Sprint PNS System (United States)

ObjectiveRefractory pain of the shoulder hinders independence and decreases quality of life. Sixty-day peripheral nerve stimulation (PNS) treatment has shown the ability to provide substantial and sustained relief in patients with chronic shoulder pain. The present study aims to identify key patient and treatment characteristics that may be utilized by physicians to optimize patient outcomes.DesignAn institutional review board–approved retrospective chart review evaluated patients who previously underwent 60-day PNS treatment for their chronic shoulder pain. Patient and treatment characteristics were extracted from electronic medical records and analyzed alongside patient-reported outcomes provided at the end of treatment.ResultsOverall, 221 patients were included in the study. Of patients with available outcomes, 75% (n = 132/176) reported substantial (i.e., ≥50%) pain relief at end of treatment. PNS treatment effectiveness was consistent when stratified by several factors, including the chronicity of pain, patient age, and the cause of pain. Regression analyses identified characteristics associated with successful outcomes.ConclusionsThe study highlights the effectiveness of 60-day peripheral nerve stimulation treatment across a variety of shoulder pain types and medical histories. These findings complement previous studies and real-world evidence supporting PNS in the management of chronic shoulder pain and provide insights that may inform patient selection and optimization of 60-day PNS treatment.

Management of refractory chronic low back pain (CLBP) includes a range of treatments (eg, physical therapy, injections, ablations, neurostimulation, surgery) with varying utilization and effectiveness. This pragmatic randomized controlled trial (RCT) evaluated the effectiveness of one treatment option, percutaneous 60-day peripheral nerve stimulation (PNS), compared to usual care with standard interventional management for CLBP. Two hundred thirty patients with CLBP were randomized in a 1:1 ratio to Group 1 (percutaneous 60-day PNS) or Group 2 (physician-directed usual care with standard interventional management). The Primary Clinical Endpoint evaluated the proportion of participants with ≥50% reductions in CLBP at 3 months post-treatment compared to baseline. At the Primary Endpoint, a greater proportion of participants receiving percutaneous 60-day PNS (55%; n = 112; 95% confidence interval [CI] = 45-65) experienced ≥50% pain relief compared to usual care with standard interventional management (26%; n = 110; 95% CI = 17-34; P < .001). Concordant with the Primary Endpoint, percutaneous 60-day PNS also produced greater improvements in patient-centric secondary endpoints, including disability, pain interference, health-related quality of life, and analgesic consumption. Reductions in pain and resulting improvements in function were sustained through 6 months with percutaneous 60-day PNS. This prospective multicenter pragmatic RCT met its Primary Clinical Endpoint and found that more participants with CLBP reported pain relief at 3 months after receiving percutaneous 60-day PNS as compared to usual care with standard interventional management. Participants treated with 60-day PNS showed greater reductions in pain and more substantial improvements in functional outcomes through 6 months. NCT04246281; Primary funding: Department of Defense (DoD), with additional funding needed to complete the study provided by the study's sponsor, SPR.The protocol is available on ClinicalTrials.gov. The statistical analysis plan and results will be made available within 12 months of the study's completion.

Shoulder pain can be a chronic, disabling condition resulting in major procedures like surgery that are invasive, costly, and pose significant risks to patients. Minimally invasive interventions that provide durable relief can improve outcomes while enabling patients to avoid accruing additional healthcare costs. The present survey study evaluated durability of pain relief in a real-world shoulder pain population following percutaneous 60-day peripheral nerve stimulation (PNS) treatment. A cross-sectional follow-up survey assessed follow-up outcomes among patients who received 60-day PNS for chronic shoulder pain. Outcomes included patient-reported percent pain relief, average and worst pain scores, and patient impression of change in quality of life, physical function, and sleep. Patients also reported other treatments and interventions used for their shoulder pain since the 60-day PNS treatment including changes in medication usage. Among 489 survey participants (mean follow-up 21months, range 6-60), 83% (405/489) reported no subsequent radiofrequency ablation, permanent implant, or surgery following 60-day PNS. Within this subset, 87% reported ongoing improvement in at least one domain at follow-up, including 71% who maintained ≥ 50% pain relief, and more than half who reported much or very much improved quality of life (61%), physical function (57%), or sleep (57%). Among those using PNS seeking to avoid surgery (n = 265), 81% reported no subsequent surgery, with 77% of those patients maintaining ≥ 50% pain relief. Outcomes were consistent across follow-up durations and shoulder pain etiologies. This real-world evidence demonstrates that a large majority of responders to 60-day PNS may experience durable shoulder pain relief and other improvements, with benefits demonstrated up to 5years post treatment. The low rate of progression to subsequent interventions including surgery suggests potential for healthcare economic benefit, supporting 60-day PNS as both a clinically effective and potentially economically advantageous approach for appropriate patients.

ObjectiveThe aim of this study was to evaluate the efficacy and safety of a 60‐day peripheral nerve stimulation (PNS) treatment targeting the occipital nerves for reducing pain and improving function in individuals diagnosed with cervicogenic headache or occipital neuralgia.BackgroundHeadache conditions are prevalent and commonly disabling, and conventional therapeutic strategies are often insufficient. Development of a percutaneous 60‐day PNS treatment has created new opportunities to evaluate PNS of the occipital nerves.MethodsThis study was an institutional review board‐approved, multicenter, prospective, single‐arm study that enrolled participants from October 2022 to March 2024. Participants with cervicogenic headache or occipital neuralgia received a 60‐day PNS treatment targeting the occipital nerves. The primary endpoint was the proportion reporting clinically significant (≥30%) reductions in average pain and/or pain interference at end of treatment (EOT). Additional analysis included the proportion of participants with ≥50% reduction in average pain intensity and/or pain interference and additional outcomes including Patient Global Impression of Change, six‐item Headache Impact Test, and Neck Disability Index.ResultsAt EOT, 90% of participants (18/20) met the primary endpoint. Further, 85% (17/20) and 83% (15/18) reported ≥50% reductions in pain and/or pain interference at EOT and 3 months, respectively. Clinically meaningful improvements were observed in functional and headache‐related disability and quality‐of‐life measures. All study‐related adverse events were non‐serious.ConclusionMost participants reported significant reductions in pain and/or pain interference following 60‐day PNS targeting the occipital nerves. Outcomes through 3 months demonstrate how 60‐day PNS offers an effective approach for the treatment of headache.

Introduction: Traditional sternal piston-type CPR (SP-CPR) is associated with rib and sternal fractures in a large fraction of porcine cardiac arrest studies. Most investigators using SP-CPR “mold” the pig’s precordium to prevent piston movement and enhance the “cardiac pump.” This molding is essentially disruption of the sternocostal joints. Although circumferential constriction CPR (CC-CPR) applies more motive force to the chest, it spreads this force over a much larger area. This results in a less concentrated force which may cause less skeletal injury. Hypothesis: CC-CPR may be associated with a lower incidence of thoracic skeletal injury. Methods: Retrospective observational report of multiple porcine studies. Ventricular fibrillation was induced in female Yorkshire swine (n = 30, 28±5 kg). CPR was provided by means of pneumatic CC-CPR prototypes in all animals. Most received thoracoabdominal CPR with pneumatic bands around both the chest and the abdomen. Thoracic vest pressures ranged from 180–300mmHg with constriction rates from 80–120 per minute and duty cycles from 30-50%. Duration of resuscitation was typically 20 min. Examination for injuries was via visual inspection and palpation both externally and internally during postmortem by the team veterinarian. We used the fracture rates reported in previous porcine CPR studies as a historical control. Results: In this large series of porcine studies with CC-CPR, which included per-constriction forces as great as 400kg and relatively long intervals of resuscitation, only 2 rib fractures were found, a rate of 0.07 fractures per pig. No sternal or chondral injuries were detected. We found four prior studies, all using SP-CPR, that appeared to reliably report a CPR-related fracture rate. The average rate was 4.45±1.6 per animal. Sternocostal joint disruption from “molding” did not appear to be reported as injury in published studies. Conclusion: CC-CPR appears to be associated with a remarkably low rate of thoracic skeletal injury in porcine models, compared with historical controls. It is not known if this enhanced safety in animals will translate to patients in the clinical setting, most of whom will have received manual and/or sternal piston type CPR before CC-CPR can be initiated.