Treatment of Refractory Low Back Pain Using Passive Recharge Burst in Patients Without Options for Corrective Surgery: Findings and Results From the DISTINCT Study, a Prospective Randomized Multicenter Controlled Trial.

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

Prospective, randomized, multicenter study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 12-month results.

INTRODUCTION: Vertebral endplates, innervated by the basivertebral nerve (BVN), are a source of chronic low back pain correlated with Modic changes. A randomized trial comparing BVN ablation to standard care (SC) recently reported results of an interim analysis. Here, we report the results of the full randomized trial, including the 3-month and 6-month between-arm comparisons, 12-month treatment arm results, and 6-month outcomes of BVN ablation in the former SC arm. METHODS: Prospective, open label, 1:1 randomized controlled trial of BVN ablation versus SC in 23 US sites with follow-up at 6 weeks, 3, 6, 9, and 12 months. SC patients were re-baselined and followed up for 6 months post BVN ablation. The primary endpoint was the between-arm comparison of mean Oswestry Disability Index (ODI) change from baseline. Secondary endpoints were Visual Analog Scale (VAS), Short Form (SF-36), EuroQual Group 5 Dimension 5-Level Quality of Life (EQ-5D-5L), responder rates, and rates of continued opioid use. RESULTS: 140 were randomized. Results from BVN ablation (n=66) were superior to SC (n=74) at 3 months for the primary endpoint (mean ODI reduction, difference between arms of -20.3 (CI -25.9 to -14.7 points; p<0.001)), VAS pain improvement (difference of -2.5 cm between arms (CI -3.37 to -1.64, p<0.001)) and quality of life outcomes. At 12 months, basivertebral ablation demonstrated a 25.7±18.5 point reduction in mean ODI (p<0.001), and a 3.8±2.7 cm VAS reduction (p<0.001) from baseline, with 64% demonstrating ≥50% reduction and 29% pain free. Similarly, the former SC patients who elected BVN ablation (92%) demonstrated a 25.9±15.5 point mean ODI reduction (p<0.001) from baseline. The proportion of opioid use did not change in either group (p=0.56). DISCUSSION/CONCLUSION: BVN ablation demonstrates significant improvements in pain and function over SC, with treatment results sustained through 12 months in patients with chronic low back pain of vertebrogenic origin.

Prospective, randomized, multicenter study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 24-Month treatment arm results.

BACKGROUND: Vertebral endplates, innervated by the basivertebral nerve, can be a source of vertebrogenic low back pain when damaged with inflammation, visible as types 1 or 2 Modic changes. A randomized controlled trial (RCT) compared basivertebral nerve ablation (BVNA) to standard care (SC) showed significant differences between arms at 3 and 6-months. At 12-months, significant improvements were sustained for BVNA. We report results of the BVNA arm at 24-months. METHODS: Prospective, open label, single-arm follow-up of the BVNA treatment arm of a RCT in 20 US sites with visits at 6-weeks, and 3, 6, 9, 12 and 24-months. Paired comparisons to baseline were made for the BVNA arm at each timepoint for Oswestry Disability Index (ODI), Visual Analog Scale (VAS), Short Form Health Survey (SF-36), EQ-5D-5L, and responder rates. RESULTS: 140 patients were randomized, 66 to BVNA. In the 58 BVNA patients completing a 24-month visit, 67% had back pain for >5 years, 36% were actively taking opioids at baseline, 50% had prior epidural steroid injections, and 12% had prior low back surgery. Improvements in ODI, VAS, SF-36 PCS, and EQ-5D-5L were statistically significant at all timepoints through 2 years. At 24 months, ODI and VAS improved 28.5±16.2 points (from baseline 44.5; p < 0.001) and 4.1±2.7 cm (from baseline 6.6; p < 0.001), respectively. A combined responder rate of ODI≥15 and VAS≥2 was 73.7%. A ≥50% reduction in pain was reported in 72.4% of patients and 31.0% were pain-free at 2 years. At 24 months, only 3(5%) of patients had BVNA-level steroid injections, and 62% fewer patients were actively taking opioids. There were no serious device or device-procedure related adverse events reported through 24 months. CONCLUSION: Intraosseous BVNA demonstrates an excellent safety profile and significant improvements in pain, function, and quality of life that are sustained through 24 months in patients with chronic vertebrogenic low back pain.

Degenerative lumbar spinal stenosis: an evidence-based clinical guideline for the diagnosis and treatment of degenerative lumbar spinal stenosis.

BACKGROUND CONTEXT: The objective of the North American Spine Society (NASS) evidence-based clinical guideline for the diagnosis and treatment of degenerative lumbar spinal stenosis (DLSS) is to provide evidence-based recommendations to address key clinical questions surrounding the diagnosis and treatment of DLSS. The guideline is intended to reflect contemporary treatment concepts for symptomatic DLSS as reflected in the highest quality clinical literature available on this subject as of April 2006. The goals of the guideline recommendations are to assist in delivering optimum, efficacious treatment, and functional recovery from this spinal disorder. PURPOSE: To provide an evidence-based tool that assists practitioners in improving the quality and efficiency of care delivered to patients with DLSS. STUDY DESIGN/SETTING: Evidence-based clinical guideline. METHODS: This report is from the Spinal Stenosis Work Group of the NASS Clinical Guidelines Committee. The work group comprised medical, diagnostic, interventional, and surgical spinal care specialists, all of whom were trained in the principles of evidence-based analysis. In the development of this guideline, the work group arrived at a consensus definition of a working diagnosis of lumbar spinal stenosis by use of a modification of the nominal group technique. Each member of the group formatted a series of clinical questions to be addressed by the group and the final list of questions agreed on by the group is the subject of this report. A literature search addressing each question and using a specific literature search protocol was performed on English language references found in MEDLINE, EMBASE (Drugs and Pharmacology), and four additional, evidence-based, databases. The relevant literature to answer each clinical question was then independently rated by at least two reviewers using the NASS-adopted standardized levels of evidence. An evidentiary table was created for each of the questions. Any discrepancies in evidence levels among the initial raters were resolved by at least two additional members' review of the reference and independent rating. Final grades of recommendation for the answer to each clinical question were arrived at in face-to-face meetings among members of the work group using the NASS-adopted standardized grades of recommendation. When Levels I to IV evidence was insufficient to support a recommendation to answer a specific clinical question, expert consensus was arrived at by the work group through the modified nominal group technique and is clearly identified as such in the guideline. RESULTS: Eighteen clinical questions were asked, addressing issues of prognosis, diagnosis, and treatment of DLSS. The answers to these 18 clinical questions are summarized in this document along with their respective levels of evidence and grades of recommendation in support of these answers. CONCLUSIONS: A clinical guideline for DLSS has been created using the techniques of evidence-based medicine and using the best available evidence as a tool to aid both practitioners and patients involved with the care of this disease. The entire guideline document including the evidentiary tables, suggestions for future research, and all references is available electronically at the NASS Web site (www.spine.org) and will remain updated on a timely schedule.