Association of Spinal Cord Stimulator Implantation With Persistent Opioid Use in Patients With Postlaminectomy Syndrome.

Importance: The results of studies evaluating spinal cord stimulation (SCS) for postlaminectomy syndrome (PLS) have yielded mixed results. This has led to an increased emphasis on objective outcome measures such as opioid prescribing. Objective: To determine the association between SCS and long-term opioid therapy (LOT) for PLS. Design, Setting, and Participants: In this cohort study, adults with PLS were identified using the TriNetx Diamond Network and separated based on whether they underwent SCS. Patients were stratified according to baseline opioid use (opioid-naive or receiving LOT) and subsequent opioid therapy over the 12-month period ranging from 3 to 15 months post-SCS implantation or post-PLS index date. Statistical analysis was performed from June to December 2021. Exposure: SCS. Main Outcomes and Measures: The main outcome was cessation of opioid use among patients receiving LOT or abstinence from opioids among opioid-naive patients. Opioid-naive patients were defined as those receiving at most 2 opioid prescriptions per year, and patients on LOT were those receiving at least 6 opioid prescriptions per year. Results: Among 552 937 eligible patients treated between December 2015 and May 2021, 26 179 with PLS received an SCS implant. The median (IQR) patient age was 60 (51-69) years; 305 802 patients (55.3%) were female. Among those reporting racial identify (37.0% [204 758 patients]), 9.3% (18 971 patients) were African American, 0.3% (648 patients) were Asian, and 90.4% (185 139 patients) were White. Compared with those who did not receive an SCS, individuals who received an SCS were more likely to be using opioids preimplantation (mean [SD] prescriptions: 4.3 [8.5] vs 4.1 [9.3]; P < .001) but less likely to be using opioids after SCS implantation (mean [SD] prescriptions: 3.8 [8.2] vs 4.0 [9.4]; P = .006). In the 12-month study period, similar proportions in the SCS and no-SCS groups receiving baseline LOT remained on LOT (70.3% [n = 74 585] vs 69.2% [n = 3882], respectively; P = .10). In opioid-naive patients, SCS was associated with a small decreased likelihood of patients subsequently receiving LOT (7.6% vs 7.0%; difference, -0.6% [95% CI, -1.0% to -0.2%]; P = .003). In multivariable analysis, SCS was associated with an increased likelihood of not being on opioids in both opioid-naive (adjusted odds ratio [OR], 0.90 [95% CI, 0.85-0.96]; P < .001) and LOT patients (adjusted OR, 0.93 [95% CI, 0.88-0.99]; P = .02). White patients were significantly more likely to be diagnosed with PLS (ie, underwent surgery) (90.4% vs 85.2%; difference, 5.2% [95% CI, 5.1%-5.4%]; P < .001) and receive an SCS (93.7% vs 90.3%; difference, 3.4% [95% CI, 2.9% to 4.0%]; P < .001) than patients of other racial identities. Conclusions and Relevance: These findings suggest that under real-life conditions, SCS was associated with small, clinically questionable associations with opioid discontinuation and not starting opioids in the context of PLS.

The effectiveness of intradiscal biologic treatments for discogenic low back pain: a systematic review.

BACKGROUND CONTEXT: There are limited treatments for discogenic low back pain. Intradiscal injections of biologic agents such as platelet-rich plasma (PRP) or stem cells (SC) are theorized to have regenerative properties and have gained increasing interest as a possible treatment, but the evidence supporting their use in clinical practice is not yet well-defined. PURPOSE: Determine the effectiveness of intradiscal biologics for treating discogenic low back pain. STUDY DESIGN: PRISMA-compliant systematic review. PATIENT SAMPLE: Patients with discogenic low back pain confirmed by provocation discography or clinical and imaging findings consistent with discogenic pain. OUTCOME MEASURES: The primary outcome was the proportion of individuals with ≥50% pain relief after intradiscal biologic injection at 6 months. Secondary outcomes included ≥2-point pain score reduction on NRS; patient satisfaction; functional improvement; decreased use of other health care, including analgesics and surgery; and structural disc changes on MRI. METHODS: Comprehensive literature search performed in 2018 and updated in 2020. Interventions included were biologic therapies including mesenchymal stem cells, platelet rich plasma, microfragmented fat, amniotic membrane-based injectates, and autologous conditioned serum. Any other treatment (sham or active) was considered for comparative studies. Studies were independently reviewed. RESULTS: The literature search yielded 3,063 results, 37 studies were identified for full-text review, and 12 met established inclusion criteria for review. The quality of evidence on effectiveness of intradiscal biologics was very low. A single randomized controlled trial evaluating platelet-rich plasma reported positive outcomes but had significant methodological flaws. A single trial that evaluated mesenchymal stem cells was negative. Success rates for platelet-rich plasma injectate in aggregate were 54.8% (95% Confidence Interval: 40%-70%). For mesenchymal stem cells, the aggregate success rate at six months was 53.5% (95% Confidence Interval: 38.6%-68.4%), though using worst-case analysis this decreased to 40.7% (95% Confidence Interval: 28.1%-53.2%). Similarly, ≥30% functional improvement was achieved in 74.3% (95% Confidence Interval: 59.8%-88.7%) at six months but using worst-case analysis, this decreased to 44.1% (95% Confidence Interval: 28.1%-53.2%). CONCLUSION: Limited observational data support the use of intradiscal biologic agents for the treatment of discogenic low back pain. According to the Grades of Recommendation, Assessment, Development and Evaluation System, the evidence supporting use of intradiscal mesenchymal stem cells and platelet-rich plasma is very low quality.

Combined thoracic medial branch radiofrequency and chemical neurotomy.

Objective: Explore the effectiveness of thoracic medial branch neurotomy (MBN) using combined radiofrequency neurotomy and neurolytic lesioning. Design: A retrospective cohort of consecutive patients with chronic thoracic axial pain treated in a community setting. Interventions: We included all patients who underwent MBN between 2010 and 2016, selected for MBN primarily based on 70% relief following single or dual diagnostic medial branch blocks. Using 18-gauge cannulas, we placed electrodes and made lesions at the suspected location of the thoracic medial branch based on anatomic knowledge at the time; the thermal lesions were supplemented with 50% dextrose to enhance the lesion radius. Measures: We defined success as ≥50% relief of their index thoracic pain not returning to baseline for at least six months. Patients not reached for follow-up were considered failures for worst-case analysis. Results: Twenty-eight patients underwent an initial MBN between 2010 and 2016: Twenty-five of twenty-eight (89%) patients reported ≥70% pain reduction not returning to baseline for six months or longer. Using a worst-case analysis (WCA), patients reported average pain relief of 73% CI (63%,84%) with a mean duration of relief following the initial MBN of 9.9 months CI (6, 13.5). Seventeen of the initial 28 patients had a total of 31 repeat MBNs, 13/17 (76%) having pain relief reinstated after one or more repeat MBNs with an average duration of relief following a first repeat MBNs of 10.9 months CI (6.6,15.2). Conclusion: Thoracic MBN combined with a mild neurolytic is a potentially effective treatment for thoracic pain in patients selected with positive diagnostic MBB. There were no complications noted. One can reinstate pain relief with repeated MBN in most patients should their symptoms return.

Assessment of technical adequacy of sacral lateral branches cooled radiofrequency neurotomy.

Objective: There were two primary objectives of the study: 1. assessment of the association between diagnostic sacral lateral branches (SLB) blocks and the ensuing numbness in the middle cluneal nerves (MCN) distribution, irrespective of whether the patients had positive or negative responses to blocks. 2. If the consistency of this causal relationship was established, we wanted to investigate a further correlation - hypoesthesia from local anesthetic blocks vs. hypoesthesia from radiofrequency neurotomy (RFN) vs. outcomes. Design: This is a prospective observational study of sixty consecutive patients with sacroiliac (SI) joint complex pain and failure of previous intraarticular SI joint injection. The patients who had two positive diagnostic SLB blocks defined as ≥ 75% reduction in NRS scores were treated with cooled RFN of the L5 dorsal ramus and S1-S3 lateral branches. The patients were interviewed and evaluated at a one-month post-neurotomy follow-up appointment. Seven patients were also evaluated at a six-month follow-up visit after the procedure. Methods: The primary outcomes of the study were absence/presence of post-procedural buttock hypoesthesia after diagnostic blocks and absence/presence of post-procedural buttock hypoesthesia at one month after a cooled RFN procedure. The secondary outcome measures related to the effectiveness of this procedure and included: pre- and post-procedure NRS scores; ODI scores initially, and at post RFN follow-up; analgesic consumption initially, and at one-month RFN follow-up; patient satisfaction with the cooled RFN treatment. A procedure was considered categorically successful if the patient gained ≥50% pain relief and was satisfied with its results. Results: 81/84 (96.4%; 95% CI [89.9%, 99.3%]) of the diagnostic SLB blocks lead to temporary sensory deficit to pinprick in the MCN distribution. If the block was positive, 58/58 (100.00%; 95% CI [93.8, 100.00%]) of the procedures led to hypoesthesia. For negative diagnostic blocks, 3/26 (11.5%; 95% CI [2.4%, 30.2%]) procedures lead to no hypoesthesia. The buttock hypoesthesia persisted in all patients with successful cooled RFN one month after this intervention. Among the patients with unsuccessful RFN, only 2/9 (22.2%, 95%CI [2.8%, 60.0]) still had hypoesthesia, but the rest of this group had no sensory deficit on pinprick examination. At 6-months follow-up buttock hypoesthesia had no association with the success of the procedure.The patients' average NRS scores decreased from baseline 7.1 (SD 1.7) to 4.3 (SD 3.3) at 1-month follow-up after RFN. Categorical success, based on ≥50% pain relief coupled with patients' satisfaction, was achieved in 12/21 (57.1%; 95% CI [34.0%, 78.2%]) of the subjects. Average ODI percentage score decreased from 41.7% (SD 15.1%) to 31.8% (SD 17.8%) at the primary endpoint of the study. Conclusion: MCNs provide regular and clinically detectable innervation to the skin area overlaying posterior-medial aspects of the gluteus maximums muscle. Therefore, any technically accurate diagnostic block, irrespective of whether the patients have positive or negative responses, should result in the development of hypoesthesia in the area supplied by the MCNs. Immediately after the completion of the diagnostic procedure, the adequacy of the block should be tested. Absence of hypoesthesia suggests that the block may have been technically inadequate. Numbness in the buttock area innervated by the MCNs may serve as a marker of an adequately performed RFN procedure. If this procedure is unsuccessful in patients who do not develop post-neurotomy numbness in the area supplied by the MCNs, the failure of the intervention may stem from its inaccurate implementation rather than from its inherent ineffectiveness.

Comparison of two needle versus one needle lesioning techniques for thoracic medial branch neurotomy.

Background and objectives: No prior studies have investigated an assumed advantage of creating a radiofrequency strip lesion for posterior element spinal axial pain using a two-needle technique (TNT) compared to a one-needle technique (ONT) that creates a single ovoid lesion. We explore the relationship of TNT compared to ONT on the magnitude and duration of pain relief following thoracic medial branch neurotomy (TMBN). Methods: This study is a retrospective audit of consecutive patients treated with TMBN at a single site and interventionalist over ten years (2007-2017). All patients had undergone TMBN after failed conservative care and, with few exceptions, patient-reported ≥ 70% pain relief after thoracic medial branch block (TMBB). All patients had TMBN performed with a medial to lateral (MLA) radiofrequency cannula approach using either an ONT or TNT technique. We used parametric and nonparametric statistics and three levels of case analysis to assess for intergroup differences. Results: Thirty-five consecutive patients underwent their primary TMBN, and two underwent both on a subsequent repeat using the MLA approach, 19 using the ONT, 18 using the TNT. The TNT group had clinically and statistically greater pain relief magnitude and duration than the ONT subgroup. The difference resulted in non-overlapping 95% confidence intervals for both percent pain relief and duration of pain relief using three levels of case analysis. Conclusion: The comparison of TMBN techniques demonstrates a statistically significant separation of TNT to ONT sample mean values for magnitude and duration of pain relief when using TNT compared to ONT for TMBN using an MLA.

Guideline summary review: an evidence-based clinical guideline for the diagnosis and treatment of low back pain.

BACKGROUND CONTEXT: The North American Spine Society's (NASS) Evidence Based Clinical Guideline for the Diagnosis and Treatment of Low Back Pain features evidence-based recommendations for diagnosing and treating adult patients with nonspecific low back pain. The guideline is intended to reflect contemporary treatment concepts for nonspecific low back pain as reflected in the highest quality clinical literature available on this subject as of February 2016. PURPOSE: The purpose of the guideline is to provide an evidence-based educational tool to assist spine specialists when making clinical decisions for adult patients with nonspecific low back pain. This article provides a brief summary of the evidence-based guideline recommendations for diagnosing and treating patients with this condition. STUDY DESIGN: This is a guideline summary review. METHODS: This guideline is the product of the Low Back Pain Work Group of NASS' Evidence-Based Clinical Guideline Development Committee. The methods used to develop this guideline are detailed in the complete guideline and technical report available on the NASS website. In brief, a multidisciplinary work group of spine care specialists convened to identify clinical questions to address in the guideline. The literature search strategy was developed in consultation with medical librarians. Upon completion of the systematic literature search, evidence relevant to the clinical questions posed in the guideline was reviewed. Work group members utilized NASS evidentiary table templates to summarize study conclusions, identify study strengths and weaknesses, and assign levels of evidence. Work group members participated in webcasts and in-person recommendation meetings to update and formulate evidence-based recommendations and incorporate expert opinion when necessary. The draft guideline was submitted to an internal and external peer review process and ultimately approved by the NASS Board of Directors. RESULTS: Eighty-two clinical questions were addressed, and the answers are summarized in this article. The respective recommendations were graded according to the levels of evidence of the supporting literature. CONCLUSIONS: The evidence-based clinical guideline has been created using techniques of evidence-based medicine and best available evidence to aid practitioners in the diagnosis and treatment of adult patients with nonspecific low back pain. The entire guideline document, including the evidentiary tables, literature search parameters, literature attrition flowchart, suggestions for future research, and all of the references, is available electronically on the NASS website at https://www.spine.org/ResearchClinicalCare/QualityImprovement/ClinicalGuidelines.aspx.

Permanent Paraplegia as a Complication of Injection of Contrast Media at L2-L3 Vertebral Level.

BACKGROUND: The lumbar intrathecal (subarachnoid) space is accessed for both therapeutic and diagnostic purposes. Occasionally, the needle may unintentionally enter the intrathecal space during lumbar interlaminar epidural steroid injections (LESIs)-one of the most commonly performed medical procedures in the United States. Ordinarily, this merely constitutes a minor complication or even a desired placement (in the case of some diagnostic procedures). However, some patients have a rare condition wherein the spinal cord terminates below the L2 vertebral level (tethered cord). In such cases, injections administered at the lumbar level may potentially result in spinal cord damage and irreversible paraplegia if the physician performing the intervention does not recognize the intramedullary position of the needle. OBJECTIVE: The aim of this study is to describe and analyze an unintentional L2-L3 injection of contrast medium into a tethered spinal cord. Many physicians may consider lumbar injections "safe" because the spinal cord usually terminates at or above the L2 vertebral level. However, complacency stemming from this false impression of safety contributes to nonadherence to practice guidelines, which may lead to catastrophic neurological complications. Presented here is the first published occurrence of paraplegia that resulted from contrast medium injection into the spinal cord during a myelography study performed below the L2 vertebral level. CONCLUSIONS: Disregard of the procedural guidelines by the physicians performing an elective diagnostic intervention may cause devastating neurological complications. The described casualty occurred because of failure to review previous imaging studies, injection of the contrast medium despite unsuccessful attempts to aspirate cerebrospinal fluid, and an unwillingness to terminate the procedure immediately when the patient reported an unusual sensation in both of his lower extremities. Consequently, we suggest that not only for cervical and thoracic but also for lumbar interlaminar ESIs, previous imaging studies should be reviewed before the injection.

Fluoroscopically Guided vs Landmark-Guided Sacroiliac Joint Injections: A Randomized Controlled Study.

OBJECTIVES: To determine the prevalence of intra- and extra-articular sacroiliac joint (SIJ) pain, which injection is more beneficial, and whether fluoroscopy improves outcomes. PATIENTS AND METHODS: This patient- and evaluator-blinded comparative effectiveness study randomized 125 participants with SIJ pain from April 30, 2014, through December 12, 2017, to receive fluoroscopically guided injections into the joint capsule (group 1) or "blind" injections to the point of maximum tenderness using sham radiographs (group 2). The primary outcome was average pain on a 0 to 10 scale 1 month after injection. A positive outcome was defined as at least a 2-point decrease in average pain score coupled with positive (>3) satisfaction on a Likert scale from 1 to 5. RESULTS: For the primary outcome, no significant differences were observed between groups (mean ± SD change from baseline, -2.3±2.4 points in group 1 vs -1.7±2.3 points in group 2; 95% CI, -0.33 to 1.36 points for adjusted difference; P=.23), nor was there a difference in the proportions of positive blocks (61% vs 62%) or 1-month categorical outcome (48% vs 40% in groups 1 and 2, respectively; P=.33). At 3 months, the mean ± SD reductions in average pain (-1.8±2.1 vs -0.9 ± 2.0 points; 95% CI, 0.11 to 1.58 points for adjusted difference; P=.02) and worst pain (-2.2±2.5 vs -1.4±2.0 points; 95% CI, 0.01 to 1.66 points for adjusted difference; P=.049) were greater in group 1 than 2, with other outcome differences falling shy of statistical significance. CONCLUSION: Although fluoroscopically guided injections provide greater intermediate-term benefit in some patients, these differences are modest and accompanied by large cost differences. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT02096653.

Guidelines for Composing and Assessing a Paper on the Treatment of Pain: A Practical Application of Evidence-Based Medicine Principles to the Mint Randomized Clinical Trials.

Objective: To perform a thorough assessment of the recently published Mint Trials in order to illustrate how to read and analyze a study critically, according to principles of evidence-based medicine. Design: Narrative review. Method: We have applied the recently published guidelines for composing and assessing studies on the treatment of pain to a recently published article describing a large study that claimed its "findings do not support the use of radiofrequency denervation to treat chronic low back pain." These guidelines describe the critical components of a high-quality manuscript that allows communication of all relevant information from authors to readers. Results: Application of evidence-based medicine principles to the publication describing the Mint Trials reveals significant issues with the methodology and conclusions drawn by the authors. A thorough assessment demonstrates issues with inclusion/exclusion criteria, diagnostic block protocols, radiofrequency neurotomy technique, co-interventions, outcome measurement, power analysis, study sample characteristics, data analysis, and loss to follow-up. A failure to definitively establish a diagnosis, combined with use of an inadequate technique for radiofrequency neurotomy and numerous other methodological flaws, leaves the reader unable to draw meaningful conclusions from the study data. Conclusions: Critical analysis, rooted in principles of evidence-based medicine, must be employed by writers and readers alike in order to encourage transparency and ensure that appropriate conclusions are drawn from study data.

Guidelines for Composing and Assessing a Paper on Treatment of Pain.

Authors, readers, and editors share a common focus. Authors want to publish their work. Readers want to see high-quality, new information. Referees and editors serve to ensure that authors provide valid conclusions based on the quality of information that readers want.Common to each of these roles are instructions to authors. However, these are typically written in an uninspiring, legalistic style, as if they are a set of rules that authors must obey if they expect to get published. This renders the instructions boring and oppressive, if not forbidding. Yet they need not be so, if they are set in context.Instructions to authors can be cast in a way as to reflect common purpose. They can remind authors what perceptive readers want to see in a paper and, thereby, prompt authors to include all necessary information. If cast in this way, instructions to authors are not a set of rules by which to satisfy publishers; they become guidelines for the etiquette of communication between authors and their readers.Against this background, the present article has been composed to serve several purposes. Foremost, it amplifies instructions to authors beyond the conventional technicalities such as headings, layout, font size, and line spacing. It prescribes the type of information that should be communicated and explains the reasons for those recommendations. Doing so not only informs authors about what to write, but also informs readers and referees about what to look for in a good paper. Secondarily, the article publicizes examples of errors and deficiencies of manuscripts submitted to the Journal in the past that have delayed their acceptance and publication, which could have been avoided had the forthcoming recommendations been followed. The recommendations also reprise the elements taught in courses conducted by the Spine Intervention Society in their extended program on evidence-based medicine. Doing so underscores that instructions for authors are not a procedural technicality but a way to ensure that what authors write, what readers read, and what the Journal publishes comply with contemporary precepts of good evidence.Some 20 years ago, the Journal of the American Medical Association published a comprehensive series of articles with a common title: "Users' Guides to the Medical Literature" [1,2]. These articles focused on the science of statistical tests and critical appraisal, and their importance for properly understanding the literature. The present article differs in that it does not presume to teach technicalities. Instead, it describes and explains, step by step, the critical components of an article, what authors should include, and what readers should look for, so that the Journal can ensure that consistent, high-quality information is shared between its authors and readers.The present article focuses on articles concerning treatment of pain, largely because this type of article is more commonly submitted than articles on reliability or validity of diagnostic procedures. Although the present article principally focuses on papers for the Spine Section of the Journal, the same principles, appropriately adapted, serve for other sections.

The Effectiveness and Risks of Fluoroscopically Guided Lumbar Interlaminar Epidural Steroid Injections: A Systematic Review with Comprehensive Analysis of the Published Data.

Objective: To determine the effectiveness and risks of fluoroscopically guided lumbar interlaminar epidural steroid injections. Design: Systematic review of the literature with comprehensive analysis of the published data. Interventions: Three reviewers with formal training in evidence-based medicine searched the literature on fluoroscopically guided lumbar interlaminar epidural steroid injections. A larger team consisting of five reviewers independently assessed the methodology of studies found and appraised the quality of the evidence presented. Outcome Measures: The primary outcome assessed was pain relief. Other outcomes such as functional improvement, reduction in surgery rate, decreased use of opioids/medications, and complications were noted, if reported. The evidence on each outcome was appraised in accordance with the Grades of Recommendation, Assessment, Development and Evaluation (GRADE) system of evaluating evidence. Results: The search yielded 71 primary publications addressing fluoroscopically guided lumbar interlaminar epidural steroid injections. There were no explanatory studies and all pragmatic studies identified were of low quality, yielding evidence comparable to observational studies. Conclusions: The body of evidence regarding effectiveness of fluoroscopically guided interlaminar epidural steroid injection is of low quality according to GRADE. Studies suggest a lack of effectiveness of fluoroscopically guided lumbar interlaminar epidural steroid injections in treating primarily axial pain regardless of etiology. Most studies on radicular pain due to lumbar disc herniation and stenosis do, however, report statistically significant short-term improvement in pain.

The Effectiveness and Risks of Non-Image-Guided Lumbar Interlaminar Epidural Steroid Injections: A Systematic Review with Comprehensive Analysis of the Published Data.

OBJECTIVE: To determine the effectiveness and risks of non-image-guided lumbar interlaminar epidural steroid injections. DESIGN: Systematic review. INTERVENTIONS: Three reviewers with formal training and certification in evidence-based medicine searched the literature on non-image-guided lumbar interlaminar epidural steroid injections. A larger team of seven reviewers independently assessed the methodology of studies found and appraised the quality of the evidence presented. OUTCOME MEASURES: The primary outcome assessed was pain relief. Other outcomes such as functional improvement, reduction in surgery rate, decreased use of opioids, and complications were noted, if reported. The evidence was appraised in accordance with the Grades of Recommendation, Assessment, Development and Evaluation (GRADE) system of evaluating evidence. RESULTS: The searches yielded 92 primary publications addressing non-image-guided lumbar interlaminar epidural steroid injections. The evidence supporting the effectiveness of these injections for pain relief and functional improvement in patients with lumbar radicular pain due to disc herniation or neurogenic claudication secondary to lumbar spinal stenosis is limited. This procedure may provide short-term benefit in the first 3-6 weeks. The small number of case reports on significant risks suggests these injections are relatively safe. In accordance with GRADE, the quality of evidence is very low. CONCLUSIONS: In patients with lumbar radicular pain secondary to disc herniation or neurogenic claudication due to spinal stenosis, non-image-guided lumbar interlaminar epidural steroid injections appear to have clinical effectiveness limited to short-term pain relief. Therefore, in a contemporary medical practice, these procedures should be restricted to the rare settings where fluoroscopy is not available.