decisions are a critical determinant in the evolution of chronic illness. In shared decision-making (SDM), patients and clinicians work collaboratively to reach evidence-based health decisions that align with individual circumstances, values, and preferences. This personalized approach to clinical care likely has substantial benefits in the oversight of degenerative cervical myelopathy (DCM), a type of nontraumatic spinal cord injury. Its chronicity, heterogeneous clinical presentation, complex management, and variable disease course engenders an imperative for a patient-centric approach that accounts for each patient's unique needs and priorities. Inadequate patient knowledge about the condition and an incomplete understanding of the critical decision points that arise during the course of care currently hinder the fruitful participation of health care providers and patients in SDM. This study protocol presents the rationale for deploying SDM for DCM and delineates the groundwork required to achieve this. OBJECTIVE: The study's primary outcome is the development of a comprehensive checklist to be implemented upon diagnosis that provides patients with essential information necessary to support their informed decision-making. This is known as a core information set (CIS). The secondary outcome is the creation of a detailed process map that provides a diagrammatic representation of the global care workflows and cognitive processes involved in DCM care. Characterizing the critical decision points along a patient's journey will allow for an effective exploration of SDM tools for routine clinical practice to enhance patient-centered care and improve clinical outcomes. METHODS: Both CISs and process maps are coproduced iteratively through a collaborative process involving the input and consensus of key stakeholders. This will be facilitated by Myelopathy.org, a global DCM charity, through its Research Objectives and Common Data Elements for Degenerative Cervical Myelopathy community. To develop the CIS, a 3-round, web-based Delphi process will be used, starting with a baseline list of information items derived from a recent scoping review of educational materials in DCM, patient interviews, and a qualitative survey of professionals. A priori criteria for achieving consensus are specified. The process map will be developed iteratively using semistructured interviews with patients and professionals and validated by key stakeholders. RESULTS: Recruitment for the Delphi consensus study began in April 2023. The pilot-testing of process map interview participants started simultaneously, with the formulation of an initial baseline map underway. CONCLUSIONS: This protocol marks the first attempt to provide a starting point for investigating SDM in DCM. The primary work centers on developing an educational tool for use in diagnosis to enable enhanced onward decision-making. The wider objective is to aid stakeholders in developing SDM tools by identifying critical decision junctures in DCM care. Through these approaches, we aim to provide an exhaustive launchpad for formulating SDM tools in the wider DCM community. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/46809.

Moving Beyond the Neck and Arm: The Pain Experience of People With Degenerative Cervical Myelopathy Who Have Pain.

STUDY DESIGN: Cross-sectional internet survey of people living with degenerative cervical myelopathy. OBJECTIVE: The purpose of this study was to quantify pain distribution, severity, and interference in persons with degenerative cervical myelopathy. METHODS: Eighty-two participants with degenerative cervical myelopathy were recruited for this internet survey. This survey utilized the Michigan Body Map and brief pain inventory (BPI) to assess anatomical distribution and severity of pain as well as the patient derived modified Japanese Orthopedic Association scale (p-mJOA) for myelopathic severity and SF-36 for measures of health-related quality of life. Internal consistency was evaluated with Cronbach's alpha. Pearson's correlations were assessed with p-mJOA and SF-36. Multivariate analysis of variance was used to determine if history of prior surgery or concomitant pain diagnosis impacted experience of pain. RESULTS: Michigan body map distribution and brief pain inventory severity and interference were correlated with p-mJOA and SF-36 scores (p < 0.05). Pain was moderate to severe in 78% of participants. Pain was commonly widespread. Pain scales were sufficiently internally consistent (α > 0.9). History of surgery or other pain diagnosis did not impact experience of pain in myelopathy. CONCLUSIONS: Pain is commonly identifiable in large areas of the body, is frequently moderate to severe in intensity and impacts quality of life and severity of myelopathy in a cohort of individuals with myelopathy who have pain.

Efficacy and Safety of 10 kHz Spinal Cord Stimulation for the Treatment of Chronic Pain: A Systematic Review and Narrative Synthesis of Real-World Retrospective Studies.

10 kHz spinal cord stimulation (SCS) is increasingly utilized globally to treat chronic pain syndromes. Real-world evidence complementing randomized controlled trials supporting its use, has accumulated over the last decade. This systematic review aims to summarize the retrospective literature with reference to the efficacy and safety of 10 kHz SCS. We performed a systematic literature search of PubMed between 1 January 2009 and 21 August 2020 for English-language retrospective studies of ≥3 human subjects implanted with a Senza® 10 kHz SCS system and followed-up for ≥3 months. Two independent reviewers screened titles/abstracts of 327 studies and 46 full-text manuscripts. In total, 16 articles were eligible for inclusion; 15 reported effectiveness outcomes and 11 presented safety outcomes. Follow-up duration ranged from 6-34 months. Mean pain relief was >50% in most studies, regardless of follow-up duration. Responder rates ranged from 67-100% at ≤12 months follow-up, and from 46-76% thereafter. 32-71% of patients decreased opioid or nonopioid analgesia intake. Complication incidence rates were consistent with other published SCS literature. Findings suggest 10 kHz SCS provides safe and durable pain relief in pragmatic populations of chronic pain patients. Furthermore, it may decrease opioid requirements, highlighting the key role 10 kHz SCS can play in the medium-term management of chronic pain.

A multicenter real-world review of 10 kHz SCS outcomes for treatment of chronic trunk and/or limb pain.

Objectives: High-frequency spinal cord stimulation (HF-SCS) at 10 kHz has proven to be efficacious in the treatment of chronic back and leg pain in a randomized, controlled, trial (SENZA-RCT). However, large observational studies have yet to be published. Therefore, we performed a real-world, multicenter, retrospective, review of therapy efficacy in 1660 patients with chronic trunk and/or limb pain. Methods: Data were collected in a real-world environment and retrospectively sourced from a global database. Included patients were trialed and/or permanently implanted with HF-SCS at 10 kHz between April 2014 and January 2018. We evaluated responder rates at 3, 6, and 12 months post-implantation. Response was defined as ≥50% pain relief from baseline. A last visit analysis included responder rate along with overall change in function, sleep, quality of life, and medication intake versus baseline. Results: Eighty-four percent of our HF-SCS-treated patients had both chronic back and leg pain. At least 70% of patients reported response to therapy throughout 12 months of follow-up. This sustained responder rate was corroborated by the last visit value (74.1%). Most patients reported concomitant improvements in function (72.3%), sleep (68.0%), and quality of life (90.3%) at their last visit versus baseline. Thirty-two percent of patients reported decreased medication intake at their last visit. Interpretation: Sustained and effective pain relief was experienced by >70% of our HF-SCS-treated patients, consistent with the findings of a previously published randomized, controlled, trial. Our review provides complementary evidence to support the treatment of chronic back and leg pain with this therapy.

Non-Obstetric Pain in Pregnancy.

The hormonal and mechanical changes which result from pregnancy have the capacity to exacerbate existing chronic pain conditions as well as produce pain unique to this physiological and anatomical state.Pain in pregnancy is very common and can impact negatively on maternal satisfaction with the pregnancy.Management of pain requires a multidisciplinary, biopsychosocial approach. The possible presence of co-existing pathology and obstetric conditions must be borne in mind when assessing pain in pregnancy.Treatment of pain in pregnancy should focus on non-pharmacological interventions in the first instance with due consideration of the risk of medications to the mother, fetus and the course of the pregnancy.