David Kloth

Bio: David Kloth is an academic researcher from Danbury Hospital. The author has contributed to research in topics: Chronic pain & Radicular pain. The author has an hindex of 14, co-authored 24 publications receiving 2382 citations. Previous affiliations of David Kloth include American Society of Interventional Pain Physicians & Yale University.

Interventional Techniques: Evidence-based Practice Guidelines in the Management of Chronic Spinal Pain

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.

American Society of Interventional Pain Physicians (ASIPP) Guidelines for Responsible Opioid Prescribing in Chronic Non-Cancer Pain: Part 2 - Guidance

Abstract: RESULTS: Part 2 of the guidelines on responsible opioid prescribing provides the following recommendations for initiating and maintaining chronic opioid therapy of 90 days or longer. 1. A) Comprehensive assessment and documentation is recommended before initiating opioid therapy, including documentation of comprehensive history, general medical condition, psychosocial history, psychiatric status, and substance use history. (Evidence: good) B) Despite limited evidence for reliability and accuracy, screening for opioid use is recommended, as it will identify opioid abusers and reduce opioid abuse. (Evidence: limited) C) Prescription monitoring programs must be implemented, as they provide data on patterns of prescription usage, reduce prescription drug abuse or doctor shopping. (Evidence: good to fair) D) Urine drug testing (UDT) must be implemented from initiation along with subsequent adherence monitoring to decrease prescription drug abuse or illicit drug use when patients are in chronic pain management therapy. (Evidence: good) 2. A) Establish appropriate physical diagnosis and psychological diagnosis if available prior to initiating opioid therapy. (Evidence: good) B) Caution must be exercised in ordering various imaging and other evaluations, interpretation and communication with the patient, to avoid increased fear, activity restriction, requests for increased opioids, and maladaptive behaviors. (Evidence: good) C) Stratify patients into one of the 3 risk categories - low, medium, or high risk. D) A pain management consultation, may assist non-pain physicians, if high-dose opioid therapy is utilized. (Evidence: fair) 3. Essential to establish medical necessity prior to initiation or maintenance of opioid therapy. (Evidence: good) 4. Establish treatment goals of opioid therapy with regard to pain relief and improvement in function. (Evidence: good) 5. A) Long-acting opioids in high doses are recommended only in specific circumstances with severe intractable pain that is not amenable to short-acting or moderate doses of long-acting opioids, as there is no significant difference between long-acting and short-acting opioids for their effectiveness or adverse effects. (Evidence: fair) B) The relative and absolute contraindications to opioid use in chronic non-cancer pain must be evaluated including respiratory instability, acute psychiatric instability, uncontrolled suicide risk, active or history of alcohol or substance abuse, confirmed allergy to opioid agents, coadministration of drugs capable of inducing life-limiting drug interaction, concomitant use of benzodiazepines, active diversion of controlled substances, and concomitant use of heavy doses of central nervous system depressants. (Evidence: fair to limited) 6. A robust agreement which is followed by all parties is essential in initiating and maintaining opioid therapy as such agreements reduce overuse, misuse, abuse, and diversion. (Evidence: fair) 7. A) Once medical necessity is established, opioid therapy may be initiated with low doses and short-acting drugs with appropriate monitoring to provide effective relief and avoid side effects. (Evidence: fair for short-term effectiveness, limited for long-term effectiveness) B) Up to 40 mg of morphine equivalent is considered as low dose, 41 to 90 mg of morphine equivalent as a moderate dose, and greater than 91 mg of morphine equivalence as high dose. (Evidence: fair) C) In reference to long-acting opioids, titration must be carried out with caution and overdose and misuse must be avoided. (Evidence: good) 8. A) Methadone is recommended for use in late stages after failure of other opioid therapy and only by clinicians with specific training in the risks and uses. (Evidence: limited) B) Monitoring recommendation for methadone prescription is that an electrocardiogram should be obtained prior to initiation, at 30 days and yearly thereafter. (Evidence: fair) 9. In order to reduce prescription drug abuse and doctor shopping, adherence monitoring by UDT and PMDPs provide evidence that is essential to the identification of those patients who are non-compliant or abusing prescription drugs or illicit drugs. (Evidence: fair) 10. Constipation must be closely monitored and a bowel regimen be initiated as soon as deemed necessary. (Evidence: good) 11. Chronic opioid therapy may be continued, with continuous adherence monitoring, in well-selected populations, in conjunction with or after failure of other modalities of treatments with improvement in physical and functional status and minimal adverse effects. (Evidence: fair) DISCLAIMER: The guidelines are based on the best available evidence and do not constitute inflexible treatment recommendations. Due to the changing body of evidence, this document is not intended to be a "standard of care." Language: en

The Appropriate Use of Neurostimulation of the Spinal Cord and Peripheral Nervous System for the Treatment of Chronic Pain and Ischemic Diseases: The Neuromodulation Appropriateness Consensus Committee

Abstract: 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.

Safeguards to prevent neurologic complications after epidural steroid injections: consensus opinions from a multidisciplinary working group and national organizations.

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 injectionsMetho

Evidence-Based Practice Guidelines for Interventional Techniques in the Management of Chronic Spinal Pain

Abstract: 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."

Tools for assessing quality and susceptibility to bias in observational studies in epidemiology: a systematic review and annotated bibliography

Abstract: Background Assessing quality and susceptibility to bias is essential when interpreting primary research and conducting systematic reviews and meta-analyses. Tools for assessing quality in clinical trials are well-described but much less attention has been given to similar tools for observational epidemiological studies. Methods Tools were identified from a search of three electronic databases, bibliographies and an Internet search using Google. Two reviewers extracted data using a pre-piloted extraction form and strict inclusion criteria. Tool content was evaluated for domains potentially related to bias and was informed by the STROBE guidelines for reporting observational epidemiological studies. Results A total of 86 tools were reviewed, comprising 41 simple checklists, 12 checklists with additional summary judgements and 33 scales. The number of items ranged from 3 to 36 (mean 13.7). One-third of tools were designed for single use in a specific review and one-third for critical appraisal. Half of the tools provided development details, although most were proposed for future use in other contexts. Most tools included items for selection methods (92%), measurement of study variables (86%), design-specific sources of bias (86%), control of confounding (78%) and use of statistics (78%); only 4% addressed conflict of interest. The distribution and weighting of domains across tools was variable and inconsistent. Conclusion A number of useful assessment tools have been identified by this report. Tools should be rigorously developed, evidence-based, valid, reliable and easy to use. There is a need to agree on critical elements for assessing susceptibility to bias in observational epidemiology and to develop appropriate evaluation tools.

Neuropathic pain: quality-of-life impact, costs and cost effectiveness of therapy.

Abstract: A number of different diseases or injuries can damage the central or peripheral nervous system and produce neuropathic pain (NP), which seems to be more difficult to treat than many other types of chronic pain. As a group, patients with NP have greater medical co-morbidity burden than age- and sex-adjusted controls, which makes determining the humanistic and economic burden attributable to NP challenging. Health-related quality of life (HR-QOL) is substantially impaired among patients with NP. Patients describe pain-related interference in multiple HR-QOL and functional domains, as well as reduced ability to work and reduced mobility due to their pain. In addition, the spouses of NP patients have been shown to experience adverse social consequences related to NP. In randomized controlled trials, several medications have been shown to improve various measures of HR-QOL. Changes in HR-QOL appear to be tightly linked to pain relief, but not to the development of adverse effects. However, in cross-sectional studies, many patients continue to have moderate or severe pain and markedly impaired HR-QOL, despite taking medications prescribed for NP. The quality of NP treatment appears to be poor, with few patients receiving recommended medications in efficacious dosages. The substantial costs to society of NP derive from direct medical costs, loss of the ability to work, loss of caregivers' ability to work and possibly greater need for institutionalization or other living assistance. No single study has measured all of these costs to society for chronic NP. The cost effectiveness of various interventions for the treatment or prevention of different types of NP has been assessed in several different studies. The most-studied diseases are post-herpetic neuralgia and painful diabetic neuropathy, for which tricyclic antidepressants (both amitriptyline and desipramine) have been found to be either cost effective or dominant relative to other strategies. Increasing the use of cost-effective therapies such as tricyclic antidepressants for post-herpetic neuralgia and painful diabetic neuropathy may improve the HR-QOL of patients and decrease societal costs. Head-to-head clinical trials comparing NP therapies are needed to help assess the relative clinical efficacy of treatments, ideally using HR-QOL and utility outcomes. The full costs to society of NP, including productivity loss costs, have not been determined for chronic NP. Improved relative efficacy, utility and cost estimates would facilitate future cost-effectiveness research in NP.

Comprehensive review of epidemiology, scope, and impact of spinal pain.

Abstract: Persistent pain interfering with daily activities is common. Chronic pain has been defined in many ways. Chronic pain syndrome is a separate entity from chronic pain. Chronic pain is defined as, "pain that persists 6 months after an injury and beyond the usual course of an acute disease or a reasonable time for a comparable injury to heal, that is associated with chronic pathologic processes that cause continuous or intermittent pain for months or years, that may continue in the presence or absence of demonstrable pathologies; may not be amenable to routine pain control methods; and healing may never occur." In contrast, chronic pain syndrome has been defined as a complex condition with physical, psychological, emotional, and social components. The prevalence of chronic pain in the adult population ranges from 2% to 40%, with a median point prevalence of 15%. Among chronic pain disorders, pain arising from various structures of the spine constitutes the majority of the problems. The lifetime prevalence of spinal pain has been reported as 54% to 80%. Studies of the prevalence of low back pain and neck pain and its impact in general have shown 23% of patients reporting Grade II to IV low back pain (high pain intensity with disability) versus 15% with neck pain. Further, age related prevalence of persistent pain appears to be much more common in the elderly associated with functional limitations and difficulty in performing daily life activities. Chronic persistent low back and neck pain is seen in 25% to 60% of patients, one-year or longer after the initial episode. Spinal pain is associated with significant economic, societal, and health impact. Estimates and patterns of productivity losses and direct health care expenditures among individuals with back and neck pain in the United States continue to escalate. Recent studies have shown significant increases in the prevalence of various pain problems including low back pain. Frequent use of opioids in managing chronic non-cancer pain has been a major issue for health care in the United States placing a significant strain on the economy with the majority of patients receiving opioids for chronic pain necessitating an increased production of opioids, and escalating costs of opioid use, even with normal intake. The additional costs of misuse, abuse, and addiction are enormous. Comorbidities including psychological and physical conditions and numerous other risk factors are common in spinal pain and add significant complexities to the interventionalist's clinical task. This section of the American Society of Interventional Pain Physicians (ASIPP)/Evidence-Based Medicine (EBM) guidelines evaluates the epidemiology, scope, and impact of spinal pain and its relevance to health care interventions.

Interventional Techniques: Evidence-based Practice Guidelines in the Management of Chronic Spinal Pain

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.