Rafael Gálvez

Background: Chronic pain is the leading cause of years lived with disability worldwide, with low back pain representing the most prevalent and disabling condition. Spinal cord stimulation (SCS) and intrathecal drug delivery (IDD) systems are established neuromodulation techniques for refractory chronic pain. However, a subset of patients experiences partial or declining benefit with either modality alone. In such cases, combined therapy may represent a rescue strategy. Methods: retrospective case series at a single center, including patients previously implanted with SCS who subsequently required IDD due to loss of efficacy or inadequate pain coverage. Pain intensity, opioid consumption, health-related quality of life, and patient satisfaction were assessed using validated instruments. Results: Twelve patients were included. Persistent low back pain with mixed nociceptive–neuropathic features was the most common indication. Combined therapy was observed in association with a mean reduction of 3.5 points on the Numeric Rating Scale, corresponding to an approximate 40% decrease in pain intensity. More than half of the patients discontinued systemic opioids. Complications occurred in seven patients (58.3%), mostly hardware-related and manageable with surgical revision; only one patient developed a device-related infection. Conclusions: In this case series, combined SCS and IDD therapy was observed in association with clinically meaningful pain reduction, decreased opioid use, and high patient-reported satisfaction. Although quality-of-life scores remained below population norms, patients consistently reported subjective improvement. Combined neuromodulation may represent a valid rescue option in selected patients with insufficient response to SCS alone.

Background: Traditional refills of intrathecal infusion pumps rely on manual palpation and the use of external templates, a method that can be challenging in patients with anatomical variations or a high body mass index. Ultrasound guidance has emerged as a precision-based alternative. This study aimed to evaluate the impact of the ultrasound-guided technique versus the conventional template-based technique on patient satisfaction. Methods: A quasi-experimental before-and-after study was conducted on a cohort of 45 chronic pain patients. Immediate satisfaction with procedure duration (IPP-SQ), overall treatment efficacy (CRES-4), and pain interference via the Brief Pain Inventory (BPI) were assessed. Results: The use of ultrasound was associated with significantly higher satisfaction regarding procedure duration, with a mean score of 5.00 (95% CI: 4.35–5.65) compared to 3.22 (95% CI: 2.70–3.75) with the traditional method (p < 0.001). Overall satisfaction (CRES-4) also improved significantly (12.4 vs. 11.3; p = 0.001). Regarding patient-reported outcome measures (PROMs), the mean pain intensity in the subsequent week was lower following the ultrasound technique (mean difference −0.48; p = 0.040). Technically, no first-attempt failures were recorded under ultrasound guidance in this sample, compared to a 20% re-attempt rate observed with the manual method. Conclusions: The transition from the traditional method to ultrasound-guided refill optimizes technical precision and substantially enhances the patient experience. By reducing pain and increasing satisfaction, ultrasound guidance proves to be a valuable resource for improving procedural precision, representing an advancement toward a more personalized medicine approach.

The clinical case of a young patient with intractable residual limb pain is presented. Following the initial administration of opioids and subsequent overuse, the patient was switched to intrathecal (IT) ziconotide infusion with complete opioid withdrawal. After 15 years of treatment with ziconotide infusion, the patient achieved sustained analgesic control and excellent functional recovery. IT ziconotide showed good long‐term tolerability and safety.

Background: There are multiple treatments and approaches available to manage pain. However, when these interventions fail to achieve adequate relief, pain management may involve the implantation of intrathecal infusion pumps. The use of ultrasound guidance may enhance nursing practice by improving procedural efficiency and patient comfort. This technique offers a more precise, safer, and less painful approach, potentially increasing patient satisfaction and reducing procedural complications. Aim: To evaluate patient pain levels during intrathecal infusion pump refills under ultrasound guidance compared to the traditional approach, also aiming to determine the time taken per technique and to assess related intra-procedural complications. Design: A prospective quasi-experimental pre-post study. Methods: The study population included individuals with intrathecal infusion pumps. Each participant underwent two refill visits: one using the traditional method and the subsequent refill using ultrasound guidance. The time required to complete the procedure, any complications, and pain related to the procedure were measured for both techniques. Time was measured using a stopwatch, and pain was assessed at the end of each procedure using a Visual Analogue Scale (VAS). Results: A total of 45 patients (25 men and 20 women), with a median age of 56.0 years were included. The estimated mean refill duration was 13.67 min for the traditional method versus 7.26 min for ultrasound-guided refills, representing a 53.2% reduction. The adjusted mean VAS was 2.76 (2.27–3.24) with ultrasound versus 5.91 (5.20–6.62) with the traditional method, yielding an adjusted mean difference of −3.16 (−4.02 to −2.30; p < 0.001). Reductions were consistent across subgroups defined by sex, refill duration, inter-procedural interval, intrathecal medication, and medical history. Complications occurred in 20.0% of traditional refills but in none of the ultrasound-guided procedures. Conclusions: Ultrasound guidance significantly reduces pain, complications, and procedure time, positioning it as the new standard of care for intrathecal pump refills. This mandates its immediate integration into nursing protocols and health management policies.

Background: Managing pain with intrathecal infusion pumps has significantly improved the treatment of individuals whose pain is uncontrollable by other methods. Using ultrasound to locate the refill port of these infusion pumps may offer an improvement over traditional methods. Objective: The objective of this systematic review is to update existing knowledge on the use of ultrasound for locating the refill port in intrathecal infusion pumps. Methods: The PRISMA review protocol was followed, and the review was registered in PROSPERO under registration number CRD 42024595671. Results: The main findings indicate that this technique is primarily used only in complex cases where access is difficult. Pain assessment, patient satisfaction, and recharge time compared to the traditional method are crucial factors for selecting the type of process to implement. Conclusions: No conclusive data are presented regarding the technique’s effect on pain reduction, patient satisfaction, reduction in time spent refilling the pump, or the prior experience level of the professional performing it, but notable improvements in these aspects are observed in certain situations.

Background: We report the efficacy and safety of E‐52862—a selective, sigma‐1 receptor antagonist—from phase 2, randomized, proof‐of‐concept studies in patients with moderate‐to‐severe, neuropathic, chronic postsurgical pain (CPSP) and painful diabetic neuropathy (PDN).Methods: Adult patients (CPSP [N = 116]; PDN [N = 163]) were randomized at a 1:1 ratio to 4 weeks of treatment with E‐52862 (CPSP [n = 55]; PDN [n = 85]) or placebo (CPSP [n = 61]; PDN [n = 78]) orally once daily. Pain intensity scores were measured using a numerical pain rating scale from 0 (no pain) to 10 (worst pain imaginable). The primary analysis population comprised patients who received study drug with ≥1 baseline and on‐treatment observation (full analysis set).Results: In CPSP, mean baseline average pain was 6.2 for E‐52862 vs. 6.5 for placebo. Week 4 mean change from baseline (CFB) for average pain was −1.6 for E‐52862 vs. –0.9 for placebo (least squares mean difference [LSMD]: −0.9; p = 0.029). In PDN, mean baseline average pain was 5.3 for E‐52862 vs. 5.4 for placebo. Week 4 mean CFB for average pain was −2.2 for E‐52862 vs. –2.1 for placebo (LSMD: –0.1; p = 0.766). Treatment‐emergent adverse events (TEAEs) were reported in 90.9% of E‐52862‐treated patients vs. 76.7% of placebo‐treated patients in CPSP and 34.1% vs. 26.9% in PDN. Serious TEAEs occurred in CPSP only: E‐52862: 5.5%; placebo: 6.7%.Conclusions: E‐52862 demonstrated superior relief of CPSP vs. placebo after 4 weeks. Reductions in pain intensity were seen in PDN with E‐52862; high placebo response rates may have prevented differentiation between treatments. E‐52862 had acceptable tolerability in both populations.Significance Statement: These proof‐of‐concept studies validate the mode of action of E‐52862, a selective sigma‐1 receptor antagonist. In CPSP, E‐52862 resulted in clinically meaningful pain relief. In PDN, reductions in pain intensity were seen with E‐52862; high placebo response rates may have prevented differentiation between E‐52862 and placebo. These findings are clinically relevant given that neuropathic pain is highly incapacitating, lacking effective treatments and representing a significant unmet medical need, and support further development of sigma‐1 receptor antagonists for peripheral neuropathic pain.

Background: Intrathecal drug delivery (IDD) is part of the fourth analgesic step. Evidence on the quality of life of patients with refractory chronic non-cancer pain (CNCP) using these devices and their long-term outcomes is scarce. This study aims to evaluate patients with IDD to assess their HRQoL. Additionally, the study seeks to understand the patients’ satisfaction with the treatment and changes in pain magnitude over time. Methods: Adult patients with CNCP and intrathecal drug delivery systems (IDDS) were included. The study population was divided into two groups: less than and more than 15 years of treatment. HRQoL was analyzed using validated questionnaires. Pain reduction was assessed using the visual analog scale (VAS), and treatment satisfaction was evaluated using the Patient Global Impression of Improvement scale. Results: The results indicate a poor HRQoL in IDD patients, with better scores in the group with ≥15 years of treatment. Pain reduction was similar in both groups, and patients reported a positive satisfaction level with the treatment. Conclusions: HRQoL in CNCP patients is severely affected. Long-term IDD patients have a similar or even better HRQoL in some respects compared to those with shorter follow-ups. IDD patients experienced pain reduction, with most feeling better or much better.

Background and Objectives: Interventional management of neuropathic pain (NP) is available to the patients who do not obtain satisfactory pain relief with pharmacotherapy. Evidence supporting this is sparse and fragmented. We attempted to summarize and critically appraise the existing data to identify strategies that yield the greatest benefit, guide clinicians, and identify areas that merit further investigation. Material and Methods: A two-round Delphi survey that involved pain clinic specialists with experience in the research and management of NP was done over an ad hoc 26-item questionnaire made by the authors. Consensus on each statement was defined as either at least 80% endorsement or rejection after the 2nd round. Results: Thirty-five and 29 panelists participated in the 1st and 2nd round, respectively. Consensus was reached in 20 out of 26 statements. There is sufficient basis to treat postherpetic neuralgias and complex regional pain syndromes with progressive levels of invasiveness and failed back surgery syndrome with neuromodulation. Radiculopathies and localized NP can be treated with peripheral blocks, neuromodulation, or pulsed radiofrequency. Non-ablative radiofrequency and non-paresthetic neuromodulation are efficacious and better tolerated than ablative and suprathreshold procedures. Conclusions: A graded approach, from least to most invasive interventions has the potential to improve outcomes in many patients with common refractory NP conditions. Preliminary promising data warrant further research on new indications, and technical advances might enhance the safety and efficacy of current and future therapies.

Interventional management of neuropathic pain (NP) is available to the many patients who do not attain satisfactory outcomes with pharmacotherapy, but evidence supporting this is sparse and fragmented. We attempted to summarize and critically appraise the existing data to identify strategies that yield maximum benefit, orient clinicians, and identify areas that merit further investigation. A two-round Delphi survey that involved pain clinic specialists with experience in the research and management of NP was done over an ad hoc 26-item questionnaire prepared by the authors. Consensus on each statement was defined as either at least 80% endorsement or rejection after the second round. Thirty-five and 29 panelists participated in the first and second round, respectively. Consensus was reached in 20 out of 26 statements. There is sufficient basis to treat postherpetic neuralgias and complex regional pain syndromes with progressive levels of invasiveness and failed back surgery syndrome with neuromodulation. Radiculopathies and localized NP could be treated with peripheral blocks and neuromodulation, or pulsed radiofrequency. Non-ablative radiofrequency and non-paresthetic neuromodulation are efficacious and better tolerated than ablative and suprathreshold procedures. A graded approach, from least to most invasive interventions has the potential to improve outcomes in many patients with common refractory NP conditions. Preliminary promising data warrant further research on new indications, and technical advances might enhance the safety and efficacy of current and future therapies.