Comparing Guidance Techniques for Chemodenervation Procedures

AAPMR WS 2015 Katharine Alter MD

WHAT’S THE EVIDENCE

Guidance Techniques: Anatomic US, EMG, Electrical Stimulation

REVIEW ARTICLE 2015

Grigoriu AI et al 2015 • Systematic review comparing the impact of

various injection guidance techniques (Manual/palpation, EMG, E-Stim, US) on the efficacy of BoNT injections.

• Ten studies were reviewed – Seven were randomized trials.

• Level of evidence was determined using the modified Sackett scale. Grigoriu AI et al. Impact of Injection-Guiding Techniques on the Effectiveness of

Botulinum Toxin for the Treatment of Focal Spasticity and Dystonia: A Systematic Review. Arch Phys Med Rehabil. 2015 May 14

Grigoriu AI et al 2015 • Conclusions: there is Level 1 evidence that

instrumented guidance (EMG, ESTIM, US) is more effective than manual needle placement when treating patients with – Spasmodic torticollis – Upper limb post stroke spasticity (PSS) – Children with cerebral palsy (CP).

Grigoriu AI et al. Impact of Injection-Guiding Techniques on the Effectiveness of Botulinum Toxin for the Treatment of Focal Spasticity and Dystonia: A Systematic Review. Arch Phys Med Rehabil. 2015 May 14

Grigoriu AI et al 2015 • Three studies provided Level 1 evidence of

similar effectiveness when using US and EStim for upper & lower limb for – Adults with Post Stroke Spasticity – Children with spastic equinus from CP

• However, the authors concluded that US appeared to be more effective than EStim for spastic equinus in adults with PSS. Grigoriu AI et al. Impact of Injection-Guiding Techniques on the Effectiveness of

Botulinum Toxin for the Treatment of Focal Spasticity and Dystonia: A Systematic Review. Arch Phys Med Rehabil. 2015 May 14

Grigoriu AI et al 2015 • There was poor or no available evidence to

support the efficacy of EMG or other instrumented techniques.

Grigoriu AI et al. Impact of Injection-Guiding Techniques on the Effectiveness of Botulinum Toxin for the Treatment of Focal Spasticity and Dystonia: A Systematic Review. Arch Phys Med Rehabil. 2015 May 14

LOWER LIMB MUSCLES

US vs. Blind Needle Placement Using Anatomic Guidance

• 2 clinicians – Experienced EMG Attending (>10 years) – Resident (6 months EMG experience)

• 14 lower limb muscles, 2 fresh frozen cadavers – Fine wire placed either by

• Standard manual needle placement • Placement under US guidance

– Accuracy of placement checked by a blinded clinician using CT

Cadaver Study, Blind Needle Placement vs. US Guided Placement, Boon A et al 2011

Accuracy of electromyography needle placement in cadavers: non-guided vs. ultrasound guided. Boon AJ et al Muscle Nerve. 2011 Jul;44(1):45-9.

• Accurate placement = in target muscle or ≤ 5mm deep to muscle

• Location of needle relative to vital structures was also noted ( ≤ 5mm )

• For inaccurate placement, trajectory of the wire was recorded i.e. correct or not

• Overall Accuracy for both clinicians – Blind placement: 39% – US Guided: 96%

Boon et al 2011 Blind Needle Placement vs. US

• Blind placement: Overall Accuracy : 39% – 0% : FDI, Semi T, Semi M, EHL, Rect. femoris – 100%: Tib anterior, Short head Biceps Femoris

• Ultrasound Guidance: Overall Accuracy; 96%

– 50% Popliteus, Semi T – 100% for all other muscles

Boon et al 2011, Blind Needle Placement vs. US

• Does experience matter? – No statistical difference between the more

experienced and less experienced clinician

– Experienced clinician had a more accurate trajectory (82% vs. 50%)

Boon et al 2001

Non-guided Ultrasound-guided Muscle # Correct % # Correct % Attempts Placement Accuracy Attempts Placement Accuracy Rect F 4 0 0 4 4 100 Gracilis 4 3 75 4 4 100 BF SH 4 4 100 4 4 100 BF LH 4 1 25 4 4 100 ST 4 0 0 4 2 50 Poplit. 4 0 0 4 2 50 Tib ant 4 4 100 4 4 100

Accuracy of electromyography needle placement in cadavers: non-guided vs. ultrasound guided. Boon AJ et al Muscle Nerve. 2011 Jul;44(1):45-9.

Non-guided Ultrasound-guided Muscle Number Correct % Number of Correct % Attempts Placement Accuracy Attempts Placement Accuracy

EHL 4 0 0 4 4 100 Per Long 4 3 75 4 4 100 Per tertius 4 3 75 4 4 100 Tib post 4 2 50 4 4 100 FHL 4 1 25 4 4 100 Abd hal 4 1 25 4 4 100 FDI pedis 4 0 0 4 4 100

Accuracy of electromyography needle placement in cadavers: non-guided vs. ultrasound guided. Boon AJ et al Muscle Nerve. 2011 Jul;44(1):45-9.

Accuracy of Manual Needle Placement Checked by US Eun Joo Yang et al, Archives PM&R 2009

• Prospective study: 272 injections, 39 children • Injection site selected by anatomic landmarks • Needle site checked by second clinician using ultrasound • Accuracy of injection

– 64% lateral gastrocnemius • Accuracy lower in younger/smaller patients

– 92 % medial gastrocnemius

• Conclusion: landmark based injection guidance not acceptable for lateral gastrocnemius

Conclusions: Even in a relatively superficial , large muscle US is superior to anatomic

localization

Lateral Gastrocnemius Medial Gastrocnemius

Prospective Study: Efficacy BoNT

• Lower limbs, children with CP according to : – Age, dose, dilution, injection site – Needle placement technique (manual vs. US) – Patient Selection:

• Children /CP > 1 year receiving BoNT-A • Add, HS, gastroc/soleus were included

US Guided BoNT Injections in Children with CP Annals Phys Med 2009

Py AG, Zein Addeen G, Perrier Y, Carlier RY, Picard A

Methods • 54 patients participated

– 30 received BoNT with US guidance • Pre-/post- BoNT evaluations were done

– Clinical examination – GMFM-88.

• RESULTS: Overall clinical effectiveness for 51% of children

• Efficacy significantly higher for children < 6 or > 12

Py AG et al continued

Py AG et al continued

Efficacy

Higher when: – Doses > 0.8 UI/kg/muscle Botox – When the injected muscles were

hamstrings or gastrocnemius, – When the injections were

guided by ultrasound – Dilution had no effect on clinical

effectiveness.

Functional Outcome – At 1 month improved in 24% – Improvement significantly

better for • < 6 years old • Injections under ultrasound

– CONCLUSIONS: study confirmed effectiveness of BoNT was • Higher in younger children • With injected doses higher than 0.8

UI/kg per muscle Botox • Injections guided by ultrasound.

US VS. E-STIM

BoNT Calf Muscles, Equinus in CP: Controlled Trial Comparing US and E-Stim:

Kwon Am J Phys Med Rehab 2010

• 32 children CP, equinus gait – Enrolled in separate categories based on GMFCS

• 2 groups: US and E-Stim • Gastrocnemius (n 30)

– Equal dose BoNT , 4-6 sites, 30 children

• Injection guidance: 14 E-Stim 16 US • Evaluation: baseline, 1, 3 months post injection

– MAS, M-Tardieu, selective motor control, PRS-gait

BoNT calf muscles for treatment of equinus in CP: controlled trial comparing US and E-stim Kwon Am J Phys

Med Rehab 2010

• Results – US Group: significantly improved PRS subscales

• Gait pattern • Hindfoot position • Maximum foot/floor contact during stance

• No statistical differences noted – MAS – M-Tardieu Scale – Selective Motor Control.

UPPER LIMB MUSCLES

Comparing US, Estim and Manual Guidance

US or Estim or Manual Guidance: Picelli et al 2014

• RCT 3 groups US, Estim or Manual guidance

• Treatment of PSS • At least 2 forearm flexor

muscles injected • Outcome measures at 4

weeks: – MAS – Tardieu Scale – Wrist and fingers PROM.

• Greater improvement in all outcome measures was noted with Estim and US when compared to manual guidance

• There was no statistical difference in the improvement when comparing the Estim and US groups

Picelli A. et al. Botulinum toxin injection into the forearm muscles for wrist and fingers spastic overactivity in adults with chronic stroke: a randomized controlled trial comparing three injection techniques. Clin Rehabil. 2014 Mar;28(3):232-42

UPPER LIMB MUSCLES

US vs. Anatomic/Manual Guidance

Santamato et al 2014: US vs Manual

• RCT of 15 patients with upper limb PSS comparing US to manual guidance techniques.

• Outcome measures included – MAS measuring reduction in tone – Subject’s finger position at rest pre and post

injection

Santamato A et al Can botulinum toxin type A injection technique influence the clinical outcome of patients with post-stroke upper limb spasticity? A randomized controlled trial comparing manual needle placement and ultrasound-guided injection techniques. J Neurol Sci. 2014 Dec 15;347(1-2):39-43

Santamato et al 2014 US vs Manual • Results

– The 2 outcome measures were improved in both treatment groups

– The improvement in both measures in the group treated using US guidance was statistically greater than those whose treatment was guided manually

• Conclusions: US guidance for BoNTA injections could improve clinical outcome measures better than manual needle placement in patients with PSS.

Santamato A et alCan botulinum toxin type A injection technique influence the clinical outcome of patients with post-stroke upper limb spasticity? A randomized controlled trial comparing manual needle placement and ultrasound-guided injection techniques. J Neurol Sci. 2014 Dec 15;347(1-2):39-43

• 18 Patients, problematic UE spasticity – Excluded patients with: severe contractures or trauma

• Anatomic localization techniques: • Delagi: FPL, FCR, PT, • Bickerton: FDS individual fascicles

– Method: • Prox-distal: reference line; medial epicondyle-psiform.

– Relative prox:distal distances calculated » Expressed as %length

• Medial-lateral coordinated: perpendicular to above line. – Measured in mm lateral (radial) to reference line

Surface vs US Localization to Identify Forearm Flexor Muscles for BoNT Henzel, Munin et al PMR 2010

• Results: significant differences in optimal site: – Proximal-Distal site:

• FPL (p.042) • PT (p .003) • Trend FCR (.066).

– Lateral distance from reference line: • FDS3 (.011) • FCR (.023) • Trend in FDS2 (.052), FDS4 (.088)

Manual vs US Localization: Forearm Flexor Muscles Henzel et al PMR 2010

• Conclusion: • US localization revealed significant differences

in optimal muscle injection site compared to surface guided recommendations – May be due to many factors

• Cadaver specimens used for surface references • Patient size • Positioning patients with spasticity for surface

techniques • 3D distortion from spasiticity

Manual vs US Localization Forearm Flexor Muscles: Henzel et al PMR 2010

Case Report: Vasogenic TOS Danielson and Odderson Am J Phys Med 2008

• Vascular TOS – Reduced BF measured in radial artery – 3 x increased velocity across stenotic

area of subclavian artery with arm hyper-abducted

• Tx: 15 Units OnabotulinumtoxinA injected into anterior scalene, US guided

• Post injection – Improved blood flow in provocative

position – Decreased symptoms

Pre OnabotulinumtoxinA

Post BotulinumtoxinA Daniel & Odderson Am J Phys Med 2008

ULTRASOUND VS EMG

Head and Neck

Elimination of dysphagia using US guidance for BoNT injections in cervical dystonia

Hong JS, Sathe GG, Niyonkuru C, Munin MC Muscle Nerve. 2012 Oct;46(4):535-9

• 5 females with CD – Dysphagia following EMG

guided injections

• Subsequent Injections performed with US guidance, reported – Effects on swallowing – SCM thickness measured

in controls and treated patients

• EMG – 98 injection sessions

• 34 episodes of dysphagia – Cumulative rate 34.7%.

– 27 Injections US+ EMG • 0% dysphagia across

• US Evaluation of Muscle thickness – Post Injection, SCM

thickness <1.1 cm

Combining US and EMG for BoNT chemodenervation for TOS: comparison with fluoroscopy/EMG guidance

Jordan et al, Pain Physician, 2007

• TOS BoNT Injections • Combined US/EMG in

77 of 245 procedures • 168 of 245 procedures,

fluoroscopy/EMG was used

• Complications – 0% US/EMG – 1.8 % (3/168) for

fluoroscopy/EMG

• Efficacy Outcomes “Good” – 91% US/EMG (70/77) – 81% Flouroscopy/EMG

136/168