Background: Low back pain (LBP) is a highly prevalent, disabling condition affecting millions of people. Patients with an identifiable anatomic pain generator and resulting neuropathic lower extremity symptoms often undergo spine surgery, but many patients lack identifiable and/or surgically corrective pathology. Nonoperative treatment options often fail to provide sustained relief. Spinal cord stimulation (SCS) is sometimes used to treat these patients, but the lack of level 1 evidence limits its widespread use and insurance coverage. The DISTINCT RCT study evaluates the efficacy of passive recharge burst SCS compared to conventional medical treatment (CMM) in alleviating chronic, refractory axial low back pain. Methods: This prospective, multicenter, randomized, study with an optional 6-month crossover involved patients who were not candidates for lumbar spine surgery. The primary and secondary endpoints evaluated improvements in low back pain intensity (NRS), back pain-related disability (ODI), pain catastrophizing (PCS), and healthcare utilization. Patients were randomized to SCS therapy or CMM at 30 US study sites. Results: The SCS arm reported an 85.3% NRS responder rate (>= 50% reduction) compared to 6.2% (5/81) in the CMM arm. After the 6M primary endpoint, SCS patients elected to remain on assigned therapy and 66.2% (49/74) of CMM patients chose to trial SCS (crossover). At the 12M follow-up, SCS and crossover patients reported 78.6% and 71.4% NRS responder rates. Secondary outcomes indicated significant improvements in ODI, PCS, and reduced healthcare utilization. Six serious adverse events were reported and resolved without sequelae. Conclusion: DISTINCT chronic low back pain patients with no indication for corrective surgery experienced a significant and sustained response to burst SCS therapy for up to 12 months. CMM patients who crossed over to the SCS arm reported profound improvements after 6 months. This data advocates for a timely consideration of SCS therapy in patients unresponsive to conservative therapy.

Introduction:Chronic pain is a personal experience influenced by multiple biopsychosocial factors. Using a pain intensity measure alone to assess the effectiveness of a chronic pain intervention fails to fully evaluate its impact on the multifaceted chronic pain experience. The holistic minimal clinically important difference (MCID) is a composite outcome developed to provide a comprehensive assessment of chronic pain in response to intervention, across 5 outcome domains: pain intensity, health-related quality of life, sleep quality, physical, and emotional function. To focus on domains where the individual need is greatest, the holistic MCID reflects the cumulative MCID averaged over only the domains where subjects were impaired preintervention. Objectives:To assess the internal and construct validity of the Holistic MCID score to inform its future use as an evidence-based tool. Methods:This validation study was undertaken using data from the EVOKE trial with 111 patients up to 24-month follow-up. Internal consistency of the holistic MCID was assessed using Cronbach alpha statistic and dimensional exploration using principal component analysis. Results:The holistic MCID measure demonstrated strong internal consistency with Cronbach alpha >0.7 at all follow-ups. Principal component analysis showed one overarching holistic dimension to be present in the composite. Construct validity was demonstrated by an increase in the holistic MCID score being associated with both increased Patients' Global Impression of Change, EuroQol visual analogue scale score, and each of the outcome domains in a "leave-one-out" analysis (all P < 0.001). Conclusion:The holistic MCID provides a valid measure for the comprehensive, personalized assessment of response after a chronic pain intervention. The validity of the holistic MCID requires further confirmation in other chronic pain populations and with different interventions.

Purpose: The American Society of Pain and Neuroscience (ASPN) identified a significant gap in resources and guidelines that aim to educate healthcare providers for best practices when engaging on social media. As part of the broader initiatives on Spine and Nerve practice, the executive board of ASPN has decided it would be beneficial to include comprehensive guidance for healthcare providers when engaging on social media. Methods: A panel of experts was chosen based on expertise, publications, diversity, and their social media presence. Along with expert guidance, the committee conducted an extensive analysis of peer-reviewed literature in communication and medical journals to determine best practices for healthcare practitioners on social media. Results: Social media messages significantly impact patients' and colleagues' perceptions and actions regarding medical issues. As such, providers and their teams must be aware of legal and ethical considerations in healthcare while maintaining a consistent, Conclusion: The advancement of communication and medical technologies and systems necessitates continued education and resources to adapt to our rapidly changing media and medical landscape.

INTRODUCTION:Interventional treatment options for the lumbar degenerative spine have undergone a significant amount of innovation over the last decade. As new technologies emerge, along with the surgical specialty expansion, there is no manuscript that utilizes a review of surgical treatments with evidence rankings from multiple specialties, namely, the interventional pain and spine communities. Through the Pacific Spine and Pain Society (PSPS), the purpose of this manuscript is to provide a balanced evidence review of available surgical treatments. METHODS:The PSPS Research Committee created a working group that performed a comprehensive literature search on available surgical technologies for the treatment of the degenerative spine, utilizing the ranking assessment based on USPSTF (United States Preventative Services Taskforce) and NASS (North American Spine Society) criteria. RESULTS:The surgical treatments were separated based on disease process, including treatments for degenerative disc disease, spondylolisthesis, and spinal stenosis. CONCLUSIONS:There is emerging and significant evidence to support multiple approaches to treat the symptomatic lumbar degenerative spine. As new technologies become available, training, education, credentialing, and peer review are essential for optimizing patient safety and successful outcomes.

Abstract Sacroiliac joint pain is one of the most common causes of low back pain, accounting for 15% to 30% of all cases. The incidence of sacroiliac joint degeneration in patients who have undergone lumbar fusion surgery is 75% at 5 years after surgery. Minimally invasive posterior sacroiliac joint fusion is a treatment option for patients who have failed conservative management, including intra-articular steroid injections, and it is an alternative to radiofrequency ablation.

Introduction:Research suggests that sacroiliac joint (SIJ) dysfunction is responsible for 15% to 30% of reported low back pain cases. Recently, there has been an increasing interest in SIJ fusion using minimally invasive surgery (MIS) due to safety. Initially, devices designed for MIS were intended for lateral approaches. A minimally invasive sacroiliac fusion implant for use with a posterior approach has been developed and is regulated for clinical use under the regulatory framework required for human cells, tissues, or cellular or tissue-based products (HCT/Ps).Methods:A multi-center, prospective, single-arm study was launched after initial studies provided preliminary data to support safety, efficacy, and durability of this minimally invasive sacroiliac posterior fusion LinQ allograft implant (NCT04423120). Preliminary results were reported previously. Final results for the full participant cohort are presented here.Results:One-hundred and fifty-nine (159) participants were enrolled across 16 investigational sites in the US between January 2020 and March 2022. One-hundred and twenty-two (122) participants were implanted. At the 1-month follow-up, 82 participants satisfied all criteria for the composite responder endpoint, representing 73.2% of the study cohort. These results stayed consistent across the remaining study timepoints with 66.0%, 74.4%, and 73.5% of participants classified as responders at the 3-, 6- and 12-month follow-up visits, respectively. VAS scores were significantly reduced (p < 0.0001) and ODI scores were significantly improved (p < 0.0001). All domains of the PROMIS-29 were also significantly improved (all p's <0.0001). Only one procedure-related serious AE was reported in the study.Conclusion:These results suggest that the posterior approach LinQ Implant System is a safe and effective treatment for sacroiliac joint dysfunction at 12 months, with results that are favorable compared to outcomes reported for an FDA-cleared lateral approach.

Aim: Low Back Pain (LBP) is a prevalent condition. Spinal cord stimulation (SCS) has emerged as a more effective, long-term treatment compared to conventional medical management (CMM). The DISTINCT study enrolled and randomized chronic LBP patients with no indication of traditional spine surgery. This analysis focuses comparing study outcomes on patients initially randomized to receive CMM treatment and subsequently crossed over to SCS after 6 months. Purpose: To compare the therapeutic effectiveness and cost-efficiency of passive recharge burst SCS to CMM. Patients and Methods: A total of 269 patients were enrolled with 162 randomly assigned to SCS and 107 to CMM. The DISTINCT study design allowed a crossover to the alternative treatment arm after 6 months. Patients underwent a trial and received a permanent implant if they reported >= 50% pain reduction. Outcome analysis included pain (NRS), disability (ODI), catastrophizing (PCS), quality of life (PROMIS-29) and health care utilization. Results: Seventy out of eighty-one patients opted to cross over to trial SCS at 6M with 94% (66/70) undergoing a trial. Among those, 88% (58/66) reported a >= 50% or more pain relief and 55 received a permanent implant. At 12M visit, 71.4% reported a >= 50% pain improvement sustained at the 18M visit, with 24.5% (12/49) indicating a >= 80% improvement. Disability reductions (79% meeting the minimally important difference of a 13-point decrease), decreased catastrophizing, and significant improvements in all PROMIS-29 domains were noted. Furthermore, 42% of the patients reported decreased or discontinued opioid usage. Clinical benefits at the 12M visit were sustained through the 18M visit accompanied by a significant reduction in healthcare utilization and a $1214 cost savings. Conclusion: SCS demonstrates superior, long-term performance and safety outcomes compared to CMM therapy in LBP patients who received both CMM and SCS therapy. Additionally, SCS patients experienced reduced healthcare resource utilization and lower costs compared to those receiving CMM.

Objectives Spinal cord stimulation (SCS) has been challenged by the lack of neurophysiologic data to guide therapy optimization. Current SCS programming by trial-and-error results in suboptimal and variable therapeutic effects. A novel system with a physiologic closed-loop feedback mechanism using evoked-compound action potentials enables the optimization of physiologic neural dose by consistently and accurately activating spinal cord fibers. We aimed to identify neurophysiologic dose metrics and their ranges that resulted in clinically meaningful treatment responses. Materials and Methods Subjects from 3 clinical studies (n = 180) with baseline back and leg pain ≥60 mm visual analog scale and physical function in the severe to crippled category were included. Maximal analgesic effect (MAE) was operationally defined as the greatest percent reduction in pain intensity or as the greatest cumulative responder score (minimal clinically important differences [MCIDs]) obtained within the first 3 months of SCS implant. The physiologic metrics that produced the MAE were analyzed. Results We showed that a neural dose regimen with a high neural dose accuracy of 2.8μV and dose ratio of 1.4 resulted in a profound clinical benefit to chronic pain patients (MAE of 79 ± 1% for pain reduction and 12.5 ± 0.4 MCIDs). No differences were observed for MAE or neurophysiological dose metrics between the trial phase and post-implant MAE visit. Conclusion For the first time, an evidence-based neural dose regimen is available for a neurostimulation intervention as a starting point to enable optimization of clinical benefit, monitoring of adherence, and management of the therapy.

Low back pain (LBP) is a highly prevalent, costly condition affecting millions of people worldwide across all sociodemographic classes. Those with an identifiable anatomic pain generator may undergo back surgery and achieve relief, but many are not candidates as they lack an identifiable surgically corrective pathology. Standard non-operative strategies include physiotherapy, oral analgesics, and image guided injections; these may not provide durable relief. Spinal cord stimulation is sometimes used to treat these patients but level I evidence is sparse. We present results from DISTINCT (NCT04479787), the largest RCT to date, comparing passive recharge burst SCS to conventional medical management (CMM) in patients suffering from chronic, refractory axial low back pain, who have not had lumbar spine surgery and for whom corrective surgery is not an option.

Dorsal root ganglion stimulation (DRG-S) is effective for the treatment of chronic focal pain conditions1 and superior to traditional spinal cord stimulation (SCS) in the treatment of CRPS types I and II (causalgia).2,3 To provide continued evidence of safety after FDA approval, a post-market, prospective, single-arm, observational study in patients with CRPS types I or II of the lower limbs treated with DRG-S was designed (NCT02800863). The primary goal of the study was to show that the proportion of serious adverse effects (SAEs) in subjects who received a permanent implant was lower than a pre-specified goal of 15.5% after 12 months.

Objective: Spinal cord stimulation (SCS) is effective for relieving chronic intractable pain conditions. The Dorsal spInal cord STImulatioN vs mediCal management for the Treatment of low back pain study evaluates the effectiveness of SCS compared with conventional medical management (CMM) in the treatment of chronic low back pain in patients who had not undergone and were not candidates for lumbar spine surgery.Methods and Materials: Patients were randomized to passive recharge burst therapy (n = 162) or CMM (n = 107). They reported severe pain and disability for more than a decade and had failed a multitude of therapies. Common diagnoses included degenerative disc disease, spondylosis, stenosis, and scoliosis-yet not to a degree amenable to surgery. The six-month primary end point compared responder rates, defined by a 50% reduction in pain. Hierarchical analyses of seven secondary end points were performed in the following order: composite responder rate (numerical rating scale [NRS] or Oswestry Disability Index [ODI]), NRS, ODI, Pain Catastrophizing Scale responder rate, Patient Global Impression of Change (PGIC) responder rate, and Patient-Reported Outcome Measure Information System-29 in pain interference and physical function.Results: Intention-to-treat analysis showed a significant difference in pain responders on NRS between SCS (72.6%) and CMM (7.1%) arms (p < 0.0001). Of note, 85.2% of those who received six months of therapy responded on NRS compared with 6.2% of those with CMM (p < 0.0001). All secondary end points indicated the superiority of burst therapy over CMM. A composite measure on function or pain relief showed 91% of subjects with SCS improved, compared with 16% of subjects with CMM. A substantial improvement of 30 points was observed on ODI compared with a 14 non-serious device-or procedure-related events were reported.Conclusions: This study found substantial improvement at six months in back pain, back pain-related disability, pain-related emotional suffering, PGIC, pain interference, and physical function in a population with severe, debilitating back pain for more than a decade. These improvements were reported in conjunction with reduced opioid use, injection, and ablation therapy.

Sacroiliac (SI) joint arthropathy is the primary pain generator in approximately 15–25% of patients with axial low back pain and traditionally diagnosed with >50% pain reduction following an intra-articular injection localized to the inferior 1/3 of the SI joint. The conventional technique for accessing the SI joint encompasses a posterior approach with fluoroscopic guidance at 10–20⁰ contralateral oblique angulation, and minor adjustments to this approach have been implemented with varying degrees of success. The authors present a novel technique for SI joint injection, infiltrating the middle third of the joint through an alternative far-contralateral oblique (FCO) approach, angulation between 20–40⁰. This approach theoretically endows easier access to the SI joint and at the very least provides another option for interventionalists in the diagnosis and treatment of sacroiliac joint pain. It can also be utilized to determine if a patient is a candidate for posterior percutaneous SI joint fusion. The authors sought to document this approach to ensure that it was both reproducible and safe, while recognizing the need for future studies.

Introduction Sacroiliac joint disease is a prominent diagnosis across the world. A novel fixation technique employing a posterior approach, single point, bone allograft transfixation has proven to be helpful anecdotally. The purpose of this is study is to investigate prospectively the safety and efficacy of this approach. Methods A multicenter, prospective, single arm study was performed after patient identification and treatment with the novel posterior fusion, single-point transfixation system and followed for 24 months. Target enrollment is 100 patients. Interim results on the first 69 consecutive patients at 6 months is presented. Primary endpoint at 6-month analysis was Pain Intensity reduction by visual analogue scale and functional improvement by Oswestry Disability Index. Adverse events were assessed for safety analysis. Results In total, 69 patients were identified for this analysis. At 6 months, a mean improvement of 34.9 was identified by a reduction in VAS and functional improvement was demonstrated by a mean reduction in ODI of 17.7. There were three adverse events, all unrelated to the device. Conclusion The posterior single point transfixation is safe and efficacious for the treatment of sacroiliac joint dysfunction with statistical improvements in pain and function.

Sacroiliac joint (SIJ) pain is a common cause of low back pain. Traditionally, treatment for SIJ joint pain and dysfunction has consisted of physical therapy, medication management, SIJ injections, and SIJ ablations. Improved recognition of the SIJ as an etiology for back pain has led to advances in treatment options. Radiofrequency of the lateral sacral branches has been shown to be effective, though evidence is fraught with inconsistent patient selection, study design and procedural technique. It also does not directly address the mechanical dysfunction of the SIJ. In order to create a more enduring approach SIJ fusion has become an attractive option to reduce pain and to improve function. This method of SI joint treatment requires guidance in the perioperative phase of care from both the physicians and advanced practice providers (APP). In order to improve care and outcomes of those undergoing posterior SI joint fusion the American Society of Pain and Neuroscience appointed an expert panel of physicians and advanced practice providers to create a best practice for the post operative care of this approach. As with any best practice, the panel considered current peer reviewed literature and clinical expertise to create guidance today. This is intended to be a living document with modifications as additional evidence comes to light in data publication. The goals of this paper are to focus on (1) wound care, (2) medication use, (3) physical activity and (4) therapeutic exercises.

BACKGROUND:The most common presentation of cluneal neuropathy is ipsilateral low back and gluteal pain. Cluneal neuralgia has been described historically in surgical contexts, with much of the description and treatment related to entrapment and decompression, respectively. Treatment options for addressing axial low back pain have evolved with advancements in the field of interventional pain medicine, though clinical results remain inconsistent. Recent attention has turned toward peripheral nerve stimulation. Nonsurgical interventions targeting the superior and medial cluneal nerve branches have been performed in cases of low back and buttock pain, but there is no known review of the resulting evidence to support these practices.OBJECTIVES:In this manuscript we provide a robust exploration and analysis of the available literature regarding treatment options for cluneal neuropathy. We provide clinical manifestations and recommendations for future study direction.STUDY DESIGN:Narrative review.METHODS:This was a systematic, evidence-based narrative, performed after extensive review of the literature to identify all manuscripts associated with interventional treatment of the superior and medial cluneal nerves.RESULTS:Eleven manuscripts fulfilled inclusion criteria. Interventional treatment of the superior and middle cluneal nerves includes blockade with corticosteroid, alcohol neurolysis, peripheral nerve stimulation, radiofrequency neurotomy, and surgical decompression.LIMITATIONS:The supportive evidence for interventions in cluneal neuropathy is largely lacking due to small, uncontrolled, observational studies with multiple confounding factors. There is no standardized definition of cluneal neuropathy.CONCLUSION:Limited studies promote beneficial effects from interventions intended to target cluneal neuropathy. Despite increased emphasis and treatment options for this condition, there is little consensus on the diagnostic criteria, endpoints, and measures of therapeutics, or procedural techniques for blocks, radiofrequency, and neuromodulation. It is imperative to delineate pathology associated with the cluneal nerves and perform rigorous analysis of associated treatment options.

BACKGROUND:Sacroiliac joint (SIJ) pain is one of the most common causes of low back pain, accounting for 15 to 30% of all cases. Although SIJ dysfunction accounts for a large portion of chronic low back pain prevalence, it is often overlooked or under diagnosed and subsequently under treated. The purpose of this review was to establish a best practices model to effectively diagnose SIJ pain through detailed history, physical exam, review of imaging, and diagnostic block.METHODS:A literature search was performed on the diagnosis of sacroiliac joint pain and sacroiliac joint dysfunction. The authors proposed diagnostic recommendations based upon the available literature and a detailed understanding of diagnosing SIJ pain.RESULTS:The practitioner must focus on the history, location of pain, observed gait pattern, and perform key points of the physical exam including sacroiliac provocative maneuvers. If the patient exhibits at least three provocative maneuvers then the SIJ may be considered as a possible source of pain. Additionally, a thorough review of the imaging should be performed to rule out other etiologies of low back pain. In the absence of any pathognomonic tests or examination findings, diagnostic SIJ blocks have evolved as the diagnostic standard.CONCLUSION:The diagnosis of SIJ pain is a multifaceted process that involves a careful assessment including differentiating other pain generators in the region. This involves careful history taking, appropriate physical examination including provocative maneuvers and diagnostic injections. Once the diagnosis is confirmed, long-term solutions may be considered, including recent advances in sacral lateral branch denervation and sacroiliac joint fusion.

BACKGROUND:Spinal cord stimulation is a well-established modality for the treatment of chronic intractable pain. The safety and efficacy of various stimulation therapy designs have been demonstrated in multiple randomized controlled studies, oftentimes comparing an investigational device to an existing commercial therapy. In the real-world setting, data are lacking regarding selection of spinal cord stimulation (SCS) therapy, as waveform, pulse trains, and programming are not interchangeable among the devices. The purpose of this study is to help dissect a methodology for a patient centric multisystem trialing.METHODS:We conducted a single center, retrospective, open label observational chart review. Between June 2017 and June 2019, 83 patients underwent SCS trials. Devices from four commercially available systems were trialed. Patients were given the opportunity to trial up to three systems. If the patient reported 50% or more pain relief/functional improvement with the trial, they were able to choose which system they liked best and proceed with implantation.RESULTS:There were 82% (68/83) of patients who proceeded to permanent implant, with 72 patients electing to trial more than one stimulation paradigm. Of those, 62 trialed 2 SCS systems, whereas 11 trialed 3. During the SCS trials, loss of efficacy due to lead migration was 1.2% (1/83) and no infections occurred. The average pain score measured on the numeric pain rating scale (NRS), improved from 6.8 at baseline to 2.9 after implantation.CONCLUSIONS:Multisystem trialing is safe and effective in providing patients increased exposure to multiple commercially available SCS systems.

Sacroiliac joint pain is a common cause of low back pain and can be a diagnostic challenge. Interventional treatment may be considered after patients fail conservative/noninterventional treatments. This article provides a review of current interventional procedures for the treatment of sacroiliac joint pain including sacroiliac joint injection, noncorticosteroid injection and radiofrequency ablation.