The evidence-based practice guidelines for the management of chronic spinal pain with interventional techniques were developed to provide recommendations to clinicians in the United States.
To ...develop evidence-based clinical practice guidelines for interventional techniques in the diagnosis and treatment of chronic spinal pain, utilizing all types of evidence and to apply an evidence-based approach, with broad representation by specialists from academic and clinical practices.
Study design consisted of formulation of essentials of guidelines and a series of potential evidence linkages representing conclusions and statements about relationships between clinical interventions and outcomes.
The elements of the guideline preparation process included literature searches, literature synthesis, systematic review, consensus evaluation, open forum presentation, and blinded peer review. Methodologic quality evaluation criteria utilized included the Agency for Healthcare Research and Quality (AHRQ) criteria, Quality Assessment of Diagnostic Accuracy Studies (QUADAS) criteria, and Cochrane review criteria. The designation of levels of evidence was from Level I (conclusive), Level II (strong), Level III (moderate), Level IV (limited), to Level V (indeterminate).
Among the diagnostic interventions, the accuracy of facet joint nerve blocks is strong in the diagnosis of lumbar and cervical facet joint pain, whereas, it is moderate in the diagnosis of thoracic facet joint pain. The evidence is strong for lumbar discography, whereas, the evidence is limited for cervical and thoracic discography. The evidence for transforaminal epidural injections or selective nerve root blocks in the preoperative evaluation of patients with negative or inconclusive imaging studies is moderate. The evidence for diagnostic sacroiliac joint injections is moderate. The evidence for therapeutic lumbar intraarticular facet injections is moderate for short-term and long-term improvement, whereas, it is limited for cervical facet joint injections. The evidence for lumbar and cervical medial branch blocks is moderate. The evidence for medial branch neurotomy is moderate. The evidence for caudal epidural steroid injections is strong for short-term relief and moderate for long-term relief in managing chronic low back and radicular pain, and limited in managing pain of postlumbar laminectomy syndrome. The evidence for interlaminar epidural steroid injections is strong for short-term relief and limited for long-term relief in managing lumbar radiculopathy, whereas, for cervical radiculopathy the evidence is moderate. The evidence for transforaminal epidural steroid injections is strong for short-term and moderate for long-term improvement in managing lumbar nerve root pain, whereas, it is moderate for cervical nerve root pain and limited in managing pain secondary to lumbar post laminectomy syndrome and spinal stenosis. The evidence for percutaneous epidural adhesiolysis is strong. For spinal endoscopic adhesiolysis, the evidence is strong for short-term relief and moderate for long-term relief. For sacroiliac intraarticular injections, the evidence is moderate for short-term relief and limited for long-term relief. The evidence for radiofrequency neurotomy for sacroiliac joint pain is limited. The evidence for intradiscal electrothermal therapy is moderate in managing chronic discogenic low back pain, whereas for annuloplasty the evidence is limited. Among the various techniques utilized for percutaneous disc decompression, the evidence is moderate for short-term and limited for long-term relief for automated percutaneous lumbar discectomy, and percutaneous laser discectomy, whereas it is limited for nucleoplasty and for DeKompressor technology. For vertebral augmentation procedures, the evidence is moderate for both vertebroplasty and kyphoplasty. The evidence for spinal cord stimulation in failed back surgery syndrome and complex regional pain syndrome is strong for short-term relief and moderate for long-term relief. The evidence for implantable intrathecal infusion systems is strong for short-term relief and moderate for long-term relief.
These guidelines include the evaluation of evidence for diagnostic and therapeutic procedures in managing chronic spinal pain and recommendations for managing spinal pain. However, these guidelines do not constitute inflexible treatment recommendations. These guidelines also do not represent a "standard of care."
Abstract
Background:
Epidural corticosteroid injections are a common treatment for radicular pain caused by intervertebral disc herniations, spinal stenosis, and other disorders. Although rare, ...catastrophic neurologic injuries, including stroke and spinal cord injury, have occurred with these injections.
Methods:
A collaboration was undertaken between the U.S. Food and Drug Administration Safe Use Initiative, an expert multidisciplinary working group, and 13 specialty stakeholder societies. The goal of this collaboration was to review the existing evidence regarding neurologic complications associated with epidural corticosteroid injections and produce consensus procedural clinical considerations aimed at enhancing the safety of these injections. U.S. Food and Drug Administration Safe Use Initiative representatives helped convene and facilitate meetings without actively participating in the deliberations or decision-making process.
Results:
Seventeen clinical considerations aimed at improving safety were produced by the stakeholder societies. Specific clinical considerations for performing transforaminal and interlaminar injections, including the use of nonparticulate steroid, anatomic considerations, and use of radiographic guidance are given along with the existing scientific evidence for each clinical consideration.
Conclusion:
Adherence to specific recommended practices when performing epidural corticosteroid injections should lead to a reduction in the incidence of neurologic injuries.
Unplanned vascular trespass occurs in 20% of cervical transforaminal epidural steroid injections (CTFESI) and rarely results in devastating neurologic complications. The Trucath Spinal Injection ...System is a novel integrated catheter and needle device that is specifically designed to minimize vascular trespass risk.
To compare the vascular trespass incidence with the Trucath Spinal Injection System versus standard spinal needles during CTFESI treatment in patients with cervical radiculopathy.
Prospective, multicenter, nonrandomized safety trial.
Six tertiary spinal pain management centers in the United States.
We treated 290 patients (411 levels) with recalcitrant cervical radiculopathy using CTFESI; 129 patients (180 levels) were treated with the Trucath Spinal Injection System (Test group) and 161 patients (231 levels) were treated with standard spinal needles (Control group). All injections were administered via a transforaminal approach. Each site attained IRB approval for this study before any research was performed. The primary study endpoint was vascular trespass per treated level. Secondary endpoints included nerve pain or paresthesia, injection accuracy, device performance measures, and procedural adverse events.
Vascular trespass occurred more often (odds ratio (OR): 3.1, 95% Confidence Interval (CI): 1.8-5.4, P < 0.001) in Controls (26.8%, 62/231 levels) versus Test patients (10.6%, 19/180 levels). Radicular pain or paresthesia from device positioning was more frequent (OR: 21.1, 95% CI: 6.9-64.5, P < 0.001) in Controls (26.4%, 61/231) versus Test participants (1.7%, 3/179). Inadequate epiradicular flow was observed in 3.0% (7/231) of Controls and 5.6% (10/179) of Test participants (OR: 0.5, 95% CI: 0.2-1.4, P = 0.22). Based on subjective physician judgment (scale: 1-10), there were no differences between the Test and Control groups, respectively, for ease of use (mean 8.9 vs. 9.0), visualization under fluoroscopy (mean 9.2 vs. 9.0), and overall performance (mean 9.0 vs. 8.6). No additional adverse effects were reported in either treatment group in this clinical study.
The study did not randomly allocate the type of injection procedure to participants and no clinical outcomes beyond the initial treatment were collected.
The Trucath Spinal Injection System demonstrated a statistically significant reduction in the rate of intravenous and intra-arterial trespass, procedural pain, and paresthesia, and has similar accuracy and performance versus standard spinal needles for CTFESI treatment of cervical radiculopathy.
Evidence-based practice guidelines for interventional techniques in the management of chronic spinal pain are systematically developed and professionally derived statements and recommendations that ...assist both physicians and patients in making decisions about appropriate health care in the diagnosis and treatment of chronic or persistent pain. The guidelines were developed utilizing an evidence-based approach to increase patient access to treatment, to improve outcomes and appropriateness of care, and to optimize cost-effectiveness. All types of relevant and published evidence and consensus were utilized. The guidelines include a discussion of their purpose, rationale, and importance, including descriptions of the patient population served, the methodology, and the pathophysiologic basis for intervention. Multiple diagnostic and therapeutic interventional techniques are included in this document. Strong evidence was shown for diagnostic facet joint blocks for the diagnosis of facet joint pain, and lumbar provocative discography for discogenic pain. Moderate evidence was shown for sacroiliac joint blocks in the diagnosis of sacroiliac joint pain, and for transforaminal epidural injections in the preoperative evaluation of patients with negative or inconclusive imaging studies, but with clinical findings of nerve root irritation. Moderate to strong evidence was shown for multiple therapeutic interventional techniques including medial branch blocks and medial branch neurotomy; caudal epidural steroid injections and transforaminal epidural steroid injections; lumbar percutaneous adhesiolysis; and implantable therapies. These guidelines do not constitute inflexible treatment recommendations. It is expected that a provider will establish a plan of care on a case-by-case basis, taking into account an individual patient's medical condition, personal needs, and preferences, and the physician's experience. Based on an individual patient's needs, treatment different from that outlined here could be warranted. These guidelines do not represent "standard of care."
Zygapophysial or facet joints have been implicated as cause of low back, mid back, upper back and neck pain with referred pain. Cervical, thoracic and lumbar facet joints are innervated by the medial ...branches of the dorsal rami. Zygapophysial (facet) joints have been implicated as the source of chronic pain in 15% to 45% of the patients with chronic low back pain, 54% to 60% of the patients with chronic neck pain and 48% of the patients with thoracic pain. A systematic review of the evidence of effectiveness of radiofrequency denervation in the management of chronic spinal pain was undertaken. This review included randomized clinical trials, as well as non-randomized or observational studies in the analysis. Literature search included MEDLINE, EMBASE, systematic reviews, narrative reviews, cross-references to the reviews and various published trials; and peer reviewed abstracts from scientific meetings during the past two years. An algorithmic approach was followed in study evaluation with a description of inclusion and exclusion criteria. A set of high-performing scales or checklists pertaining to randomized clinical trials and observational trials derived from the Agency for Healthcare Research and Quality (AHRQ) was utilized; Systems to Rate the Strength of Scientific Evidence. Qualitative analysis was conducted, using five levels of evidence for effectiveness of medial branch neurotomy. Our search strategy identified over 1,000 citations as the result of electronic and manual screening. A total of 7 randomized trials of radiofrequency neurotomy for spinal pain were identified. However, only 4 related to medial branch neurotomy. Two of the four met the inclusion criteria. Among the multiple observational studies considered for inclusion, 4 prospective evaluations were included in the systematic review. In addition, 3 retrospective evaluations were also included. Two randomized trials comprised of 27 patients receiving active treatment. The first study consisted of cervical facet joint pain and the second consisted of lumbar facet joint pain. Both studies showed positive results. Similar to randomized trials, prospective, as well as retrospective evaluations showed positive evidence, both in short-term and long-term. The results of this systematic review of 2 well-designed randomized trials, 4 prospective well-designed trials without randomization and 3 retrospective evaluations provided strong evidence that radiofrequency denervation offers short-term relief and moderate evidence of long-term pain relief of facet joint origin.
Epidural corticosteroid injections are a common treatment for radicular pain caused by intervertebral disc herniations, spinal stenosis, and other disorders. Although rare, catastrophic neurologic ...injuries, including stroke and spinal cord injury, have occurred with these injections.
A collaboration was undertaken between the U.S. Food and Drug Administration Safe Use Initiative, an expert multidisciplinary working group, and 13 specialty stakeholder societies. The goal of this collaboration was to review the existing evidence regarding neurologic complications associated with epidural corticosteroid injections and produce consensus procedural clinical considerations aimed at enhancing the safety of these injections. U.S. Food and Drug Administration Safe Use Initiative representatives helped convene and facilitate meetings without actively participating in the deliberations or decision-making process.
Seventeen clinical considerations aimed at improving safety were produced by the stakeholder societies. Specific clinical considerations for performing transforaminal and interlaminar injections, including the use of nonparticulate steroid, anatomic considerations, and use of radiographic guidance are given along with the existing scientific evidence for each clinical consideration.
Adherence to specific recommended practices when performing epidural corticosteroid injections should lead to a reduction in the incidence of neurologic injuries.
Abstract
Objective
For many medical professionals dealing with patients with persistent pain following spine surgery, the term Failed back surgery syndrome (FBSS) as a diagnostic label is inadequate, ...misleading, and potentially troublesome. It misrepresents causation. Alternative terms have been suggested, but none has replaced FBSS. The International Association for the Study of Pain (IASP) published a revised classification of chronic pain, as part of the new International Classification of Diseases (ICD-11), which has been accepted by the World Health Organization (WHO). This includes the term Chronic pain after spinal surgery (CPSS), which is suggested as a replacement for FBSS.
Methods
This article provides arguments and rationale for a replacement definition. In order to propose a broadly applicable yet more precise and clinically informative term, an international group of experts was established.
Results
14 candidate replacement terms were considered and ranked. The application of agreed criteria reduced this to a shortlist of four. A preferred option—Persistent spinal pain syndrome—was selected by a structured workshop and Delphi process. We provide rationale for using Persistent spinal pain syndrome and a schema for its incorporation into ICD-11. We propose the adoption of this term would strengthen the new ICD-11 classification.
Conclusions
This project is important to those in the fields of pain management, spine surgery, and neuromodulation, as well as patients labeled with FBSS. Through a shift in perspective, it could facilitate the application of the new ICD-11 classification and allow clearer discussion among medical professionals, industry, funding organizations, academia, and the legal profession.
Introduction
The Neuromodulation Appropriateness Consensus Committee (NACC) of the International Neuromodulation Society (INS) evaluated evidence regarding the safety and efficacy of neurostimulation ...to treat chronic pain, chronic critical limb ischemia, and refractory angina and recommended appropriate clinical applications.
Methods
The NACC used literature reviews, expert opinion, clinical experience, and individual research. Authors consulted the Practice Parameters for the Use of Spinal Cord Stimulation in the Treatment of Neuropathic Pain (2006), systematic reviews (1984 to 2013), and prospective and randomized controlled trials (2005 to 2013) identified through PubMed, EMBASE, and Google Scholar.
Results
Neurostimulation is relatively safe because of its minimally invasive and reversible characteristics. Comparison with medical management is difficult, as patients considered for neurostimulation have failed conservative management. Unlike alternative therapies, neurostimulation is not associated with medication‐related side effects and has enduring effect. Device‐related complications are not uncommon; however, the incidence is becoming less frequent as technology progresses and surgical skills improve. Randomized controlled studies support the efficacy of spinal cord stimulation in treating failed back surgery syndrome and complex regional pain syndrome. Similar studies of neurostimulation for peripheral neuropathic pain, postamputation pain, postherpetic neuralgia, and other causes of nerve injury are needed. International guidelines recommend spinal cord stimulation to treat refractory angina; other indications, such as congestive heart failure, are being investigated.
Conclusions
Appropriate neurostimulation is safe and effective in some chronic pain conditions. Technological refinements and clinical evidence will continue to expand its use. The NACC seeks to facilitate the efficacy and safety of neurostimulation.
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