Fast-Acting Sub-perception Spinal Cord Stimulation for a Case of Painful Diabetic Polyneuropathy. Just an Antalgic Treatment or Even a Therapy?

Introduction: Painful diabetic polyneuropathy (P-DPN) occurs in 20% - 30% of diabetic patients. Currently, therapeutic strategies include lifestyle modifications, good glycemic control, and neuropathic pain drugs. Spinal cord stimulation (SCS) has been shown to be successful in patients who have not responded to other treatments. The American Diabetes Association strongly recommends early screening and diagnosis for this condition through clinical tests and nerve conduction study (NCS). In recent years, high-resolution ultrasonography (HRUS) with the analysis of cross-sectional area (CSA) has shown an increasingly important role in detecting changes in the nervous structures, blood vessels, echo, and mobility of the nerve. Cross-sectional area is frequently enlarged in these patients, even those with normal NCS. We aimed to use SCS with fast-acting sub-perception therapy (FAST) modality to treat P-DPN. We also evaluated the CSA of the involved nerves before and after treatment. Case Presentation: A 58-year-old female patient was referred to our hospital in 2020 (Civitavecchia, Italy). She suffered from P-DPN for 3 years and did not respond to conventional medical treatments. Preoperative electromyography (EMG) was negative for radiculopathy, while electroneurography (ENG) showed a reduction in sensory conduction velocity (SCV) in the sural nerve (SN) bilaterally. Clinical tests on perceived pain and quality of life showed high severity. The report was confirmed by HRUS with enlargement of the CSA of the posterior tibial nerve (PTN), external popliteal nerve (EPN), and SN. The patient was successfully subjected to all-in-one SCS implantation in the FAST modality. She obtained immediate pain relief that remained unaltered at the 3-month follow-up. The patient completely discontinued drug therapy. One month after implantation, ENG highlighted an increased SN SCV, and the HRUS of PTN EPN and SN showed a significant reduction in CSA in all 3 nerves involved. Conclusions: Early diagnosis and treatment are crucial in improving the clinical outcome of P-DPN, but there is still no gold standard therapy. Spinal cord stimulation in the new FAST modality was effective in this clinical case. The pain relief was supported by a significant reduction in the CSA of the studied nerves observed on HRUS 1 month after SCS implantation. The results and the improvement of a pathological nervous pattern, albeit with a short follow-up of only 3 months, could suggest not only a symptomatic but perhaps also a therapeutic role of SCS in P-DPN.

The Role of Hypertonic Saline in Ablative Radiofrequency of the Sacroiliac Joint: Observational Study of 40 Patients.

BACKGROUND: The aim of this retrospective uncontrolled article is to illustrate a technique of neurotomy of the sensitive branches of S1 S2 S3 in RFA that appears to result in a better success rate and longer-lasting pain relief. METHODS: 40 patients were treated, 26 females and 14 males, with an average age of 74 (92-55). After the examination, the patients underwent an ultrasound-guided diagnostic block of the affected sacroiliac joint. Only patients who presented pain relief greater than 60% after the diagnostic block were candidates for the RFA procedure. The procedure was always performed in the operating room on an outpatient basis. After obtaining the best fluoroscopic visualization of the joint to be treated, two RFA cannulae were placed starting from the lower medial margin parallel to the SIJ to perform a bipolar RFA along the entire medial margin of the SIJ. Lidocaine 2% and hypertonic saline 2 mEq/mL were used for each RFA level. Patients were followed-up at 3, 6, 12, 18, and 24 months by evaluating the NRS and SF-12. RESULTS: Patients reported extreme satisfaction with the procedure performed and reported a significant improvement in NRS and SF-12 at FU visits. No adverse events occurred. CONCLUSIONS: Bipolar RFA treatment of the sacroiliac joint with the use of a hypertonic saline solution appears to improve the success of the method and its durability. We are inclined to believe that the use of hypertonic saline may significantly increase the lesion area and result in a greater effect on the sensory branches.

Peripheral Nerve Stimulation: Two Cases of Intractable Neuropathic Pain.

INTRODUCTION: Neuropathic pain can be caused by several pathologies affecting the nervous system. Peripheral neuralgias may be related to nerve entrapment, traumatic or iatrogenic events, and may also accompany many other diseases. Peripheral nerve stimulation is effective in treating many of these neuralgic syndromes. CASE PRESENTATION: We treated two patients suffering from chronic neuropathic pain of peripheral origin with the implantation of a Bioness (Valencia CA, USA) StimRouter® peripheral nerve stimulation system with follow-up visits at 1 - 3 - 6 - 12 months. CONCLUSIONS: PNS performed with the StimRouter® system, implanted percutaneously under ultrasound guidance, is safe and effective for patients.

Peripheral Nerve Stimulation in the Treatment of Chronic Pain Syndromes From Nerve Injury: A Multicenter Observational Study.

INTRODUCTION: Assessing the feasibility, technical implications, and clinical benefits of peripheral nerve stimulation (PNS) performed by an implantable pulse generator (IPG) located close to the stimulation site. MATERIALS AND METHODS: Selected patients were affected by neuropathic pain associated with a documented peripheral nerve lesion, refractory to conventional surgical or pharmacological treatment. A PNS system specifically designed for peripheral placement (Neurimpulse, Padova, Italy) was implanted and followed for six months, recording the degree of patient's satisfaction (PGI-I questionnaire), the pain numerical rating scale (NRS) and the quality of life (SF36 questionnaire), as well as any change in drug regimen and work capability. The statistical significance of differences was determined by the paired Student's t-test. RESULTS: A total of 58 patients were referred to permanent IPG implantation. Stimulation failure due to lead damage or dislocation was noticed in two cases (3.4%) in six months. At the follow-up end, the relative NRS reduction averaged -58 ± 30% (p < 10-6 ) and was greater than 50% in 69% of the cases. Quality-of-life physical and mental indices were increased by 18% (p < 0.005) and 29% (p < 0.0005), respectively. The administration of antalgic drugs was stopped in 55% and reduced in 16% of the patients. Low-energy stimulation was possible in most cases, resulting in an IPG estimated life of 80 ± 35 months. CONCLUSIONS: Successful PNS was achieved with a stimulation system designed for peripheral location. This new technology reduced the incidence of lead-related adverse events and the energy cost of the treatment.

The Italian experience with octopolar perc-paddle leads.

OBJECTIVE: The aim of this study is to evaluate the efficacy of spinal cord stimulation using octopolar perc-paddle leads (S-Series, St. Jude Medical, St. Paul, MN, USA) introduced percutaneously with St. Jude Medical's Epiducer Lead Delivery System in patients suffering from low back and leg pain. MATERIALS AND METHOD: We performed a retrospective review of patients implanted from 2009 to 2012 in Italy. Seventy-six patients were initially enrolled in the study. The patients' follow-up varies from 12 to 30 months. RESULTS: Seventy-one patients, 60 suffering from failed back surgery syndrome and 11 from spinal stenosis, reported significant improvement in pain symptoms and good paresthesia coverage of the affected regions. Pain reduction according to the Numerical Rating Scale ranged from 55% to 63%. The use of this new device appears to enhance the recruitment of the fibers of the lumbar region to obtain a reduction of the energy required for the stimulation and a more pleasant stimulation reported by patients. CONCLUSION: The possibility of using a percutaneous paddle lead, reducing the surgical aggressiveness but taking advantage of a different electric field and a better recruitment of the fibers of the lumbar region, has allowed pain therapists to be more effective in the treatment of these patients. The use of this device system suggests that the percutaneous paddle placement is safe and effective.

Evaluation of pulsed radiofrequency denervation in the treatment of chronic facetjoint pain: an observational study.

BACKGROUND: Low back disorder is the most common problem in the entire spinal axis. About two-thirds of adults suffer from low back pain (LBP) at some time. Pain generators in the lumbar spine include the annulus of the disc, the posterior longitudinal ligament, a portion of the dural membrane, the facet joints, the spinal nerve roots and ganglia, and the associated paravertebral muscle fascia. There is no doubt that the facet joint is a potential source of chronic LBP. Facet joints are true synovial joints that have a joint space, hyaline cartilage surfaces, a synovial membrane, and a fibrous capsule. Two medial branches of the dorsal rami innervate the facet joints. If conservative measures fail in the treatment of facet joint pain, pulsed radiofrequency (PRF) of the medial branches can be administered. OBJECTIVES: The aim of this observational study was to evaluate the efficacy of PRF in the treatment of lumbar chronic facet joint pain. PATIENTS AND METHODS: In this prospective observational study, we selected 300 patients who suffered from lumbar facet joint pain, were referred to the Pain Therapy Department, and underwent PRF treatment of the lumbar medial branches. We analyzed patients with facet joint pain that was unresponsive to conventional treatment, with a positive response to diagnostic medial branch block, who underwent PRF of the lumbar area for 18 months at San Giovanni Hospital of Rome. RESULTS: Three hundred patients were eligible for the study. After 1 month, 62% of patients (186 patients) reported good pain relief [95% confidence interval (CI) 0.53, 0.7]; 8.6% (26 patients) reported excellent pain relief (95% CI 0.07-0.09); 20. 4% (61 patients) reported poor pain relief (95% CI 0.18-0.22), and 9% (27 patients) reported no pain relief (95% CI 0.08-0.099). The average pain numeric rating scale (NRS) score before the procedure was 6 (range 4-9), decreasing to 2 after the procedure (range 0-4). SF-36 physical and mental parameters improved significantly after the treatment [≥ 1 standard deviation (SD)]. Results after 6 months were similar to those obtained after 1 month. CONCLUSIONS: This study suggests that PRF treatment of the lumbar medial branches provides good pain relief for at least 6 months in 70% of patients who suffer from lumbar facet joint pain.

Spinal cord stimulation: predictive parameters of outcome in patients suffering from critical lower limb ischemia. A preliminary study.

INTRODUCTION: The aim of our study is to identify the assessment of metabolic and dynamic capillaroscopy parameters that may be predictive of the outcome of spinal cord stimulation in patients affected with non-revascularisable chronic critical limb ischemia. MATERIALS AND METHODS: Forty patients, 16 female and 24 male, average age 69 ± 8, underwent microcirculatory screening with transcutaneous oximetry and dynamic capillaroscopy. Microcirculatory assessment was performed before temporary implantation of the spinal cord stimulation stimulator and after one month. The following metabolic parameters were considered: TcPO2-TcPCO2 and with dependent limb, difference between dependent limb and supine values (Δ TcPO2, Δ TcPCO2), change in TcPO2-TcPCO2 after stimulation. Dynamic capillaroscopy parameters were recorded. Follow-up visits were scheduled at three, six, and twelve months after implantation. The procedure was performed placing an Octrode (St. Jude Medical, St. Paul, MN, USA) on the dorsal columns of the spinal cord. RESULTS: Two groups were identified on the basis of transcutaneous oximetry measurements: group A (22 patients) and group B (18 patients), responding differently to the postural test. After one month of home testing period, there was an improvement in metabolic parameters, differing from one group to the other. The morphofunctional data provided by capillaroscopy highlighted the percentage of open capillaries poststimulation as being a significant parameter, although not mentioned in previous studies. CONCLUSIONS: Spinal neuromodulation is an effective therapy option in the management of patients affected by non-reconstructable chronic critical limb ischemia.

Controlled-release oxycodone and pregabalin in the treatment of neuropathic pain: results of a multicenter Italian study.

AIMS: The aim of our study was to compare the efficacy, safety, and quality of life of combination therapy with controlled-release (CR) oxycodone plus pregabalin versus monotherapy with either CR oxycodone or pregabalin in patients with neuropathic pain. MATERIALS AND METHODS: Patients with moderate to severe neuropathic pain, despite the use of various pharmacologic treatments prior to study entry, were enrolled (n = 409) and treated with CR oxycodone plus pregabalin (n = 169), CR oxycodone (n = 106), and pregabalin (n = 134). Pain intensity was rated on an 11-point numerical rating scale (NRS). RESULTS: The combination of CR oxycodone plus pregabalin and CR oxycodone monotherapy were both more effective for alleviating neuropathic pain than pregabalin monotherapy (reduction in NRS value: 80, 76, and 46%, respectively; p