Back Pain: Schultz DM

Boswell MV, Trescot AM, Datta S, Schultz DM, Hansen HC, Abdi S, Sehgal N, Shah RV, Singh V, Benyamin RM, Patel VB, Buenaventura RM, Colson JD, Cordner HJ, Epter RS, Jasper JF, Dunbar EE, Atluri SL, Bowman RC, Deer TR, Swicegood JR, Staats PS, Smith HS, Burton AW, Kloth DS, Giordano J, Manchikanti L, Anonymous00089. · American Society of Interventional Pain Physicians, Paducah, KY 42001, USA. · Pain Physician. · Pubmed #17256025 links to  free full text

Abstract: BACKGROUND: 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. OBJECTIVE: 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. DESIGN: 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. METHODS: 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). RESULTS: 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. CONCLUSION: 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."

Manchikanti L, Singh V, Derby R, Schultz DM, Benyamin RM, Prager JP, Hirsch JA. · Pain Management Center of Paducah, Paducah, KY, USA. · Pain Physician. · Pubmed #18690276 links to  free full text

Abstract: BACKGROUND: Appropriately developed practice guidelines present statements of best practice based on a thorough evaluation of the evidence from published studies on the outcomes of treatments, which include the application of multiple methods for collecting and evaluating evidence for a wide range of clinical interventions and disciplines. However, the guidelines are neither infallible, nor a substitute for clinical judgment. While the guideline development process is a complex phenomenon, conflict of interest in guideline development and inappropriate methodologies must be avoided. It has been alleged that the guidelines by the American College of Occupational and Environmental Medicine (ACOEM) prevent injured workers from receiving the majority of medically necessary and appropriate interventional pain management services. An independent critical appraisal of both chapters of the ACOEM guidelines showed startling findings with a conclusion that these guidelines may not be applied in patient care as they scored below 30% in the majority of evaluations utilizing multiple standardized criteria. OBJECTIVE: To reassess the evidence synthesis for the ACOEM guidelines for the low back pain and chronic pain chapters utilizing an expanded methodology, which includes the criteria included in the ACOEM guidelines with the addition of omitted literature and application of appropriate criteria. METHODS: For reassessment, randomized trials were utilized as it was in the preparation of the guidelines. In this process, quality of evidence was assessed and recommendations were made based on grading recommendations of Guyatt et al. The level of evidence was determined utilizing the quality of evidence criteria developed by the U.S. Preventive Services Task Force (USPSTF), as well as the outdated quality of evidence criteria utilized by ACOEM in the guideline preparation. Methodologic quality of each individual article was assessed utilizing the Agency for Healthcare Research and Quality (AHRQ) methodologic assessment criteria for diagnostic interventions and Cochrane methodologic quality assessment criteria for therapeutic interventions. RESULTS: The results of reassessment are vastly different from the conclusions derived by the ACOEM guidelines. The differences in strength of rating for the diagnosis of discogenic pain by provocation discography and facet joint pain by diagnostic facet joint nerve blocks is established with strong evidence. Therapeutic cervical and lumbar medial branch blocks and radiofrequency neurolysis, therapeutic thoracic medial branch blocks, cervical interlaminar epidural steroid injections, caudal epidural steroid injections, lumbar transforaminal epidural injections, percutaneous and endoscopic adhesiolysis, and spinal cord stimulation qualified for moderate to strong evidence. Additional insight is also provided for evidence rating for intradiscal electrothermal therapy (IDET), automated percutaneous disc decompression, and intrathecal implantables. CONCLUSION: The reassessment and reevaluation of the low back and chronic pain chapters of the ACOEM guidelines present results that are vastly different from the published and proposed guidelines. Contrary to ACOEM's conclusions of insufficient evidence for most interventional techniques, the results illustrate moderate to strong evidence for most diagnostic and therapeutic interventional techniques.

Abdi S, Datta S, Trescot AM, Schultz DM, Adlaka R, Atluri SL, Smith HS, Manchikanti L. · University of Miami, Miller School of Medicine, Miami, FL 33136, USA. · Pain Physician. · Pubmed #17256030 links to  free full text

Abstract: BACKGROUND: Epidural injection of corticosteroids is one of the most commonly used interventions in managing chronic spinal pain. However, there has been a lack of well-designed randomized, controlled studies to determine the effectiveness of epidural injections. Consequently, debate continues as to the value of epidural steroid injections in managing spinal pain. OBJECTIVE: To evaluate the effect of various types of epidural steroid injections (interlaminar, transforaminal, and caudal), in managing various types of chronic spinal pain (axial and radicular) in the neck and low back regions. STUDY DESIGN: A systematic review utilizing the criteria established by the Agency for Healthcare Research and Quality (AHRQ) for evaluation of randomized and non-randomized trials, and criteria of Cochrane Musculoskeletal Review Group for randomized trials were used. METHODS: Data sources included relevant English literature performed by a librarian experienced in Evidence Based Medicine (EBM), as well as manual searches of bibliographies of known primary and review articles and abstracts from scientific meetings within the last 2 years. Three reviewers independently assessed the trials for the quality of their methods. Subgroup analyses were performed among trials with different control groups, with different techniques of epidural injections (interlaminar, transforaminal, and caudal), with different injection sites (cervical/thoracic, lumbar/sacral), and with timing of outcome measurement (short- and long-term). OUTCOME MEASURES: The primary outcome measure is pain relief. Other outcome measures were functional improvement, improvement of psychological status, and return to work. Short-term improvement is defined as 6 weeks or less, and long-term relief is defined as 6 weeks or longer. RESULTS: In managing lumbar radicular pain with interlaminar lumbar epidural steroid injections, the evidence is strong for short-term relief and limited for long-term relief. In managing cervical radiculopathy with cervical interlaminar epidural steroid injections, the evidence is moderate. The evidence for lumbar transforaminal epidural steroid injections in managing lumbar radicular pain is strong for short-term and moderate for long-term relief. The evidence for cervical transforaminal epidural steroid injections in managing cervical nerve root pain is moderate. The evidence is moderate in managing lumbar radicular pain in post lumbar laminectomy syndrome. The evidence for caudal epidural steroid injections is strong for short-term relief and moderate for long-term relief, in managing chronic pain of lumbar radiculopathy and postlumbar laminectomy syndrome. CONCLUSION: There is moderate evidence for interlaminar epidurals in the cervical spine and limited evidence in the lumbar spine for long-term relief. The evidence for cervical and lumbar transforaminal epidural steroid injections is moderate for long-term improvement in managing nerve root pain. The evidence for caudal epidural steroid injections is moderate for long-term relief in managing nerve root pain and chronic low back pain.

Trescot AM, Chopra P, Abdi S, Datta S, Schultz DM. · University of FL, Gainesville, FL, USA. · Pain Physician. · Pubmed #17256027 links to  free full text

Abstract: BACKGROUND: Percutaneous epidural adhesiolysis and spinal endoscopic adhesiolysis are interventional pain management techniques used to treat patients with refractory low back pain due to epidural scarring. Standard epidural steroid injections are often ineffective, especially in patients with prior back surgery. Adhesions in the epidural space can prevent the flow of medicine to the target area; lysis of these adhesions can improve the delivery of medication to the affected areas, potentially improving the therapeutic efficacy of the injected medications. STUDY DESIGN: A systematic review utilizing the methodologic quality criteria of the Cochrane Musculoskeletal Review Group for randomized trials and the criteria established by the Agency for Healthcare Research and Quality (AHRQ) for evaluation of randomized and non-randomized trials. OBJECTIVE: To evaluate and update the effectiveness of percutaneous adhesiolysis and spinal endoscopic adhesiolysis in managing chronic low back and lower extremity pain due to radiculopathy, with or without prior lumbar surgery, since the 2005 systematic review. METHODS: Basic search identified the relevant literature, in the MEDLINE, EMBASE, and BioMed databases (November 2004 to September 2006). Manual searches of bibliographies of known primary and review articles, and abstracts from scientific meetings within the last 2 years were reviewed. Randomized and non-randomized studies are included in the review based on criteria established. Percutaneous adhesiolysis and endoscopic adhesiolysis are analyzed separately. OUTCOME MEASURES: The primary outcome measure was significant pain relief (50% or greater). Other outcome measures were functional improvement, improvement of psychological status, and return to work. Short-term relief was defined as less than 3 months, and long-term relief was defined as 3 months or longer. RESULTS: Studies regarding the treatment of epidural adhesions for the treatment of low back and lower extremity pain were sought and reviewed. The evidence from the previous systematic review was combined with new studies since November 2004. There is strong evidence for short term and moderate evidence for long term effectiveness of percutaneous adhesiolysis and spinal endoscopy. CONCLUSION: Percutaneous adhesiolysis and spinal endoscopy may be effective interventions to treat low back and lower extremity pain caused by epidural adhesions.

Datta S, Everett CR, Trescot AM, Schultz DM, Adlaka R, Abdi S, Atluri SL, Smith HS, Shah RV. · Vanderbilt University School of Medicine, Nashville, TN, USA. · Pain Physician. · Pubmed #17256026 links to  free full text

Abstract: BACKGROUND: Selective nerve root blocks or transforaminal epidural injections are used for diagnosis and treatment of different spinal disorders. A clear consensus on the use of selective nerve root injections as a diagnostic tool does not currently exist. Additionally, the effectiveness of this procedure as a diagnostic tool is not clear. A systematic review of diagnostic utility of selective nerve root blocks was performed and published in January 2005, which concluded that selective nerve root injections may be helpful as a diagnostic tool in evaluating spinal pain with radicular features, but its role needs to be further clarified. OBJECTIVE: To evaluate and update the accuracy of selective nerve root injections in diagnosing spinal disorders. STUDY DESIGN: A systematic review of selective nerve root blocks for the diagnosis of spinal pain. METHODS: A systematic review of the literature for clinical studies was performed to assess the accuracy of selective nerve root injections in diagnosing spinal pain. Methodologic quality evaluation was performed utilizing Agency for Healthcare Research and Quality (AHRQ) and Quality Assessment Studies of Diagnostic Accuracy (QUADAS) criteria. Studies were graded and evidence classified into 5 levels: conclusive, strong, moderate, limited, or indeterminate. An extensive literature search was performed utilizing resources from the library at Vanderbilt University Medical Center, PubMed, EMBASE, BioMed, and Cochrane Reviews. Manual searches of bibliographies of known primary and review articles, and abstracts from scientific meetings within the last 2 years were also reviewed. RESULTS: There is limited evidence on the effectiveness of selective nerve root injections as a diagnostic tool for spinal pain. There is insufficient research for stronger support, but the available literature is supportive of selective nerve root injections as a diagnostic test for equivocal radicular pain. There is moderate evidence for use in the preoperative evaluation of patients with negative or inconclusive imaging studies. The positive predictive value of diagnostic selective nerve root blocks is low, but they have a useful negative predictive value. CONCLUSION: Selective nerve root injections may be helpful as a diagnostic tool in evaluating spinal pain with radicular features. However, their role needs to be further clarified by additional research and consensus.

Frey ME, Manchikanti L, Benyamin RM, Schultz DM, Smith HS, Cohen SP. · Advanced Pain Management and Spine Specialists, Fort Myers, FL 33919, USA. · Pain Physician. · Pubmed #19305486 links to  free full text

Abstract: BACKGROUND: Failed back surgery syndrome is common in the United States. Management of post lumbar surgery syndrome with multiple modalities includes interventional techniques, resulting in moderate improvement, leaving a proportion of patients in intractable pain. The systematic reviews of long-term benefits and risks of spinal cord stimulation (SCS) for patients with failed back surgery syndrome showed limited to moderate evidence and cost effectiveness. However, with the exponential increase in surgery in the United States, spinal cord implants are also increasing. Thus, the discussion continues with claims of lack of evidence on one hand and escalating increases in utilization on the other hand. STUDY DESIGN: A systematic review of SCS in patients with failed back surgery syndrome. OBJECTIVES: This systematic review is undertaken to examine the evidence from randomized controlled trials (RCTs) and observational studies to evaluate the effectiveness of SCS in post lumbar surgery syndrome and to demonstrate clinical and cost effectiveness. METHODS: Review of the literature was performed according to the Cochrane Musculoskeletal Review Group Criteria as utilized for interventional techniques for randomized trials and the Agency for Healthcare Research and Quality (AHRQ) criteria for observational studies. The 5 levels of evidence were classified as Level I, II, or III with 3 subcategories in Level II based on the quality of evidence developed by the U.S. Preventive Services Task Force (USPSTF). Data sources included relevant literature of the English language identified through searches of PubMed and EMBASE from 1966 to December 2008, and manual searches of bibliographies of known primary and review articles. OUTCOME MEASURES: The primary outcome measure was pain relief (short-term relief < or = one-year and long-term > one-year). Secondary outcome measures of improvement in functional status, psychological status, return to work, and reduction in opioid intake were utilized. RESULTS: The indicated evidence is Level II-1 or II-2 for long-term relief in managing patients with failed back surgery syndrome. LIMITATIONS: The limitations of this review included the paucity and heterogeneity of the literature. CONCLUSION: This systematic review evaluating the effectiveness of SCS in relieving chronic intractable pain of failed back surgery syndrome indicated the evidence to be Level II-1 or II-2 for clinical use on a long-term basis.

Manchikanti L, Singh V, Vilims BD, Hansen HC, Schultz DM, Kloth DS. · Pain Management Center of Paducah, 2831 Lone Oak Road, Paducah, KY 42003, USA. · Pain Physician. · Pubmed #16886020 links to  free full text

Abstract: 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.

Manchikanti L, Singh V, Schultz DM. · No affiliation provided · Arch Phys Med Rehabil. · Pubmed #18996254 No free full text.

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