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 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 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.