Cannabidiol (CBD) as a treatment of acute and chronic back pain: A case series and literature review.

OBJECTIVE: Two patient case reports are presented describing the use of cannabidiol (CBD) for the symptomatic relief of a lumbar compression fracture and in the mitigation of thoracic discomfort and dysesthesia secondary to a surgically resected meningioma. DISCUSSION: CBD appears to have antisnociceptive and anti-inflammatory effects on opioid-naive patients with neuro-pathic and radicular pain. Of note, the patients in this case series used the same CBD cream: Baskin Essentials Body Wellness Cream (400 mg CBD per two oz.) Conclusion: Hemp-derived CBD in a transdermal cream provided significant symptom and pain relief for the patients described in this case series. Based on these results, we believe further investigation is warranted to see if CBD-containing products should have a more prominent role in the treatment of acute and chronic pain.

Bone Marrow Concentrate (BMC) Therapy in Musculoskeletal Disorders: Evidence-Based Policy Position Statement of American Society of Interventional Pain Physicians (ASIPP).

BACKGROUND: The use of bone marrow concentrate (BMC) for treatment of musculoskeletal disorders has become increasingly popular over the last several years, as technology has improved along with the need for better solutions for these pathologies. The use of cellular tissue raises a number of issues regarding the US Food and Drug Administration's (FDA) regulation in classifying these treatments as a drug versus just autologous tissue transplantation. In the case of BMC in musculoskeletal and spine care, this determination will likely hinge on whether BMC is homologous to the musculoskeletal system and spine. OBJECTIVES: The aim of this review is to describe the current regulatory guidelines set in place by the FDA, specifically the terminology around "minimal manipulation" and "homologous use" within Regulation 21 CFR Part 1271, and specifically how this applies to the use of BMC in interventional musculoskeletal medicine. METHODS: The methodology utilized here is similar to the methodology utilized in preparation of multiple guidelines employing the experience of a panel of experts from various medical specialties and subspecialties from differing regions of the world. The collaborators who developed these position statements have submitted their appropriate disclosures of conflicts of interest. Trustworthy standards were employed in the creation of these position statements. The literature pertaining to BMC, its effectiveness, adverse consequences, FDA regulations, criteria for meeting the standards of minimal manipulation, and homologous use were comprehensively reviewed using a best evidence synthesis of the available and relevant literature. RESULTS/Summary of Evidence: In conjunction with evidence-based medicine principles, the following position statements were developed: Statement 1: Based on a review of the literature in discussing the preparation of BMC using accepted methodologies, there is strong evidence of minimal manipulation in its preparation, and moderate evidence for homologous utility for various musculoskeletal and spinal conditions qualifies for the same surgical exemption. Statement 2: Assessment of clinical effectiveness based on extensive literature shows emerging evidence for multiple musculoskeletal and spinal conditions. • The evidence is highest for knee osteoarthritis with level II evidence based on relevant systematic reviews, randomized controlled trials and nonrandomized studies. There is level III evidence for knee cartilage conditions. • Based on the relevant systematic reviews, randomized trials, and nonrandomized studies, the evidence for disc injections is level III. • Based on the available literature without appropriate systematic reviews or randomized controlled trials, the evidence for all other conditions is level IV or limited for BMC injections. Statement 3: Based on an extensive review of the literature, there is strong evidence for the safety of BMC when performed by trained physicians with the appropriate precautions under image guidance utilizing a sterile technique. Statement 4: Musculoskeletal disorders and spinal disorders with related disability for economic and human toll, despite advancements with a wide array of treatment modalities. Statement 5: The 21st Century Cures Act was enacted in December 2016 with provisions to accelerate the development and translation of promising new therapies into clinical evaluation and use. Statement 6: Development of cell-based therapies is rapidly proliferating in a number of disease areas, including musculoskeletal disorders and spine. With mixed results, these therapies are greatly outpacing the evidence. The reckless publicity with unsubstantiated claims of beneficial outcomes having putative potential, and has led the FDA Federal Trade Commission (FTC) to issue multiple warnings. Thus the US FDA is considering the appropriateness of using various therapies, including BMC, for homologous use. Statement 7: Since the 1980's and the description of mesenchymal stem cells by Caplan et al, (now called medicinal signaling cells), the use of BMC in musculoskeletal and spinal disorders has been increasing in the management of pain and promoting tissue healing. Statement 8: The Public Health Service Act (PHSA) of the FDA requires minimal manipulation under same surgical procedure exemption. Homologous use of BMC in musculoskeletal and spinal disorders is provided by preclinical and clinical evidence. Statement 9: If the FDA does not accept BMC as homologous, then it will require an Investigational New Drug (IND) classification with FDA (351) cellular drug approval for use. Statement 10: This literature review and these position statements establish compliance with the FDA's intent and corroborates its present description of BMC as homologous with same surgical exemption, and exempt from IND, for use of BMC for treatment of musculoskeletal tissues, such as cartilage, bones, ligaments, muscles, tendons, and spinal discs. CONCLUSIONS: Based on the review of all available and pertinent literature, multiple position statements have been developed showing that BMC in musculoskeletal disorders meets the criteria of minimal manipulation and homologous use. KEY WORDS: Cell-based therapies, bone marrow concentrate, mesenchymal stem cells, medicinal signaling cells, Food and Drug Administration, human cells, tissues, and cellular tissue-based products, Public Health Service Act (PHSA), minimal manipulation, homologous use, same surgical procedure exemption.

Needle position analysis in cases of paralysis from transforaminal epidurals: consider alternative approaches to traditional technique.

BACKGROUND: Transforaminal technique for epidural steroid injections, unlike other approaches, is uniquely associated with permanent, bilateral, lower extremity paralysis. OBJECTIVE: To review the literature and analyze the reported cases of paralysis from lumbar transforaminal epidural steroid injections to possibly establish a cause and to prevent this complication. STUDY DESIGN: Eighteen cases of paralysis from transforaminal epidural injection have been reported. We could analyze the position of the needle within the neural foramen based on the available images and/or description among 10 of these 18 cases. Five cases were performed with computed tomography guidance and 12 cases were performed with fluoroscopic guidance [unknown in one case]. Additionally, other variables associated with the procedure, including the technique, were also examined. METHODS: Analysis of the needle position in the neural foramen in cases of paralysis from transforaminal epidural steroid injections. This analysis is based on images and/or description provided in published reports. RESULTS: Paralysis in these cases seems to be associated with a well performed traditional safe triangle approach with good epidural contrast spreads. Analyzed data shows that 77.7% of the time, the needle was in the superior part of the foramen. In 71.4% of the cases, the needle was in the anterior part of the foramen. This coincides with the location of the radicular artery in the foramen. In 22.2%, the needle was in the midzone (neither in the superior nor inferior zone). No level was spared as this event occurred at every foramen from T12 to S1. Ten of these events happened during a left-sided procedure and 8 during a right-sided procedure. No relation to this complication was noted when other variables like type and size of the needles, side of the injection, local anesthetic, contrast, or volume of injectate were taken into consideration. LIMITATIONS: Only 18 cases of paralysis from transforaminal epidurals have been reported. Out of these, only 10 cases included images or descriptions which could be evaluated for our study. CONCLUSION: In light of the anatomical and radiological evidence in the literature that radicular arteries dwell in the superior part of the foramen and along with our needle position analysis, we suggest that the traditional technique of placing the needle in the superior and anterior part of the foramen must be reexamined. Alternative, safer techniques must be considered, one of which is described.

Sacral kyphoplasty for the treatment of painful sacral insufficiency fractures and metastases.

BACKGROUND CONTEXT: Sacral insufficiency fractures and metastases are a source of severe intractable pain, with limited therapeutic options. Sacroplasty has demonstrable efficacy and safety; sacral kyphoplasty, however, is rarely reported. PURPOSE: To evaluate the safety and efficacy of sacral kyphoplasty for sacral insufficiency fractures and metastases. STUDY DESIGN: Retrospective, with long-term follow-up; rural community-based practice. PATIENT SAMPLE: Patients with sacral insufficiency fractures and metastases. OUTCOME MEASURES: Numerical pain rating scale, opioid equivalent usage. SELF-REPORT MEASURE: Numerical pain rating scale. FUNCTIONAL MEASURE: Opioid equivalent consumption. METHODS: Retrospective analysis. RESULTS: Statistically significant improvement in pain; overall, an improvement in opioid consumption. CONCLUSIONS: Sacral kyphoplasty appears to be a safe and efficacious procedure, comparable to sacroplasty, in the treatment of SIFs and sacral metastases.

Sternal kyphoplasty for metastatic lung cancer: image-guided palliative care, utilizing fluoroscopy and sonography.

Skeletal metastases can cause severe pain and functional impairment, secondary to direct invasion or osteolysis. Direct palliation of these metastases can reduce the burden of pain. Surgical excision or radiotherapy has been used to target these tumors. In precarious locations, such as the sternum, surgery may lead to significant morbidity. Radiotherapy requires multiple visits, which may be difficult for the severely disabled. Minimally invasive, image-guided procedures are gaining wider acceptance in treating these lesions. Kyphoplasty has been used for vertebral column metastases. Osteoplasty of a metastasis to a flat, non-weight-bearing bone is rarely reported. The author reports the successful palliation of a sternal metastasis with kyphoplasty. Ultrasound imaging was used with fluoroscopy. Reproducibility, by other providers, is imperative with any emerging technique; this will facilitate wider patient access and device innovation. Hopefully, future multicenter trials will validate the efficacy and safety of this technique.

A systematic review of randomized trials of long-term opioid management for chronic non-cancer pain.

BACKGROUND: Even though opioids have been used for pain for thousands of years, opioid therapy for chronic non-cancer pain is controversial due to concerns regarding the long-term effectiveness and safety, particularly the risk of tolerance, dependance, or abuse. While the debate continues, the use of chronic opioid therapy for chronic non-cancer pain has increased exponentially. Even though evidence is limited, multiple expert panels have concluded that chronic opioid therapy can be effective therapy for carefully selected and monitored patients with chronic non-cancer pain. STUDY DESIGN: A systematic review of randomized trials of opioid management for chronic non-cancer pain. OBJECTIVE: The objective of this systematic review is to evaluate the clinical efficacy of opioids in the treatment of chronic non-cancer pain. METHODS: A comprehensive evaluation of the literature relating to opioids in chronic non-cancer pain was performed. The literature was evaluated according to Cochrane review criteria for randomized controlled trials (RCTs) and Jadad criteria. A literature search was conducted by using PubMed, EMBASE, Cochrane library, ECRI Institute Library, U.S. Food and Drug Administration (FDA) website, U.S. National Guideline Clearinghouse (NGC), Database of Abstracts of Reviews of Effectiveness (DARE), clinical trials, systematic reviews and cross references from systematic reviews. The level of evidence was classified as good, fair, or poor based on the quality of evidence developed by the United States Preventive Services Task Force (USPSTF) and used by other systematic reviews and guidelines. OUTCOME MEASURES: Pain relief was the primary outcome measure. Other outcome measures were functional improvement, withdrawals, and adverse effects. RESULTS: Based on the USPSTF criteria, the indicated level of evidence was fair for Tramadol in managing osteoarthritis. For all the drugs assessed, including Tramadol, for all other conditions, the evidence was poor based on either weak positive evidence, indeterminate evidence, or negative evidence. LIMITATIONS: A paucity of literature, specifically with follow-up beyond 12 weeks for all types of opioids with controlled trials for various chronic non-cancer pain conditions. CONCLUSIONS: This systematic review illustrated fair evidence for Tramadol in managing osteoarthritis with poor evidence for all other drugs and conditions. Thus, recommendations must be based on non-randomized studies.

Monitoring opioid adherence in chronic pain patients: assessment of risk of substance misuse.

BACKGROUND: Use of opioids for chronic non-cancer pain (CNCP) has increased in recent years because this pain had been undertreated. There was also a simultaneous increase in misuse and abuse of opioids. Deaths due to such abuse and misuse also have risen as seen in the many reports published every day in local papers as well as in the medical literature. So, it is imperative that patients who are prescribed these medications be monitored for adherence so misuse and abuse can be curtailed and opioids are available to those who genuinely need them for chronic pain control. There are various screening tools available to monitor such adherence, and there is an abundance of literature about it in addiction and psychiatric medicine. There is, though, a paucity of such literature as applied to pain medicine. OBJECTIVES: Our objectives for this review were twofold. We wanted to identify which screening tools are available to monitor opioid adherence and we wanted to see if there were prospective comparative studies of these tools to identify a single best tool that can be applied to all chronic non-cancer pain patients managed with opioids. STUDY DESIGN: We did a review of the current literature about monitoring of opioid adherence. We also looked at their use, validity, and comparative studies. METHODS: We performed a literature search using PubMed, EMBASE, and the Cochrane library. The search was conducted using the terms opioids, non-cancer pain, monitoring, and adherence. The databases from 1996 to November 2010 were reviewed. The search included prospective and retrospective studies, review articles, and FDA records. Bibliographies and cross references were reviewed when deemed appropriate. CONCLUSION: We found 52 publications, of which 22 met the criteria to be included in this manuscript. We found only one study that was prospective, and compared the various screening tools that are available to monitor opioid adherence. In the majority of the studies the number treated was small. There was not a single screening tool that can be applied universally to all patients who are on opioid therapy for chronic non-cancer pain.

Anticoagulants: newer ones, mechanisms, and perioperative updates.

With a growing number of new anticoagulant/antiplatelet agents being developed, it is likely that an increasing number of patients taking these drugs will present for surgery and other procedures. A familiarity with mechanisms of action and drug interactions helps to maintain optimal patient safety in the perioperative period. Furthermore, it is crucial for anesthesiologists to remain current on recommendations regarding discontinuation or need to continue the newer anticoagulants/antiplatelet drugs in patients presenting for surgery and/or regional anesthesia. Further studies are needed for monitoring of many of these newer agents and to identify antidotes.

Respiratory failure following delayed intrathecal morphine pump refill: a valuable, but costly lesson.

BACKGROUND: Spinal analgesia, mediated by opioid receptors, requires only a fraction of the opioid dose that is needed systemically. By infusing a small amount of opioid into the cerebrospinal fluid in close proximity to the receptor sites in the spinal cord, profound analgesia may be achieved while sparing some of the side effects due to systemic opioids. Intraspinal drug delivery (IDD) has been increasingly used in patients with intractable chronic pain, when these patients have developed untoward side effects with systemic opioid usage. The introduction of intrathecal opioids has been considered one of the most important breakthroughs in pain management in the past three decades. A variety of side effects associated with the long-term usage of IDD have been recognized. Among them, respiratory depression is the most feared. OBJECTIVE: To describe a severe adverse event, i.e., respiratory failure, following delayed intrathecal morphine pump refill. CASE REPORT: A 65-year-old woman with intractable chronic low back pain, due to degenerative disc disease, and was referred to our clinic for an intraspinal drug delivery evaluation, after failing to respond to multidisciplinary pain treatment. Following a psychological evaluation confirming her candidacy, she underwent an outpatient patient-controlled continuous epidural morphine infusion trial. The infusion trial lasted 12 days and was beneficial in controlling her pain. The patient reported more than 90% pain reduction with improved distance for ambulation. She subsequently consented and was scheduled for permanent intrathecal morphine pump implantation. The intrathecal catheter was inserted at right paramedian L3-L4, with catheter tip advanced to L1, confirmed under fluoroscopy. Intrathecal catheter placement was confirmed by positive CSF flow and by myelogram. A non-programmable Codman 3000 constant-flow rate infusion pump was placed in the right mid quandrant between right rib cage and right iliac crest. The intrathecal infusion consisted of preservative free morphine, delivering 1.0 mg /day. Over the following 6 months, the dosage was gradually titrated up to 4 mg/day with satisfactory pain control without significant side effects. However, the patient was not able to return to the clinic for pump refill until 12 days later than the previously scheduled pump-refill date. Her pump was accessed and was noted to be empty. Her intrathecal pump was refilled with preservative free morphine, delivering 4 mg/day (the same daily dose as her previous refill). However, on the night of pump refill, 10 hours after the pump refill, the patient was found to be unresponsive by her family members. 911 was called. Upon arriving, paramedics found her in respiratory failure, with shallow breathing at a rate of 5/min, pulse oxymetry showing oxygen saturation about 55-58%. She was emergently intubated on site and rushed to local hospital ER. The on call physician for our clinic was immediately contacted, and advised the administration of intravenous Naloxone. Her respiratory effort improved dramatically after receiving a total of 0.6 mg IV Naloxone IV over 25 minutes. Her intrathecal pump was immediately accessed by clinic on call physician and the remainder of the medication in the catheter space was aspirated. The pump infusate was immediately diluted with preservative free normal saline, to deliver preservative free morphine at 1mg/day. She was transferred to the intensive care unit and extubated the next morning. She recovered fully without any sequelae. CONCLUSION: Loss of opioid tolerance due to delayed pump refill may subject patients to the development of severe respiratory depression. Meticulous approach should be employed when refilling pumps in these patients when their pumps are completely empty. To our knowledge, this is the first reported case of this type.

Root cause analysis of paraplegia following transforaminal epidural steroid injections: the 'unsafe' triangle.

The utilization rate of transforaminal epidural steroid injections (TFESIs), an elective diagnostic and therapeutic spinal procedure, has risen dramatically over the past decade. In 2006 alone, greater than 300,000 thoracolumbar TFESIs were performed on Medicare beneficiaries. Despite the purported superiority of the transforaminal route, compared to other modes of epidural injection, TFESIs are associated with potential hazards. The artery of Adamkiewicz (ARM) might enter any mid thoracic, lower thoracic, or lumbar foramen; the exact level, in a specific patient, will be unknown to the proceduralist. The authors propose that the "safe triangle" approach to transforaminal epidural injections is not safe (TFESIs). Injury to the ARM can lead to paraplegia, independent of operator skill or adjuvant safety initiatives (digital subtraction angiography, local anesthetic test dose). Injury to the ARM is a "black swan" event. The authors believe that catastrophic injury may be averted when performing TFESIs by avoiding the "un-safe," superoanterior triangle in the foramen and that transforaminal injections should be performed at the inferior aspect of the foramen, known as Kambin's triangle.

Systematic review of cervical discography as a diagnostic test for chronic spinal 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 often 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 cervical discography literature. OBJECTIVE: To evaluate the validity and usefulness of cervical provocation discography in managing and diagnosing discogenic pain by means of a systematic review. METHODS: Following a comprehensive search of the literature, selected studies were subjected to a modified Agency for Healthcare Research and Quality (AHRQ) diagnostic accuracy evaluation. Qualitative analysis was conducted using 5 levels of evidence, ranging from Level I to III with 3 subcategories in Level II. The rating scheme was modified to evaluate the diagnostic accuracy. RESULTS: A systematic review of the literature demonstrated that cervical discography plays a significant role in selecting surgical candidates and improving outcomes, despite concerns regarding the false-positive rate, lack of standardization, and assorted potential confounding factors. Based on the studies utilizing the International Association for the Study of Pain (IASP) criteria, the data show a prevalence rate ranging between 16% and 20%. Based on the 3 studies that utilized IASP criteria during the performance of cervical discography, the evidence derived from studies evaluating the diagnostic validity of the procedure, the indicated level of evidence is Level II-2 based on modified U.S. Preventive Services Task Force (USPSTF) criteria. LIMITATIONS: Limitations include a paucity of literature, poor methodologic quality, and very few studies performed utilizing IASP criteria. CONCLUSION: Cervical discography performed according to the IASP criteria may be a useful tool for evaluating chronic cervical pain, without disc herniation or radiculitis. Based on a modified AHRQ accuracy evaluation and USPSTF level of evidence criteria, this systematic review indicates the strength of evidence as Level II-2 for diagnostic accuracy of cervical discography.

Systematic review of thoracic discography as a diagnostic test for chronic spinal pain.

BACKGROUND: Even though the prevalence of thoracic pain has been reported to be 15% 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 researched. 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. OBJECTIVE: To systematically assess the quality of clinical studies evaluating the diagnostic accuracy of provocation thoracic discography. STUDY DESIGN: A systematic review 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. Studies meeting the Agency for Healthcare Research and Quality (AHRQ) methodologic quality criteria with scores of 50 or higher were included for the assessment of the level of evidence. Level of evidence was based on the United States Preventive Services Task Force (USPSTF) criteria for the assessment of accuracy of diagnostic studies. Based on the level of evidence, recommendations were made according to Guyatt et al's criteria. RESULTS: The clinical value of thoracic provocation discography is limited (Level II-3) with 2C/weak recommendation derived from low quality or very low quality evidence indicating that other alternatives may be equally reasonable. CONCLUSION: Based on the available evidence for this systematic review, thoracic provocation discography is provided with a weak recommendation for the diagnosis of discogenic pain in the thoracic spine, if conservative management has failed. This is qualified by the need to appropriately evaluate and diagnose other causes of chronic thoracic pain including pain originating from thoracic facet joints.

Bleeding risk and interventional pain management.

PURPOSE OF REVIEW: Interventional pain management is an emerging specialty that uses procedures to diagnose and treat chronic pain. Most of these procedures are performed percutaneously and carry a risk of bleeding. Patients undergoing these treatments may be receiving exogenous anticoagulants. The pain practitioner faces a dilemma in performing an elective procedure on a patient with a bleeding risk. RECENT FINDINGS: A literature review about coagulation physiology and pathophysiology, anticoagulants, and bleeding complications in interventional pain would be useful to a busy pain physician. This review aims to meet this knowledge goal. SUMMARY: Knowledge about normal and impaired hemostasis, coupled with a bleeding risk tool, enables practitioners to make informed decisions when offering interventional pain care to their patients.