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IMPORTANCE Many patients with diabetic peripheral neuropathy experience chronic pain and inadequate relief despite best available medical treatments.OBJECTIVE To determine whether 10-kHz spinal cord stimulation (SCS) improves outcomes for patients with refractory painful diabetic neuropathy (PDN). DESIGN, SETTING, AND PARTICIPANTSThe prospective, multicenter, open-label SENZA-PDN randomized clinical trial compared conventional medical management (CMM) with 10-kHz SCS plus CMM. Participants with PDN for 1 year or more refractory to gabapentinoids and at least 1 other analgesic class, lower limb pain intensity of 5 cm or more on a 10-cm visual analogue scale (VAS), body mass index (calculated as weight in kilograms divided by height in meters squared) of 45 or less, hemoglobin A 1c (HbA 1c ) of 10% or less, daily morphine equivalents of 120 mg or less, and medically appropriate for the procedure were recruited from clinic patient populations and digital advertising. Participants were enrolled from multiple sites across the US, including academic centers and community pain clinics, between August 2017 and August 2019 with 6-month follow-up and optional crossover at 6 months. Screening 430 patients resulted in 214 who were excluded or declined participation and 216 who were randomized. At 6-month follow-up, 187 patients were evaluated.INTERVENTIONS Implanted medical device delivering 10-kHz SCS. MAIN OUTCOMES AND MEASURESThe prespecified primary end point was percentage of participants with 50% pain relief or more on VAS without worsening of baseline neurological deficits at 3 months. Secondary end points were tested hierarchically, as prespecified in the analysis plan. Measures included pain VAS, neurological examination, health-related quality of life (EuroQol Five-Dimension questionnaire), and HbA 1c over 6 months. RESULTSOf 216 randomized patients, 136 (63.0%) were male, and the mean (SD) age was 60.8 (10.7) years. Additionally, the median (interquartile range) duration of diabetes and peripheral neuropathy were 10.9 (6.3-16.4) years and 5.6 (3.0-10.1) years, respectively. The primary end point assessed in the intention-to-treat population was met by 5 of 94 patients in the CMM group (5%) and 75 of 95 patients in the 10-kHz SCS plus CMM group (79%; difference, 73.6%; 95% CI, 64.2-83.0; P < .001). Infections requiring device explant occurred in 2 patients in the 10-kHz SCS plus CMM group (2%). For the CMM group, the mean pain VAS score was 7.0 cm (95% CI, 6.7-7.3) at baseline and 6.9 cm (95% CI, 6.5-7.3) at 6 months. For the 10-kHz SCS plus CMM group, the mean pain VAS score was 7.6 cm (95% CI, 7.3-7.9) at baseline and 1.7 cm (95% CI, 1.3-2.1) at 6 months. Investigators observed neurological examination improvements for 3 of 92 patients in the CMM group (3%) and 52 of 84 in the 10-kHz SCS plus CMM group (62%) at 6 months (difference, 58.6%; 95% CI, 47.6-69.6; P < .001).CONCLUSIONS AND RELEVANCE Substantial pain relief and improved health-related quality of life sustained over 6 months demonstrates 10-kHz SCS can s...

Introduction The sacroiliac joint (SIJ) has been estimated to contribute to pain in as much as 38% of cases of lower back pain. There are no clear diagnostic or treatment pathways. This article seeks to establish a clearer pathway and algorithm for treating patients. Methods The literature was reviewed in order to review the biomechanics, as well as establish the various diagnostic and treatment options. Diagnostic factors addressed include etiology, history, physical exam, and imaging studies. Treatment options reviewed include conservative measures, as well as interventional and surgical options. Results Proposed criteria for diagnosis of sacroiliac joint dysfunction can include pain in the area of the sacroiliac joint, reproducible pain with provocative maneuvers, and pain relief with a local anesthetic injection into the SIJ. Conventional non-surgical therapies such as medications, physical therapy, radiofrequency denervation, and direct SI joint injections may have some limited durability in therapeutic benefit. Surgical fixation can be by a lateral or posterior/posterior oblique approach with the literature supporting minimally invasive options for improving pain and function and maintaining a low adverse event profile. Conclusion SIJ pain is felt to be an underdiagnosed and undertreated element of LBP. There is an emerging disconnect between the growing incidence of diagnosed SI pathology and underwhelming treatment efficacy of medical treatment. This has led to an increase in SI joint fixation. We have created a clearer diagnostic and treatment pathway to establish an algorithm for patients that can include conservative measures and interventional techniques once the diagnosis is identified.

In this cadaveric study, US guidance produced superior accuracy compared with nonguided injections with respect to both the tibiotalar joint and sinus tarsi. Although further research is warranted, clinicians should consider US guidance to optimize injectate placement into these areas when optimal accuracy is necessary for diagnostic or therapeutic purposes.

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