bluuebunny/crossref_metadata_2025 huggingface dataset:
Preliminary Results of a Randomized,
Equivalence Trial of Fluoroscopic Caudal Epidural
Injections in Managing Chronic Low Back Pain:
Part 2 — Disc Herniation and Radiculitis
Authors: Manchikanti Laxmaiah
Published: March 2021

Background: The pathophysiology of lumbar radicular pain is a subject of ongoing research.
The prevalence of sciatica or radiculitis ranges from 1.2% to 43%. Epidural injections are one of
the most commonly performed interventions in the United States in managing chronic low back
and lower extremity pain secondary to disc herniation and radiculitis. There is a paucity of evidence with contemporary methodology used in performing epidural injections under fluoroscopy
and based on pain relief and functional status improvement.
Study Design: A randomized, double-blind, equivalence trial.
Setting: An interventional pain management practice, a specialty referral center, a private practice setting in the United States.
Objective: To evaluate the effectiveness of caudal epidural injections with or without steroids
in managing chronic low back and lower extremity pain secondary to disc herniation or radiculitis in providing effective and long-lasting pain relief and evaluate the differences between local
anesthetic with or without steroids.
Methods: Patients were assigned to one of 2 groups; Group I patients received caudal epidural
injections with an injection of local anesthetic (lidocaine 0.5%), whereas, Group II patients received
caudal epidural injections with 0.5% lidocaine 9 mL mixed with 1 mL of steroid. Randomization
was performed by computer-generated random allocations sequence by simple randomization.
Outcomes Assessment: Multiple outcome measures were utilized which included the Numeric Rating Scale (NRS), the Oswestry Disability Index 2.0 (ODI), employment status, and opioid
intake with assessment at 3 months, 6 months, and 12 months post-treatment.
Significant pain relief was defined as 50% or more, whereas significant improvement in disability
score was defined as a reduction of 40% or more.
Results: The percentage of patients with significant pain relief of 50% or greater at 12 months
was 79% in Group I and 81% in Group II. Reduction of Oswestry scores of at least 40% was seen
in 83% of the patients in Group I and 91% in Group II.
The overall average procedures per year were 3.9 ± 1.26 in Group I and 3.6 ± 1.08 in Group II
with an average total relief per year of 35.2 ± 17.18 weeks in Group I and 35.9 ± 15.34 weeks
in Group II over a period of 52 weeks.
Limitations: The results of this study are limited by lack of a placebo group and a preliminary
report of 42 patients in each group.
Conclusion: Caudal epidural injections with or without steroids may be effective in patients
with disc herniation or radiculitis with between 79% to 91% of patients showing significant pain
relief and improvement in functional status.
Key words: Chronic low back pain, disc herniation, radiculitis, lower extremity pain, caudal epidural injections, epidural steroids, local anesthetic
Neuromodulation in the Management of
Pain from Brachial Plexus Injury
Authors: Brill Silviu
Published: March 2021

We are presenting a paper on the effectiveness of spinal cord stimulation (SCS) in 2
patients suffering pain from brachial plexus injury (BPI).
After a traumatic brachial plexus lesion about 80% of patients develop pain in the
deafferentated arm. This pain is considered very resistant to many forms of therapy.
In the early 1970s, SCS was introduced in the treatment of BPI pain with disappointing results. There are only about 20 published cases of BPI pain treated with SCS.
Many injuries are due to motorcycle accidents, so that patients are often young and
require long-term pain relief.
During the SCS trial the pain relief was more than 50% with an absolute improvement in the quality of life and significant drug reduction. The results of the SCS
were excellent in these 2 patients, defined as more than 50% pain relief at 6 and
18 months.
Key words: Spinal cord stimulation, brachial plexus injury, neurophatic pain.
Preliminary Results of a Randomized,
Equivalence Trial of Fluoroscopic Caudal
Epidural Injections in Managing Chronic Low
Back Pain: Part 3 – Post Surgery Syndrome
Authors: Manchikanti Laxmaiah
Published: March 2021

Background: Post surgery syndrome resulting in persistent pain following lumbar spine surgery
is common. Speculated causes of post lumbar surgery syndrome include stenosis, degeneration of
adjacent segments, internal disc disruption, recurrent disc herniation, retained disc fragment, epidural or intraneural fibrosis, radiculopathy, and various other causes. Epidural injections are most
commonly used in post surgery syndrome. There is lack of evidence for the effectiveness of epidural injections in managing chronic low back pain with or without lower extremity pain secondary to
post surgery syndrome.
Study Design: A randomized, double-blind, equivalence trial.
Setting: An interventional pain management practice, a specialty referral center, a private practice
setting in the United States.
Objectives: To evaluate the effectiveness of caudal epidural injections in patients with chronic low
back and lower extremity pain after surgical intervention with post lumbar surgery syndrome.
Methods: Patients were randomly assigned to one of 2 groups; Group I patients received caudal epidural injections with local anesthetic (lidocaine 0.5%), whereas Group II patients received caudal epidural injections with 0.5% lidocaine 9 mL mixed with 1 mL of 6 mg non-particulate Celestone. Randomization was performed by computer-generated random allocation sequence by simple randomization.
Outcomes Assessment: Multiple outcome measures were utilized which included the Numeric Rating Scale (NRS), the Oswestry Disability Index 2.0 (ODI), employment status, and opioid intake
with assessment at 3 months, 6 months, and 12 months post-treatment.
Significant pain relief was described as 50% or more, whereas significant improvement in the disability score was defined as a reduction of 40% or more.
Results: Significant pain relief (≥ 50%) was recorded in 60% to 70% of the patients with no significant differences noted with or without steroid over a period of one-year. In addition, functional
assessment measured by the ODI also showed significant improvement with at least 40% reduction
in Oswestry scores in 40% to 55% of the patients. The average procedures per year were 3.4 with
an average total relief per year of 31.7 ± 19.10 weeks in Group I and 26.2 ± 18.34 weeks in Group
II over a period of 52 weeks.
Limitations: The results of this study are limited by the lack of a placebo group and the preliminary
report size of only 20 patients in each group.
Conclusion: Caudal epidural injections in chronic function-limiting low back pain in post surgery
syndrome without facet joint pain demonstrated effectiveness with over 55% of the patients showing improvement in functional status with significant pain relief in 60% to 70%.
Key words: Post lumbar surgery syndrome, post lumbar laminectomy syndrome, chronic low back
pain, epidural adhesions, epidural steroid injections, epidural fibrosis, recurrent disc herniation, spinal stenosis
Preliminary Results of a Randomized,
Equivalence Trial of Fluoroscopic Caudal
Epidural Injections in Managing Chronic Low
Back Pain: Part 4 — Spinal Stenosis
Authors: Manchikanti Laxmaiah
Published: March 2021

Background: Spinal stenosis is one of the 3 most common diagnoses of low back and leg
symptoms which also include disc herniation and degenerative spondylolisthesis. Spinal stenosis
is a narrowing of the spinal canal with encroachment on the neural structures by surrounding the
bone and soft tissue. In the United States, one of the most commonly performed interventions
for managing chronic low back pain are epidural injections, including their use for spinal stenosis. However, there have not been any randomized trials and evidence is limited with regards to
the effectiveness of epidural injections in managing chronic function-limiting low back and lower
extremity pain secondary to lumbar spinal stenosis.
Study Design: A randomized, double-blind, equivalence trial.
Setting: An interventional pain management practice, a specialty referral center, a private practice setting in the United States.
Objectives: To evaluate the effectiveness of caudal epidural injections with or without steroids in
providing effective and long-lasting pain relief in the management of chronic low back pain in spinal stenosis and to evaluate the differences between local anesthetic with or without steroids.
Methods: Patients were randomly assigned to one of 2 groups, with Group I patients receiving
caudal epidural injections of local anesthetic (lidocaine 0.5%), whereas Group II patients received
caudal epidural injections with 0.5% lidocaine 9 mL mixed with 1 mL of steroid. Randomization is
being performed by computer-generated random allocation sequence by simple randomization.
Outcomes Assessment: Multiple outcome measures were utilized which included the Numeric Rating Scale (NRS), the Oswestry Disability Index 2.0 (ODI), employment status, and opioid
intake with assessment at 3 months, 6 months, and 12 months post-treatment.
Significant pain relief was defined as 50% or more, whereas significant improvement in disability
score was defined as reduction of 40% or more.
Results: Significant pain relief (≥ 50%) was demonstrated in 55% to 65% of the patients and
functional status improvement with 40% reduction in ODI scores in 55% to 80% of the patients.
The overall average procedures per year were 3.4 ± 1.27 in Group I and 2.6 ± 1.35 in Group II
with an average total relief per year of 30.3 ± 19.49 weeks in Group I and 23.1 ± 21.36 weeks
in Group II over a period of 52 weeks.
Limitations: The results of this study are limited by the lack of a placebo group and a preliminary report of 20 patients in each group, even though sample was justified.
Conclusion: Caudal epidural injections with or without steroids may be effective in patients
with chronic function-limiting low back and lower extremity pain with spinal stenosis in approximately 60% of the patients.
Key words: Low back pain, lower extremity pain, spinal stenosis, epidural injections, steroids,
local anesthetics
Contrast Flow Selectivity During
Transforaminal Lumbosacral Epidural
Steroid Injections
Authors: Furman Michael B.
Published: March 2021

Background: Lumbosacral transforaminal epidural steroid injections (LS-TFESIs) are an accepted procedure used in the comprehensive, conservative care for lumbar disc pathology and/or spinal stenosis induced low back pain with a radicular component. Historically, the terminology used
to describe the transforaminal technique of instilling medications into the epidural space and/or
exiting structures has varied. These procedures have also been referred to as either diagnostic or
therapeutic selective nerve root blocks (SNRBs). Although this procedure is typically used to “selectively” treat isolated pathology, the “SNRB” terminology suggests that one can selectively diagnose or treat a specific nerve root as a pain generator by anesthetizing or blocking it. It has
been recently demonstrated that L4 and L5 SNRBs are often non-“selective” by investigating the
extent of epidural contrast flow patterns after injecting 1.0 mL of contrast. Our study attempts
to identify the minimum injectate volume at which LS-TFESIs may still be considered “selective”
with no injectate extending to either the adjacent (superior and/or inferior) levels or to the contralateral side.
Objective: Quantitatively evaluate contrast flow level selectivity noted during fluoroscopically
guided lumbosacral transforaminal epidural steroid injections (LS-TFESIs).
Study Design: Prospective, nonrandomized, observational human study.
Methods: Thirty patients (female = 10, male = 20) undergoing LS-TFESIs were investigated. After
confirming appropriate spinal needle position with biplanar imaging, 4.0 mL of nonionic contrast
was slowly injected. Fluoroscopic images were recorded at 0.5 mL increments. These biplanar contrast flow images were evaluated to determine which 0.5 mL volume increment was no longer specific for the injected level. In particular, we documented when contrast extended either to a superior or inferior spinal segment or crossed the midline spine to the contralateral side.
Results: After injecting 0.5 mL of contrast, 30% of LS-TFESIs performed in this study were no
longer “selective” for the specified root level. After injecting 1.0 mL of contrast, 67% of LS-TFESIs performed in this study were no longer “selective” for the specified root level. After injecting
1.5 mL of contrast, 87% of LS-TFESIs performed in this study were no longer “selective” for the
specified root level. After injecting 2.5 mL of contrast, 90% of LS-TFESIs performed in this study
were no longer “selective” for the specified root level.
Conclusions: Diagnostic LS-TFESI or SNRB blocks limiting injectate to a single, ipsilateral segmental level cannot reliably be considered diagnostically selective with volumes exceeding 0.5mL.
Injectate volumes greater than 0.5mL are consistently non-selective and cannot be used reliably
for diagnostic block procedures in the epidural space.
Key words: Epidural steroid injections, selective nerve root block, transforaminal, contrast
flow
Systematic Review of the Effectiveness of
Cervical Epidurals in the Management of
Chronic Neck Pain
Authors: Benyamin Ramsin
Published: March 2021

Background: Chronic neck pain is a common problem in the adult population with a typical 12-month prevalence of 30% to 50%, and 14% of the patients reporting grade II to IV
neck pain with high pain intensity and disability that has a substantial impact on health care
and society.
Cervical epidural injections for managing chronic neck pain are one of the commonly performed interventions in the United States. However, the literature supporting cervical epidural
steroids in managing chronic pain problems has been scant and no systematic review dedicated to the evaluation of cervical interlaminar epidurals has been performed in the past.
Study Design: A systematic review of cervical interlaminar epidural injections.
Objective: To evaluate the effect of cervical interlaminar epidural injections in managing various types of chronic neck and upper extremity pain emanating as a result of cervical spine pathology.
Methods: The available literature of cervical interlaminar epidural injections in managing
chronic neck and upper extremity 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 Agency for
Healthcare Research and Quality (AHRQ) criteria for observational studies.
The level of evidence was classified as Level I, II, or III based on the quality of evidence developed by the U.S. Preventive Services Task Force (USPSTF) for therapeutic interventions.
Data sources included relevant literature of the English language identified through searches
of PubMed and EMBASE from 1966 to November 2008, and manual searches of 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: The indicated evidence is Level II-1 in managing chronic neck and upper extremity pain.
Limitations: The limitations of this systematic review include the paucity of literature and
lack of randomized trials performed under fluoroscopy.
Conclusion: The results of this systematic evaluation of cervical interlaminar epidural injection showed significant effect in relieving chronic intractable pain of cervical origin and also
providing long-term relief with an indicated evidence level of Level II-1.
Key words: Cervical disc herniation, cervical post surgery syndrome, cervical spinal stenosis, cervical radiculitis, cervical interlaminar epidural injections, local anesthetic steroids, chronic discogenic pain
Continuous Cervical Epidural Analgesia for
Rehabilitation after Shoulder Surgery: A
Retrospective Evaluation
Authors: Narouze Samer N.
Published: March 2021

Background: Patients with frozen shoulder who fail conservative therapy need surgical
treatment and aggressive post-operative rehabilitation.
Objective: To evaluate the effect of continuous cervical epidural analgesia on pain scores
and range of motion of the shoulder joint in patients undergoing surgery for treatment of refractory frozen shoulder.
Methods: Twenty-one patients with refractory frozen shoulder who had failed conservative
treatment and undergone surgical procedure (manipulation under anesthesia or capsular release) were identified and the data were collected retrospectively. These patients had cervical tunneled epidural catheter (TEC) placement for continuous infusion of a mixture of lowdose narcotic and local anesthetics at the time of surgery and were discharged home with the
catheter in place. They were then involved in an active physical therapy program to increase
the range of motion of the affected shoulder joint.
The patients (N = 21) were followed for a median of 4.7 weeks. They were assessed for range
of motion, function, visual analog pain scores (VAS), and opiate use before the surgery and
after tunneled epidural catheter removal.
Results: Statistically significant changes from the time of placement to the time of removal
of the tunneled epidural catheter (TEC) were observed for VAS pain score and range of motion of the shoulder in forward flexion, external rotation, and internal rotation. The mean
rate of change among the patients for pain score, forward flexion, external rotation, and internal rotation was also computed. The mean change per week in each of these 4 measurements significantly differed from zero. 33 percent of the patients returned to work within
one week.
Conclusion: Our data show that the continuous infusion of epidural opioids and local anesthetics through a tunneled cervical epidural catheter during the rehabilitation phase after
shoulder surgery for adhesive capsulitis may be a safe and effective tool for post-operative
pain control and to facilitate rehabilitation.
Key words: Cervical epidural, epidural analgesia, shoulder surgery
Systematic Review of the Role of Sedation in
Diagnostic Spinal Interventional Techniques
Authors: Smith Howard
Published: March 2021

Background: There is ongoing controversy regarding the validity of controlled diagnostic blocks due to variability in sensitivity, specificity, and accuracy. Consequently, identification of false-positive rates, false-negative rates, and placebo responses is crucial. The reasons
described for false-positive responses to diagnostic anesthetic blocks are many; however, sedation and psychological factors have been implied as causes. Further, there is no consensus
with regards to sedation prior to controlled diagnostic blocks and their influence on the accuracy and validity of a diagnosis.
Study Design: A systematic review of the literature evaluating the influence of sedation on
diagnostic spinal interventional techniques.
Objectives: To systematically assess the quality of clinical studies evaluating the diagnostic
accuracy of controlled diagnostic blocks in the diagnosis of chronic spinal pain.
Methods: A comprehensive evaluation of the literature relating to sedation in diagnostic interventional techniques was performed. The methodologic quality assessment of the studies
was carried out by utilizing Agency for Healthcare Research and Quality (AHRQ) methodologic quality criteria with scores of 50 or higher included in the assessment of the level of evidence. Level of evidence was based on the U.S. Preventive Services Task Force (USPSTF) criteria for the assessment of accuracy of diagnostic studies.
Limitations: All 3 of the studies were produced by one group of authors. Thus paucity of
the literature on the subject of facet joint pain and the lack of literature on the subjects of discogenic pain and sacroiliac joint pain are major limitations.
Results: Three studies were identified which met inclusion and methodologic assessment
quality criteria. Sedation can be a confounding factor in a small population of patients specifically if fentanyl is employed and non-stringent criteria are followed. Based on the 3 randomized double-blind trials with stringent criteria utilizing 80% pain relief and the ability to perform prior painful movements without any significant pain following the diagnostic injection
in evaluation of facet joint pain, the indicated evidence is Level II-1.
Conclusion: This systematic review provides no significant evidence of the influence of sedation either with midazolam or fentanyl in the evaluation of cervical and lumbar facet joint
pain with controlled cervical and lumbar facet joint nerve blocks with an indicated evidence
of Level II-1, with application of stringent criteria of at least 80% pain relief and the ability to
perform previously painful movements after the diagnostic blocks.
Key words: Sedation, chronic spinal pain, anxiolytics, analgesics, controlled diagnostic
nerve blocks, opioids, benzodiazepines, zygapophysial or facet joint blocks, provocation discography, sacroiliac joint injections
Systematic Review of Therapeutic Lumbar
Transforaminal Epidural Steroid Injections
Authors: Buenaventura Ricardo M.
Published: March 2021

Background: Epidural injection of corticosteroids is one of the most commonly used interventions in managing chronic spinal pain. The transforaminal route to the lumbar epidural space for steroid injection has gained rapid and widespread acceptance for the treatment
of lumbar and leg pain. However, there are few well-designed randomized, controlled studies to determine the effectiveness of epidural injections. The role and value of transforaminal
lumbar epidural steroid injections is still questioned.
Study Design: A systematic review of transforaminal epidural injection therapy for low
back and lower extremity pain.
Objective: To evaluate the effect of transforaminal lumbar epidural steroid injections in
managing lumbar (low-back) and sciatica (leg) pain.
Methods: The available literature of lumbar transforaminal epidural injections in managing
chronic low back and lower extremity 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
Agency for Healthcare Research and Quality (AHRQ) criteria for observational studies.
The level of evidence was classified as Level I, II, or III based on the quality of evidence developed by the U.S. Preventive Services Task Force (USPSTF).
Data sources included relevant literature of the English language identified through searches
of PubMed and EMBASE from 1966 to November 2008, 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: The indicated evidence is Level II-1 for short-term relief and Level II-2 for long-term
relief in managing chronic low back and lower extremity pain. .
Limitations: The limitations of this systematic review include the paucity of literature.
Conclusion: The indicated evidence for transforaminal lumbar epidural steroid injections is
Level II-1 for short-term relief and Level II-2 for long-term improvement in the management
of lumbar nerve root and low back pain.
Key words: Spinal pain, chronic low back pain, lower extremity pain, transforaminal epidural steroids, radiculopathy, sciatica, steroids, local anesthetic
Transoral Approach to CT-Guided
C2 Interventions
Authors: Arra Suresh Reddy
Published: March 2021

Background: Lesions involving C2 are unique as it is challenging to approach these lesions.
The transoral approach to C2 lesions has been extensively used by surgeons and increasingly used by interventional radiologists for vertebroplasty as it is safer and less demanding
than other approaches like anterolateral and posterolateral (transpedicular). However, using this approach for image-guided biopsies is little described in literature with a few cases
described so far being under fluoroscopic guidance. We describe a series of 5 procedures
using transoral approach — 4 biopsies (and one vertebroplasty that was published earlier)
on C2 lesions under CT guidance. To our knowledge, our series is the first one where the
transoral biopsies were performed using Computed Tomography (CT) guidance.
Objective: To describe our initial experience with the transoral approach to image-guided
biopsies on C2 vertebra and its relative advantages and disadvantages.
Methods: We performed 5 procedures — 4 biopsies (and one vertebroplasty published
earlier) on different types of lesions involving C2, through the transoral approach, using CT
guidance under general anesthesia and appropriate precautions to reduce potential complications like infection, hemorrhage, etc.
Results: The procedures were well tolerated by the patients without any complications,
immediately as well as at follow-up. All the biopsies in our series were technically successful without any minor or major complications. The biopsy yield was 50% which may be due
to the thinner needles used.
Conclusion: CT-guided transoral approach to biopsies on C2 lesions is a direct, safe, and
precise technique when performed with appropriate precautions.
Key words: Transoral, C2, image-guided, CT-guided, interventions, biopsy
Potential Analgesic Mechanisms of
Acetaminophen
Authors: Smith Howard
Published: March 2021

Despite nearing the end of the decade of pain research, the analgesic mechanisms
of one of the most widely used and popular analgesics remains uncertain.
Acetaminophen (APAP) (paracetamol [PARA]) has been used clinically for over a
half of a century and although clinicians seem to be comfortable with its benefits,
risks, and limitations, they still remain in the dark as to precisely what is providing its
pain relief. What does seem clearer is that the predominant mechanisms of APAP’s
analgesic effects are in the central nervous system (CNS).
Although, which central effects are largely responsible for APAP’s effects on pain
continue to be uncertain. Perhaps, the most accepted theory is that of APAP’s
positive effects on the serotonergic descending inhibitory pathways. However,
interactions with opioidergic systems, eicosanoid systems, and/or nitric oxide
containing pathways may be involved as well.
Furthermore, endocannabinoid signaling may play a role in APAP’s activation of the
serotonergic descending inhibitory pathways. A greater understanding of APAP’s
analgesic mechanisms may promote optimal utilization of analgesic polypharmacy.
Key words: Acetaminophen (APAP), paracetamol (PARA), pain, analgesia,
mechanisms of action, serotonin, opioids, endocannabinoids
Obama Health Care for All Americans:
Practical Implications
Authors: Manchikanti Laxmaiah
Published: March 2021

Rapidly rising health care costs over the decades have prompted the application of business practices to medicine with goals of improving the efficiency, restraining expenses, and increasing quality. Average health insurance premiums and individual contributions for family coverage have increased approximately 120% from 1999 to 2008. Health care spending in the United States is
stated to exceed 4 times the national defense, despite the wars in Iraq and Afghanistan. The U.S.
health care system has been blamed for inefficiencies, excessive administrative expenses, inflated
prices, inappropriate waste, and fraud and abuse. While many people lack health insurance, others who do have health insurance allegedly receive care ranging from superb to inexcusable.
In criticism of health care in the United States and the focus on savings, methodologists, policy
makers, and the public in general seem to ignore the major disadvantages of other global health
care systems and the previous experiences of the United States to reform health care. Health care
reform is back with the Obama administration with great expectations. It is also believed that for
the first time since 1993, momentum is building for policies that would move the United States
towards universal health insurance. President Obama has made health care a central part of his
domestic agenda, with spending and investments in Children’s Health Insurance Program (CHIP),
American Recovery and Reinvestment Act of 2009, and proposed 2010 budget. It is the consensus now that since we have a fiscal emergency, Washington is willing to deal with the health care
crisis. Many of the groups long opposed to reform, appear to be coming together to accept a major health care reform.
Reducing costs is always at the center of any health care debate in the United States. These have
been focused on waste, fraud, and abuse; administrative costs; improving the quality with health
technology information dissemination; and excessive regulations on the health care industry in the
United States. Down payment on health care reform, American Recovery and Reinvestment Act,
and CHIP include many provisions to reach towards universal health care.
Key words: Health care reform, universal health care, national health expenditures, gross domestic product, sustained growth rate formula, physician payments, American Recovery and Reinvestment Act of 2009, Children’s Health Insurance Program, health information technology
Systematic Review of Intrathecal Infusion
Systems for Long-Term Management of Chronic
Non-Cancer Pain
Authors: Patel Vikram B.
Published: March 2021

Background: Disability, societal, and health impact of chronic intractable pain secondary to various failed therapies is a major issue. As advanced therapy, implantable therapies,
which include intrathecal devices and spinal cord stimulation systems, are frequently used
in managing chronic intractable pain. Thus, continuous infusion of intrathecal medication is
one of the methods used for the control of chronic, refractory, cancer, and non-cancer pain.
However, despite the high costs of chronic non-cancer pain, it has been claimed that there
is a lack of evidence for intrathecal infusion systems and the cost effectiveness of these systems has been questioned in improving pain and function.
Study Design: A systematic review of intrathecal infusion devices for chronic non-cancer pain.
Objective: To determine the efficacy, utilization, safety, and complications associated with
the use of intrathecal infusion devices for long-term management of chronic non-cancer
pain.
Methods: Literature search was performed through EMBASE, Medline, Cochrane databases, and systematic reviews identified from 1966 to December 2008. Studies were then
reviewed and assessed using the Agency for Healthcare Research and Quality (AHRQ) criteria for observational studies and the Cochrane Musculoskeletal Review Group criteria for
randomized trials.
The level of evidence was determined using 5 levels of evidence, ranging from Level I to III
with 3 subcategories in Level II, based on the quality of evidence developed by the U.S. Preventive Services Task Force (USPSTF).
Outcome Measures: The primary outcome measure was pain relief (short-term relief
≤ one-year and long-term > one-year). Secondary outcome measures of improvement in
functional status, psychological status, return to work, and reduction in opioid intake were
also utilized.
Results: The level of evidence for intrathecal infusion systems indicated either Level II-3 or
Level III (limited) based on U.S. Preventive Services Task Force (USPSTF) criteria.
Limitations: The limitations of this study include the paucity of literature, lack of quality
evidence, and lack of randomized trials.
Conclusion: This systematic review illustrates Level II-3 or Level III (limited) evidence for intrathecal infusion systems for long-term relief in chronic non-cancer pain.
Key words: Intrathecal infusion, intraspinal infusion, programmable infusion systems,
spinal infusion, intra-spinal infusion devices, baclofen infusion, intrathecal opiates
Systematic Assessment of the Quality of
Research Studies of Conventional and
Alternative Treatment(s) of Primary Headache
State of the Data at the Mid-Point of the Decade of
Pain Control and Research
Authors: Crawford Cindy C.
Published: March 2021

Background: Diversity of treatments used for headache, and varied quality of research conduct and reporting make it difficult to accurately assess the literature and to determine the
best treatment(s) for patients.
Objectives: To compare the quality of available research evidence describing the effects and
outcomes of conventional, and complementary and alternative medicine (CAM) approaches
to treating primary (migraine, tension, and/or cluster-type) headache.
Study Design: A systematic review of quality of research studies of conventional and alternative treatment(s) of primary headache.
Methods: Randomized, controlled clinical trials (RCTs) of treatment(s) of chronic primary
headache (in English between 1979 to June 2004) were searched through MEDLINE, PsycInfo, EMBASE, Cochrane Library, and the NIH databases. Studies were evaluated using standard approaches for assessing and analyzing quality indicators.
Results: 125 studies of conventional, and 121 CAM treatments met inclusion criteria. 80%
of studies of conventional treatment(s) reported positive effects (P<0.05), versus 73% of
studies of CAM approaches (chi2
= 3.798, 1 df, p=0.051). Overall, the literature addressing
the treatment of primary headache received a mean Jadad score of 2.72 out of 5 (SD 1.1).
The mean Jadad score for studies of conventional therapeutics was significantly better than
for those studies of CAM approaches: 3.21 ± 0.9 vs 2.23 ± 1.1 (t=7.72, 246 df, mean difference 0.98, p < 0.0005).
Conclusions: Studies of conventional treatments scored higher on reporting quality than
studies of CAM approaches. It is possible that these differences may reflect distinctions in
1) methodologic integrity, 2) therapeutic paradigm(s), and/or 3) bias(es) in the approach(es)
used to evaluate certain types of therapies. Each of these possibilities — and the implications
— is addressed and considered.
Key words: chronic headache, complementary and alternative medicine, research quality,
randomized controlled trial, Jadad scores
Ethics, Law, and Pain Management as a
Patient Right
Authors: Hall John K.
Published: March 2021

Ethical and legal considerations in pain management typically relate to 2 issues. The
first refers to pain management as a human right. The second involves the nature of
the patient-physician relationship as it relates to pain management. Although pain
physicians often like to think of pain management as a human right, it remains difficult to support this position as a point of law or as a matter of ethics. Medical organizations generally do not define pain management as a specific duty of the physician,
apart from the provision of competent medical care. To date, neither law nor ethics
creates a duty of care outside of the traditional patient-physician relationship. Absent
a universal duty, no universal right exists. Pursuing pain management as a fundamental human right, although laudable, may place the power of the government in the
middle of the patient-physician relationship. Despite apparent altruistic motives, attempts to define pain management as a basic human right could have unintended
consequences, such as nationalization of medicine to ensure provision of pain management for all patients.
Key words: Ethics, law, patient-physician relationship, human right, pain
management
The Influence of Prescription Monitoring
Programs on Chronic Pain Management
Authors: Christo Paul J.
Published: March 2021

Background: Abuse of prescribed controlled substance has become a serious social as
well as health care issue over the past decade. A particularly alarming trend exists among
patients aged 12 to 17. Common abuse behaviors include doctor shopping, drug theft,
feigned pain symptoms to gain health care access, drug sharing, prescription forgery,
and improper prescription practices. In response to this epidemic of abuse, many states
have adopted prescription monitoring programs (PMPs). Such programs first originated
in the early twentieth century. As of 2006, 38 states had such programs, many of which
are supported by federal grants. As PMPs become more widespread, they have also increased in sophistication. By keeping a record of the prescription and dispensing of narcotics, these programs are able to build a comprehensive data network for tracking prescription medications. These databases aid law enforcement agencies in investigations of
narcotic trafficking; they also help state regulatory boards to monitor improper prescription practices.
Objective: This manuscript examines the basic structure of a PMP, including the way the
data are collected and the way these data are stored and used. It also looks at the organizational differences amongst state programs. NASPER and Harold Rogers are two federal programs that provide funding to the state PMPs, and the current study examines
the differences as well as similarities between these 2 programs. This study also compares
the results of 2 reports: the U.S. General Accounting Office Study and the Twillman study.
Both studies have evaluated the efficiency of the PMPs.
Discussion: The U.S. General Accounting Office Study showed that while considerable differences exist among the state PMPs, these programs not only reduce the time
and effort for law enforcement agencies to conduct investigations, but also cut the supply of prescription medications. However, the Twillman report suggests that prescription
programs caused a shift in prescription practice, while the actual rate of abuse may not
have been reduced. These 2 studies both point to the challenges the PMPs face. However,
more recent data suggest that proactive use of the PMPs results in the decreased growth
of prescription medication sales. Finally, a number of states have also begun to objectively
evaluate the efficiencies of the system.
Conclusion: Many states have developed PMPs to help regulatory agencies as well as
physicians detect prescription drug abuse. Limited data so far suggest that such programs
reduce abuse practices. In addition, proactive usage of the data further prevents abuse.
Key words: Prescription monitoring programs, drug abuse, National All Schedules Prescription Electronic Reporting Act, Government Accountability Office, Health Insurance
Portability and Accountability Act
Serial Stellate Ganglion Blocks for Intractable
Postherpetic Itching in a Pediatric Patient: A
Case Report
Authors: Gulati Amitabh
Published: March 2021

Background: While intractable itching may be rarely associated with
postherpetic neuralgia, it can have catastrophic complications if present.
Method: We highlight a severe case of postherpetic itching in a 10-year-old
male with Fanconi’s and aplastic anemia, refractory to conventional treatments and requiring intravenous sedation.
Results: Our use of 3 sequential stellate ganglion blocks with 5.5 mL of
0.25% bupivacaine provided significant improvement of the symptoms for 4
months after the last procedure.
Conclusion: Although further evaluation is needed, we feel that novel use
of sympathetic blockade may provide treatment for intractable itching. Highlighted is the possible influence of the sympathetic system in the pathophysiology of postherpetic itch.
Implication: The use of serial stellate ganglion blocks may be a treatment
option for patients with intractable itching and postherpertic neuralgia of
the neck and arm region. This technique may lead to more permanent solutions such as pulse radiofrequency lesion or chemical neurolysis of sympathetic ganglions for postherpetic itch.
Key words: Stellate, intractable itching, postherpetic itch, pain, pediatric
Allogeneic Epidural Blood Patch in the
Setting of Persistent Spinal Headache and
Disseminated Coccidioidomycosis
Authors: Trentman Terrence L.
Published: March 2021

In most cases of post-dural puncture headache, the positional symptoms will resolve
spontaneously within 2 weeks. Conservative therapies include oral analgesics and hydration,
bed rest, and abdominal binders. For refractory cases, an autologous epidural blood patch
remains the treatment of choice. However, in certain cases the use of autologous blood for
the blood patch may place the patient at risk for infectious or malignant contamination of the
central nervous system.
Coccidioidomycosis results from inhalation of the arthroconidia (spore) stage of the fungal
lifecycle. The most common manifestation of coccidioidomycosis is acute pulmonary
symptoms, while the most feared complication is meningitis. Immunocompromised patients
are at increased risk of fungemia; therefore, introduction of fungal elements into the central
nervous system can occur if autologous blood is used for an epidural blood patch.
We report a case of persistent dural-puncture headache in the setting of disseminated
coccidioidomycosis. An autologous blood epidural blood patch was considered but deferred
due to risk of coccidioidomycosis meningitis. Other epidural space interventions such as fibrin
glue injection or saline infusions were judged to be too imprecise or ineffective. The patient
was successfully treated with allogeneic blood donated by his wife, but only after testing of her
blood as is required for any directed blood donation. Allogeneic epidural blood patches are an
option for refractory dural puncture headaches when autologous blood may cause meningitis
or malignant seeding of the central nervous system.
Key words: Epidural blood patch, post-dural puncture headache, Coccidioidomycosis,
arthroconidia, acute pulminary symptoms
Redo Kyphoplasty with Vertebroplasty
Technique: A Case Report and Review of the
Literature
Authors: Frey Micheal E.
Published: March 2021

Osteoporosis is a metabolic disorder which may result in devastating medical problems if not
treated appropriately. However, even in the best treated patients fractures may occur.
The most devastating fractures are spine and hip. Traditionally, treating fractures of the spine
consisted of bed rest, opioid analgesic medications, and bracing. This resulted in increased
risk of side-effects from medication, myocardial infarction, pulmonary embolism, pneumonia,
admissions to nursing homes, and death.
Vertebroplasty and kyphoplasty techniques were developed to decrease the detrimental effects
of “conservative care” by decreasing or eliminating the pain and stabilizing the fracture. The
safety and efficacy of vertebroplasty and kyphoplasty are similar with several biased opinions
in the literature which denotes conflict. Choosing one technique over the other is a physician
and/or facility performed preference.
There are a small percentage of patients that either vertebroplasty or kyphoplasty does not
help. Possibilities could be that not enough cement was used, an adjacent level fracture has
occurred, or worsening fracture around the previously treated fracture is causing the pain.
For the latter, a repeat vertebral augmentation could be medically necessary. Due to technical
constraints, placing an additional kyphoplasty after one has already been accomplished may
be technically dangerous and a simpler less costly vertebroplasty technique may be beneficial.
This is a case report and review of the literature on the treatment of repeat vertebral
augmentation after a previously treated vertebral fracture with kyphoplasty technique. To this
date, this is the first article published regarding the use of vertebroplasty technique over a
kyphoplasty treated patient.
In this case report, a redo vertebroplasty was performed over a previously treated kyphoplasty
or vertebroplasty. This procedure can give a patient significant pain relief when they are
suffering with pain after a previously treated fracture.
Key words: Vertebroplasty, kyphoplasty, vertebral fractures, redo-vertebroplasty/kyphoplasty,
spine fracture, hip fracture
Vertebroplasty of the First Sacral Vertebra
Authors: Betts Andres
Published: March 2021

The treatment of sacral insufficiency fractures remains an area of active investigation and
development, which has typically concentrated on the lateral elements of the sacrum and the sacral
ala. Although these fractures frequently involve the first sacral (S1) vertebral body, this structure
has eluded a successful technique to accurately access its central portion for percutaneous cannula
placement and cement delivery.
In this article, we describe a percutaneous cannula placement technique developed in cadaver models, utilizing fluoroscopic imaging to enter the S1 vertebral body using a transpedicular approach. The
pedicle provides an anatomically safe entry point, but limits the cannula trajectory to the lateral aspect
of the S1 vertebral body, which makes delivery of poly(methyl methacrylate) (PMMA) cement to the
central body of S1 difficult and unreliable by cannula placement alone. To access the central body
of S1 we describe the application of the AVAflex curved nitinol needle, which can be readily directed
though the cannula, previously placed through the S1 pedicle, into the central body of S1. The PMMA
cement is delivered through the AVAflex needle under fluoroscopic monitoring and results in controlled
deposition and good distribution within the central body of S1. The technique employs an extreme caudad angulation of the fluoroscope image intensifier that provides excellent visualization of the sacral
spinal canal similar to that obtained with an axial view under CT scan. This view allows for improving
transpedicular cannula placement at S1, and real-time fluoroscopic monitoring of the cement deposition to quickly detect and avert possible extravasation toward the central spinal canal. This technique
can be used with CT guidance for cannula placement combined with fluoroscopy for cement deposition or done entirely under fluoroscopy alone. Sacroplasty of the lateral sacral element and sacral ala
may also be performed at the same time as the S1 vertebroplasty. It appears that with this curved nitinol needle technique, sacral insufficiency fractures that involve the S1 vertebral body may now be safely and accurately addressed.
Conclusion: The treatment of sacral insufficiency fractures by sacroplasty remains an evolving
field. The technique using the curved AVAflex nitinol needle is another way to address the S1
component.
Key Words: Vertebroplasty, sacroplasty, kyphoplasty, vertebral augmentation, sacral insufficiency
fractures, osteoporosis
The Medicare Audit and Appeals Process:
A Guide for Interventional Pain Practitioners
Authors: Myckowiak Vicki
Published: March 2021

Background: Health care is a highly regulated industry and interventional pain physicians
(IPPs) are right in the government’s bull’s eye. Over the next few years, IPPs will find themselves
responding to audit requests from Medicare. An IPP’s response to a Medicare record request
should be tailored specifically to the type of request and the specific circumstances of the IPP.
With so much at stake, IPPs should not underestimate the importance of an immediate and
thoughtful response.
Objectives: This article discusses 1) the various types of record requests used by Medicare, 2)
the practical steps an IPP should take in response to a record request, 3) the Medicare appeals
process, and, 4) the practical steps an IPP should take in connection with the appeals process.
Discussion: IPPs should maintain an effective compliance program and ensure that medical
records are appropriately documented before any audit takes place. If a Medicare audit decision
is unfavorable, IPPs should understand the available appeals process and the steps that need to
be taken to win the appeal.
Conclusion: With advance preparation and a considered response, IPPs can positively influence the outcome of a Medicare audit.
Key words: Medicare audit, appeals process, interventional pain management, interventional
pain practitioners, Office of Inspector General (OIG), Comprehensive Error Rate Testing (CERT),
Carrier Medical Review Program, Recovery Audit Contractor (RAC) audits