Development of an interventional pain management specific instrument for methodologic quality assessment of nonrandomized studies of interventional techniques.

BACKGROUND: The major component of a systematic review is assessment of the methodologic quality and bias of randomized and nonrandomized trials. While there are multiple instruments available to assess the methodologic quality and bias for randomized controlled trials (RCTs), there is a lack of extensively utilized instruments for observational studies, specifically for interventional pain management (IPM) techniques. Even Cochrane review criteria for randomized trials is considered not to be a "gold standard," but merely an indication of the current state of the art review methodology. Recently a specific instrument to assess the methodologic quality of randomized trials has been developed for interventional techniques. OBJECTIVES: Our objective was to develop an IPM specific instrument to assess the methodological quality of nonrandomized trials or observational studies of interventional techniques. METHODS: The item generation for the instrument was based on a definition of quality, to the extent to which the design and conduct of the trial were congruent with the objectives of the study. Applicability was defined as the extent to which procedures produced by the study could be applied using contemporary IPM techniques. Multiple items based on Cochrane review criteria and Interventional Pain Management Techniques - Quality Appraisal of Reliability and Risk of Bias Assessment for Nonrandomized Studies (IPM-QRBNR) were utilized. RESULTS: A total of 16 items were developed which formed the IPM-QRBNR tool. The assessment was performed in multiple stages. The final assessment was 4 nonrandomized studies. The inter-rater agreement was moderate to good for IPM-QRBNR criteria. LIMITATIONS: Limited validity or accuracy assessment of the instrument and the large number of items to be scored were limitations. CONCLUSION: We have developed a new comprehensive instrument to assess the methodological quality of nonrandomized studies of interventional techniques. This instrument provides extensive information specific to interventional techniques is useful in assessing the methodological quality and bias of observational studies of interventional techniques.

An update of comprehensive evidence-based guidelines for interventional techniques in chronic spinal pain. Part II: guidance and recommendations.

OBJECTIVE: To develop evidence-based clinical practice guidelines for interventional techniques in the diagnosis and treatment of chronic spinal pain. METHODOLOGY: Systematic assessment of the literature. EVIDENCE: I. Lumbar Spine • The evidence for accuracy of diagnostic selective nerve root blocks is limited; whereas for lumbar provocation discography, it is fair. • The evidence for diagnostic lumbar facet joint nerve blocks and diagnostic sacroiliac intraarticular injections is good with 75% to 100% pain relief as criterion standard with controlled local anesthetic or placebo blocks. • The evidence is good in managing disc herniation or radiculitis for caudal, interlaminar, and transforaminal epidural injections; fair for axial or discogenic pain without disc herniation, radiculitis or facet joint pain with caudal, and interlaminar epidural injections, and limited for transforaminal epidural injections; fair for spinal stenosis with caudal, interlaminar, and transforaminal epidural injections; and fair for post surgery syndrome with caudal epidural injections and limited with transforaminal epidural injections. • The evidence for therapeutic facet joint interventions is good for conventional radiofrequency, limited for pulsed radiofrequency, fair to good for lumbar facet joint nerve blocks, and limited for intraarticular injections. • For sacroiliac joint interventions, the evidence for cooled radiofrequency neurotomy is fair; limited for intraarticular injections and periarticular injections; and limited for both pulsed radiofrequency and conventional radiofrequency neurotomy. • For lumbar percutaneous adhesiolysis, the evidence is fair in managing chronic low back and lower extremity pain secondary to post surgery syndrome and spinal stenosis. • For intradiscal procedures, the evidence for intradiscal electrothermal therapy (IDET) and biaculoplasty is limited to fair and is limited for discTRODE. • For percutaneous disc decompression, the evidence is limited for automated percutaneous lumbar discectomy (APLD), percutaneous lumbar laser disc decompression, and Dekompressor; and limited to fair for nucleoplasty for which the Centers for Medicare and Medicaid Services (CMS) has issued a noncoverage decision. II. Cervical Spine • The evidence for cervical provocation discography is limited; whereas the evidence for diagnostic cervical facet joint nerve blocks is good with a criterion standard of 75% or greater relief with controlled diagnostic blocks. • The evidence is good for cervical interlaminar epidural injections for cervical disc herniation or radiculitis; fair for axial or discogenic pain, spinal stenosis, and post cervical surgery syndrome. • The evidence for therapeutic cervical facet joint interventions is fair for conventional cervical radiofrequency neurotomy and cervical medial branch blocks, and limited for cervical intraarticular injections. III. Thoracic Spine • The evidence is limited for thoracic provocation discography and is good for diagnostic accuracy of thoracic facet joint nerve blocks with a criterion standard of at least 75% pain relief with controlled diagnostic blocks. • The evidence is fair for thoracic epidural injections in managing thoracic pain. • The evidence for therapeutic thoracic facet joint nerve blocks is fair, limited for radiofrequency neurotomy, and not available for thoracic intraarticular injections. IV. Implantables • The evidence is fair for spinal cord stimulation (SCS) in managing patients with failed back surgery syndrome (FBSS) and limited for implantable intrathecal drug administration systems. V. ANTICOAGULATION • There is good evidence for risk of thromboembolic phenomenon in patients with antithrombotic therapy if discontinued, spontaneous epidural hematomas with or without traumatic injury in patients with or without anticoagulant therapy to discontinue or normalize INR with warfarin therapy, and the lack of necessity of discontinuation of nonsteroidal anti-inflammatory drugs (NSAIDs), including low dose aspirin prior to performing interventional techniques. • There is fair evidence with excessive bleeding, including epidural hematoma formation with interventional techniques when antithrombotic therapy is continued, the risk of higher thromboembolic phenomenon than epidural hematomas with discontinuation of antiplatelet therapy prior to interventional techniques and to continue phosphodiesterase inhibitors (dipyridamole, cilostazol, and Aggrenox). • There is limited evidence to discontinue antiplatelet therapy with platelet aggregation inhibitors to avoid bleeding and epidural hematomas and/or to continue antiplatelet therapy (clopidogrel, ticlopidine, prasugrel) during interventional techniques to avoid cerebrovascular and cardiovascular thromboembolic fatalities. • There is limited evidence in reference to newer antithrombotic agents dabigatran (Pradaxa) and rivaroxan (Xarelto) to discontinue to avoid bleeding and epidural hematomas and are continued during interventional techniques to avoid cerebrovascular and cardiovascular thromboembolic events. CONCLUSIONS: Evidence is fair to good for 62% of diagnostic and 52% of therapeutic interventions assessed. DISCLAIMER: The authors are solely responsible for the content of this article. No statement on this article should be construed as an official position of ASIPP. The guidelines do not represent "standard of care."

An updated review of automated percutaneous mechanical lumbar discectomy for the contained herniated lumbar disc.

BACKGROUND: Lumbar disc prolapse, protrusion, and extrusion are the most common causes of nerve root pain and surgical interventions, and yet they account for less than 5% of all low back problems. The typical rationale for traditional surgery is that it is an effort to provide more rapid relief of pain and disability. It should be noted that the majority of patients do recover with conservative management. The primary rationale for any form of surgery for disc prolapse associated with radicular pain is to relieve nerve root irritation or compression due to herniated disc material. The primary modality of treatment continues to be either open or microdiscectomy, although several alternative techniques, including automated percutaneous mechanical lumbar discectomy, have been described. There is, however, a paucity of evidence for all decompression techniques, specifically alternative techniques including automated and laser discectomy. STUDY DESIGN: A systematic review of the literature of automated percutaneous mechanical lumbar discectomy for the contained herniated lumbar disc. OBJECTIVE: To evaluate and update the effectiveness of automated percutaneous mechanical lumbar discectomy. METHODS: The available literature on automated percutaneous mechanical lumbar discectomy in managing chronic low back and lower extremity pain was reviewed. The quality assessment and clinical relevance criteria utilized were the Cochrane Musculoskeletal Review Group criteria, as utilized for interventional techniques for randomized trials, and the criteria developed by the Newcastle-Ottawa Scale criteria for observational studies.The level of evidence was classified as good, fair, and limited or poor, based on the quality of evidence scale developed by the U.S. Preventive Services Task Force (USPSTF). Data sources included relevant literature identified through searches of PubMed and EMBASE from 1966 to September 2012, and manual searches of the bibliographies of known primary and review articles. OUTCOME MEASURES: Pain relief was the primary outcome measure. Other outcome measures were functional improvement, improvement of psychological status, opioid intake, and return to work. Short-term effectiveness was defined as one year or less, whereas long-term effectiveness was defined as greater than one year. RESULTS: Nineteen studies were included; none of the randomized trials and 19 observational studies met inclusion criteria for methodological quality assessment. Overall, 5,515 patients were studied with 4,412 patients (80%) showing positive results lasting one year or longer. Based on USPSTF criteria, the indicated evidence for automated percutaneous mechanical lumbar discectomy is limited for short- and long-term relief. LIMITATIONS: A paucity of randomized controlled trials in the literature describing automated percutaneous mechanical disc decompression.  CONCLUSION: This systematic review shows limited evidence for automated percutaneous mechanical lumbar discectomy. Automated percutaneous mechanical lumbar discectomy may provide appropriate relief in properly selected patients with contained lumbar disc herniation.

Intrathecal infusion systems for long-term management of chronic non-cancer pain: an update of assessment of evidence.

BACKGROUND: Intrathecal infusion systems are often used for patients with intractable pain when all else fails, including surgery. There is, however, some concern as to the effectiveness and safety of this treatment. STUDY DESIGN:   A systematic review of intrathecal infusion systems for long-term management of chronic non-cancer pain. OBJECTIVE: To evaluate and update the effect of intrathecal infusion systems in managing chronic non-cancer pain. METHODS: The available literature on intrathecal infusion systems in managing chronic pain was reviewed. The quality assessment and clinical relevance criteria utilized were the Cochrane Musculoskeletal Review Group criteria as utilized for interventional techniques for randomized trials and the Newcastle-Ottawa Scale criteria for observational studies. The level of evidence was classified as good, fair, and limited or poor based on the quality of evidence developed by the U.S. Preventative Services Task Force (USPSTF). Data sources included relevant literature identified through searches of PubMed and EMBASE from 1966 to December 2012, and manual searches of the bibliographies of known primary and review articles. OUTCOME MEASURES: The primary outcome measure was pain relief with short-term relief < 12 months and long-term relief ≥ 12 months. Secondary outcome measures were improvement in functional status, psychological status, return to work, and reduction in opioid intake. RESULTS: There were 28 studies identified for this systematic review. Of these, 21 were excluded from further review. A total of 7 non-randomized studies met inclusion criteria for methodological quality assessment. No randomized trials met the inclusion requirements.The evidence is limited based on observational studies. LIMITATIONS: The limitations of this systematic review include the paucity of literature. CONCLUSION: The evidence is limited for intrathecal infusion systems.

An update of the appraisal of the accuracy of thoracic discography as a diagnostic test for chronic spinal pain.

BACKGROUND: Even though the prevalence of thoracic pain has been reported to be 13% of the general population and up to 22% of the population in interventional pain management settings, the role of thoracic discs as a cause of chronic thoracic and extrathoracic pain has not been well studied. The intervertebral discs, zygapophysial or facet joints, and other structures including the costovertebral and costotransverse joints have been identified as a source of thoracic pain. STUDY DESIGN: A systematic review of provocation thoracic discography. OBJECTIVE: To systematically assess and update the quality of clinical studies evaluating the diagnostic accuracy of provocation thoracic discography. METHODS: A systematic review of the literature was performed to assess the diagnostic accuracy of thoracic discography with respect to chronic, function limiting, thoracic or extrathoracic pain. The available literature on thoracic discography was reviewed. A methodological quality assessment of included studies was performed using Quality Appraisal of Reliability Studies (QAREL). The level of evidence was classified as good, fair, and limited (or poor) based on the quality of evidence developed by the U.S. Preventive Services Task Force (USPSTF). Data sources included relevant literature identified through searches of PubMed and EMBASE from 1966 to June 2012, and manual searches of the bibliographies of known primary and review articles. RESULTS: The evidence and clinical value of thoracic provocation discography is limited (poor) with a paucity of evidence, with only 2 studies meeting inclusion criteria. LIMITATIONS: The limitation of this study continues to be the paucity of literature. CONCLUSION: Based on the available evidence for this systematic review, due to limited evidence, thoracic provocation discography is rarely recommended for the diagnosis of discogenic pain in the thoracic spine, if conservative management has failed and facet joint pain has been excluded.

An update of the effectiveness of therapeutic lumbar facet joint interventions.

BACKGROUND: Therapeutic lumbar facet joint interventions are implemented to provide long-term pain relief after the facet joint has been identified as the basis for low back pain. The therapeutic lumbar facet joint interventions generally used for the treatment of low back pain of facet joint origin are intraarticular facet joint injections, lumbar facet joint nerve blocks, and radiofrequency neurotomy. OBJECTIVE: To evaluate and update the effect of therapeutic lumbar facet joint interventions in managing chronic low back pain. STUDY DESIGN: A systematic review of therapeutic lumbar facet joint interventions for the treatment of chronic low back pain. METHODS: The available literature on lumbar facet joint interventions in managing chronic low back pain was reviewed. The quality assessment and clinical relevance criteria utilized were the Cochrane Musculoskeletal Review Group criteria as utilized for interventional techniques for randomized trials and the criteria developed by the Newcastle-Ottawa Scale criteria for observational studies. The level of evidence was classified as good, fair, and limited or poor based on the quality of evidence developed by the U.S. Preventative Services Task Force. Data sources included relevant literature identified through searches of PubMed and EMBASE from 1966 through June 2012, and manual searches of the bibliographies of known primary and review articles. OUTCOME MEASURES: The primary outcome measure was pain relief with short-term relief defined as up to 6 months and long-term relief as 12 months. Secondary outcome measures were improvement in functional status, psychological status, return to work, and reduction in opioid intake. RESULTS: For this systematic review, 122 studies were identified. Of these, 11 randomized trials and 14 observational studies met inclusion criteria for methodological quality assessment. The evidence for radiofrequency neurotomy is good and fair to good for lumbar facet joint nerve blocks for short- and long-term improvement; whereas the evidence for intraarticular injections and pulsed radiofrequency neurotomy is limited. LIMITATIONS: The limitations of this systematic review include the continued paucity of evidence, specifically for intraarticular injection therapy. CONCLUSION: In summary, there is good evidence for the use of conventional radiofrequency neurotomy, and fair to good evidence for lumbar facet joint nerve blocks for the treatment of chronic lumbar facet joint pain resulting in short-term and long-term pain relief and functional improvement. There is limited evidence for intraarticular facet joint injections and pulsed radiofrequency thermoneurolysis.

An update of the appraisal of the accuracy and utility of cervical discography in chronic neck pain.

BACKGROUND: Chronic neck pain represents a significant public health problem. Despite high prevalence rates, there is a lack of consensus regarding the causes or treatments for this condition. Based on controlled evaluations, the cervical intervertebral discs, facet joints, and atlantoaxial joints have all been implicated as pain generators. Cervical provocation discography, which includes disc stimulation and morphological evaluation, is occasionally used to distinguish a painful disc from other potential sources of pain. Yet in the absence of validation and controlled outcome studies, the procedure remains mired in controversy. STUDY DESIGN: A systematic review of the diagnostic accuracy of cervical discography. OBJECTIVE: To systematically evaluate and update the diagnostic accuracy of cervical discography. METHODS: The available literature on cervical discography was reviewed. Methodological quality assessment of included studies was performed using Quality Appraisal of Reliability Studies (QAREL). Only diagnostic accuracy studies meeting at least 50% of the designated inclusion criteria were utilized for analysis. However, studies scoring less than 50% are presented descriptively and analyzed critically. The level of evidence was classified as good, fair, and limited or poor based on the quality of evidence developed by the U.S. Preventive Services Task Force (USPSTF).Data sources included relevant literature identified through searches of PubMed and EMBASE from 1966 to June 2012, and manual searches of the bibliographies of known primary and review articles. RESULTS: A total of 41 manuscripts were considered for accuracy and utility of cervical discography in chronic neck pain. There were 23 studies evaluating accuracy of discography. There were 3 studies meeting inclusion criteria for assessing the accuracy and prevalence of discography, with a prevalence of 16% to 53%. Based on modified Agency for Healthcare Research and Quality (AHRQ) accuracy evaluation and United States Preventive Services Task Force (USPSTF) level of evidence criteria, this systematic review indicates the strength of evidence is limited for the diagnostic accuracy of cervical discography. LIMITATIONS: Limitations include a paucity of literature, poor methodological quality, and very few studies performed utilizing International Association for the Study of Pain (IASP) criteria. CONCLUSION: There is limited evidence for the diagnostic accuracy of cervical discography. Nevertheless, in the absence of any other means to establish a relationship between pathology and symptoms, cervical provocation discography may be an important evaluation tool in certain contexts to identify a subset of patients with chronic neck pain secondary to intervertebral disc disorders. Based on the current systematic review, cervical provocation discography performed according to the IASP criteria with control disc(s), and a minimum provoked pain intensity of 7 of 10, or at least 70% reproduction of worst pain (i.e. worst spontaneous pain of 7 = 7 x 70% = 5), may be a useful tool for evaluating chronic pain and cervical disc abnormalities in a small proportion of patients.

An update of the systematic assessment of the diagnostic accuracy of lumbar facet joint nerve blocks.

BACKGROUND: Lumbar facet joints are a well recognized source of low back pain and referred pain in the lower extremity in patients with chronic low back pain. Conventional clinical features and other non-invasive diagnostic modalities are unreliable in diagnosing lumbar zygapophysial joint pain. Controlled diagnostic studies with at least 80% pain relief as the criterion standard have shown the prevalence of lumbar facet joint pain to be 16% to 41% of patients with chronic low back pain without disc displacement or radiculitis, with a false-positive rate of 17% to 49% with a single diagnostic block. STUDY DESIGN: A systematic review of the diagnostic accuracy of lumbar facet joint nerve blocks. OBJECTIVE: To determine and update the diagnostic accuracy of lumbar facet joint nerve blocks in the assessment of chronic low back pain. METHODS: A methodological quality assessment of included studies was performed using Quality Appraisal of Reliability Studies (QAREL). Only diagnostic accuracy studies meeting at least 50% of the designated inclusion criteria were utilized for analysis. Studies scoring less than 50% are presented descriptively and analyzed critically. The level of evidence was classified as good, fair, and limited or poor based on the quality of evidence developed by the United States Preventive Services Task Force (USPSTF). Data sources included relevant literature identified through searches of PubMed and EMBASE from 1966 to June 2012, and manual searches of the bibliographies of known primary and review articles. OUTCOME MEASURES: Studies must have been performed utilizing controlled local anesthetic blocks. Pain relief was categorized as at least 50% pain relief from baseline pain and the ability to perform previously painful movements. RESULTS: A total of 25 diagnostic accuracy studies were included. Of these, one study evaluated 50% to 74% relief as criterion standard with a single block with prevalence of 48%, 4 studies evaluated 75% to 100% relief as the criterion standard with a single block with a prevalence of 31% to 61%, 5 studies evaluated 50% to 74% relief as the criterion standard with controlled blocks with a prevalence of 15% to 61%, and 13 studies evaluated 75% to 100% relief as the criterion standard with controlled blocks with a prevalence of 25% to 45% in heterogenous populations. False-positive rates ranged from 17% to 66% relief and 27% to 49% with at least 75% relief as the criterion standard. Based on this evaluation, the evidence showed that there is good evidence for diagnostic facet joint nerve blocks with 75% to 100% pain relief as the criterion standard with dual blocks and fair evidence with 50% to 74% pain relief as the criterion standard with controlled diagnostic blocks; however, the evidence is poor with single diagnostic blocks of 50% to 74%, and limited for 75% or more pain relief as the criterion standard. LIMITATIONS: The shortcomings of this systematic review of the accuracy of diagnostic lumbar facet joint nerve blocks include a paucity of literature and continued debate on an appropriate gold standard. CONCLUSION: There is good evidence for diagnostic facet joint nerve blocks with 75% to 100% pain relief as the criterion standard with dual blocks, with fair evidence with 50% to 74% pain relief.

Alternative approach for lumbar transforaminal epidural steroid injections.

The traditional superoanterior approach for transforaminal epidural steroid injection (TFESI) carries a risk of complication by obstructing arterial flow to the anterior portion of the spinal cord by puncturing the spinal radicular artery that passes through the superoanterior foraminal zone or "safe triangle" zone, which does not describe vascular safety, but rather describes neural safety. Consequently, multiple disasters have been described in recent years with transforaminal epidural injections. They are utilized extensively even though their effectiveness has been debated. Here we describe a dorsal technique through transforaminal epidural injections to place the tip of the needle immediately dorsal to the dorsal root ganglion. Multiple different techniques have been discussed and described in recent years, the majority of them to avoid the radicular artery injection. The primary goal of this paper is to describe another posterior approach to place the tip of spinal needle directly toward the posterior epidural space to avoid puncturing the spinal radicular artery and minimize nerve root penetrations while delivering medication into the epidural space through the foramen.

Cross talk: a new method for peripheral nerve stimulation. An observational report with cadaveric verification.

BACKGROUND: Relief of regional, non-appendicular pain, particularly low back pain, through spinal cord stimulation (SCS) has proven challenging. Recently, peripheral nerve stimulation (PNS), also known as peripheral nerve field stimulation (PNFS) depending on the stimulation area, has demonstrated efficacy for the treatment of well-localized, small areas of pain involving the abdomen, inguinal region, pelvis, face, occipital area, and low back. More widespread application of peripheral nerve stimulation has been limited by its narrow field of coverage in a larger group of patients with diffuse or poorly localized pain. OBJECTIVES: To determine if cross talk (the creation of an electrical circuit and therefore electrical stimulation between separate subcutaneously placed PNS leads [i.e. inter-lead stimulation]) was clinically possible across large painful areas, assess the breadth of stimulation coverage via cross talk, evaluate the clinical efficacy of peripheral nerve stimulation cross talk (PNSCT), and confirm the existence of cross talk across a large area in a cadaveric model. STUDY DESIGN: Case series observational report and cadaveric experimentation. SETTING: A private, comprehensive interventional pain management practice with pain medicine fellowship training in the United States. METHODS: Eighteen consecutive patients with non-appendicular, regional pain were included in the study. Data collection for the implanted patients included the presence or absence of stimulation between the PNS leads, stimulation tolerability, stimulation region, lead orientation, lead montage, inter-lead distance, and pain relief from PNSCT compared to PNS without cross talk. A cadaveric analysis was performed to determine the presence or absence of an electrical circuit with 2 subcutaneously PNS leads to confirm or refute the existence of electrical stimulation from on lead to the other within subcutaneous fat with the leads placed at a significant distance apart from one another. RESULTS: All 18 patients experienced significant pain relief, reduction of pain medication, and functional improvement. Cadaveric experimentation confirmed the presence of an electrical circuit with PNS leads placed at a distance far apart from one another and verified that inter-lead stimulation (cross talk) does occur in subcutaneous fat over a great distance. LIMITATIONS: This study was limited by its small sample size, and the short-term follow-up after implantation. CONCLUSIONS: The use of the PNSCT technique allows for significant analgesia for large painful areas that have been poorly captured using traditional SCS techniques and not considered as an option with the current application of peripheral nerve stimulation.