bluuebunny/crossref_metadata_2025 huggingface dataset:
Marijuana Correlates with Use of Other Illicit
Drugs in a Pain Patient Population
Authors: West Cameron
Published: March 2021

Background: A significant number of chronic pain patients may use marijuana.
Physicians treating those patients can benefit by knowing whether their patients
using marijuana are at higher risk for using other illicit drugs such as cocaine and/or
methamphetamine.
Objective: Our objective was to determine whether marijuana-using chronic pain
patients have a higher incidence of cocaine and/or methamphetamine use.
Study Design: A retrospective study of the incidence of pain patients using marijuana
and/or other illicit drugs such as methamphetamine and cocaine versus the incidence of
pain patients not using marijuana but using methamphetamine and/or cocaine.
Methods: Urine specimens from chronic pain patients were analyzed by LC-MS/MS to
determine the co-occurrence of these abused substances.
Results: In this study 21,746 urine specimens were obtained from chronic pain
patients. We found a 13.0% incidence of patients positive for the acid form of
Tetrahydrocannabinol (THCA). The percentage of those positive for cocaine was 4.6%,
those positive for methamphetamine totaled 1.07%. Using both chi-square and a Logistic
Regression analysis, we determined that there was a correlation between marijuana use
and the use of other illicit drugs. The odds ratio was > 3.7 for other illicit drug use.
Limitations: The study is limited in that we obtained no data as to the causal
relationships of this type of drug use.
Conclusions: Pain physicians should be aware that this relationship exists and
marijuana-using patients are at greater risk for use of other illicit drugs although no
causal relationship is implied. Increased monitoring of these patients may help minimize
potential morbidity due to drug interactions as well as identify patients who may be
diverting prescriptions in order to pay for illicit drugs.
Key words: Marijuana, Tetrahydrocannabinol (THCA), Cocaine, Methamphetamine,
Pain patients, correlation study
Evaluation of the Effectiveness of Lumbar
Interlaminar Epidural Injections in Managing
Chronic Pain of Lumbar Disc Herniation or
Radiculitis: A Randomized, Double-Blind,
Controlled Trial
Authors: Manchikanti Laxmaiah
Published: March 2021

Background: The pathophysiology of lumbar radicular pain is the subject of ongoing research, with
a reported prevalence of sciatica or radiculitis ranging from 1.2% to 43%. Among the numerous nonsurgical interventions available, epidural injections are the most commonly performed interventions in
the United States in managing chronic low back and lower extremity pain.
Study Design: A randomized, double-blind, controlled 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 lumbar interlaminar epidural injections with local
anesthetic, 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.
Methods: Patients were assigned to one of 2 groups with local anesthetic only or with local
anesthetic mixed with non-particulate betamethasone.
Randomization was performed by computer-generated random allocations sequence by simple
randomization. Seventy patients were included in this analysis.
Outcomes Assessment: Patient outcomes were measured at baseline, 3, 6, and 12 months
post-treatment with the Numeric Rating Scale (NRS), the Oswestry Disability Index 2.0 (ODI),
employment status, and opioid intake. Decrease of ≥ 50% of NRS scores and Oswestry scores
were considered significant.
Results: Significant pain relief (≥ 50%) was seen at 12 months in 74% of patients in Group I
and 86% in Group II, and 69% and 83% in ODI scores respectively.
Significant differences were noted in pain relief characteristics at 6 months between Group I and
Group II (P = 0.001) and functional status improvement was significantly better in Group II at 6
months and 12 months (P = 0.019 and 0.045). The overall average procedures per year were 4.3
in Group I and 4.2 in Group II with an average total relief per year of 42.2 ± 10.5 weeks in Group
I and 41.4 ± 11.0 weeks in Group II over a period of 52 weeks in the successful group.
Limitations: The study limitations include the lack of a placebo group and the fact that this is
a preliminary report of 35 patients in each group.
Conclusion: Overall, 74% of patients in Group I without steroids and 86% in Group II with steroids
with lumbar disc herniation or radiculitis might benefit from lumbar interlaminar epidural injections.
Key words: Chronic low back pain, lower extremity pain, disc herniation, radiculitis, lumbar
interlaminar epidural injections, epidural steroids, local anesthetic
A Report of Paraparesis Following Spinal Cord
Stimulator Trial, Implantation and Revision
Authors: Smith Clark
Published: March 2021

Background: Spinal cord injury has been reported as a rare complication of spinal cord
stimulation (SCS). A review of the literature shows a very low incidence of neurological
injury after spinal cord stimulation trial, implantation and revision. The most common
reported complication is equipment failure without neurologic injury. The incidence
of spinal cord injury after SCS trial, implantation and revision is unknown. There have
been limited reports of neurologic injury secondary to dural puncture, infection, cord
contusion, actual needle penetration of the spinal cord and epidural hematoma.
Study Design: A report of 4 cases.
Objective: To report 4 occurrences of neurological complication after spinal cord
stimulator implantation.
Methods: Four patients are presented who were admitted to an acute spinal cord
rehabilitation hospital over a 4-month period. All 4 patients presented with paraparesis
after spinal cord stimulator trial or implantation. One of the injuries is secondary to
cord contusion, while the other 3 are secondary to cord compressions. Two of these
compressions are due to epidural hematomas and one secondary to implantation in the
setting of broad based thoracic disc herniations. The clinical cases are presented as well
as a review of the literature.
Results: All 4 patients had the electrodes and neurostimulators successfully removed
prior to their acute rehabilitation admissions. At discharge from acute inpatient
rehabilitation, one patient continued to experience complete paraplegia, 2 patients had
incomplete paraparesis and one had fully recovered all of his neurologic function.
Conclusion: SCS is considered a safe procedure. Further investigation into the true
incidence of neurologic injury after SCS is warranted.
Key words: spinal cord stimulation, spinal cord injury, rehabilitation, pain, epidural
hematoma, cord contusion, disc herniation
MiDAS I (mild® Decompression Alternative
to Open Surgery): A Preliminary Report of a
Prospective, Multi-Center Clinical Study
Authors: Chopko Bohdan
Published: March 2021

ackground: Neurogenic claudication due to lumbar spinal stenosis is a common problem that can be
caused by many factors including hypertrophic ligamentum flavum, facet hypertrophy, and disc protrusion.
When standard medical therapies such as pain medication, epidural steroid injections, and physical therapy
fail, or when the patient is unwilling, unable, or not severe enough to advance to more invasive surgical
procedures, both physicians and patients are often left with a treatment dilemma. Patients in this study
were treated with mild®, an ultra-minimally invasive lumbar decompression procedure using a dorsal
approach. The mild procedure is performed under fluoroscopic imaging to resect bone adjacent to, and
achieve partial resection of, the hypertrophic ligamentum flavum with minimal disruption of surrounding
muscular and skeletal structure.
Objective: To assess the clinical application and patient safety and functional outcomes of the mild
lumbar decompression procedure in the treatment of symptomatic central canal spinal stenosis.
Study Design: Multi-center, non-blinded, prospective clinical study.
Setting: Fourteen US spine specialist practices.
Methods: Between July 2008 and January 2010, 78 patients were enrolled in the MiDAS I Study and
treated with the mild procedure for lumbar decompression. Of these patients, 6-week follow-up was
available for 75 patients.
Outcome Assessment: Visual Analog Score (VAS), Oswestry Disability Index (ODI), Zurich
Claudication Questionnaire (ZCQ), and SF-12v2® Health Survey. Outcomes were assessed at baseline
and 6 weeks post-treatment.
Results: There were no major device or procedure-related complications reported in this patient cohort.
At 6 weeks, the MiDAS I Study showed statistically and clinically significant reduction of pain as measured
by VAS, ZCQ, and SF-12v2. In addition, improvement in physical function and mobility as measured by ODI,
ZCQ, and SF-12v2 was statistically and clinically significant in this study.
Limitations: This is a preliminary report encompassing 6-week follow-up. There was no control
group.
Conclusions: In this 75-patient series, and in keeping with a previously published 90-patient safety
cohort, the mild procedure proved to be safe. Further, based on near-term follow-up, the mild procedure
demonstrated efficacy in improving mobility and reducing pain associated with lumbar spinal canal
stenosis.
Key words: Spine, lumbar, decompression, fluoroscopy, mild, stenosis, ligamentum flavum, minimally
invasive
Opioid-Sparing Effect of Intravenous Outpatient
Ketamine Infusions Appears Short-Lived
in Chronic-Pain Patients with High Opioid
Requirements
Authors: Kapural Leo
Published: March 2021

Background and Objectives: Ketamine is opioid-sparing. It attenuates the onset
of opioid tolerance, and suppresses opioid-induced hyperalgesia. This study evaluated
whether or not repeated outpatient infusions of intravenous ketamine reduced the amount
of pain and the amount of opioid requirements for patients suffering with chronic, noncancerous pain.
Study Design: Retrospective study
Setting: Outpatient pain clinic
Methods: We reviewed the records of 18 patients taking high doses of opioids chronically
and nonetheless reporting poorly controlled pain. A comparison control group of 18 similar
patients with high opioid requirements who were not given ketamine were selected from
our clinic population.
Intervention: Intravenous ketamine infusions
Measurement: VAS pain scores and opioid use
Results: Morphometric and demographic characteristics, baseline opioid use, and pain
scores were similar in the ketamine and comparison groups. Five patients given ketamine
experienced no benefit and discontinued treatment after 1-2 infusions. One patient
developed a supraventricular arrhythmia which immediately resolved upon cessation of
the infusion. And another, despite pain relief, felt overly-anxious and opted out. Eleven
patients thus completed 3-6 weekly ketamine infusions. At 6 months, 5 patients maintained
less than 50% of their baseline opioid use, while the remaining patients returned to the
baseline opioid use or increased their requirements. There was no significant difference in
pain scores at 6 months in patients who received ketamine infusions and control group
patients.
Limitations: Retrospective nature of the study
Conclusions: Outpatient intravenous ketamine infusions did not improve long-term pain
scores in patients with high opioid requirements and only a few were able to substantially
reduce opioid use. Considering infusion risks and cost of such outpatient treatment,
ketamine infusions do not appear to be a feasible option for improving pain relief and
decreasing opioid use in high-opioid requirement patients.
Key words: Ketamine; anesthesia; chronic pain; opioids; continuous infusion; opioid
requirements
The Efficacy of Two Electrodes Radiofrequency
Technique: Comparison Study Using a Cadaveric
Interspinous Ligament and Temperature
Measurement Using Egg White
Authors: Lee Chang-Hyung
Published: March 2021

Background: One technique in radiofrequency neurotomies uses 2 electrodes
that are simultaneously placed to lie parallel to one another. Comparing lesions on
cadaveric interspinous ligament tissue and measuring the temperature change in
egg white allows us to accurately measure quantitatively the area of the lesion.
Methods: Fresh cadaver spinal tissue and egg white tissue were used. A series
of samples were prepared with the electrodes placed 1 to 7 mm apart. Using
radiofrequency, the needle electrodes were heated in sequential or simultaneous
order and the distance of the escaped lesion area and temperature were
measured.
Results: Samples of cadaver interspinous ligament showed sequential heating of
the needles limits the placement of the needle electrodes up to 2 mm apart from
each other and up to 4 mm apart when heated simultaneously. The temperature at
the escaped lesion area decreased according to the distance for egg white. There
was a significant difference in temperature at the escaped lesion area up to 6 mm
apart and the temperature was above 50 ºC up to 5 mm in simultaneous lesion and
3 mm in the sequential lesion.
Limitations:: The limitations of this study include cadaveric experimentation and
use of intraspinous ligament rather than medial branch of the dorsal ramus which
is difficult to identify.
Conclusion: Heating the 2 electrodes simultaneously appears to coagulate a
wider area and potentially produce better results in less time.
Key words: Rhizotomy, radiofrequency neurotomy, 2 needles, facet joint pain,
low back pain, cadaveric tissue
C-arm Fluoroscopic Cone Beam CT for Guidance
of Minimally Invasive Spine Interventions
Authors: Powell Michael F.
Published: March 2021

Background: Isocentric C-arm fluoroscopic cone beam CT (CBCT) is a new technique for
near real time 3-D volume imaging guidance of percutaneous interventional procedures. In
combination with digital flat panel detectors, CBCT has high spatial resolution with isotropic
voxel size, allowing for high resolution image reconstruction in any plane, including 3D rotational
reconstructions. CBCT combines the advantages of conventional CT imaging guidance with
the improved spatial resolution, patient positioning, and access of fluoroscopy.
Objective: The aim of this study is to demonstrate the advantages of CBCT over conventional
CT and biplane fluoroscopy for imaging guidance of minimally invasive spinal and paraspinal
interventional procedures.
Methods: Five patients referred to the department of interventional neuroradiology for
percutaneous spinal or paraspinal interventional procedures were intraoperatively evaluated
with CBCT to assist in guidance of instrumentation placement. Procedures included transoral
cervical vertebral biopsy, percutaneous thoracic vertebral biopsy, vertebroplasty, pelvic
paraspinal/epidural abscess drainage, and paraspinal fiducial marker placement for treatment
of osteoid osteoma.
Results: All procedures were successfully performed with satisfactory diagnostic yield or
therapeutic effect without procedure-related complications.
Conclusion: Isocentric C-arm fluoroscopic cone beam CT (CBCT) is a new technique for
3D volume imaging guidance of interventional procedures of the spine with the capability
to produce near real time high resolution image reconstructions in any plane. Compared to
conventional CT and biplane fluoroscopy, CBCT offers improved anatomic visualization allowing
high accuracy instrumentation placement, improving procedure results and minimizing risk of
complications.
Key words: Vertebroplasty, kyphoplasty, biopsy, computed tomography, CT, fluoroscopy, Carm, percutaneous, interventional radiology, imaging guidance
Comparison of Clonazepam Compliance
by Measurement of Urinary Concentration
by Immunoassay and LC-MS/MS in Pain
Management Population
Authors: West Cameron
Published: March 2021

Background: Physicians determine patient compliance with their medications by use of urine drug
testing. It is known that measurement of benzodiazepines is limited by immunoassay specificity and
cutoff limits and therefore does not offer physicians an accurate picture of their patients’ compliance
with these medications. A few studies have used lower cutoffs to demonstrate patient compliance.
Objectives: To define more appropriate cutoffs for compliance monitoring of patients prescribed
clonazepam as determined using immunoassay and liquid chromatography-tandem mass
spectrometry (LC-MS/MS).
Study Design: A diagnostic accuracy study of the urinary excretion of clonazepam.
Methods: Millennium Laboratories performed measurements on the urinary excretion of pain
patients prescribed clonazepam as the indicator test. This benzodiazepine was chosen because it
forms one major metabolite, 7-aminoclonazepam which is specific for that drug. Patients whose only
benzodiazepine medication was clonazepam were selected as the test population.
The Millennium Laboratories test database was filtered first to select patients on clonazepam, then
a second filter was used to eliminate patients with any other listed benzodiazepine medications.
Samples were tested using the Microgenics DRI ® benzodiazepine assay with a 200 ng/mL cutoff.
The same samples were quantitatively assessed for 7-aminoclonazepam by LC-MS/MS with a cutoff
of 40 ng/mL. The results from the immunoassay were scored as positive or negative while the
quantitative results from the LC-MS/MS were also scored as positive or negative depending upon
their concentration.
Results: Samples from 180 patients met these medication criteria. The positivity rates were 21% (38
samples) by immunoassay. The positivity rate was 70% (126 samples) if the LC-MS/MS cutoff was set at
200 ng/mL. However, the positivity rate was 87% (157 samples) if the LC-MS/MS was set at 40 ng/mL.
Concentration distributions revealed a significant fraction (7%) in the 40 – 100 ng/mL range.
Limitations: A limitation of the study was the inability to measure lower than 40 ng/mL. There may
be another fraction of the population that was positive below the cutoff value.
Conclusions: The difference in positivity rate between the immunoassay and the LC-MS/MS result
showed that the nominal 200 ng/mL cutoff of the immunoassay did not apply to 7-aminoclonazepam.
This low immunoassay positivity rate is inconsistent with the manufacturer’s published cross reactivity
data for clonazepam and 7-aminoclonazepam. These data illustrate the limitations of using a 200 ng/
mL cutoff to monitor clonazepam compliance and suggest that a cutoff of 40 ng/mL or less is needed
to reliably monitor use of this drug.
Key words: Clonazepam, 7-aminoclonazepam, pain management, LC-MS/MS, immunoassay,
patient compliance
Consensus Guidelines for the Selection and
Implantation of Patients With Noncancer Pain
for Intrathecal Drug Delivery
Authors: Deer Timothy R.
Published: March 2021

Intrathecal therapy offers an invasive alternative for the long-term management
of select patients with intractable pain associated with various disease states,
including those of noncancer origin. It is commonly accepted that proper
patient selection is essential to optimizing treatment outcomes, yet the practice
of candidate selection for device implantation varies widely. A multifaceted
approach—with consideration of preexisting medical comorbidities; psychological
status; associated social, technical, and economic issues; and response to
intrathecal trialing—enables practitioners to fully evaluate the appropriateness
of implanting a patient with an intrathecal drug delivery system. Yet, to date no
standard set of guidelines have been developed to aid practitioners in navigating
this evaluation process.
Using experience- and knowledge-based expert opinion to systematically evaluate
the available evidence, this article provides consensus guidelines aimed at
optimizing the selection of patients with noncancer pain for intrathecal therapy.
In conclusion, complete assessment of a patient’s physical, psychological, and
social characteristics, can guide practitioners in determining the appropriateness
of initiating intrathecal therapy. These consensus guidelines are intended to assist
with weighing this risk/benefit ratio of intrathecal therapy, thereby minimizing
the potential for treatment failure, unacceptable adverse effects, and excess
mortality.
Key words: Chronic pain, noncancer pain, opioids, intrathecal drug delivery
systems, guidelines, consensus guidelines
Comparative Evaluation of the Accuracy of
Immunoassay with Liquid Chromatography
Tandem Mass Spectrometry (LC/MS/MS) of Urine
Drug Testing (UDT) Opioids and Illicit Drugs in
Chronic Pain Patients
Authors: Manchikanti Laxmaiah
Published: March 2021

Background: The challenge for physicians in treating chronic pain with opioids is to eliminate or
significantly curtail abuse of controlled prescription drugs while assuring proper treatment when
indicated. Urine drug testing (UDT) has been shown to be a useful approach in identifying patterns
of compliance, misuse, and abuse. However, significant controversy surrounds the diagnostic
accuracy of UDT performed in the office (immunoassay) and the requirement for laboratory
confirmation with liquid chromatography tandem mass spectrometry (LC/MS/MS).
Study Design: A diagnostic accuracy study of urine drug testing.
Study Setting: The study was performed in an interventional pain management practice, a
tertiary referral center, in the United States.
Objective: The objective of this study was to compare the results of UDT of immunoassay inoffice testing (index test) to LC/MS/MS (reference test).
Methods: One-thousand participants were recruited from an interventional pain management
program. Urine sample was collected from all the consecutive patients with demographic
information. Immunoassay testing was performed by a nurse at the location, laboratory assessment
was performed with LC/MS/MS.
Results of the index test were compared to the reference test in all patients. The sensitivity, specificity,
false-positive, and false-negative rates, and index test efficiency (agreement) were calculated.
Results: Overall, results showed that confirmation was required in 32.9% of the specimens. Agreement
for prescribed opioids was high with the index test (80.4%). The reference test of opioids improved the
accuracy by 8.9% from 80.4% to 89.3%. Non-prescribed opioids were used by 5.3% of patients. The
index test provided false-positive results for non-opioid use in 44% or 83 of 120 patients.
For illicit drugs, the false-positive rate by index test was 0% for cocaine, whereas it was 2% for
marijuana, 0.9% for amphetamines, and 1.2% for methamphetamines.
Limitations: The limitations include a single site study utilizing a single POC kit and a single
laboratory, as well as technical sponsorship.
Conclusion: The UDT with immunoassay in an office setting is appropriate, convenient, and
cost-effective. Compared with laboratory testing for opioids and illicit drugs, immunoassay inoffice testing had high specificity and agreement, demonstrating the value of immunoassay drug
testing. Because of variable sensitivity, clinicians would be well-advised to take a cautious approach
when interpreting the results.
Key words: Controlled substances, opioids, illicit drugs, abuse, liquid chromatography tandem
mass spectrometry, immunoassay, urine drug testing
Illicit Drug Use in the Pain Patient Population
Decreases with Continued Drug Testing
Authors: Pesce Amadeo
Published: March 2021

Background: A major concern of physicians treating pain patients with chronic opioid
therapy and similar drugs is determining whether the patients are also using illicit drugs.
This is commonly determined by urine drug testing (UDT). However, there are few studies
on whether or not monitoring patients by this technique decreases illicit drug use.
Objective: To determine if the presence of illicit drugs decreases over a number of
physician visits where UDT was performed.
Method: The method involved a retrospective study of tests for the illicit drugs
marijuana, cocaine, methamphetamine, ecstacy (MDMA) phencyclidine (PCP) and the
heroin metabolite, 6-acetylmorphine as confirmed by Liquid Chromatography-Tandem
Mass Spectrometry (LC-MS/MS). A database of 150,000 patient visits was examined for
the presence of any of these 6 drugs.
Results: A total of 87,000 patients were initially tested. The number of patients who
were repeatedly tested decreased over time. The percentage of patients positive for any
of these illicit drugs decreased from 23% to 9% after 14 visits where UDT was performed.
When graphed there was a trend to decreasing use. The Spearman correlation = -0.88,
P < 0.0001. The major illicit drug was marijuana. When this was removed from the
analysis, there was an even greater correlation with decreased illicit drug use. Spearman
correlation = -0.92 (P < 0.0001) using a weighted correlation.
Limitation: Patients continuing to use illicit drugs might be dismissed from practices
thus biasing the study towards illicit drug avoidance.
Conclusion: Continued UDT might decrease illicit drug use among pain patients.
Key words: Pain patients, UDT, urine drug testing, LC-MS/MS, illicit drugs, decrease
drug use
CT-Guided Percutaneous Infiltration for the
Treatment of Alcock’s Neuralgia
Authors: Filippiadis Dimitrios K.
Published: March 2021

The pudendal nerve may be strained either between the sacrospinous
and sacrotuberous ligaments at the ischial spine level or within Alcock’s
canal. Alcock’s neuralgia is a rare, painful condition caused by compression
of the pudendal nerve within Alcock’s canal (pudendal canal) which is
an aponeurotic tunnel that cannot be stretched. Patients usually present
with intense, unilateral pain involving anatomic areas along the pudendal
nerve’s root, genital, anal, and pelvic regions causing mobility impairment.
A computed tomography (CT) - guided percutaneous infiltration of the
pudendal nerve with a mixture of a local anesthetic and a long-acting
corticosteroid is a safe and efficient method that reduces the pain caused
by the neuralgia. Corticosteroids and local anesthetics interfere with the
neurons, the encoding, and the processing of noxious stimuli; interrupt the
pain-spasm cycle; and reduce inflammation. The injected glucocorticosteroid
may take 3-5 days to reach its anti-inflammatory effect; therefore, the initial
pain relief from the local anesthetic is followed by a baseline pain return and
then secondary pain relief at 3-5 days. The procedure is performed under
minimal or no anesthesia. In general, at discharge, a responsible person must
accompany the patient and ensure a safe return home. Clinical evaluation
is performed after 7-10 days. There are 2 types of potential complications
that are associated with percutaneous steroid infiltrations: intra-operative
(associated with needle placement) and post-operative (infection, bleeding
and those associated with the injectate administration). In all cases that
steroids were administered within therapeutic doses, no complications were
noted. In conclusion, CT-guided percutaneous infiltration with a mixture
of long-acting corticosteroid and local anesthetic seems to be a safe and
efficient method for the treatment of Alcock’s neuralgia.
Key words: Alcock’s canal, neuralgia, corticosteroid, pudendal; nerve,
local anesthetic, computed tomography, infiltration, percutaneous, image
guided.
One-Year Results of a Randomized, Double-Blind,
Active Controlled Trial of Fluoroscopic Caudal
Epidural Injections With or Without Steroids in
Managing Chronic Discogenic Low Back Pain
Without Disc Herniation or Radiculitis
Authors: Manchikanti Laxmaiah
Published: March 2021

Background: Lumbar radicular pain pathophysiology continues to be the subject of research and
debate as discogenic pain is increasingly seen as a cause of non-specific low back pain. Among
non-surgical methods used to manage chronic low back pain with or without disc herniation,
epidural injections are one of the most common modalities. However, there is little evidence utilizing
contemporary methodology for using epidural injections in patients with discogenic pain.
Study Design: A randomized, double-blind, active-controlled 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 local anesthetic, with
or without steroids, in managing chronic low back pain without disc herniation or radiculitis.
Methods: A total of 120 patients were assigned to one of 2 groups. Group I patients received caudal
epidural injections with local anesthetic (lidocaine 0.5% 10 mL); Group II patients received caudal epidural
injections with 9 mL of 0.5% lidocaine mixed with 1 mL of steroid (either brand name or non-particulate
betamethasone [6 mg] or methylprednisolone [40 mg]. Computer-generated randomization and random
allocation sequence by simple randomization were the randomization techniques utilized.
Outcomes Assessment: Multiple outcome measures were utilized which included the Numeric
Rating Scale (NRS), the Oswestry Disability Index 2.0 (ODI), employment status, functional status,
and opioid intake at 3, 6, and 12 months post treatment. Significant pain relief and functional status
improvement were described as a 50% or more reduction in scores from baseline.
Results: Significant pain relief and functional status improvement were observed in 55% of the
patients in Group I and 68% of the patients in Group II. In contrast, 84% of patients in Group I
and 85% in Group II saw significant pain relief and functional status improvement in the successful
group (62% in Group I and 68% in Group II). The average procedures per year were 3.8 ± 0.9 for
Group I and 4.3 ± 0.9 for Group II. Average pain scores decreased from 8.0 ± 0.9 to 4.3 ± 1.79 for
Group I and from 7.9 ± 1.0 to 3.8 ± 1.59 for Group II. There were no differences among the patients
receiving one of the 3 steroids.
Limitations: The results of this study are limited by lack of a placebo group.
Conclusion: Caudal epidural injections with local anesthetic with or without steroids are effective
in patients with chronic low back pain of discogenic origin without facet joint pain, disc herniation,
and/or radiculitis.
Clinical Trial: NCT00370799
Key words: Chronic low back pain, lower extremity pain, discogenic pain, facet joint pain, disc
herniation, radiculitis, lumbar interlaminar epidural injections, epidural steroids, local anesthetic
Caudal Normal Saline Injections for the
Treatment of Post-Dural Puncture Headache
Authors: Abdulla Prof. Walied
Published: March 2021

Background: Post-dural puncture headache (PDPH) is the most common complication
of procedures in which the dura mater is penetrated.
Objectives: To evaluate the effectiveness of caudal saline injections as a therapeutic
approach for handling post-dural puncture headache.
Study Design: Prospective observational study between 1995 and 2010.
Setting: Associated teaching hospital.
Methods: A 5-cm 20-gauge short-beveled needle, connected by extension tube to a 20-
mL syringe filled with normal saline was used for injection. During injection in increments
(limited by patient discomfort), the patients were asked continually to quantify their pain
experience on a visual analog scale (VAS) and on a 0-3 verbal categorical rating scale
(VRS) after 50, 80 and 100 mL of infusion over a 20 minute period.
Limitations: This study is limited by its sample size, observational design, and lack of
long-term outcomes.
Results: PDPH occurred in 60 of 1,716 patients undergoing dural puncture (3.5%). It
was significantly more common in women and occurred more often in young adults.
The rate was highest in the spinal catheter group (13%) and lowest in the Sprotte
needle group (0.98%). Fifty-six patients underwent caudal saline injections which were
repeated in sessions of 1-2 times a day for 1-2 days. Most patients (n = 48) needed 3
or 4 (n=18) sessions. Mean volumes during the 4 sessions were 120.0 mL, 114.9 mL,
106.5 mL, and 97.8 mL. Four patients were finally treated with a blood patch.
Conclusions: The use of fine gauge pencil-point needles may reduce the incidence
of PDPH. The technique of repeated caudal saline injections is easy, rapid, and effective
in providing the patient with almost immediate headache relief. In cases where this
treatment fails, a blood patch should be considered. Observations from this study
suggest that randomized, controlled, double-blind studies may be warranted.
Key words: Post-dural puncture headache (PDPH), dural puncture, spinal anesthesia,
caudal saline injection
Pulsed Radiofrequency of the Sural Nerve for
the Treatment of Chronic Ankle Pain
Authors: Todorov Lyudmil
Published: March 2021

Background: The application of radiofrequency (RF) has been successfully used in
the treatment of chronic pain conditions, including facet arthropathy, sacroiliac joint
pain, groin pain, radicular pain, cervicogenic headaches, and phantom limb pain. Due
to the neurodestructive effect of continuous RF ablation and possible deafferentation
sequelae, only pulsed radiofrequency (PRF) has been applied to peripheral sensory
nerves. There are no previous reports of successful PRF application to the sural nerve.
Objectives: To report on the successful use of PRF to the sural nerve for the
treatment of ankle pain. To discuss current theories on the mechanism by which PRF
produces pain relief.
Methods: The report presented here describes the case of a 39-year old patient who
sustained injury to her ankle. The patient was complaining of pain in the distribution
of the sural nerve, which was confirmed by electrodiagnostic studies. The pain did
not respond to oral and topical analgesics. The patient had short-term relief with
a sural block with bupivacaine and triamcinolone. The patient then underwent PRF
application to the right sural nerve for 240 seconds at 45 volts.
Results: The patient reported complete relief. There was no pain recurrence 5
months after the procedure.
Limitations: This report describes a single case report.
Conclusions: It is conceivable that PRF may provide long-term pain relief in cases of
sural nerve injury. The exact mechanism of the antinociceptive effect is still unknown.
Possible mechanisms include changes in molecular structure by the electric field,
early gene expression, stimulation of descending inhibitory pathways, and transient
inhibition of excitatory transmission.
Key words: chronic ankle pain, sural neuropathy, radiofrequency, pulsed
radiofrequency application
A Prospective Evaluation of Bleeding Risk of
Interventional Techniques in Chronic Pain
Authors: Manchikanti Laxmaiah
Published: March 2021

Background: The role of antithrombotic therapy is well known for primary and secondary
prevention of cardiovascular disease to decrease the incidence of acute cerebral and
cardiovascular events. Data shows that the risk of coronary thrombosis after antiplatelet drug
withdrawal is much higher than that of surgical bleeding if the antiplatelet drug therapy were
continued. However, it has been a common practice to discontinue antiplatelet therapy prior to
performing interventional techniques, which may potentially increase the risk of acute cerebral
and cardiovascular events.
Study Design: A prospective study of 3,179 patients undergoing interventional techniques
with 12,000 encounters and 18,472 procedures from May 2008 to December 2009.
Study Setting: An interventional pain management practice, a specialty referral center, a
private practice setting in the United States.
Objective: To assess the rates of adverse events in patients undergoing interventional
techniques on antithrombotic therapy with cessation or without cessation and compare them
to a group of patients without antithrombotic therapy.
Methods: Measurable outcomes employed were intravascular entry of the needle, bruising,
local bleeding, profuse bleeding, local hematoma, oozing, and postoperative soreness.
The prospective evaluation was performed utilizing the Strengthening the Reporting of
Observational Studies in Epidemiology (STROBE) statement which was developed with
recommendations to improve the quality of reporting observational studies.
Results: The results of this study illustrated that in one-quarter (3,087) of patient encounters
utilizing interventional pain management techniques, antithrombotic therapy was included.
Among these, for approximately 55%, or 1,711 encounters, antithrombotic therapy was
continued during the interventional techniques, whereas, for 45%, or 1376 encounters,
antithrombotic therapy was discontinued.
Overall, these results illustrate that while intravascular penetration and oozing were higher in
patients with continued antithrombotic therapy, bruising and local bleeding were higher in
patients with discontinued antithrombotic therapy without any difference either statistical or
clinical in any of the other aspects, either intraoperative, post procedure in the recovery room,
or postoperative period.
Limitations: Limitations include the nonrandomized observational nature of the study and
that antiplatelet therapy was limited to aspirin and clopidogrel (Plavix).
Conclusion: No significant prevalence of adverse events was observed in those who continued
with or ceased antithrombotic therapy.
Key words: Interventional pain management, interventional techniques, bleeding disorders,
hemorrhagic complications, aspirin, nonsteroidal anti-inflammatory agents, clopidogrel (Plavix),
warfarin (Coumadin), regional anesthesia, hemostasis, anticoagulants, antithrombotic agents
Alternative Approach for Lumbar
Transforaminal Epidural Steroid Injections
Authors: Zhu Jie
Published: March 2021

The traditional superoanterior approach for transforaminal epidural steroid
injection (TFESI) carries a risk of complication by obstructing arterial
flow to the anterior portion of the spinal cord by puncturing the spinal
radicular artery that passes through the superoanterior foraminal zone
or “safe triangle” zone, which does not describe vascular safety, but
rather describes neural safety. Consequently, multiple disasters have been
described in recent years with transforaminal epidural injections. They are
utilized extensively even though their effectiveness has been debated.
Here we describe a dorsal technique through transforaminal epidural
injections to place the tip of the needle immediately dorsal to the dorsal
root ganglion. Multiple different techniques have been discussed and
described in recent years, the majority of them to avoid the radicular artery
injection.
The primary goal of this paper is to describe another posterior approach to
place the tip of spinal needle directly toward the posterior epidural space
to avoid puncturing the spinal radicular artery and minimize nerve root
penetrations while delivering medication into the epidural space through
the foramen.
Key words: transforaminal epidural injection, selective nerve root block,
safe triangle zone, radicular artery, radiculomedullary artery, lumbar spinal
artery, lumbar vein, intervertebral vein
Feasibility of Combined Epicranial Temporal
and Occipital Neurostimulation: Treatment of a
Challenging Case of Headache
Authors: Wininger Kevin L .
Published: March 2021

Background: Evidence of a paradigm shift towards epicranial neurostimulation treatment
techniques aimed at the site of headache pain is beginning to populate the literature.
This is most apparent by 2 recently published reports describing alternative approaches
to peripheral nerve stimulation techniques for refractory migraine, including hemiplegic
migraine.
Objectives: To contribute to the emerging literature on epicranial-based neuroaugmentative
approaches which target site-specific areas of distinct, but relatively diffuse, headache pain.
Specifically, we describe the feasibility of a novel neurostimulation technique: occipital nerve
stimulation, com­bined with bilateral subcutaneous electrical stimulation over the temporal
region, to treat a patient dually diagnosed with “compli­cated migraine” and occipital
neuralgia. Integral to this report, key stimulation programming data are also presented to
better distinguish the role of this form of therapy in migraine, or other headache forms,
from both the clinical and biomedical perspectives.
Methods: Case presentation with literature review.
Results: At 24-month follow-up, headache onset had been reduced by more than 50%,
including cessation of neurologic deficits that accompanied the patient’s migraines. No
complications or adverse side effects are reported. The programming data reported here
supports a proposed mechanism of action concerning stimulation of the auriculotemporal
nerve distribution/anterior temporal region for management of refractory pain in
migraine.
Limitations: Case presentation provides only initial assessment of treatment safety, not
conclusive evidence of treatment effectiveness. Future studies which consider “followthe-path” epicranial approaches to peripheral nerve stimulation techniques for refractory
headache pain are needed to better quantify outcomes and mechanisms of action.
Conclusions: In the single case reported here, the feasibility of a novel neurostimulation
technique (occipital nerve stimulation/bilateral subcutaneous temporal region stimulation)
to treat headache is presented. At the 24-month follow-up, no complications (such as
loss of coverage due to lead displacement or lead fracture or erosion) or adverse side
effects were reported. Finally, inclusion of fundamental programming data in reports on
neuroaugmentative approaches to headache care will complement initiatives in research
from the clinical and biomedical communities involved in this field.
Key words: Epicranial neurostimulation technique, peripheral nerve stimulation,
stimulation parameters, complicated migraine, occipital neuralgia.
Automatic Adaptation of Neurostimulation
Therapy in Response to Changes in Patient
Position: Results of the Posture Responsive
Spinal Cord Stimulation (PRS) Research Study
Authors: Schade Cristy M.
Published: March 2021

Background: Variation in the intensity of neurostimulation with body position is a
practical problem for many patients implanted with a spinal cord stimulation system because
positional changes may result in overstimulation or understimulation. These posture-related
changes in patients’ perception of paresthesia can affect therapeutic outcomes of spinal
cord stimulation therapy. An accelerometer-based algorithm that automatically adjusts
spinal cord stimulation based on sensed body position or activity represents a potential
solution to the problem of position-mediated variations in paresthesia perception.
Objective: The objective of this study was to compare patient satisfaction ratings for
manual versus automatic adjustment of spinal cord stimulation amplitude in response to
positional changes.
Study Design: Prospective, multicenter, open-label, randomized trial
Setting: 2 pain centers in the US.
Method: Twenty patients at 2 centers in the U.S. who had been implanted with a
spinal cord stimulation system for low back and/or leg pain were enrolled in the study.
During a 3-day run-in phase, patient position and activity changes were monitored with
an ambulatory data recorder and with a research patient programmer which recorded all
stimulation parameter changes. Patients who made ≥ 2 amplitude adjustments per 24-
hour period were invited to participate in an in-clinic phase. During the in-clinic phase,
patients’ preferred stimulation amplitude and therapy impedance measured at the preferred
stimulation amplitude were determined as they performed a series of 8 physical tasks.
Satisfaction ratings were determined during position transitions between the physical tasks
using both manual and automatic adjustments.
Results: Among the 15 patients who completed the in-clinic test protocol, overall
satisfaction ratings were significantly higher for automatic adjustment of stimulation
amplitudes versus manual adjustments. Patients reported statistically significant
improvements with automatic versus manual adjustment for the standing to supine
transition and for supine to standing transition. Approximately 74% of participants rated
the paresthesia intensity of the automatic adjustment algorithm as “just right” for the
physical tasks that were completed.
Limitations: Small study size.
Conclusion: Patients preferred automatic versus manual adjustment of stimulation
amplitude in response to changes in paresthesia consequent to positional changes during
in-clinic testing.
Key words: spinal cord stimulation, automaticity, paresthesia, neuromodulation,
neurostimulation, adaptive stimulation, posture responsive stimulation, accelerometry
Infection Control Practices (Safe Injection and
Medication Vial Utilization) for Interventional
Techniques: Are They Based on Relative Risk
Management or Evidence?
Authors: Manchikanti Laxmaiah
Published: March 2021

Background: Recently, multiple regulations and recommendations for safe infection control practices
and safe injection and medication vial utilization have been implemented. These include single dose
and multi-dose vials for a single patient and regulations. It is a well known fact that transmission
of bloodborne pathogens during health care procedures continues to occur because of the use
of unsafe and improper injection, infusion, and medication administration. Multiple case reports
have been published illustrating the occurrence of infections in interventional pain management
and other minor techniques because of lack of safe injection practices, and noncompliance with
other precautions. However, there are no studies or case reports illustrating the transmission of
infection due to the use of single dose vials in multiple patients when appropriate precautions are
observed. Similarly, the preparation standards for simple procedures such as medial branch blocks or
transforaminal epidurals have not been proven to be essential. Further, the effectiveness or necessity
of surgical face masks and hats, etc., for interventional techniques has not been proven.
Objective: To assess the rates of infection in patients undergoing interventional techniques.
Study Design: A prospective, non-randomized study of patients undergoing interventional
techniques from May 2008 to December 2009.
Study Setting: An interventional pain management practice, a specialty referral center, a private
practice setting in the United States.
Methods: All patients presenting for interventional techniques from May 2008 to December 2009
are included with documentation of various complications related to interventional techniques
including infection.
Results: May 2008 to December 2009 a total of 3,179 patients underwent 12,000 encounters
with 18,472 procedures.
A total of 12 patients reported suspicion of infection. All of them were evaluated by a physician
and only one of them was a superficial infection due to the patient’s poor hygienic practices which
required no antibiotic therapy.
Limitations: Limitations include the nonrandomized observational nature of the study.
Conclusion: There were no infections of any significance noted in approximately 3,200 patients
with over 18,000 procedures performed during a 20 month period in an ambulatory surgery center
utilizing simple precautions for clean procedures with the use of single dose vials for multiple
patients and using safe injection practices.
Clinical Trial Registrion: NCT00625248
Key words: Interventional pain management, interventional techniques, complications, infection,
safe injection practices, single dose vials, multi-dose vials, surgical face masks, relative risk.