The MOTION study: Two-year results of a real-world randomized controlled trial of the mild® procedure for treatment of lumbar spinal stenosis.

OBJECTIVE: The MOTION study is designed to measure the impact of percutaneous image-guided lumbar decompression as a first-line therapy on patients otherwise receiving real-world conventional medical management for lumbar spinal stenosis with neurogenic claudication secondary to hypertrophic ligamentum flavum. This prospective, multicenter randomized controlled trial uses objective and patient-reported outcome measures to compare the combination of the mild® percutaneous treatment and nonsurgical conventional medical management (CMM) to CMM-Alone. METHODS: Test group patients received the mild procedure after study enrollment. Test and control groups were allowed conventional conservative therapies and low-risk interventional therapies as recommended by their physicians. Subjective outcomes included the Oswestry Disability Index, Numeric Pain Rating Scale, and Zurich Claudication Questionnaire. Objective outcomes included a validated Walking Tolerance Test, the rate of subsequent lumbar spine interventions, and safety data. RESULTS: Two-year follow-up included 64 mild + CMM and 67 CMM-Alone patients. All outcome measures showed significant improvement from baseline for mild + CMM, whereas the majority of CMM-Alone patients had elected to receive mild treatment or other lumbar spine interventions by 2 years, precluding valid 2-year between-group comparisons. Neither group reported any device- or procedure-related adverse events. CONCLUSIONS: The durability of mild + CMM for this patient population was demonstrated for all efficacy outcomes through 2 years. Improvements in walking time from baseline to 2 years for patients treated with mild + CMM were significant and substantial. The lack of reported device or procedure-related adverse events reinforces the strong safety profile of the mild procedure. These results provide support for early interventional treatment of symptomatic LSS with the mild procedure.

The MOTION Study: A Randomized Controlled Trial with Objective Real-World Outcomes for Lumbar Spinal Stenosis Patients Treated with the mild® Procedure: One-Year Results.

OBJECTIVE: The purpose of this study is to provide Level-1 objective, real-world outcome data for patients with lumbar spinal stenosis suffering from neurogenic claudication secondary to hypertrophic ligamentum flavum. DESIGN: The MOTION Study is a prospective, multicenter, randomized controlled trial comparing the mild® Procedure (minimally invasive lumbar decompression; Vertos Medical, Aliso Viejo, CA, USA) as a first-line therapy in combination with nonsurgical conventional medical management (CMM) vs CMM alone as the active control. METHODS: Patients in the test group received the mild Procedure at baseline. Both the mild+CMM group and the control group were allowed unrestricted access to conventional real-world therapies. Patient-reported outcomes included the Oswestry Disability Index, the Zurich Claudication Questionnaire, and the Numeric Pain Rating Scale. A validated Walking Tolerance Test, the incidence of subsequent lumbar spine interventions, and the occurrence of adverse events were used to measure objective outcomes. RESULTS: Sixty-nine patients in each group were analyzed at 1-year follow-up. No device- or procedure-related adverse events were reported in either group. Results from all primary and secondary outcome measures showed statistical significance in favor of mild+CMM. CONCLUSIONS: One-year results of this Level-1 study demonstrated superiority of mild+CMM over CMM alone for patients with lumbar spinal stenosis who were suffering from neurogenic claudication secondary to hypertrophic ligamentum flavum. Use of the validated Walking Tolerance Test to objectively measure increased ability to walk without severe symptoms provided evidence of statistically significantly better outcomes for mild+CMM than for CMM alone. With no reported device or procedure-related adverse events, the long-standing safety profile of the mild Procedure was reaffirmed. mild is a safe, durable, minimally invasive procedure that has been shown to be effective as an early interventional therapy for patients suffering from symptomatic lumbar spinal stenosis.

The Neurostimulation Appropriateness Consensus Committee (NACC): Recommendations for Surgical Technique for Spinal Cord Stimulation.

INTRODUCTION: The field of neurostimulation for the treatment of chronic pain is a rapidly developing area of medicine. Although neurostimulation therapies have advanced significantly as a result of technologic improvements, surgical planning, device placement, and postoperative care are of equal importance to optimize outcomes. This Neurostimulation Appropriateness Consensus Committee (NACC) project intends to provide evidence-based guidance for these often-overlooked areas of neurostimulation practice. MATERIALS AND METHODS: Authors were chosen based on their clinical expertise, familiarity with the peer-reviewed literature, research productivity, and contributions to the neuromodulation literature. Section leaders supervised literature searches of MEDLINE, BioMed Central, Current Contents Connect, Embase, International Pharmaceutical Abstracts, Web of Science, Google Scholar, and PubMed from the last NACC publication in 2017 to the present. Identified studies were graded using the United States Preventive Services Task Force criteria for evidence and certainty of net benefit. Recommendations are based on evidence strength and consensus when evidence was scant. RESULTS: This NACC project provides guidance on preoperative assessment, intraoperative techniques, and postoperative management in the form of consensus points with supportive evidence. These results are based on grade of evidence, strength of consensus, and expert opinion. CONCLUSIONS: The NACC has given guidance for a surgical plan that encompasses the patient journey from the planning stage through the surgical experience and postoperative care. The overall recommendations are designed to improve efficacy and the safety of patients undergoing these neuromodulation procedures and are intended to apply throughout the international community.

A Systematic Literature Review of Dorsal Root Ganglion Neurostimulation for the Treatment of Pain.

OBJECTIVE: To conduct a systematic literature review of dorsal root ganglion (DRG) stimulation for pain. DESIGN: Grade the evidence for DRG stimulation. METHODS: An international, interdisciplinary work group conducted a literature search for DRG stimulation. Abstracts were reviewed to select studies for grading. General inclusion criteria were prospective trials (randomized controlled trials and observational studies) that were not part of a larger or previously reported group. Excluded studies were retrospective, too small, or existed only as abstracts. Studies were graded using the modified Interventional Pain Management Techniques-Quality Appraisal of Reliability and Risk of Bias Assessment, the Cochrane Collaborations Risk of Bias assessment, and the US Preventative Services Task Force level-of-evidence criteria. RESULTS: DRG stimulation has Level II evidence (moderate) based upon one high-quality pivotal randomized controlled trial and two lower-quality studies. CONCLUSIONS: Moderate-level evidence supports DRG stimulation for treating chronic focal neuropathic pain and complex regional pain syndrome.

Spinal Cord Stimulator Electrode Dislodging into the Ligamentum Flavum: A Case Report.

To date, no case studies specifically reporting an electrode dislodging from its lead wire have been reported. Here we describe a case involving an electrode shearing from the spinal cord stimulator lead, and lodging into the ligamentum flavum during implantation. In this case, an experienced board certified interventional pain management specialist was performing the implantation procedure of a magnetic resonance imaging (MRI) compatible spinal cord stimulator with MR conditional leads. After successful placement of the first lead, the epidural space was accessed via a T11/12 interlaminar approach using loss of resistance technique. When the lead would not advance past the tip of the needle, it was removed in order to reposition the needle slightly. Upon removal of the lead, it was discovered that the first electrode was no longer attached to the wire. Subsequent fluoroscopic imaging revealed that the electrode had lodged within the ligamentum flavum. Upon discussion with the medical director of the device company, it was agreed upon that the electrode should be left in place. The decision was made to proceed with only one lead in place and the remainder of the procedure was completed uneventfully. The patient followed up two weeks later in clinic, and no adverse effect related to the dislodged electrode was reported. The indications and common complications associated with spinal cord stimulation are discussed, followed by factors to consider to help guide decision making in the event of a retained foreign body during a procedure.

Elevated circulating levels of the pro-inflammatory cytokine macrophage migration inhibitory factor in individuals with acute spinal cord injury.

OBJECTIVE: To test the hypothesis that macrophage migration inhibitory factor (MIF) is elevated in the circulation of individuals with acute spinal cord injury (SCI) compared with uninjured individuals. DESIGN: Prospective, observational pilot study. SETTING: Academic medical center. PARTICIPANTS: Adults with acute traumatic SCI (n=18) and uninjured participants (n=18), comparable in age and sex distribution. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: The primary outcome measure was the plasma MIF levels. Potential correlations were examined between MIF and clinical/demographic variables. The secondary outcome was to determine if other immune mediators were elevated in participants with acute SCI and if their levels correlated with the MIF. RESULTS: MIF was significantly elevated in subjects with acute SCI compared with control subjects at 0 to 3 (P<.0029), 4 to 7 (P<.0001), and 8 to 11 (P<.0015) days postinjury (DPI). At 0 to 3 DPI, levels of cytokines interleukin-6 (P<.00017), interleukin-9 (P<.0047), interleukin-16 (P<.007), interleukin-18 (P<.014), chemokines growth-related oncogene α/chemokine (C-X-C motif) ligand 1 (P<.0127) and macrophage inflammatory protein 1-ß/chemokine (C-C motif) ligand 4 (P<.0015), and growth factors hepatocyte growth factor (HGF) (P<.0001) and stem cell growth factor-ß (P<.0103) were also significantly elevated in subjects with acute SCI. With the exception of interleukin-9, all of these factors remained significantly elevated at 4 to 7 DPI; a subset (interleukin-16, HGF, stem cell growth factor-ß) remained elevated throughout the study. Within individuals, MIF levels correlated with HGF (P<.018) and interleukin-16 (P<.01). CONCLUSIONS: These data demonstrate that MIF is significantly elevated in subjects with acute SCI, supporting further investigation of MIF and other inflammatory mediators in acute SCI, where they may contribute to primary and secondary functional outcomes.

Safety, Efficacy, and Durability of Outcomes: Results from SECURE: A Single Arm, Multicenter, Prospective, Clinical Study on a Minimally Invasive Posterior Sacroiliac Fusion Allograft Implant.

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.

Intrathecal Drug Delivery Systems Survey: Trends in Utilization in Pain Practice.

Background: The use of intrathecal drug delivery for chronic and cancer pain medicine has been established for decades. However, optimization and utilization of this technique still lag behind other modalities for pain control. Some of this may be due to variability of surgical technique, medication usage and education. It is currently unclear on whether or not practitioners follow available algorithms for the use of intrathecal drug delivery systems. Methods: A survey developed by the American Society of Pain and Neuroscience (ASPN) was sent to its members via email using the cloud-based SurveyMonkey. After 30 days of being available, 159 different providers responded to the survey that consisted of 31 various multiple choice and free response questions. Each question was not required and the number of responses to each varied from 128 to 159. Results: Approximately 9% of those who successfully received and opened the email containing the survey responded, likely due to a small number of providers working with intrathecal drug delivery systems. Eighty-six of respondents practice medicine in the United States, and 87% of the respondents were attending physicians. A majority of respondents, approximately 74%, were board certified in pain medicine with 69% of respondents being train in anesthesiology. The first and second most used medications for intrathecal pump trial were morphine and fentanyl, respectively. Most respondents, approximately 96%, provide pre-operative/intra-operative antibiotics. The most common first-choice medication for implanted intrathecal pumps was also morphine with the most common implanted location being the abdomen. Conclusion: Interestingly, there is currently fairly substantial variation in the way providers utilize intrathecal pump delivery for both chronic and cancer pain. There is variation from the training background of the providers providing care, to the pre-implantation trial medications, to where the pump is implanted for each patient, to if the patient has the option to give themselves boluses once implanted. Further research is needed to elucidate current and best practices for intrathecal drug delivery system trials, implantations, and utilization.

A post-market, randomized, controlled, prospective study evaluating intrathecal pain medication versus conventional medical management in the non-cancer, refractory, chronic pain population (PROSPER).

INTRODUCTION: Intrathecal therapy has been limited by non-randomized prospective studies, particularly for those suffering from non-cancer. Further, no prospective, randomized studies investigating the efficacy, safety, and utilization of intrathecal polyanalgesic consensus guidelines exist. METHODS: After IRB approval, patients were enrolled in a 1:1 fashion for intrathecal drug delivery (IDD) or conventional management (CMM), employing standard of care, excluding intrathecal drug delivery, based on the principal investigator's discretion. They were followed 3, 6, 9, and 12 months. Assessments included PROMIS 29, NPRS, and PriceMonkey. RESULTS: Seventy-nine patients were screened, 54 patients were enrolled: 26 to IDD and 28 to CMM. At 3 months, there was no measurable difference in pain improvement in either subgroups within the CMM for chronic pain-related syndromes (CPRS) or failed back and related spine disorders (FBRS). For the IDD, early and maintained benefit from the baseline was statistically achieved. Cost analysis of pump to CMM breakeven was 4.5 months. There were no adverse events related to compounded intrathecal medications. CONCLUSION: This is the first randomized prospective, multicenter study investigating the safety, cost, and efficacy of off-label medications for intrathecal therapy, as compared to conventional management, and suggests early detection of improvement, cost savings, safety of intrathecal compounded medication use, and safety and efficacy of employing the PACC guidance.

Best Practices for Minimally Invasive Lumbar Spinal Stenosis Treatment 2.0 (MIST): Consensus Guidance from the American Society of Pain and Neuroscience (ASPN).

Introduction: Lumbar spinal stenosis (LSS) is a common spinal disease of aging with a growing patient population, paralleling population growth. Minimally invasive treatments are evolving, and the use of these techniques needs guidance to provide the optimal patient safety and efficacy outcomes. Methods: The American Society of Pain and Neuroscience (ASPN) identified an educational need for guidance on the prudent use of the innovative minimally invasive surgical therapies for the treatment of symptomatic LSS. The executive board nominated experts spanning anesthesiology, physiatry, orthopedic surgery, and neurosurgery based on expertise, publications, research, diversity and field of practice. Evidence was reviewed, graded using the United States Preventive Services Task Force (USPSTF) criteria for evidence and recommendation strength and grade, and expert opinion was added to make consensus points for best practice. Results: The world literature in English was searched using Medline, EMBASE, Cochrane CENTRAL, BioMed Central, Web of Science, Google Scholar, PubMed, Current Contents Connect, Scopus, and meeting abstracts to identify and compile the evidence (per section) for LSS-related pain. Search words were selected based upon the section represented. Identified peer-reviewed literature was critiqued using USPSTF criteria and consensus points are presented. Discussion: The algorithm for patient selection in the management of symptomatic spinal stenosis is evolving. Careful consideration of patient selection and anatomic architecture variance is critical for improved outcomes and patient safety. Conclusion: ASPN created a guidance for best practice for minimally invasive surgical treatment of symptomatic spinal stenosis.

Dorsal Root Ganglion Stimulation as Treatment for Complex Regional Pain Syndrome of the Foot Refractory to Spinal Cord Stimulation: A Case Report.

The ACCURATE study demonstrated non-inferiority and superiority of dorsal root ganglion stimulation (DRGS) over traditional spinal cord stimulation (t-SCS) in patients with complex regional pain syndrome (CRPS). Yet, its efficacy in patients who had previously failed SCS therapy is unknown. A mid-60-year-old-male patient with right foot CRPS previously implanted with SCS system experienced relapse in pain. The patient was offered DRGS at right L5/S1 with 90% pain reduction. The patient subsequently proceeded to implant with continued pain relief. This case report demonstrates the effectiveness of DRGS in a patient who previously failed SCS. DRGS can be a viable salvage treatment option in the face of tolerance or loss of efficacy with SCS.

Alternative Implantation Site of Intrathecal Pump in the Submuscular Plane of the Pectoralis Major Muscle: A Case Report.

An intrathecal drug delivery system (IDDS) has been widely utilized in the management of chronic pain and spasticity when oral pharmacologic agents are deemed ineffective. Typically, intrathecal pumps are implanted in the abdominal region; however, previous case reports have described nontraditional pump implantation sites, such as anterior thigh, gluteal region, and iliac fossa. Adding to the growing literature of alternative implantation sites, this case report discusses the implantation of the pump into the submuscular plane of the pectoralis major muscle and reviews the advantages and disadvantages of this location.

Spinal cord stimulation for the treatment of neuropathic pain: expert opinion and 5-year outlook.

INTRODUCTION: Spinal cord stimulation (SCS) is an effective treatment for chronic, intractable neuropathic pain. There have been relatively few high-level studies that suggest its unequivocal use. The decay of stimulation efficacy over time have opened opportunity for the entrance of new pulse trains and waveforms. AREAS COVERED: In this state-of-the-art review, we focused on many of the major studies published in the last 10 years that were considered level one evidence. A retrospective narrative approach was taken to conceptualize foundation studies as they pertain to current evidence. A special focus was taken on reported safety outcomes in comparison to foundation studies especially as they pertain to our 5-year outlook on the use of spinal cord stimulation. EXPERT OPINION: We find there are still significant limitations in the body of reviewed evidence and suggest that long-term data beyond 24 months are lacking in the literature. In addition, adverse event rates, device explantation rates and the sham effect looms as important concepts to address in the future in spite of the existing novel stimulation paradigms.

Minimally invasive lumbar decompression: a review of indications, techniques, efficacy and safety.

Lumbar spinal stenosis is a common degenerative spine condition. In properly selected patients, minimally invasive lumbar decompression (mild®) may be an option to improve outcomes. This review provides an in-depth description of the mild procedure and a comprehensive examination of safety and efficacy. Two randomized controlled trials, together with 11 other controlled clinical studies, have established the efficacy of mild, which is a minimally invasive procedure that does not involve implants and has demonstrated excellent efficacy and safety. With an established safety profile equivalent to epidural steroid injections, and efficacy that has been shown to be superior to such injections, mild can reasonably be positioned early in the treatment algorithm for these patients. Based on extensive review of the literature, robust safety and efficacy through 2 years, and in accordance with minimally invasive spine treatment guidelines, mild is recommended as the first intervention after failure of conservative measures for lumbar spinal stenosis patients with neurogenic claudication and ligamentum flavum hypertrophy.

Retained Curved Needle After Balloon Kyphoplasty: A Complication with a Novel Device and Its Management.

To date, no case studies specifically describing a curved kyphoplasty needle becoming lodged in the vertebral body with the inability to be withdrawn have been reported. We describe a case involving a single level balloon kyphoplasty with a curved coaxial needle during which the cement delivery device could not be removed after cavity filling. In this case, a board-certified interventional pain management specialist was performing balloon kyphoplasty for an L2 osteoporotic vertebral compression fracture. The tools utilized in this procedure included flexible curved instruments designed to traverse the vertebral body and achieve uniform cement distribution through a unipedicular approach. Cannulation and cavity formation were completed without issue. Upon conclusion of cement filling, the curved cement delivery device was unable to be removed. After several attempts to remove the needle and consultation with both the device company and local spine surgeons, it was agreed that the device should be cut at the level of entry into the pedicle and left as a retained foreign object. The involved area was surgically exposed, the retained instrument was cut flush to the pedicle, and the free portion was removed without further complication. The patient followed up in clinic several months later without evidence of neurologic complications. Considerations when using a curved kyphoplasty device and a method of resolution when faced with the inability to remove such an instrument are discussed.

Near Death Experience from Placement of an Intrathecal Catheter.

UNLABELLED: The management of pain due to cancer is challenging and often requires invasive therapy in addition to medication management. Intrathecal drug delivery is a form of advanced therapy that delivers medication locally in the intrathecal space while reducing systemic side effects associated with high doses of opioids. Although risks associated with intrathecal drug delivery are low, some common complications include dislodgement, kinking, or fracture of the catheter, bleeding, neurological injury, infection, and cerebrospinal leaks. We present a case of a 38-year-old woman with a medical history significant for stage IV breast cancer, L2 metastatic lesion, opioid tolerance, and chronic neck and low back pain who was admitted to the hospital for intractable pain. She had failed multiple interventional procedures in the past including lumbar medial nerve radiofrequency ablation, epidural steroid injection, and trigger point injections as well as a kyphoplasty at the L2 level. Failing both oral and parenteral opioid treatments, the decision was made to place an intrathecal pump in the patient. After placement of the intrathecal catheter and prior to any bolus of medication being given, the patient became bradycardic with a heart rate in the 20s and experienced a 10 second pause. The patient had intermittent bradycardia over the following days and symptoms resolved only after removal of the intrathecal catheter itself. To our knowledge, this is the first reported case with a complication of recurrent bradycardic and asystolic episodes prior to the administration of intrathecal opioid but shortly after placement of the intrathecal catheter itself. KEY WORDS: Intrathecal drug delivery, complications, cancer pain, intrathecal analgesia, bradycardia, opioids.