European randomized controlled trial evaluating differential target multiplexed spinal cord stimulation and conventional medical management in subjects with persistent back pain ineligible for spine surgery: 24-month results.

BACKGROUND: Differential target multiplexed spinal cord stimulation (DTM SCS) was shown to be superior to conventional SCS for treating chronic low back pain (CLBP) in subjects with persistent spinal pain syndrome with previous spinal surgery (PSPS-T2) or ineligible for it (PSPS-T1). This study reports 24-month efficacy and safety of DTM SCS vs. conventional medical management (CMM) in PSPS-T1 subjects across four European countries. METHODS: This is a prospective, multicenter, open-label, randomized, controlled trial with optional crossover. Subjects randomized 1:1 to DTM SCS or CMM. Primary endpoint was responder rate (% subjects reporting ≥50% CLBP relief) at 6 months. A superiority test compared responder rates between treatments. CLBP and leg pain levels, functional disability, quality of life (QoL), patient satisfaction and global impression of change were evaluated for 24 months. A Composite Responder Index (CRI) was obtained using CLBP relief, disability and QoL. Incidence of study-related adverse events evaluated safety. RESULTS: A total of 55 and 57 subjects were randomized to DTM SCS and CMM respectively. DTM SCS was superior, with CLBP responder rates ≥80% and CLBP relief >5.6 cm (>70% reduction) through the 24-month follow-up. Improvements with DTM SCS in other outcomes were sustained. The CRI was >80% for DTM SCS through 24 months. Opioid medication intake decreased in subjects treated with DTM SCS. Most patients treated with DTM SCS felt satisfied and improved at the end of the study. Safety was congruent with other studies. CONCLUSION: DTM SCS is efficacious and safe during 24 months for the treatment of CLBP and leg pain in PSPS-T1 patients ineligible for spine surgery. SIGNIFICANCE STATEMENT: This randomized controlled trial shows that Differential Target Multiplexed SCS (DTM SCS) is an effective and safe long-term treatment for PSPS type 1 patients suffering from axial low back pain with or without leg pain and who are ineligible for spinal surgery. Currently, CMM treatments are their only option and provide limited benefits. Besides superior pain relief, DTM SCS provides significant improvements in functional disability, quality of life, high levels of satisfaction and perceived impression of change.

Long-term safety of spinal cord stimulation systems in a prospective, global registry of patients with chronic pain.

Aim: The availability of long-term (>2 years) safety outcomes of spinal cord stimulation (SCS) remains limited. We evaluated safety in a global SCS registry for chronic pain. Methods: Participants were prospectively enrolled globally at 79 implanting centers and followed out to 3 years after device implantation. Results: Of 1881 participants enrolled, 1289 received a permanent SCS implant (1776 completed trial). The annualized rate of device explant was 3.5% (all causes), and 1.1% due to inadequate pain relief. Total incidence of device explantation >3 years was 7.6% (n = 98). Of these, 32 subjects (2.5%) indicated inadequate pain relief as cause for removal. Implant site infection (11 events) was the most common device-related serious adverse event (<1%). Conclusion: This prospective, global, real-world study demonstrates a high-level of safety for SCS with low rate of explant/serious adverse events. Clinical Trial Registration: NCT01719055 (ClinicalTrials.gov).

Clinical Management of Chronic Pelvic Pain in Endometriosis Unresponsive to Conventional Therapy.

BACKGROUND: Although several treatments are currently available for chronic pelvic pain, 30-60% of patients do not respond to them. Therefore, these therapeutic options require a better understanding of the mechanisms underlying endometriosis-induced pain. This study focuses on pain management after failure of conventional therapy. METHODS: We reviewed clinical data from 46 patients with endometriosis and chronic pelvic pain unresponsive to conventional therapies at Puerta de Hierro University Hospital Madrid, Spain from 2018 to 2021. Demographic data, clinical and exploratory findings, treatment received, and outcomes were collected. RESULTS: Median age was 41.5 years, and median pain intensity was VAS: 7.8/10. Nociceptive pain and neuropathic pain were identified in 98% and 70% of patients, respectively. The most common symptom was abdominal pain (78.2%) followed by pain with sexual intercourse (65.2%), rectal pain (52.1%), and urologic pain (36.9%). A total of 43% of patients responded to treatment with neuromodulators. Combined therapies for myofascial pain syndrome, as well as treatment of visceral pain with inferior or superior hypogastric plexus blocks, proved to be very beneficial. S3 pulsed radiofrequency (PRF) plus inferior hypogastric plexus block or botulinum toxin enabled us to prolong response time by more than 3.5 months. CONCLUSION: Treatment of the unresponsive patient should be interdisciplinary. Depending on the history and exploratory findings, therapy should preferably be combined with neuromodulators, myofascial pain therapies, and S3 PRF plus inferior hypogastric plexus blockade.