Download back and leg pain

Best Spine Articles 2015
Brian D. Steinmetz, DO, FAAPMR
Interventional Spine & Sports Medicine
OSS Health
Orthopedic & Spine Specialists
York, PA
Conflicts/Disclosures
• Nothing to disclose
Thanks to Justin Waltrous, MD for his contribution to preparation of this article summary
Background
• Steep rise in transforaminal epidural steroid
injections from the year 2000 to 2011
• Particulate steroids traditionally used given
perceived efficacy; however, spinal cord ischemia
documented with triamcinolone,
methyprednisolone and betamethasone
acetate/phosphate
• Non-Particulate steroid (dexamethasone) has not
been demonstrated to cause spinal cord ischemia
• Necessary to study head to head efficacy of
particulate vs non-particulate steroids
Methods
• Study completed in two academic centers in
Montreal, Canada
• Carried out between 12/2010 and 1/2013 and
patients selected from ED or outpatient center
with lumbosacral radicular pain
• One of three physicians, 1 anesthesiologist
and 2 physiatrists, evaluated patients
Methods
• Inclusion criteria:
• >18 years old
• More radicular than lumbar pain
• MRI findings of a herniation correlating to pain distribution
• Exclusion criteria:
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Contraindication to procedure
Cauda equina syndrome
Tumors, infection, or inflammatory etiology of back pain
Previous surgery
ESI in past 3 months
Workers comp or disability insurance claims
Pregnancy or nursing
• Medications allowed as needed
• Other treatments (like PT) discouraged
Methods
• Following anesthetic test dose of 1ml of 2%
lidocaine:
• One group 6mg betamethasone (1mL)
• Second group received 7.5mg dexamethasone
in 0.25mL saline (total of 1mL)
• Injectate blinded to patient and treating
physicians
• Injection could be repeated at 1 month or later
with same steroid, no cross over
• Decision to inject 1 or 2 levels up to treating
physician
Results
• Demographic characteristics similar across
groups
• 76 TFESI series, 99 total injected levels
• L5=46, S1=43, L4=7, L3=3
Results
Results
Results
Results
Results
Results
Complications
• Most significant complication was dural
puncture in one injection improved with blood
patch, no long term side effects related to
steroid use
• Complication rates similar to other studies
Discussion
• Similar results to recent studies by El
Yahchouchi et al. (2013) and Kennedy et al.
(2014) regarding non-inferiority of
dexamethasone.
• Conflicting with Park et al. (2010) –
triamcinolone superior
• O’Donnell et al. (2008) used non-equivalent
steroid doses – triamcinolone superior
Limitations
• Biggest limitation is they did not reach
statistical power
• Probably best utilized in a future Metaanalysis
Conclusion
• A third study suggesting non-inferiority of
dexamethasone for lumbar transforaminal
epidural steroid injections
• I switched to Dex last year as first line
• Will consider particulate for impressive shortterm responders requiring a second injection
– Informed consent regarding particulate risk
Questions?
Thanks to Simon Shapiro, DO for his contribution to preparation of this article summary
Introduction
• To improve safety of cervical interlaminar ESIs,
the contralateral oblique (CLO) view has been
proposed as a compliment or alternative to
the lateral view to assess needle depth
• No study has assessed the optimal angle and
predictability of the projection of the needle
tip in the CLO view
• No study has compared the CLO view to the
lateral view
Materials/Methods
• All patients scheduled for cervical interlaminar
ESIs with available MRI
• No contrast allergies or posterior surgeries
included
• 20g Tuohy needle placed with saline loss of
resistance technique
• Fluoroscopic images in AP, lateral, 30⁰, 40⁰,
45⁰, 50⁰, isointense, measured angle
30 Degree Oblique
30 Degree Oblique
53 Degree Oblique
53 Degree Oblique
Results
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24 subjects completed study
15 men, 9 women
36 to 76 years old, mean 53 years old
9 injections C6-7, 15 at C7-T1
Mean measured CLO on MRI was 53⁰ (48-56⁰)
at C6-7 and 52⁰ (50-57⁰) at C7-T1
• Mean ligamentum flavum thickness was
1.8mm at injection level
Results
Results
Results
• Of the 13 needles placed in AP zone 2:
– 10 projected in lateral zones 2 or 3 and 2 were not
visualized
• Of the 9 needles placed in AP zone 1:
– 6 projected in lateral zones 2 or 3 and 1 was not
visualized
Limitations
• Relatively small sample size
• No attempt to optimize patient position for
lateral view (downward shoulder traction,
swimmers view)
Conclusions
Questions?
Thanks to Amir Tahaei, MD for his contribution to preparation of this article summary
Background
• HF10, involves application of 10KHz, short
duration (30 micro Seconds), Low Amplitude
(1-5 mA)
• Traditional SCS stim frequency 40-60Hz
• No perceptible paresthesia with HF10 like
traditional SCS
• No need for paresthesia mapping during trial
typical of traditional SCS
SENZA-RCT study
• Safety and efficacy of HF10 SCS to traditional
SCS in patient with back and leg pain
• Multicenter, Randomized, Controlled
• Pivotal trial (Per FDA: pivotal study is a
definitive study in which evidence gathered to
support the safety and effectiveness
evaluation of the medical device for its
intended use)
Study Design
• Primarily assess non inferiority and then superiority of
HF10 K SCS to traditional SCS
• Chronic and intractable back and leg pain
• Refractory to conservative management for 3 months
• Average Back or leg pain of 5 /10 on VAS
• ODI 41 to 80/100, and appropriate candidate for
implant surgery
• Exclusion criteria: Active disruptive psychological or
psychiatric disorder, or other condition with improper
perception of pain, mechanical instability in Flex/Ext Xray, prior SCS experience
Study
• Randomized in 1:1 to HF10 (Senza system,
Nevro Corp USA), vs commercially available
(Boston Scientific)
• Randomized per gender and primary pain area
• Both has two 8-contacts leads and a
rechargeable IPG placed
• Due to practical consideration, study subjects,
and investigators were not masked
Interventions
• SCS trial for up to 14 days
• 40% or greater pain reduction for permanent
placement (less than 50% endpoint requirement)
• Oral analgesia stabilization 28 days before
enrollment
• Traditional SCS in parallel at ~T8 with paresthesia
mapping
• HF10 SCS overlapping near midline T9 T10
spanning T8 to T11, no mapping
Outcome assessment
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Assessment in Baseline, 1, 3, 6, 9 and 12 months
VAS, ODI, Global assessment
Adverse event
Neurological assessment (Motor, Sensory, reflex)
Responders or non-responders
Remitters (pain VAS =<2.5), non-remitters
Assess non-inferiority, if not inferior then assess
superiority
Results
• Randomized subjects:
– 13.6 years since diagnosis
– mean age 54.9
– 86.6% previous back surgery
– 77.1% failed back
– 88.3% on opioids
• Baseline VAS:
– back pain: 7.6 +1.2
– Leg pain: 7.3+1.4
Results
• 3 months:
– Back Pain:
• 84% back pain responder in HF10
• 43.8% in traditional SCS (P<0.001)
– Leg Pain:
• 83.1% leg pain responders in HF10
• 55.5% in traditional (P<0.001)
Results
• 12 Months:
– Back pain:
• 80% responders in HF10
• 50% in traditional SCS (P<0.001)
– Leg Pain:
• 80% responders in HF10
• 50-55% in traditional SCS (P<0.001)
Results
• 12 Months:
– Remitters:
• 67% were back and leg pain remitters in HF10
• Back pain 35% and leg pain 40% in traditional SCS (P<0.001)
– VAS decrease:
• Back Pain:
– 67% in HF10
– 44% in traditional SCS
• Leg Pain:
– 70% in HF10
– 49% in traditional SCS
Results
• 12 months:
– Opioids:
• 35.5% off opioid therapy in HF10
• 26.4% in traditional SCS (P=0.41)
– Patient satisfaction:
• 55.4% in HF10
• 32.3% in traditional SCS
• Significant improvements in ODI and Global
Assessment of Function favoring HF10
• No uncomfortable stimulation in HF10 versus 46.5% in
traditional group
Results
• 12 months: ODI improved by 16.5 in HF10,
versus 13 for traditional SCS
• 12 months: Disability decreased 62.9% in
HF10, versus 45.7% for traditional SCS
(P=0.03)
• 12 months: Global assessment of functioning
70.8% in HF10, versus 59.3% for traditional
SCS (P=0.15)
Adverse effects
• Adverse effects comparable
• lead migration:
– HF10 3.0%
– Traditional SCS 5.2%
Discussion
• Both traditional and HF10 SCS demonstrated
safety and efficacy
• Low incidence of study related adverse effects
over 12 months (4-7.2%).
• Success of HF10 is superior traditional SCS for
both leg and back pain
• Back pain coverage nearly 2x that of
traditional SCS
Discussion
• HF10 SCS: 2/3 of patients achieved remitter
(VAS<2.5) in back and leg pain, and 1/3 of
patients decreased or eliminated opioid
analgesic usage at 12 months
• Dramatic improvement of ADL, and quality of
life
Discussion
• This article mirrors a
previous observational
study of HF10 in Europe
Limitations
• No masking of investigators
• 30-45 mins of recharging daily in HF10 vs 5.2
times recharging for 2.3 hours monthly in
traditional SCS
• Programming was not measured in this study
Conclusion
• HF10 therapy provides the first randomized,
controlled trial demonstrating superiority of
HF10 over traditional SCS for treatment of
chronic back and leg pain
• Paresthesia free, no need for intra-operative
paresthesia mapping, better tolerated
• Game Changer?
Questions?
Background
• Previous Medicare database studies have
demonstrated increased all cause mortality in
conservatively managed patients compared to
patients after cement augmented vertebral
compression fractures (VCFs)
• Goal to compare non-surgically managed VCF
to balloon kyphoplasty (BKP) and
vertebroplasty (VP) treated patients
Methods
• Medicare database study of all ICD-9 codes
indicating new vertebral compression
fractures from 2005-2009
• 1-year look back period for 12 specific
comorbidities and used to determine premorbid health status
• Also recorded diagnosis of pneumonia within
90 days of death
Methods
• Exclusion criteria:
– Cement augmentation procedure in look
back period
– Younger than age 65 (ie disability)
– Managed Medicare patients
– Spinal fusion in year following VCF
Methods
• Statistical analysis included Propensity
Matching
– VP and BKP patients were matched to 3
non-surgical patients most closely matching
pre-morbid health for analysis
• 4 year morbidity, mortality, treatment
risks calculated
Results
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1,038,956 patients met criteria
BKP 141,343 (13.6%)
VP 75,364 (7.3%)
Non-surgical (79.1%)
Augmented patients more likely to be Dx with
pathologic fracture
• Non-surgical more likely to be Dx with
traumatic fracture
Results
• 4 year adjusted mortality:
– Non-surgical cohort risk is 55% higher than
the BKP cohort and 25% higher than the VP
cohort
• Non-matched 4 year mortality:
– Non-surgical 49.4%, VP 46.2%, BKP 41.8%
Results
• Compared to BKP at 4 years:
– Non-surgical cohort carried higher adjusted risk of
pneumonia, MI, DVT, UTI
– Non-surgical cohort carried lower adjusted risk of
subsequent augmentation/fusion, and
pulmonary/respiratory complications
• Compared to VP at 4 years:
– Non-surgical cohort carried higher adjusted risk of
UTI
– Non-surgical cohort carried lower adjusted risk of
subsequent augmentation/fusion, and
pulmonary/respiratory complications, and PE
Results
• For osteoporotic VCF:
– Non-operative carries 70% higher adjusted 4 year
mortality risk compared to BKP
– BKP carries 17% lower adjusted 4 year mortality
risk compared to VP
Discussion
• Improved risk of mortality may be from
improved pulmonary function, earlier
mobility, decreased opioid and NSAID use
• Differences between BKP and VP may be from
height restoration or higher/more controlled
cement volume in BKP
• Similar results seen in other large population
based studies
Limitations
• Fracture severity was not assessed
– More severe fractures, especially in sicker
individuals may go untreated
• Obesity and smoking not evaluated due to
database limitations
• Did not look at younger VCF patients
Conclusion
• Multiple database studies now saying
increased mortality if fractures conservatively
managed
• Should we be more aggressive at offering this?
• Counseling should include this in discussion
• Is it really the balloon?
Questions?
Background
• Lumbar flexion-extension radiographs are
often helpful in evaluating for
spondylolisthesis and segmental instability
• Study is often limited by quality of X-ray tech
and patient tolerance to motion
• Various measurement conventions are used
for define instability
• Most common technique is in standing
position
Background
• Comparison of upright lateral to supine saggital
MRI may be useful and has not been formally
studied
• Objectives:
– Compare observed mobility between upright
(U) X-ray and saggital MRI (S) (combined, US)
– Compare US measurements to lateral flexionextension X-ray (FE)
– Identify factors associated with findings on
each
Methods
• Power analysis required 58 patients
• 68 consecutive patients with lumbar
spondylolisthesis at a single outpatient center
• FE films obtained in a single radiology
department in a standardized manner
• % saggital translation measured by 2 similar
published criteria
– >8% of the width of the above adjacent vertebra
considered unstable
F
E
U
S
Results
• Demonstrated mobility statistically higher in
US (7.68±5.34%) compared to FE (4.90±3.82%,
p=0.001)
• 70.6% had greater mobility with US
• 29.4% had greater mobility with FE
• Greater translation in U or F compared with E
or S
• Dynamic instability identified in 42.6% on US
compared to 17.6% on FE (P=0.003)
Results
• Females and shorter stature demonstrated
more mobility on FE
• Lack of back pain demonstrated increased
mobility on FE
• No difference with age, weight, BMI, level,
grade, type on FE
• High BMI, Grade II/III listhesis and isthmic
listhesis had greater mobility on US
Discussion
• Similar findings to a prior study comparing
upright X-ray to supine CT
• Similar findings to a prior study which showed
that extension films added little compared to
upright and flexion
• Back pain and muscle tension may account for
differences compared to supine MRI
• Flexion may paradoxically reduce translation
in higher grade listhesis in some patients
Conclusion
• Comparing upright films to supine MRI is high
yield for demonstrating instability
• May reduce cost, radiation exposure, and
patient discomfort
Facet Diastasis
Questions?
Thank you