bluuebunny/crossref_metadata_2025 huggingface dataset:
A Systematic Review of Randomized Trials of
Long-Term Opioid Management for Chronic
Non-Cancer Pain
Authors: Manchikanti Laxmaiah
Published: March 2021

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 noncancer 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.
Key words: Chronic non-cancer pain, opioids, opioid efficacy, opioid effectiveness, significant
pain relief, functional improvement, adverse effects, morphine, hydrocodone, hydromorphone,
fentanyl, tramadol, buprenorphine, methadone, tapentadol, oxycodone, oxymorphone, systematic
reviews, randomized trials
Breakthrough Pain in Chronic Non-Cancer Pain:
Fact, Fiction, or Abuse
Authors: Manchikanti Laxmaiah
Published: March 2021

Treatment of chronic non-cancer pain with opioid therapy has escalated in recent years,
resulting in exploding therapeutic use and misuse of prescription opioids and multiple
adverse drug events. Breakthrough pain is defined as a transient exacerbation of pain
experienced by individuals who have relatively stable and adequately controlled baseline
cancer pain. Further, the definition of breakthrough pain, prevalence, characteristics,
implications, and treatment modalities have been extensively described for chronic
cancer pain. However, the literature for breakthrough pain in chronic non-cancer pain
including its terminology, prevalence, relevance, characteristics, and treatments, have
been poorly described and continue to be debated.
The philosophy of breakthrough pain in chronic non-cancer pain raises multiple
issues leading almost all patients to be on high dose long-acting opioids, followed by
supplementing with short-acting drugs, instead of treating the patients with only shortacting drugs as required. Consequently, the subject of breakthrough pain in chronic
non-cancer pain is looked at with suspicion due to the lack of evidence and inherent bias
associated with its evaluation, followed by escalating use and abuse of opioids.
Multiple issues related to the concept of breakthrough pain in chronic non-cancer
pain evolve around extensive use, overuse, misuse, and abuse of opioids. In the era of
eliminating opioids or significantly curtailing their use to only appropriate indications, the
concept of breakthrough pain raises multiple questions without any scientific evidence.
This review illustrates that there is no significant evidence for any type of breakthrough
pain in chronic non-cancer pain based on available literature, methodology utilized, and
response to opioids in chronic non-cancer pain. The advocacy for increased usage of
opioids in the treatment of chronic pain dates back to the liberalization of laws governing
opioid prescription for the treatment of chronic non-cancer pain by state medical boards
in the late 1990s, and is exploding with new pain management standards for inpatient
and outpatient medical care implemented by the Joint Commission on Accreditation
of Health Care Organizations in 2000, and the advocacy by many physicians and
organizations for increased use of opioids.
This comprehensive review critically evaluates the available evidence of breakthrough
pain in chronic non-cancer pain including its existence, prevalence, and managing
symptoms which are described as breakthrough pain or episodic pain.
Key words: Breakthrough pain, opioids, chronic non-cancer pain, opioid abuse, opioid
misuse, addiction, opioid hyperalgesia, interventional techniques
Effectiveness of Long-Term Opioid Therapy for
Chronic Non-Cancer Pain
Authors: Manchikanti Laxmaiah
Published: March 2021

Background: Opioids have been utilized for thousands of years to treat pain and their use
continues to escalate. It is estimated that 90% of the patients who present to pain centers and
receive treatment in such facilities are on opioids. However, in contrast to increasing opioid
use and the lack of evidence supporting long-term effectiveness in chronic non-cancer pain,
is the escalating misuse of prescription opioids, including abuse and diversion. There is also
uncertainty about the incidence and clinical salience of multiple, poorly characterized adverse
drug events, including endocrine dysfunction, immunosuppression, infectious disease, opioidinduced hyperalgesia, overdoses, deaths, and psychosocial and economic implications.
Study Design: A comprehensive review of the literature.
Objective: The objective of this comprehensive review is to evaluate the clinical effectiveness
and safety of chronic opioid therapy in chronic non-cancer pain.
Methods: A comprehensive review of the literature relating to chronic opioid therapy
in chronic non-cancer pain. The literature was collected from various electronic and other
sources. The literature that was evaluated included randomized trials, observational studies,
case reports, systematic reviews, and guidelines.
Outcome Measures: Pain relief was the primary outcome measure. The secondary outcome
measures were functional improvement and adverse effects. Short-term effectiveness was
considered to be less than 6 months; long-term effectiveness was considered to be at least
one year.
Results: Given the complexity and widespread nature of opioid therapy, there is a paucity
of qualitative and/or quantitative literature. The available evidence is weak for pain relief
combined with improvement in functional status. Only one drug, tramadol, is effective for
pain relief and improvement of functional status.
Limitations: This is a narrative review without application of methodologic quality
assessment criteria. Even so, a paucity of literature exists concerning both controlled and
observational literature for multiple drugs and multiple conditions of chronic non-cancer
pain.
Conclusions: This comprehensive review illustrates the lack of literature on long-term
opioid therapy; thus, opioid therapy should be provided with great restraint and caution,
based on the weak evidence available.
Key words: Chronic non-cancer pain, opioids, opioid effectiveness, adverse effects,
morphine, hydrocodone, hydromorphone, fentanyl, tramadol, methadone, oxycodone
The Independent Payment Advisory Board
Authors: Manchikanti Laxmaiah
Published: March 2021

The Independent Payment Advisory Board (IPAB) is a vastly powerful component of the
president’s health care reform law, with authority to issue recommendations to reduce the
growth in Medicare spending, providing recommendations to be considered by Congress
and implemented by the administration on a fast track basis. Ever since its inception, IPAB
has been one of the most controversial issues of the Patient Protection and Affordable
Care Act (ACA), even though the powers of IPAB are restricted and multiple sectors of
health care have been protected in the law.
IPAB works by recommending policies to Congress to help Medicare provide better care
at a lower cost, which would include ideas on coordinating care, getting rid of waste in
the system, providing incentives for best practices, and prioritizing primary care. Congress
then has the power to accept or reject these recommendations. However, Congress faces
extreme limitations, either to enact policies that achieve equivalent savings, or let the
Secretary of Health and Human Services (HHS) follow IPAB’s recommendations. IPAB has
strong supporters and opponents, leading to arguments in favor of or against to the
extreme of introducing legislation to repeal IPAB.
The origins of IPAB are found in the ideology of the National Institute for Health and
Clinical Excellence (NICE) and the impetus of exploring health care costs, even though
IPAB’s authority seems to be limited to Medicare only. The structure and operation of IPAB
differs from the Medicare Payment Advisory Commission (MedPAC) and has been called
“MedPAC on steroids”. The board membership consists of 15 full-time members appointed
by the president and confirmed by the Senate with options for recess appointments.
The IPAB statute sets target growth rates for Medicare spending. The applicable percent
for maximum savings appears to be 0.5% for year 2015, 1% for 2016, 1.25% for 2017,
and 1.5% for 2018 and later. The IPAB Medicare proposal process involves mandatory
recommendations and advisory recommendations with multiple reporting requirements.
However, although IPAB has been described as having limited authority, some believe that
it has unlimited authority due to the lack of judicial review and the requirement of twothirds of the Congress to override any recommendations by IPAB.
Key Words: Independent Payment Advisory Board (IPAB), Patient-Centered Outcomes
Research Institute (PCORI), Congressional Budget Office (CBO), National Institute for
Health and Clinical Excellence (NICE), Patient Protection and Affordable Care Act (ACA),
interventional pain management, interventional techniques.
Pharmacology of Opioids in the Treatment of
Chronic Pain Syndromes
Authors: Vallejo Ricardo
Published: March 2021

The perpetual pursuit of pain elimination has been constant throughout human
history and pervades human cultures. In some ways it is as old as medicine
itself. Cultures throughout history have practiced the art of pain management
through remedies such as oral ingestion of herbs or techniques believed to
have special properties. In fact, even Hippocrates wrote about the practice of
trepanation, the cutting of holes in the body to release pain. Current therapies
for management of pain include the pervasive utilization of opioids, which
have an extensive history, spanning centuries.
There is general agreement about the appropriateness of opioids for the
treatment of acute and cancer pain, but the long-term use of these drugs for
treatment of chronic non-malignant pain remains controversial. The pros and
cons regarding these issues are beyond the scope of this review. Instead, the
purpose of this review will be directed towards the pharmacology of commonly
prescribed opioids in the treatment of various chronic pain syndromes.
Opium, derived from the Greek word for “juice,” is extracted from the latex
sap of the opium poppy (Papaverum somniferum). The juice of the poppy is
the source of some 20 different alkaloids of opium. These alkaloids of opioids
can be divided into 2 chemical classes: phenanthrenes (morphine, codeine,
and thebaine) and benzylisoquinolines (agents that do not interact with opioid
receptors).
Key words: Opioid metabolism, opioid interactions, morphine, codeine,
hydrocodone, oxycodone, hydromorphone, methadone, intractable pain,
endorphins, enkephalins, dynorphins, narcotics, pharmacology, propoxyphene,
fentanyl, oxymorphone, tramadol
Opioid Abuse in Cancer Pain: Report of Two
Cases and Presentation of an Algorithm of
Multidisciplinary Care
Authors: Koyyalagunta Lakshmi
Published: March 2021

Background: The growing awareness of opioid abuse and addiction in the chronic
pain population, along with increasing cancer survivorship, has heightened our
awareness of this potential problem in the cancer patient. An increasing number of
patients who abuse opioids have been identified in our clinical setting.
Objective: We present an algorithm of multidisciplinary care for the treatment of
cancer patients at risk for abusing opioids.
Setting: Two illustrative patient examples were identified recently from our clinic.
Results: These 2 patient examples demonstrate our multidisciplinary approach to
treatment. A discussion of safe prescribing principles adapted from the literature is
presented. Also, a brief point of added complexity is introduced; specifically, ethical
considerations due to the unique nature of cancer pain.
Limitations: Although validation studies exist for the use of screening tools in
patients with chronic noncancer pain, there have been no instrument validation
studies on patients with cancer pain. The educational treatment model that we refer
to regarding facilitating safe use of opioids also has not been studied on patients with
cancer pain. Lastly, we express caution in generalizing our guidelines to patients with
noncancer pain. Our patient population differs in the multiple co-existing stressors
and symptom burden associated with cancer.
Conclusions: We have become increasingly aware of the problem of opioid abuse
in the cancer pain population. With an approach to using safe prescribing principles
adapted from chronic pain literature, and an ethically based multidisciplinary
approach, clinicians can continue to treat pain successfully in the opioid-misusing
cancer patient. We outline our approach in this article.
Key words: opioids, opioid abuse and addiction, substance abuse and addiction,
multidisciplinary care
The Effect of Epidural Resiniferatoxin in the
Neuropathic Pain Rat Model
Authors: Lee Mi Kyoung
Published: March 2021

Background: Resiniferatoxin (RTX) is a potent synthetic agonist for transient receptor
potential vanilloid subtype 1 (TRPV1), which has a selectivity for antinociception. The
analgesic effect of epidural RTX in a rat model of neuropathic pain has not yet been
studied.
Objectives: The purpose of this study was to evaluate the analgesic effect of epidural
RTX on neuropathic pain in a rat model to mechanical and thermal stimulation. The
dose-related behavior changes and side effects were also studied.
Study design: A randomized, experimental trial.
Setting: Department of Anesthesiology and Pain Medicine, Korea University Guro
Hospital
Methods: A spinal nerve ligation model was prepared using male Sprague-Dawley
rats (7 weeks old, weight 230-250 g). An epidural catheter was placed at the L4-L5
level. Each study group (n = 6) received a different dose of RTX: 100 ng, 500 ng, 1
µg, 2 µg, 4 µg and 10 µg. All substances were administered in 20 µL volume doses.
The control group (n = 6) received 20 µL of normal saline. We evaluated the response
to mechanical and thermal stimuli as well as the sedation score at both short-term (3
hours) and long-term (20 days) after the epidural RTX injection.
Results: Prolonged analgesia to thermal stimulation was preceded by a transient
dose-dependent hyperalgesia (500 ng, 1 µg) or sedation (≥ 2 µg) during the initial 60
minutes after RTX administration. Marked sedation and hyperventilation were noted at
higher doses (≥ 2 µg), while 2 out of 6 rats died with a 10 µg dose. ED50 for epidural
RTX was 265 ng (95% confidence interval 216.1–324.9 ng). The increased latency
to thermal stimulation continued for 20 days at RTX ≥ 1 µg. But the threshold to
mechanical stimulation increased only in the acute period and returned to the baseline
after 3-5 days, regardless of the administered dose.
Limitations: A histological examination by electron-microscopic staining was not
performed. The observation period was not very long (20 days).
Conclusion: RTX has potential to be used in an epidural route for neuropathic pain
in a rat model with a relatively small amount, which produces transitory improvement
of mechanical hypersensitivity and prolonged thermal analgesic response.
Key words: Epidural administration, mechanical allodynia, mechanical hypersensitivity,
resiniferatoxin, sedation, spinal nerve ligation rat model, thermal hyperalgesia.
Study of Percutaneous Lumbar Decompression
and Treatment Algorithm for Patients Suffering
from Neurogenic Claudication
Authors: Deer Timothy R.
Published: March 2021

Background: Symptomatic lumbar spinal stenosis (LSS) patients often suffer from multiple etiologies,
and patient symptoms must be differentiated and identified as either neurogenic claudication, radicular
pain, or both. The most common symptom associated with LSS is neurogenic claudication, which has been
reported to occur in 91% to 100% of the LSS patient population. Neurogenic claudication symptoms are
described as pain radiating to the lower extremities that begins and worsens as the patient ambulates.
Neurogenic claudication symptoms worsen over time and can eventually result in significant life-altering
functional limitations. Symptomatic LSS patients may also suffer from radicular pain, which is a persistent
pain transmitted through neural pathways, and is associated with inflammation of the exiting nerve root.
Objective: To assess patient safety, pain reduction, and functional status of patients treated with
percutaneous lumbar decompression.
Study Design: Single-center, prospective clinical study of 46 consecutive patients with neurogenic
claudication symptoms related to lumbar spinal stenosis.
Setting: US interventional pain management practice.
Methods: From March 2010 to January 2011, 46 LSS patients suffering from neurogenic claudication
underwent mild percutaneous lumbar decompression. Of these, 12-week, 6-month and one-year followup was available for 35 patients.
Outcome Assessment: Visual Analog Scale (VAS), Oswestry Disability Index (ODI), and Zurich
Claudication Questionnaire (ZCQ). Outcomes were assessed at baseline, 12-week, 6-month and one-year
follow-up.
Results: One-year follow-up patients in this study experienced statistically and clinically significant
improvement in physical function, as well as reduction of pain intensity. The initial improvement in these
patients, which was significant, was sustained through one year, with no significant differences among
the interim follow-up visit periods. These results demonstrate early improvement following treatment with
a high degree of durability over time. There were no serious device or procedure-related complications
reported in this study.
Limitations: Single-center study with no control group.
Conclusions: In this study, the mild procedure was shown to be safe. In addition, patients experienced
significant improvement in mobility and reduction of pain one year after the procedure. One-year
outcomes were not significantly different from interim results, indicating that the significant improvement
following treatment, occurring as early as 12 weeks, was maintained through one year. This high degree
of consistency over time indicates the durability of percutaneous lumbar decompression in the treatment
of neurogenic claudication in symptomatic LSS.
Key words: Spine, lumbar, lumbar spinal stenosis, neurogenic claudication, decompression, ligamentum
flavum, mild, percutaneous.
A Systematic Evaluation of Thoracic
Interlaminar Epidural Injections
Authors: Benyamin Ramsin M.
Published: March 2021

Background: There is a paucity of literature on the use of epidural injections for the treatment
of chronic mid and upper back pain due to disc herniation and radiculitis, axial or discogenic pain,
spinal stenosis, post surgery syndrome, and post thoracotomy pain syndrome.
Study Design: A systematic review of therapeutic thoracic epidural injection therapy for chronic
mid and upper back pain.
Objective: The objective of this systematic review is to determine the effects of thoracic
interlaminar epidural injections with or without steroids, with or without fluoroscopy, and for
various conditions including disc herniation and radiculitis, axial or discogenic pain, spinal stenosis,
post thoracic surgery syndrome, and post thoracotomy pain syndrome.
Methods: The available literature on thoracic interlaminar epidural injections with or without
steroids in managing various types of chronic mid and upper 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, or 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 March 2012, and manual searches of the bibliographies of known primary and
review articles.
Outcome Measures: The primary outcome measure was pain relief (short-term relief = up
to 6 months and long-term > 6 months). Secondary outcome measures were improvement in
functional status, psychological status, return to work, and reduction in opioid intake.
Results: For this review, 17 studies were identified, including studies examining adverse reactions.
Only 2 studies were included: one randomized trial and one non-randomized or observational
study.
The results of this systematic review evaluating the effectiveness of thoracic epidural injections
with or without steroids in managing chronic thoracic pain shows fair evidence with one
randomized trial in patients with various causes; whereas the evidence is limited based on one
non-randomized study evaluating chronic pain in post thoracotomy syndrome.
Limitations: The limitations of this study include paucity of evidence.
Conclusion: The evidence based on this systematic review for thoracic epidural injection in
treating chronic thoracic pain is considered fair and limited for post thoracotomy pain.
Key words: Spinal pain, chronic mid back pain, chronic upper back pain, post-thoracotomy pain,
thoracic epidural injection, radiculopathy, herniation, steroids, local anesthetic, epidural steroid
Obamacare 2012: Prognosis Unclear for
Interventional Pain Management
Authors: Manchikanti Laxmaiah
Published: March 2021

The Patient Protection and Affordable Care Act (ACA), informally referred to as
ObamaCare, is a United States federal statute signed into law by President Barack
Obama on March 23, 2010. ACA has substantially changed the landscape of medical
practice in the United States and continues to influence all sectors, in particular evolving
specialties such as interventional pain management. ObamaCare has been signed into
law amidst major political fallouts, has sustained a Supreme Court challenge and
emerged bruised, but still very much alive. While proponents argue that ObamaCare
will provide insurance for almost everyone, with an improvement in the quality of and
reduction in the cost of health care, opponents criticize it as being a massive bureaucracy
laden with penalties and taxes, that will ultimately eliminate personal medicine and
individual practices.
Based on the 2 years since the passage of ACA in 2010, the prognosis for interventional
pain management is unclear. The damage sustained to interventional pain management
and the majority of medicine practices is irreparable. ObamaCare may provide insurance
for all, but with cuts in Medicare to fund ObamaCare, a limited expansion of Medicaid,
the inadequate funding of exchanges, declining employer health insurance coverage
and skyrocketing disability claims, the coverage will be practically nonexistent.
ObamaCare is composed of numerous organizations and bureaucracies charged with
controlling the practice of medicine through the extension of regulations. Apart from
cutting reimbursements and reducing access to interventional pain management,
administration officials are determined to increase the role of midlevel practitioners and
reduce the role of individual physicians by liberalizing the scope of practice regulations
and introducing proposals to reduce medical education and training.
Key words: Patient Protection and Affordable Care Act, ObamaCare, interventional
pain management, Patient-Centered Outcomes Research Institute, Independent
Payment Advisory Board, Centers for Medicare and Medicaid Services, Accountable
Care Organizations, Medicare, Medicaid
Pain in Patients with Chronic Fatigue
Syndrome: Time for Specific Pain Treatment?
Authors: Nijs Jo
Published: March 2021

Background: Besides chronic fatigue, patients with chronic fatigue syndrome (CFS) have
debilitating widespread pain. Yet pain from CFS is often ignored by clinicians and researchers.
Objectives: To examine whether pain is a unique feature of CFS, or does it share the same
underlying mechanisms as other CFS symptoms? Second, it is examined whether effective
treatments for pain from CFS are currently available.
Study Design: Narrative review covering the scientific literature up through December 2011.
Setting: Several universities.
Results: From the available literature, it is concluded that musculoskeletal factors are unlikely
to account for pain from CFS. Pain seems to be one out of many symptoms related to central
sensitization from CFS. This idea is supported by the findings of generalized hyperalgesia (including
widespread increased responsiveness to painful stimuli) and dysfunctional endogenous analgesia
in response to noxious thermal stimuli. Pain catastrophizing and depression partly account for
pain from CFS. Pain increases during exercise is probably due to the lack of endogenous analgesia
and activation of several genes in response to exercise in CFS. There is currently no evidence in
support for the efficacy of complementary medicine in the treatment of pain from CFS. Intensive
education about the biology of pain from CFS (within the framework of central sensitization)
has positive short-term effects for patients with CFS, and fatigue-targeting cognitive behavioral
therapy appears to be effective for pain from CFS as well.
Limitations: The role of the deficient hypothalamus-pituitary-adrenal axis in relation to pain
from CFS, as well as the interactions with immune (dys)functioning require further study.
Conclusion: Recent research has increased our understanding of pain from CFS, including
its treatment. It is advocated to optimize current CFS treatment protocols by targeting the
underlying mechanism for those patients having severe pain.
Key words: Chronic pain, chronic fatigue syndrome, fibromyalgia, central sensitization,
catastrophizing, exercise, cognitive behavioral therapy.
Tissue Distribution of Clonidine Following
Intraforaminal Implantation of Biodegradable
Pellets: Potential Alternative to Epidural
Steroid for Radiculopathy
Authors: McKay William F.
Published: March 2021

Background: Epidural steroid injections have shown efficacy in short-term pain relief, but often
require repeated injections in order to provide continued pain relief. It has been suggested that a
continuous, locally administered dose of an anti-inflammatory compound may provide sustained
pain relief at doses lower than those needed with injections.
Objective: To evaluate the distribution of clonidine after transforaminal placement of a
biodegradable drug delivery depot system.
Study Design: A preclinical animal study.
Methods: A biodegradable polymer drug depot designed to provide sustained delivery of
clonidine was placed in or near a single lumbar neural foramen in 12 farm pigs. Clonidine
tissue concentrations were measured at the implant site and at incremental distances from the
implant over a time period of 12 weeks. Plasma clonidine levels were measured at 4 hours
postimplantation on days 1, 2, 3, 5, and 7, and then weekly until the termination of the study.
Results: Clonidine was detectable up to 6 cm away from the drug depot. The highest
concentrations of clonidine were present within the targeted spinal nerve; the concentration
decreased with increasing distance from the depot. Clonidine was undetectable in plasma from
all animals at all time points.
Limitations: While clonidine was detected up to 6 cm from the drug depot, it is unknown if
the drug concentration has clinical relevance.
Conclusions: The results indicate that a biodegradable depot designed to be placed in a specific
location to provide local sustained release of an anti-inflammatory and analgesic drug may be a
feasible new approach to treat radicular pain associated with intervertebral disc pathology and
other spinal conditions.
Key Words: clonidine, radiculopathy, pain, intraforaminal, injection, spine, sciatica
An Update of the Effectiveness of Therapeutic
Lumbar Facet Joint Interventions
Authors: Falco Frank J.E.
Published: March 2021

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.
Key Words: Spinal pain, chronic low back pain, lumbar intraarticular facet joint blocks, lumbar
facet joint nerve blocks, lumbar conventional radiofrequency neurotomy, pulsed radiofrequency
neurolysis
Utilization of Interventional Techniques
in Managing Chronic Pain in the Medicare
Population: Analysis of Growth Patterns from
2000 to 2011
Authors: Manchikanti Laxmaiah
Published: March 2021

Background: Reports from the United States Government Accountability Office (GAO), the
Institute of Medicine (IOM), the Medicare Payment Advisory Commission (MedPAC), and the
Office of Inspector General (OIG) continue to express significant concern with the overall fiscal
sustainability of Medicare and the exponential increase in costs for chronic pain management.
Study Design: The study is an analysis of the growth of interventional techniques in
managing chronic pain in Medicare beneficiaries from 2000 to 2011.
Objective: To evaluate the use of all interventional techniques in chronic pain management.
Methods: The study was performed utilizing the Centers for Medicare and Medicaid
Services (CMS) Physician Supplier Procedure Summary Master Data from 2000 to 2011.
Results: Interventional techniques for chronic pain have increased dramatically from 2000
to 2011. Overall, the increase of interventional pain management (IPM) procedures from
2000 to 2011 went up 228%, with 177% per 100,000 Medicare beneficiaries.
The increases were highest for facet joint interventions and sacroiliac joint blocks with a total
increase of 386% and 310% per 100,000 Medicare beneficiaries, followed by 168% and
127% for epidural and adhesiolysis procedures, 150% and 111% for other types of nerve
blocks and finally, 28% and 8% increases for percutaneous disc procedures. The geometric
average of annual increases was 9.7% overall with 13.7% for facet joint interventions and
sacroiliac joint blocks and 7.7% for epidural and adhesiolysis procedures.
Limitations: The limitations of this study included a lack of inclusion of Medicare participants
in Medicare Advantage plans, as well as potential documentation, coding, and billing errors.
Conclusion: Interventional techniques increased significantly in Medicare beneficiaries from
2000 to 2011. Overall, there was an increase of 177% in the utilization of IPM services per
100,000 Medicare beneficiaries, with an annual geometric average increase of 9.7%. The
study also showed an exponential increase in facet joint interventions and sacroiliac joint
blocks.
Key words: Interventional techniques, interventional pain management, facet joint
injections, epidural steroid injections, sacroiliac joint injections, chronic pain, chronic spinal
pain
Child identity development affected by language disorder – A literature review
Authors:   University of Silesia, Poland, Krzeszewska Paulina
Published: March 2021

Identity construction reflects the view of a person as a unique individual and a member of society at the same time. It is strongly related to one’s speaking language and limitations of communication abilities may impact the specific identity development. The article reviews the literature concerning issues of child identity development as one of the aspects affected by language impairment. The aim of this review is to answer three questions: 1. To what extent do language disorders affect identity in children? 2. Who should be involved in the supporting process for the development of child identity? 3. What are the implications for professional practice and further research? The conclusions may contribute to awareness-raise about the link between identity development and language disorders as well as increasing the efficacy of interventions dedicated to children with language disorders./ Keywords: child identity, identity development, language disorders, language impairment
Understanding State Agency Independence
Authors: Seifter Miriam
Published: March 2021

Conflicts about the independence of executive branch officials are brewing across the states. Governors vie with separately elected executive officials for policy control; attorneys general and governors spar over who speaks for the state in litigation, and legislatures seek to alter governors’ influence over independent state commissions. These disputes over intrastate authority have weighty policy implications both within states and beyond them, on topics from election administration and energy markets to healthcare and welfare. The disputes also reveal a blind spot. At the federal level, scholars have long analyzed the meaning and effects of agency independence—a dialogue that has deepened under the Trump Administration. In contrast, there is virtually no systematic scholarly attention to the theory or practice of agency independence in the states.

This Article begins that study. Surveying historical developments, judicial decisions, and legislative enactments across the country, it shows that state agency independence is an inexact, unstable, and variegated concept. Whereas federal courts treat independent agencies as a distinct legal category, state courts tend to eschew categorization in favor of contextual holdings. Moreover, despite the common notion that states’ plural-executive structure cements independence, these rulings just as frequently undermine it. State legislatures, for their part, revisit independence frequently, often in the wake of partisan realignments. And their creations are diverse, combining a range of vectors of insulation in different arrangements. The result is that there is no single meaning of state agency independence even within a state, and rarely a strong norm surrounding it.

States’ legislatively driven, bespoke approach to independence offers insights for scholars of both state and federal institutional design. The state approach may yield better-tailored and more democratic arrangements. But it also displays raw partisanship, and the combination of weak norms with strong governors may stack the deck against independence. The state approach also raises deeper questions for public law: What are the costs and benefits of allowing the rules of the game to be consistently up for grabs? There is no formula for weighing these considerations beyond the context of any individual dispute, but this Article provides a launching pad for their sustained exploration.
Preventive accounting of the rapist in the practical activities of authorized units of the National Police of Ukraine for the prevention of domestic violence
Authors: Guseva Кaterina , Gorbach-Kudrya Ivanna
Published: March 2021

The article presents a model of legal support for the functioning of preventive accounting of the offender a special measure inthe system of the National Police of Ukraine, such as, specifies the list of authorized units and formulates the grounds for accountingof the offender National Police of Ukraine.Preventive accounting of the offender is the organizational and practical measures in the practical activities of authorized unitsof the National Police of Ukraine to control the behavior of the offender in order to prevent recurrence of domestic violence, compliancewith temporary restrictions on his rights and responsibilities the commission of domestic violence. The authorized subdivisions of theNational Police of Ukraine, which are responsible for taking the offender into preventive accounting and carrying out preventive workwith the offender, are district police officers and juvenile prevention units.It is proposed to amend the order of the Ministry of Internal Affairs of Ukraine “On approval of the Procedure for accounting,preventive work and disaccounting of the offender by an authorized unit of the National Police of Ukraine” from 02/25/2019 № 124taking a person on preventive accounting of the offender of the National Police of Ukraine, in order to ensure the effective functioningof the latter. In particular, to change part 1 item of 4 Section I, part 1 item 1 of Section II – by analogy to part 2 item 1 of this Section,to delete item 5 of Section I, part 1 and part 2 items of 2 Section.
Criminal liability for bringing bankruptcy of certain business entities
Authors: Tarasevich Tetyana , Lazarenko Vitaliy
Published: March 2021

The article distinguishes between financial insolvency and bankruptcy, which is recognized by the economic court as the debtor’sinability to satisfy monetary claims of creditors differently than through the application of the liquidation procedure. The legislation ofUkraine on criminal liability for bankruptcy provides for a fine of two thousand to three thousand non-taxable minimum incomes ofcitizens with the deprivation of the right to occupy certain positions or engage in certain activities for up to three years.Bringing an enterprise to bankruptcy, in particular state or state-owned, is very common in Ukraine and outwardly manifests itselfmainly as covert forms of privatization. Such actions against state-owned enterprises result not only in dubious privatization agreements,but also in the destruction of integral property complexes of strategically important objects for the state, a sharp rise in unemployment,and so on.The activity of agricultural enterprises plays an extremely important role in the development of the market economy of Ukraine,as it is caused by attracting a significant amount of investment in the economy of our country and improving the economic situation inUkraine. The share of agriculture in Ukraine’s GDP in 2019 was 8.9%, or almost 360 billion hryvnias.At the same time, for the bankruptcy of an agricultural or state-owned enterprise, the guilty person may be punished by a finewith restriction of the right to hold certain positions or engage in certain activities. The imposition of a penalty in the form of a finewith restriction of certain rights for the commission of this crime is not sufficient to achieve the purposes of punishment and entails aninjustice in the application of criminal law, which cannot be considered acceptable. Conclusions have been drawn on the need tostrengthen criminal liability for bankruptcy of an agricultural, state-owned enterprise and enterprise, in the authorized capital of whichthe share of state ownership exceeds 50 percent.
Criminal liability for violation of the order of enforcement of judgments under the laws of foreign countries
Authors: Yusubov Kostyantyn
Published: March 2021

The article deals with the study of foreign experience of criminal responsibility for separate crimes that infringe on the executionorder of conviction. The presence of alternative models of consolidation in the criminal laws of European countries and the norms ofresponsibility for failure to execute judicial decisions, primarily due to the national characteristics of the criminal law. Features of re -gulation of criminal responsibility for crimes against the order of execution of a judgment of conviction for which the person is sentencedto the punishment associated with the restriction of freedom in the EU member States. Determined that the norms about criminalliability for failure to execute court decisions may be presented as a single article (General rule), and in the form of several rules, whichprovide for liability for failure to enforce court decision of a particular kind, namely: 1) qualification of aiding escape from prison asseparate crimes; 2) the establishment of criminal liability for the qualified form of escape from the place of deprivation of liberty; 3) theconsolidation of criminal liability of the person who organized the escape from prison with the simultaneous involvement of the perpetratorsescape, is subject to disciplinary, and not criminal liability; 4) the establishment of criminal liability for illegal release fromplaces of detention and mitigation of the regime of serving sentences, as well as the application of more serious penalties against thesubjects of the offences against the penal system, what is the officials of the penitentiary institutions.It was determined that in some member States of the EU enshrines the criminal liability only for the qualified form of escapefrom the place of imprisonment and the liability of the person who organized this escape, and while the perpetrator of the escape, subjectto disciplinary, and not criminal liability. However, a significant proportion of the EU countries provides criminal responsibility forescaping from places of imprisonment without any other aggravating circumstances that can explain the substantial public danger ofthe crime.
Defining war crimes: a look to the prosecution by international criminal judicial bodies
Authors: Allahverdiyev Alovsat
Published: March 2021

The article is dedicated to the overview of the scope and application of international prosecution on war crimes. Although theterm “war crimes” is not a new concept in international law, different approaches exist in defining the precise limits of it. War crimesare always considered as one of the primary challenges and pecularities minimizing the whole efficiency of international law. Nevertheless,not all known prosecutions on war crimes ended with success. In traditional international law war crimes are always related tomilitary or armed conflicts what may be international or non-international conflict. History of international humanitarian law demonstratesthat almost all of the military conflicts were associated with war crimes. However, international law was not able to buil upstrong judicial mechanisms for the prosecution of war crimes for a long time. Modern type of international prosecution over war crimescan be linked to military tribunals established after World War I. At the same time, we should not forget that most of war crimes committedbefore and during WWI still remain unpunished. These problems demand new conceptual approach to the understanding of warcrimes as well as methodology of international prosecution. We know that first military tribunals were of quasi-international character.Although modern international law contains fully international military tribunals, still there are a lot of cases of failure to punish warcrimes. We need to understand that being a type of international crimes against peace and humanity, war crimes can be committed outsidethe active period of war. Thus, there is a need to re-define again the scope and subject matter of war crimes. On the other hand,prosecution of war crimes should be studied apart from other international law violations, human rights in particular.