Botulinum Toxin Injection Guid

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I B R . O D D E R S O N

I N J E C T I O N G U I D E

S P A S T I C I T Y

D Y S T O N I A

M I G R A I N E

H Y P E R H I D R O S I S

D R O O L I N G

P A I N

R A T I N G S C A L E S

C O D I N G / B I L L I N G

BOTULINUM

TOXIN


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BOTUL INUM TOX INI N J E C T I O N G U I D E


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BOTULINUM TOXINI N J E C T I O N G U I D E

Ib R. Odderson, MD, PhDAssociate ProfessorUniversity of Washington Medical Center

Seattle, Washington

Medical Publishing


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Acquisitions Editor: R. Craig Percy

Cover Designer: Steve Pisano

Indexer: Christine Lindemer

Compositor: Lapiz Digital Services

Printer: Malloy Litho

Visit our web site at www.demosmedpub.com

2008 Demos Medical Publishing, LLC. All rights reserved. This book is protected

by copyright. No part of it may be reproduced, stored in a retrieval system, or

transmitted in any form or by any means, electronic, mechanical, photocopying,

recording, or otherwise, without the prior written permission of the publisher.

Library of Congress Cataloging-in-Publication DataOdderson, Ib R.

Botulinum toxin injection guide / Ib R. Odderson.

p. ; cm.

Includes bibliographical references and index.

ISBN-13: 978-1-933864-21-1 (pbk. : alk. paper)

ISBN-10: 1-933864-21-4 (pbk. : alk. paper)

1. Botulinum toxin--Therapeutic use--Handbooks, manuals, etc. I. Title.

[DNLM: 1. Botulinum Toxins--administration & dosage. 2. BotulinumToxins--therapeutic use. 3. Injections--methods. QW 630.5.B2 O22 2008]

RL120.B66O33 2008

615.788--dc22

2007052989

Medicine is an ever-changing science undergoing continual development. Research

and clinical experience are continually expanding our knowledge, in particular

our knowledge of proper treatment and drug therapy. The authors, editors, and

publisher have made every effort to ensure that all information in this book is inaccordance with the state of knowledge at the time of production of the book.

Nevertheless, this does not imply or express any guarantee or responsibility on the

part of the authors, editors, or publisher with respect to any dosage instructions and

forms of application stated in the book. Every reader should examine carefully the

package inserts accompanying each drug and check with his physician or specialist

whether the dosage schedules mentioned therein or the contraindications stated by

the manufacturer differ from the statements made in this book. Such examination

is particularly important with drugs that are either rarely used or have been newlyreleased on the market. Every dosage schedule or every form of application used is

entirely at the readers own risk and responsibility. The editors and publisher welcome

any reader to report to the publisher any discrepancies or inaccuracies noticed.

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Made in the United States of America

08 09 10 11 5 4 3 2 1


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To

Ingrid, Erik, and Eva


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George H. Kraft, MD,has been a mentor and a good friend since the

beginning of my residency program at the University of Washington,

Seattle. He is a breath of fresh air, always optimistic, inspiring, and

fun to be around. He is truly an academic statesman, has advised

me well, and opened many doors for me. Thank you, George.


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Acknowledgments

I would like to thank the following people for their help. George H. Kraft,

MD, professor, for his help in connecting me with all the right people.

R. Craig Percy, senior medical editor, for his advice and support with this

project.Jennifer Smith, medical illustrator, for her hard work and artistic

skill in rendering the illustrations for this book. Gerard Francisco, MD,

adjunct associate professor, for kindly reviewing the manuscript and

his thoughtful comments. Srinivas Nalamachu, MD, clinical assistant

professor, for his vast clinical expertise and helpful suggestions. Kenneth

H. Willer, medical librarian, and Carmen Townsend, librarian specialist,

for their prompt and extraordinary librarian service. My patients, who

have had procedures, you have taught me much and helped me learn and

improve my skills.


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Contents

Preface xiii

Introduction xv

1Head and Neck

1

Migraine 1/3 2

Migraine 2/3 6

Migraine 3/3 8

Facial Hemispasms 10

Blepharospasms 12

Drooling/Sialorrhea 14

Lingual Dystonia 16

Oromandibular Dystonia 18

Cervical DystoniaTorticollis 1/2 20

Cervical DystoniaTorticollis 2/2 22

Cervical DystoniaRetrocollis 24 Cervical DystoniaLaterocollis 26

Cervical DystoniaAnterocollis 28

2Spasticity/Dystonia: Upper Extremities 31

Adducted/Internally Rotated Shoulder 1/2 32

Adducted/Internally Rotated Shoulder 2/2 34


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Flexed Elbow 36

Pronated Forearm 38

Flexed Wrist 40

Extended Wrist 42

Clenched Fist 44

Thumb-in-Palm 46

Adducted Thumb 48

Intrinsic Plus Hand 50

Extended Digits 52

Writers Cramp 1/3 54



Safety Information Update 60

Pediatric Dosing for Upper Extremities 61

3Spasticity/Dystonia: Lower Extremities 63

Flexed Hip 1/2 64

Flexed Hip 2/2 66

Adducted Thigh 68

Flexed Knee 70

Extended (Stiff) Knee 72

Equinovarus Foot 1/3 74



Valgus Foot 1/2 80 Valgus Foot 2/2 82

Striatal Toe 84

Flexed Toes 86

Safety Information Update 88

Pediatric Dosing for Lower Extremities 89

4Pain Syndromes 91

Cervicothoracic/Myofascial Pain 92

Lumbosacral/Myofascial Pain 94

Thoracic Outlet Syndrome 96

Piriformis Syndrome 98

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Neuropathic Cutaneous Pain 100

Lateral Epicondylitis 102

5Hyperhidrosis 105

Forehead/Scalp 106

Axillae 108

Palms 110

Residual Limb 112

Feet 114

Nerve BlocksHands 116

Nerve BlocksFeet 118

6Billing and Reimbursement 121

CPT Codes 122

Guidance Codes 122

Modifiers 123

HCPCS Codes 124

Insurance Coverage of Drugs and Procedures 125

Web Sites for Local CoverageDetermination (LCD) by Medicare 126

Resources for Coding and Billing 126

ICD-9-CM Codes 127

BTX-A and BTX-B Interchangeability 128

Secondary ICD-9-CM Codes 129

7Billing Codes for Specific Conditions

131

Migraine 132

Blepharospasm/Facial Hemispasms 133

Drooling/Sialorrhea 134

Lingual Dystonia 135

Oromandibular Dystonia 136

Cervical Dystonia 137

Spasticity and Other Dystonias 138

Pain 140

Thoracic Outlet Syndrome 142

Hyperhidrosis 143

Nerve Blocks 144

CONTENTS xi


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Example of Financial Waiver 145

Charges for Botulinum Toxin Procedures 146

Body Areas and Related ICD-9-CM Codes 148

8Scales 151

Cervical DystoniaTWSTRS Scale 152

Hyperhidrosis Disease Severity Scale (HDSS) 154

Drooling Impact Score (DIS) 155

Questionnaire-based Scoring System forDrooling Severity and Frequency 156

Drooling Rating Scale 157

The Ashworth Scale 158

The Tardieu Scale 159

Spasm Frequency Score 161

Degree of Adductor Tone 162

Hygiene Score 162

9Clinical Data Forms 163

Neurotoxin Clinic Evaluation andTreatment for Migraine 164

Neurotoxin Clinic Evaluation andTreatment for Facial Spasms 165

Neurotoxin Clinic Evaluation andTreatment for Cervical Dystonia 166

Neurotoxin Clinic Evaluation andTreatment for Spasticity (Upper Extremities) 167

Neurotoxin Clinic Evaluation andTreatment for Spasticity (Lower Extremities) 168

Index 169

CONTENTS xii


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xiii

Preface

In any field of medicine, the quality of care is proportional to the knowledge

of the physician. For the clinician the real challenge is to stay abreast of

new developments in clinical treatments and drug therapies. New indica-

tions for drug therapies are continually emerging. The first indication for

treatment with botulinum toxin was approved by the US Food and Drug

Administration (FDA) in 1989. Currently, there are six FDA-approved

indications (hemifacial spasm, 1989; blepharospasm, 1989; strabismus,

1989; cervical dystonia, 2000; glabellar lines, 2002; and hyperhidrosis,

2004). In addition, there has been a wide-spread growth of applications

beyond the FDA-approved indications for botulinum toxin. The toxin

is used to treat numerous conditions across many specialties. Therefore,

most of the current uses and about half of the applications in this manual

are off-label, and thus should be applied with caution.

This handbook is designed to be a practical introductory and reference

guide for the busy clinician and newcomers to the field of neurotoxin

applications. To facilitate easy clinical use of this handbook the dosing

range tables and related illustrations appear are on facing pages. For some

conditions, however, the anatomic illustrations required multiple pages ofdisplay (migraine, cervical dystonia-torticollis, adducted/internally rotated

shoulder, writers cramp, flexed hip, equinovarus foot, and valgus foot).

In these cases, the dosing tables for the illustrations are repeated on the

facing pages.

The information contained in this book is no substitute for appro-

priate clinical training, knowledge of the anatomy, familiarization with


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xv

Introduction

Muscle Overactivity

Botulinum Toxin

Properties of Botulinum Toxin Preparations

Comparison of Type A and Type B Units FDA-Approved Indications

Botulinum Toxin Dosing

Frequency of Injection

BTX-A Contacts BTX-B Contacts

BTX Resources

Safety Information

BTX-A Dilutions BTX-B Dilutions

Guidance Technique for Injection

Techniques to Minimize Injection Pain

Dilutions


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Muscle Overactivity1

Spasticity Velocity dependentincreased muscle contractionwith stretching. The resistance to movement is

increased with increased velocity of motion. Also,the EMG activity is increased with joint move-

ment and muscle stretching. See the AshworthScale on page 158.

Spastic

dystonia

Active muscle contraction at rest without joint

or limb movement.2The EMG shows continuedmuscle activity at rest. Also, stretch-sensitive andincreased EMG activity with muscle stretching.

Spastic

cocontractionCocontraction of the antagonist muscle with

voluntary muscle contraction of the agonist, andwithout stretching of the antagonist. Also, stretch-sensitive and increased EMG activity with muscle

stretching.

Dystonia Involuntary muscle contractions frequentlycausing twisting and repetitive movements orabnormal postures.3The muscle activity is often

increased with voluntary movements or whenopposing the dystonia. The muscle activitymay involve both the agonist and antagonist

(cocontraction). The EMG may show rhythmicor sustained muscle activity that is increased in

the antagonist with attempted contraction of theagonist.

Focal dystoniaincludes: Blepharospasm Cervical dystonia Oromandibular Writers cramp

dystonia Spasmodic Torticollis dysphonia

See the TWSTRS scale for cervical dystonia on page 152153.

References

1. Gracies JM. Pathophysiology of spastic paresis. II: emergence of muscle

overactivity. Muscle Nerve2005;31:55271.

2. Denny-Brown D. The Cerebral Control of Movement. Liverpool: Liverpool

University Press, 1966;12443, 17184.

3. Rowland LP. Merritts Textbook of Neurology, 8th ed. Philadelphia:

Lea & Febiger, 1989.

xvi INTRODUCTION


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Botulinum Toxin

Botulinum toxinsare produced by the bacterium Clostridium botulinum.It is a gram-positive and spore-forming obligate anaerobic bacteria found

in the soil.

Seven serotypes exist (types A, B, C1, D, E, F and G),and two arecommercially available for clinical use in the United States, namely type A

(Botox, Allergan, Inc.) and type B (Myobloc, Solstice Neurosciences,Inc.). At this writing, another type A (Dysport, Ipsen Ltd., U.K.) is notavailable in the United States.

Mechanism of action. Botulinum toxin inhibits the release ofneurotransmitters such as acetylcholine by entering the presynaptic

neurons and cleaving proteins responsible for docking and fusion of thesynaptic vesicles to the presynaptic membrane. Type B acts on the outsideof the synaptic vesicle, cleaving the vesicle-associated membrane protein

(VAMP, synaptobrevin), whereas type A acts on the inner surface of

the postsynaptic membrane (synaptosomal-associated protein of 25kd,SNAP-25). In addition to inhibiting acetylcholine release, botulinum

toxin also appears to inhibit the release of other neurotransmitters suchas noradrenaline, dopamine, gamma-aminobutyrate, glycine, peptide

methionine-enkephalin, as well as the pain nociceptor substance P.1,2

In the muscle,botulinum toxin inhibits the release of acetylcholineat the neuromuscular junction of the muscle fibers (extrafusal fibers) and

at the muscle spindles (intrafusal fibers). The reduced activation of themuscle spindles may contribute to muscle relaxation. In the periphery,botulinum toxin may reduce the release of pain nociceptors.

Mouse unit.Biologic activity is measured in mouse units(medianlethal dose LD

50). One unit (U) is the median lethal intraperitoneal dose

for female Swiss Webster mice weighing 18 to 20 g.

References1. MacKenzie I, Burnstockk G, Dolly JO. The effects of purified botulinum

toxin type A on cholinergic, adrenergic and non-adrenergic atropine-resistant

autonomic neuromuscular transmission. Neuroscience1982;7:9971006.

2. Ishikawa H, Mitsui Y, Yoshitomi T, et al. Presynaptic effects of botulinum

toxin type A on the neuronally evoked response of albino and pigmented

rabbit iris sphincter and dilator muscles.Jpn J Ohpthalmol2000;44:10609.

INTRODUCTION xvii


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xviii INTRODUCTION

Properties of Botulinum Toxin Preparations1,2

BTX-A (Botox) BTX-B (Myobloc)Vials 100 U 2,500 U, 5,000 U, 10,000 U

Albumin 0.5 mg 0.05%

Toxin 5 ng 25 ng, 50 ng, 100 ng

pH 7.3 after constitution 5.6

Storage 24 months refrigerated(Note expiration date) 30 months refrigeration9 months room temp3

(Note expiration date)

Vials Single use Single use

Use within 4 hours of dilution no preservatives

References

1. Mayer NH, Simpson DM, eds. Spasticity: etiology, evaluation, management,and the role of botulinum toxin. We Move, Sept 2002.

2. Package insert for Botox and Myobloc.

3. Royal MA. Botulinum toxins in pain management. Phys Med Rehabil

Clin N Am14(2003):805820.

Comparison of Type A and Type B UnitsUnits of biologic activity of botulinum toxins type A and B cannot be

compared to or converted into units of any other botulinum toxin.

FDA-Approved Indications

BTX-A (Botox) BTX-B (Myobloc)

Hemifacial spasm, 1989

Blepharospasm, 1989

Strabismus, 1989

Cervical dystonia, 2000 Cervical dystonia, 2000

Glabellar lines, 2002

Hyperhidrosis, 2004


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INTRODUCTION xix

Botulinum Toxin Dosing

The dose should be influenced by the patients size, musclehypertrophy, degree of activation by EMG, types of movement,weakness, risk of side effects, potential loss of function, total dose,

diagnosis and responses to prior injections.

Frequency of Injection

Generally, the duration of benefit last for 3-6 months. Thelikelihood of antibody formation appears related to the dose andfrequency of injections. Therefore, extending the time between

injections and using the lowest dose for symptom management maybe desirable. However, the recurrence of symptoms and insurancecoverage may be the ultimate determining factors.

BTX-A Contacts

Allergan for practitioners

Botox information line

1-800-433-8871

1-800-44-Botoxhttp://www.allergan.com/

http://www.botox.com/

BTX-B Contacts

Solstice Neurosciences

Myobloc information

1-888-461-2255

http://www.solsticeneuro.com/

BTX Resources

The NeurotoxinInstitute

We Move

MDVU MovementDisorder VirtualUniversity

http://www.neurotoxininstitute.com/

Independent source of information relatedto the basic science and the clinical

applications of neurotoxin therapies

Free CME materialhttp://www.wemove.org/Worldwide Education and Awareness for

Movement Disorders

http://www.mdvu.org/

Movement Disorder Virtual Universitydosing guidelines


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xx INTRODUCTION

Safety Information

The listed dose suggestions have been obtained from the literatureand the Internet web sites for Allergan, Solstice Neuroscience, MDVUand We Move. Some of the dose recommendations have been made

by consensus panels of clinical experts, such as those published byWe Move and MDVU. Other doses have been obtained from the lit-

erature, while, some of the listed doses have only been found in casestudies. Consequently, the injector should err on the side of safetywhen starting injections in a particular patient. The listed doses do

not guarantee the absence of any untoward effects, because inherentadverse events are associated with all drugs and their administration.The starting dose should be individualized according to the patients

size, weight, weakness, degree of spasticity, potential for functionallosses, and degree of dysfunction. The treating physician is encour-

aged to review the literature for specific dosing.

Contraindications Botulinum toxin treatment is contraindicated in

the presence of infection at the injection site(s)and in individuals with known hypersensitivityto any ingredient in the formulation.

Warnings Serious and/or immediate hypersensitivity reac-tions have been rarely reported. These reactions

include anaphylaxis, urticaria, soft-tissue edema,and dyspnea. If such a reaction occurs, further

injection should be discontinued and appropriatemedical therapy immediately instituted. Patientswith peripheral motor neuropathic diseases (e.g.,

amyotrophic lateral sclerosis or motor neuropa-thy) or neuromuscular junctional disorders (e.g.,myasthenia gravis or Lambert-Eaton syndrome)

should only receive treatment with caution. Pa-tients with neuromuscular disorders may be at

increased risk of clinically significant systemiceffects, including severe dysphagia and respira-tory compromise from typical botulinum toxin

doses. Treatment of botulinum toxinnave pa-tients should be initiated at lower doses. Cautionshould be given to injection of nursing women

and only to pregnant women if clearly needed.

Adverse events There have been rare reports of adverse eventsinvolving the cardiovascular system, including

arrhythmia and myocardial infarction, somewith fatal outcomes.

ReferencePackage insert for Botox and Myobloc.


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INTRODUCTION xxi

BTX-B Safety Information

Botulinumtoxin type B

Myobloc

The initial dose of Myobloc for patients witha prior history of tolerating botulinum toxininjections is 2,500 to 5,000 U divided among

affected muscles. Patients withouta prior historyof tolerating botulinum toxin injections should

receive a lower initial dose.1

Reference

1. Myobloc product information.

Safety Information Update

At the time of this writing the U.S. Food & Drug Administration (FDA)has issued an early communication about an ongoing safety reviewof botulinum toxins type A and B. The FDA has received reports of

systemic adverse reactions including respiratory compromise and deathfollowing the use of botulinum toxins types A and B for both FDA-

approved and unapproved uses. The reactions reported are suggestiveof botulism, which occurs when botulinum toxin spreads in the bodybeyond the site where it was injected. The most serious cases had out-

comes that included hospitalization and death, and occurred mostlyin children treated for cerebral palsy-associated limb spasticity. Useof botulinum toxins for treatment of limb spasticity (severe arm and

leg muscle spasms) in children or adults is not an approved use in theUnited States.

The pediatric botulism cases occurred in patients less than 16 yearsold, with reported symptoms ranging from dysphagia to respiratoryinsufficiency requiring gastric feeding tubes and ventilatory support.

Serious outcomes included hospitalization and death. The mostcommonly reported use of botulinum toxin among these cases was

treatment of limb muscle spasticity associated with cerebral palsy. ForBotox, doses ranged from 6.25 to 32 Units/kilogram (U/kg) in thesecases. For Myobloc, reported doses were from 388 to 625 U/kg.

FDA is aware of the body of literature describing the use ofbotulinum toxins to treat limb spasticity in children and adults.The safety, efficacy and dosage of botulinum toxins have not been

established for the treatment of limb spasticity of cerebral palsy orfor use in any condition in children less than 12 years of age.

The reports of adult botulism cases described symptoms includingpatients experiencing difficulty holding up their heads, dysphagia andptosis. Some reports described systemic effects that occurred distant

from the site of injection and included weakness and numbness ofthe lower extremities. Among the adult cases that were serious,

including hospitalization, none required intubation or ventilatorysupport. No deaths were reported. The doses for Botox ranged from100 to 700 Units and for Myobloc from 10,000 to 20,000 U.


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xxii INTRODUCTION

Safety Information (continued)

Until such time that FDA has completed its review, healthcareprofessionals who use medicinal botulinum toxins should: Understand that potency determinations expressed in Units

or U are different among the botulinum toxin products;clinical doses expressed in units are not comparable from one

botulinum product to the next Be alert to the potential for systemic effects following admin-

istration of botulinum toxins such as: dysphagia, dysphonia,

weakness, dyspnea or respiratory distress Understand that these effects have been reported as early as one

day and as late as several weeks after treatment Provide patients and caregivers with the information they need

to be able to identify the signs and symptoms of systemic effects

after receiving an injection of a botulinum toxin Tell patients they should receive immediate medical attention

if they have worsening or unexpected difficulty swallowing or

talking, trouble breathing, or muscle weakness

From: FDA, Early Communication, February 8, 2008.

http://www.fda.gov/cder/drug/early_comm/botulinium_toxins.htm


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INTRODUCTION xxiii

BTX-A Dilutions

Dilution with preservative-free saline.

100 U/syringe10 U/0.1 cc

100 U1 cc

50 U/syringe5 U/0.1 cc

100 U2 cc

100 U/syringe25 U/1 cc

100 U

4 cc


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xxiv INTRODUCTION

BTX-B Dilutions

Myobloc may be diluted with normal saline.

2,500 U/ 0.5 cc500 U/0.1 cc

2,500 U/0.5 cc 0.5 cc

5,000 U/1 cc500 U/0.1 cc

5,000 U/1 cc1 cc

5,000 U/1 cc

500 U/0.1 cc

10,000 U/2 cc 1 cc


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INTRODUCTION xxv

Guidance Techniquefor Injection of Botulinum Toxin

Electricalstimulation

Particularly useful for dynamic muscle overactivity,where the EMG activity is only present when reflexesare elicited. This may be the case for an upgoing

hallux or toe curling seen only during stance or gait.In such cases, the EMG activity may be too difficult

to elicit at rest. Electrical stimulation may be theonly way to localize the muscles.

Also useful to target smaller muscle groups in theforearm, while avoiding weakening of nearby usefulmuscles. Not useful with strongly contracting muscle

groups in which the electrical stimulation may nothave any effect on limb movement.

Can be used to localize motor points (area of smallmotor nerve endings in the muscle and often close to

the motor endplate zone).1This requires full musclerelaxation. The needle is directed to the part of themuscle where a contraction can be elicited with

stimulation of only 1 mAmp or less.

NeedleEMG

First palpate for the overactive muscle during rangeof motion of the involved joint.

Then, after needle insertion, target the area of themost EMG activity and place the needle so that themotor unit produces a crisp sound. This assures

placement closest to the most active motor units.Placement of the needle at the midbelly of the musclevs. close to the motor endplate (neuromuscular junc-

tion) or motor point has not clearly shown any func-tional benefits.1,2The majority of motor endplates

will be found within the greatest bulk of the muscle.3

Passive stretch of the involved muscle will elicitincreased EMG activity, which can be used to guide

the injection as well. Again, inject into the area withthe most EMG activity elicited and with the crispest

sound.

Needle EMG can also be used to identify motor

endplates. However, this requires the patient to beable to relax the muscles completely. The charac-teristic features of the endplate are: a low-voltage

increase in the baseline of about 10 to 40 mV,irregularly firing monophasic spike discharges,

and deep pain described by the patient.1


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xxvi INTRODUCTION

Guidance Techniquefor Injection of Botulinum Toxin (Continued)

Audio-onlyEMG

Audio only and no EMG display. This may causethe injector to mistake the sound of muscle denerva-tion potentials for muscle motor units. Recommend

the user first becomes familiar with the combinedaudio and visual display of EMG activity (denerva-

tion potentials and motor unit activity), before usingaudio-only EMG. Also, Medicare may not cover the

monitoring unless both visual and auditory compo-nents are procured.

References1. Childers MD. The importance of electromyographic guidance and electrical

stimulation for injection of botulinum toxin. Phys Med Rehabil Clin N Am

2003;14:78192.

2. Satila H, Iisalo T, Pietikainen T, et al. Botulinum toxin treatment of spasticequinus in cerebral palsy. Am J Phys Med Rehabil2005;84:35565.

3. Childers MK. Targeting the neuromuscular junction in skeletal muscles.

Am J Phys Med Rehabil2004;83(Suppl);S38S44.

Techniques to Minimize Injection Pain

Topical Spray with an evaporant such as ethyl chlo-

ride or Flouri-Methane.Topical anesthetic such as lidocaine/

prilocaine in the form of a gel or

transdermal patch.

Oral Medications Premedication with opioids or anxiolytics.

Dilution withpreservative1

Botulinum toxin type B: further dilution withpreserved saline.

Dilution withanesthetic2

With a pH of 5.6, the Myobloc preparationmay cause local injection discomfort. There-

fore, recommendations have been made todilute the BTX preparation with preservedsaline, lidocaine, or bupivacaine to provide a

local anesthetic effect.

Nerve blocksSee pages 116118.

References

1. van Laborde, S, Dover JS, Moore M, et al. Reduction in injection pain

with botulinum toxin type B further diluted using saline with preservative:

a double-blind, randomized controlled trial.J Am Acad Dermatol

2003;489(6):87577.

2. Royal MA. The use of botulinum toxin in the management of myofascial

pain and other conditions associated with painful muscle spasm. In: Brin

MF, Jankovic J, Hallet M, eds. Scientific and Therapeutic Aspects ofBotulinum Toxin. Philadelphia: Lippincott Williams & Wilkins, 2002.


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INTRODUCTION xxvii

Dilutions

BTX-A (Botox) BTX-B (Myobloc)*

100 U/1 cc = 100 U/cc100 U/2 cc = 50 U/cc

100 U/4 cc = 25 U/cc

Undiluted = 250 U/0.05 cc

2,500 U + 1 cc NS= 83 U/0.05 cc

5,000 U + 1 cc NS= 125 U/0.05 cc

2,500 U + 2 cc NS

= 50 U/0.05 cc

5,000 U + 2 cc NS

= 83 U/0.05 cc

*Each vial has an overfill amount beyond what is noted on the label.Therefore, do not perform dilutions in the vial. Pull out the desired volume

in a syringe and add the desired additional volume of saline.


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BOTUL INUM TOX INI N J E C T I O N G U I D E


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1

CHAPTER1Head and Neck

Migraine

Facial Hemispasms

Blepharospasms

Drooling/Sialorrhea

Lingal Dystonia

Oromandibular Dystonia

Cervical Dysontia


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Migraine 1/3 Dosing Ranges

Botox(BTX-A)units1,2

Myobloc(BTX-B)units3

Injectionsites permuscle

Procerus 2.55.0/site 50100

(125500)*1

Corrugator, medial 2.54.0/site Limited data 1

Frontalis 2.5/site(46/side)

5007505001,2504,8

812

Temporalis(each muscle)

2.55/site

(4/side)

Limited data for

specific musclesSee data for

regions belowreference 3

4

Occipitalis 510/side 1

Splenius capitis 515/side 12

Masseter 515/side 12

Levator scapulae 1025/side6,7

Trapezius 515/side 6251,000/side4,5,8 13

Semispinalis 510/side Limited data forspecific muscles

1

Sternocleidomastoid 1020/side 2

Total dose 100200 2,5005,000

Dilution 100 U/24 ccDispensed in

1 cc syringes

Dilutions,see page xxvii.

Needle 30 G, 0.5 in

Facial injections are done bilaterally to avoid asymmetric expressions.

* Data for facial hemispasms.

Author recommendation.

3. Inadequate data for specific muscles. Dose ranges for areas3,4:

Lateral neck muscles 625 U/sideCervical paraspinals 500650 U/sideOccipital 500625/side

Temporal 250/side

6,7. Doses used for trigger points/tender points.5,6

Injection Technique (see page 5)

References (see page 4).

Safety information (see pages xxxxii).

2 HEAD AND NECK


35/207

MIGRAINE 1/3 3

Muscles possibly involved Migraine 1/3Procerus

CorrugatorFrontalisTemporalisOccipitalisSplenius capitisMasseterLevator scapulaeTrapeziusSternocleidomastoid

Cervical paraspinal muscles

Authors technique

Orbicularisoculi

Levatorlabii superioris

Zygomaticus

Orbicularis oris

Depressoranguli oris

Mentalis

Blumenfeld technique

Procerus

Orbicularis

oculi

Levatorani nasi

Levatoranguli oris

Nasalis


36/207

4 HEAD AND NECK

References

1. Blumenfeld A, Binder W, Silberstein SD, Blitzer A. Procedures for

administering botulinum toxin type A for migraine and tension-typeheadache. Headache2003;43:88491.

2. MDVU. MD Virtual University, We Move. BTX-A Adult Dosing Guidelines.

Management of Spasticity with Botulinum Toxin Type A (Botox).

Edition 2.0. Revised August 2005.

3. Fadeyi MO, Adams QM. Use of botulinum toxin type b for migraine and

tension headaches. Am J Health-Syst Pharm2002;59:186062.

4. Schulte-Mattler WJ, Martinez-Castillo JC. Botulinum toxin therapy of

migraine and tension-type headache: comparing different botulinum toxinpreparations. Eur J Neurol2006;13(Suppl 1):5154.

5. Kamanli A, Kaya A, Ardicoglu O, et al. Comparison of lidocaine injection,

botulinum toxin injection, and dry needling to trigger points in myofascial

pain syndrome. Rheumatol Int2005;25:60411.

6. Graboski CL, Gray DS, Burnham RS. Botulinum toxin a versus bupivacaine

trigger point injections for the treatment of myofascial pain syndrome: a

randomized double blind crossover study. Pain2005;118:17075.

7. Lake AE III, Saper JR. Botulinum toxin type B for migraine prophylaxis:

a 4-month, open-label, prospective outcome study. Poster presented at the

22ndAnnual Scientific Meeting of the American Pain Society, March 2023,

2003, Chicago, IL.

8. Mathew MT, Frishberg M, Gawel M, et al. Botox CDH study group.

Headache2005;45:293307.


37/207

MIGRAINE 1/3 5

Injection Precautions

Bruising Avoid injecting into visible superficial bloodvessels.

For facial injections, place the patient inupright or semiupright position to minimizebleeding and bruising.

Apply pressure and cold packs after theinjection.

Angle needle ~45 degrees.

Depth ofinjection

Intramuscular. Intradermal and periostealinjections are less effective.

Symmetricalinjections

For facial injections, to avoid asymmetricexpression. Consider preinjection photos.

Ptosis Avoid injections into the brow areas. Inject

approximately 2 cm above the brows.Avoid injections above the levator palpebra(see page 1213).

Intravascular

injectionsCan be minimized by applying vacuum to

the syringe before the injection, avoidingvisible superficial vessels and intraperiostealinjections.

Injection Techniques

Follow-the-pain This approach for injections allows a more

individualized approach depending on thepatients localization of pain and tender/trigger points. The dosing may vary from side

to side except for the facial area.

Fixed-siteinjections

Fixed, symmetrical injections are used toinfiltrate the target region. This approachmay not include areas with pain such as the

scalp. On the other hand, this approach mayalso include injections of areas with no pain

or trigger/tender points such as the frontalismuscle. Conceivably, the cosmetic benefits

may influence the patients decision to havefuture treatments regardless of the effects onpain relief.

Combination

approachHere the fixed-site approach is used forcertain areas, while the follow-the-pain

approach is used for other areas.

Modified after Blumenfeld et al.


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6 HEAD AND NECK






(125500)*

1


Frontalis 2.5/site

(46/side)

500750

5001,2504,8

812

Temporalis(each muscle)

2.55/site(4/side)

Limited data forspecific muscles

See data for

regions belowreference 3

4







1


Total dose 100200 2,5005,000

Dilution 100 U/24 cc

Dispensed in1 cc syringes

Dilutions,

see page xxvii

Needle 30 G, 0.5 in


* Data for facial hemispasms.


3.

Inadequate data for specific muscles. Dose ranges for areas4,5

:Lateral neck muscles 625 U/sideCervical paraspinals 500650 U/sideOccipital 500625/side

Temporal 250/side






39/207


CorrugatorFrontalisTemporalisOccipitalisMasseterLevator scapulaeSternocleidomastoidSplenius capitisTrapezius


Temporalis

Occipitalis

Sternocleidomastoid

Masseter

Levator scapuli

MIGRAINE 2/3 7


40/207

8 HEAD AND NECK






(125500)*

1


Frontalis 2.5/site

(46/side)

500750

5001,2504,8

812

Temporalis

(each muscle)2.55/site(4/side)

Limited data forspecific muscles

See data forregions below

reference 3

4







1


Total dose 100200 2,5005,000



Dilutions,

see page xxvii

Needle 30 G, 0.5 in


* Data for facial hemispasms


3. Inadequate data for specific muscles. Dose ranges for areas4,5:

Lateral neck muscles 625 U/sideCervical paraspinals 500650 U/sideOccipital 500625/side

Temporal 250/side






41/207


CorrugatorFrontalisTemporalisOccipitalisMasseterSternocleidomastoidLevator scapulaeSplenius capitisTrapezius


Trapezius

Splenius capitis

Semispinalis capitis

Occipitalis

Splenius cervicis

Levator scapuli

MIGRAINE 3/3 9


42/207


43/207

Muscles possibly involved Facial HemispasmsProcerus

Orbicularis oculiNasalisLevator ani nasiLevator anguli orisZygomaticus majorOrbicularis orisBuccinatorRisoriusDepressor anguli oris

Depressor labii inferiorisMentalis

Orbicularis

oculi

Orbicularisoculi

Zygomaticus

Orbicularis orisDepressoranguli oris

Mentalis

Levatorani nasi

Levatoranguli oris

Depressorlabii inferioris

Risorius

Procerus

Nasalis

Buccinator

FACIAL HEMISPASMS 11


44/207

12 HEAD AND NECK

Blepharospasms Dosing Ranges

Botox

(BTX-A)units1

Myobloc

(BTX-B)units2

Injection

sites permuscle

Orbicularis oculi

Pretarsal fibers512.5/site

2501,000 25

Procerus 2.552.57/site

250500 1/side

Frontalis 10

2.57.5/site

500750

5001,250*

2/side

Corrugator 5

37.5/site

250750 1/side

Total dose 12.515 7502,500U/side



Dilutions,

see page xxvii

Needle 30 G, 0.5 in

*Dose from migraine chart.1


Injection Technique

See additional

informationunder migrainepage 5.

Injection sites will vary according the muscleactivity.

Injections of the orbicularis oculare are donemedial and lateral to the levator palpebrae to

avoid ptosis.

Avoiding injecting the central part of thelower lid helps prevent entropion and sagging

of the lower lid.3

Injections too deeply into the medial lowereyelid may cause diffusion into the inferioroblique muscle with a potential for diplopia.4

References

1. MDVU. MD Virtual University. Adult Dosing Guidelines. Management

of Dystonia with Botulinum Toxin Type A (Botox). Edition 2.0. Revised

August 2005.

2. MDVU. MD Virtual University. BTX-B Adult Dosing Guidelines. Edition

1.0. Botulinum Toxin Type B (Myobloc). At http://www.mdvu.org/library/

dosingtables/btxb_adg.html. Updated 1.28.05. Accessed 11.30.06.

3. Bhidayasiri R, Cardoso F, Truong DD. Botulinum toxin in blepharospasm

and oromandibular dystonia: comparing different botulinum toxin

preparations. Eur J Neurol2006;13(Suppl 1):2129.

4. Campos EC, Bolzani R, Schiavi C, et al. Effect of injection sites of

botulinum toxin for blepharospasm treatment: statistical analysis.Neuro-ophthalmol1999;22:1723.


45/207

Muscles possibly involved BlepharospasmsOrbicularis oculiProcerus

FrontalisCorrugator

Orbicularis oculi

Levator palpebrae

Orbicularisoculi

Orbicularisoculi

Orbicularisoculi

Corrugator

Levatorani nasi

Levator

anguli oris

Procerus

Nasalis

BLEPHAROSPASMS 13


46/207

Drooling/Sialorrhea Dosing Ranges

Botox(BTX-A)units1


Injectionsites pergland

Parotid glands 1540/gland 5001,000/

gland*1,000/gland

2

Submandibular

glands +/ ultrasoundguidance

1015/gland 250/gland 1

Dilution 100 U/12 ccDispensed in1 cc syringes

Dilutions,see page xxvii

Needle 30 G, 0.5 in

Injection Technique

Parotid Posterior to the palpated masseter muscle andanterior to the external ear2

Submandibular Anterior and medial to the genu of the mandible2

* Author recommendation.

References

1. Porta M, Gamba M, Bertacchi G, Vaj P. Treatment of sialorrhea with

ultrasound guided botulinum toxin type A injection in patients with

neurological disorders.J Neurol Neurosurg Psychiatry2001;70:53840.

2. Ondo WG, Hunter C, Moore W. A double-blind placebo-controlled trial

of botulinum toxin B for sialorrhea in Parkinsons disease. Neurology

2004;62:3740.

See drooling scales pages 155157.

14 HEAD AND NECK


47/207

Glands possibly involved Drooling/SialorrheaParotid glands

Submandibular glandsSublingual glands

Parotid

Submandibular

Sublingual

Submandibular

Sublingual

DROOLING/SIALORRHEA 15


48/207

16 HEAD AND NECK

Lingual Dystonia Dosing Ranges

Botox(BTX-A) units1,2 Myobloc(BTX-B) units Injection sitesper muscle

Genioglossusmuscle

10301,2 5001,0004 12/side

Hypoglossus 1030 Limited data* 1

Total dose 1030



Dilutions,

see page xxvii

EMG needle 2725 G, 1 in

*Inadequate data for dose recommendations.

Injection Technique

Intraoral Genioglossus. 1520 U/side injected at two sites atthe base of the tongue, using 27G, 1 in needle.3

Intrinsic muscles. 1520 U/side in two locations,middle lateral side of tongue, using 30 G,1/2 in needle.3

Submandibular

approachGenioglossus. 515 U/side injected at two sitesbilaterally through a percutaneous submandibular

approach,1using a 2725 G EMG needle.

Other

Adverse events Dysphagia, dysarthria

Tongue protrusion Due to the action of the posterior fibers of thegenioglossus5

Tongue retraction Due to the action of the anterior fibers5

References

1. Charles PD, Davis T, Shannon KM, Hook MA, Warner JS. Tongue

protrusion dystonia: treatment with botulinum toxin. 1997;90:52225.

2. MDVU. MD Virtual University. We Move. Adult Dosing Guidelines.

Management of Dystonia with Botulinum Toxin Type A (Botox).


3. Clark TG. The management of oromandibular motor disorders and facial

spasms with injections of botulinum toxin. Phys Med Rehabil Clin N Am

2003;14:72748.

4. MDVU. MD Virtual University. BTX-B Adult Dosing Guidelines

Edition 1.0. Botulinum Toxin Type B (Myobloc). At http://www.mdvu.org/

library/dosingtables/btxb_adg.html. Updated 1.28.05. Accessed 11.30.06.



preparations. Eur J Neurol2006;13(Suppl 1):2129.


49/207

Digastric Mylohyoid

Genioglossus muscle

Geniohyoid muscle

Mylohyoid muscle

Muscle possibly involved Lingual DystoniaGenioglossus muscle

LINGUAL DYSTONIA 17


50/207

18 HEAD AND NECK

Oromandibular Dystonia Dosing Ranges

Botox

(BTX-A) units2

Myobloc

(BTX-B) units3

Injection

sitesMasseter 40/side (25100) 1,0003,000 2/side

Temporalis 40/side (2060) 5001500

1,0003,00024/side

Orbicularis oris 1520*4/side 250500 24/side

Anterior digastric,geniohyoid,

mylohyoid

10 (10200) 250750 1/side

Medial pterygoid 15 (1550) 1,0003,000 1/side

Lateral pterygoid 40 (20100) 1,0003,000 1/side

Total dose 1,2505,000 U

per side



Dilutions,

see page xxvii

Needle 30 G, 0.5 in to 27 G, 37 mm

*Inject below the lower lip in four locations. Only inject in the upperlip if this approach does not work fully.4 Author recommendation. May lower dose with bilateral multiplemasticatory muscle injections.

Injection Technique

Medianpterygoid

Can be approached either intraorally or from below.1From below: The needle is inserted 0.5 to 1 cm anteriorto the angle of the mandible along the interior aspect of

the mandible and angled perpendicular to the mandibleuntil it can be verified by EMG with the patient clenching

his teeth. Oral approach: Posterior to the lower molars.The facial artery lies anteriorly. A bite bloc placed later-ally can be helpful to prevent trauma to the fingers.

Lateralpterygoid

Laterally, the entry point is approximately 35 mm from

the external auditory canal and 10 mm from theinferior margin of the zygomatic arch.1The EMG

needle is angled upward about 15 degrees to reach the

inferior head of the lateral pterygoid.

Other

Mouth opening Lateral pterygoid is the major contributor.

Mouth closure Masseter, medial pterygoid, temporalis.

Adverse events Potential for hypernasal speech due to palatal

muscle weakness, especially with the lateralpterygoid muscle injection.4


51/207

References



preparations. Eur J Neurol2006;13(Suppl 1):2129.2. MDVU. MD Virtual University. We Move. Adult Dosing Guidelines.



3. MDVU. MD Virtual University. BTX-B Adult Dosing Guidelines Edition 1.0.

Botulinum Toxin Type B (Myobloc). At http://www.mdvu.org/library/

dosingtables/btxb_adg.html. Updated 1.28.05. Accessed 11.30.06.

4. Clark GT. The management of oromandibular motor disorders and facial

spasms with injections of botulinum toxin. Phys Med Rehabil Clin N Am2003;14:72748.

Muscles possibly involved Oromandibular DystoniaMasseter

TemporalisOrbicularis orisMedial pterygoidLateral pterygoidDigastricGeniohyoidMylohyoid

Temporalis

Digastric

Lateralpterygoid

Medial pterygoid Masseter

See previous illustrations for the anterior digastric, geniohyoid, and

mylohyoid muscles.

Orbicularis

oris

OROMANDIBULAR DYSTONIA 19


52/207

20 HEAD AND NECK

Cervical Dystonia Torticollis 1/2 Dosing Ranges

Botox(BTX-A) units1,2 Myobloc(BTX-B) units3 Injection sitesper muscle

Splenius capitis 75 (50150) 1,0005,000 24

Splenius cervicis 30 (2060) Limited data 2

Inferior obliquelongus capitis

304 Limited data

Sternocleidomastoid contralateral

50 (1575) 1,0003,000 14

Levator scapula 50 (25100) 1,0004,000 13

Cervical dystonia 5,00010,000



Dilutions,

see pagexxvii

EMG needle 27 G, 37 mm

Injection Technique

Splenius capitis Posterior approach: One finger breadth lateralto the C5 spinous process.

Splenius cervicis Posterior approach: Onetwo finger breadths

lateral to the T1 spinous process.Inferior obliquelongus capitis

Lateral approach: Approximately twothree fingerbreadths below the tip of mastoid process at thetop level of the C2 spinous process. Beware of

the location of the vertebral artery and the super-ficial occipital nerve.5The greater occipital n. lies

posterior over the inferior oblique capitis.

Posterior approach: Less than one fingerbreadth lateral to the C2 spinous process.Be aware of the intervertebral space of C1-C2anterior to the inferior oblique longus capitis.

Neck injections pose a significant risk for dysphagia.

References




2. Clinical experience helps you determine the lowest effective dose.

BTX 0104. Irvine CA: Allergan Inc., 2002.

3. MDVU. MD Virtual University. BTX-B Adult Dosing Guidelines.



4. Walker FO. Botulinum toxin therapy for cervical dystonia. Phys Med

Rehabil Clin N Am2003;14:74966.


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Splenius capitis


Occipitalis

Splenius cervicis

Levator scapuli

Inferior obliquelongus capitis

Muscles possibly involved Cervical Dystonia Ipsilateral splenius capitis Torticollis 1/2

Splenius cervicisInferior oblique longus capitisLevator scapulaeContralateral sternocleidomastoid

CERVICAL DYSTONIA TORTICOLLIS 1/2 21


54/207

22 HEAD AND NECK

Cervical DystoniaTorticollis 2/2 Dosing Ranges

Botox(BTX-A) units1,2 Myobloc(BTX-B) units3 Injectionsites permuscle

Splenius capitis(ipsilateral)

75 (50150) 1,0005,000 24

Splenius cervicis 30 (2060) Limited data 2

Inferior oblique

longus capitis304 Limited data

Sternocleidomastoid

(contralateral)50 (1575) 1,0003,000 14

Levator scapula 50 (25100) 1,0004,000 13

Cervical dystonia 5,00010,000



Dilutions,

see pagexxvii


Injection Technique

Sternocleidomastoid(contralateral) The midbelly of the muscle is verticallybelow the angle of the jaw.

Levator scapula Lateral approach:is at the level of thethyroid cartilage and one finger breadth,

anterior to the trapezius and posterior tothe vertical line of the styloid process.

Posterior approach:is approximately three

finger breadths lateral to the C6 sponoursprocess.


References






3. MDVU. MD Virtual University. We Move. BTX-B Adult Dosing Guidelines.



4. Walker FO. Botulinum toxin therapy for cervical dystonia. Phys Med

Rehabil Clin N Am2003;14:74966.


55/207

Muscles possibly involved Cervical Dystonia

Ipsilateral splenius capitis Torticollis 2/2

Splenius cervicisInferior oblique longus capitisLevator scapulaeContralateral sternocleidomastoid

Sternocleidomastoid

Levatorscapulae

Levatorscapulae

CERVICAL DYSTONIA TORTICOLLIS 2/2 23


56/207

24 HEAD AND NECK

Cervical DystoniaRetrocollis Dosing Ranges




Splenius capitis bilateral

7550150/side

1,0005,000 24

Semispinalis capitis 7550150

1,0005,000 14

Longissimus 75

50150

1,0005,000 14




For retrocollis, inject bilaterally to avoid tilting of the head.

Author recommends lower doses with bilateral injections.

Injection Technique

Splenius capitis bilateral Posterior approach: One finger breadth

lateral to the C5 spinous process.

Semispinalis capitis One finger breadth lateral to the C3spinous process.

Longissimus Two finger breadths lateral to the C7spinous process.


References










57/207

Muscles possibly involved Cervical DystoniaRetrocollisSplenius capitis

Semispinalis capitisLongissimus

Splenius capitis


Occipitalis

Splenius cervicisLevator scapuli

Semispinalis capitis Longissimus

CERVICAL DYSTONIA RETROCOLLIS 25


58/207

26 HEAD AND NECK

Cervical DystoniaLaterocollis Dosing Ranges

Botox

(BTX-A) units1,2

Myobloc

(BTX-B) units3

Injection

sites permuscle

Splenius capitis 75

50150

1,0005,000 24

Scalene complex ipsilateral

351550

1,0003,000 13

Levator

scapulae

50

25100

1,0004,000 13

Longissimus 7550150

1,0005,000 14

Dilution 100 U/2 cc


Dilutions,

see pagexxvii


Injection Technique

Spleniuscapitis

Posterior approach: One finger bredth lateral to the

C5 spinous process.

Scalene

complex ipsilateral

The injector should be familiar with the anatomy,because the phrenic nerve lies on anterolateral

surface of the anterior scalene muscle.

Lateral approach: approximately two finger breadthsabove the clavicle.

The anterior scalene is immediately posterior to theclavicular head of the sternocleidomastoid muscle.

Approach the needle slowly and withdraw if anyradiation of pain. The posterior scalene is immedi-

ately anterior to the anterior border of the trapezius.

Ultrasound or fluoroscopy guidance is helpful.Levator

scapulaeLateral approach:Midpoint from the clavicle to themastoid process and immediately anterior the trapezius.

Posterior approach:is approximately three fingerbreadths lateral to the C7 spinous process.

Longissimus Two finger breadths lateral to the C7 spinous process.


References







Edition 1.0. Botulinum Toxin Type B (Myobloc). At http://www.mdvu.org/library/dosingtables/btxb_adg.html. Updated 1.28.05. Accessed 11.30.06.


59/207

Muscles possibly involved Cervical DystoniaLaterocollisSplenius capitis

Scalene complexLevator scapulaeLongissimus

Splenius capitis


Occipitalis

Splenius cervicisLevator scapuli

Longissimus

Posterior scalene

Middle scalene

Anterior scalene

Levator scapuli

CERVICAL DYSTONIA LATEROCOLLIS 27


60/207

28 HEAD AND NECK

Cervical DystoniaAnterocollis Dosing Ranges

Botox(BTX-A) units1,2 Myobloc(BTX-B) units3 Injection sitesper muscle

Sternocleido-mastoid

(bilateral)

501575

1,0003,000 12

Dilution 100 U/2 cc

Dispensed in

1 cc syringes

Dilutions,

see page

xxviiEMG needle 27 G, 37 mm

The dose should be reduced by 50% if both SCM muscles are injected.

Injection Technique

Sternocleidomastoid The midbelly of the muscle is vertically

below the angle of the jaw.


References




2. Clinical experience helps you determine the lowest effective dose.BTX 0104. Irvine CA: Allergan Inc., 2002.





61/207

Sternocleidomastoid

Anterior scalene

Middle scalene

Trapezius

Levator scapulae

Muscles possibly involved Cervical Dystonia

Bilateral Anterocollissternocleidomastoid

CERVICAL DYSTONIA ANTEROCOLLIS 29


62/207


63/207

31

CHAPTER2Spasticity/Dystonia:Upper Extremities

Adducted/Internally Rotated Shoulder

Flexed Elbow Pronated Forearm

Flexed Wrist

Extended Wrist

Clenched Fist

Thumb-in-Palm

Adducted Thumb

Intrinsic Plus Hand

Extended Digits

Writers Cramp Safety Information Update

Pediatric Dosing for Upper Extremities


64/207

32 SPASTICITY/DYSTONIA: UPPER EXTREMITIES

Adducted/Internally Rotated Shoulder 1/2 Dosing Ranges

Botox(BTX-A)units1



Pectoralis complex 100 (50200) 2,5005,000 26

Latissimus dorsi 100 (50200) 2,5005,000 26

Teres major 50 (25100) 1,0003,000 14

Subscapularis 75 (50100) 1,0003,000 12Total dose 5,00015,000




Pediatric dosing see page 61.

Injection Technique

Pectoralismajor

Palpate the anterior axillary fold between thumband fingers and inject the muscle. Use caution withneedle depth when injecting over the chest wall.Inject over the ribs to reduce the potential for

pneumothorax.

Latissimusdorsi

Palpate the posterior axillary fold between thumband fingers and inject the muscle. Potential forpneumothorax exists.

Teres major Palpate the muscle at the top of the posterior axillaryfold and direct the needle towards the acromion.

Subscapularis Medial approach: Place patient prone or sitting withhand on back and close to the shoulder blade to wingthe scapula. Inject laterally toward and under thescapula. Lateral (axillary) approach3: Inject betweenthe posterior axillary fold and the brachial pulse.Direct the needle posteriorly towards the subscapularfossas lateral edge. Potential for pneumothorax exists.

Guidelines1,2

BTX-A BTX-B StartingDose

Total maximum bodydose/visit

400600 10,00015,000


65/207

Muscles possibly involved

Pectoralis major

Teres majorLatissimus dorsiSubscapularis

Adducted/InternallyRotated Shoulder 1/2

References

1. MDVU. MD Virtual University. We Move. BTX-A Adult Dosing Guidelines.

Management of Spasticity with Botulinum Toxin Type A (Botox). Edition 3.0.

Revised August 2005.

2. MDVU. MD Virtual University. We Move. BTX-B Adult Dosing GuidelinesEdition 1.0. Botulinum Toxin Type B (Myobloc). At http://www.mdvu.org/


3. Chiodo A, Goodmurphy C, haig A. Cadaveric study of methods

for subscapularis muscle needle insertion. Am J Phy Med Rehabil

2005;84:662665.

Pectoralis major

ADDUCTED/INTERNALLY ROTATED SHOULDER 1/2 33


66/207


Adducted/Internally Rotated Shoulder 2/2 Dosing Ranges

Botox(BTX-A)units1



Pectoralis complex 100 (50200) 2,5005,000 26

Latissimus dorsi 100 (50200) 2,5005,000 26

Teres major 50 (25100) 1,0003,000 14

Subscapularis 75 (50100) 1,0003,000 12

Total dose 5,00015,000


Dilutionssee pagexxvii



Injection Technique

Pectoralis

major

Palpate the anterior axillary fold between thumb andfingers and inject the muscle. Use caution with needledepth when injecting over the chest wall. Inject overthe ribs to reduce the potential for pneumothorax.

Latissimusdorsi

Palpate the posterior axillary fold between thumband fingers and inject the muscle. Potential forpneumothorax exists.

Teres major Palpate the muscle at the top of the posterior axillaryfold and direct the needle towards the acromion.

Subscapularis Medial approach: Place patient prone or sittingwith hand on back and close to the shoulder blade

to wing the scapula. Inject laterally toward andunder the scapula.

Lateral (axillary) approach3: Inject betweenthe posterior axillary fold and the brachialpulse. Direct the needle posteriorly towards thesubscapular fossas lateral edge. Potential forpneumothorax exists.

Guidelines1,2



400600 10,00015,000


67/207

References1. MDVU. MD Virtual University. We Move. BTX-A Adult Dosing

Guidelines. Management of Spasticity with Botulinum Toxin Type A

(Botox). Edition 3.0. Revised August 2005.




3. Chiodo A, Goodmurphy C, haig A. Cadaveric study of methods

for subscapularis muscle needle insertion. Am J Phy Med Rehabil2005;84:662665.

Muscles possibly involved

Pectoralis major

Teres majorLatissimus dorsiSubscapularis

Adducted/InternallyRotated Shoulder 2/2

Teresmajor

Trapezius

Subscapularis

Latissimus dorsi

ADDUCTED/INTERNALLY ROTATED SHOULDER 2/2 35


68/207


Flexed Elbow Dosing Ranges

Botox(BTX-A)units1



Brachioradialis 6025100

1,0003,00014

Biceps 8075200

2,5005,00024

Brachialis 5040150

1,0003,00012

Dilution 100 U/4 cc Dilutions,see page xxvii



Injection Technique

Brachioradialis The midbelly of the muscle is at the level ofthe insertion of the biceps tendon.

Biceps Since the biceps supinates the forearmneurolysis may increase forearm pronation.

Brachialis A lateral approach will avoid the bicepsmuscle and the median and ulnar nervesand vessels. At the level of four fingerbreadths above the lateral epicondyle.

Guidelines1,3


Total maximum

body dose/visit400600 10,00015,000


69/207

Muscles possibly involved Flexed ElbowBrachioradialis

BicepsBrachialis

Biceps

Brachialis

Brachioradialis

HumerusProfundabrachii artery

Radial nerve

Brachial

arteryMedian nerve

Ulnar nerve

Basilic vein

Biceps

Brachialis

Triceps musclemedial head

Triceps musclelateral head

Triceps musclelong head

FLEXED ELBOW 37


70/207


Pronated Forearm Dosing Ranges

Botox(BTX-A)units1



Pronatorquadratus

251050

1,0002,50012

Pronator teres 40502575

1,0002,50012




Injection Technique

Pronator teres Midbelly of the muscle is three fingerbreadths distal to the biceps tendon andone finger breadth medially.

Pronator quadratus Dorsal approach between the radius andthe ulnar at one-quarter the distance fromthe ulnar styloid process to the insertion

of the biceps tendon.

Guidelines1,2

BTX-A BTX-B Starting

Dose

Total maximum body

dose/visit

400600 10,00015,000


71/207

PRONATED FOREARM 39

Pronator teres

Pronator quadratus

Muscles possibly involved Pronated ForearmPronator teres

Pronator quadratus


72/207


Flexed Wrist Dosing Ranges

Botox(BTX-A)units1



Flexor carpi radialis 5025100

1,0003,00012

Flexor carpi ulnaris 4020100

1,0003,00012

Flexor digitorumprofundus 202050* 1,0003,000* 12

Palmaris longus 4020100^

1,0003,000^12



Pediatric dosing see page 61.*Values used for clenched fist/fingers.1,2

^Values used for flexor carpi ulnaris.

Injection Technique

Flexor carpiradialis

Midbelly of the muscle at four finger breadthsbelow the elbow crease. Insert one finger breadth

medial to the distal part of the biceps tendon.Flexor carpi

ulnaris

Midbelly of the muscle at one-third the distancefrom the medial epicondyle to the wrist.

Flexor digitorum

profundus

Midbelly of the muscle at the midpoint of thebiceps tendon and the ulnar styloid process.

Palmaris longus Midbelly of the muscle at four finger breadthsbelow the biceps tendon and one finger breadth

medial to a line between the midwrist and thebiceps tendon.

Guidelines1,2

BTX-A BTX-B Starting Dose

Total maximumbody dose/visit

400600 10,00015,000


73/207

Flexorcarpi ulnaris

Flexorcarpi radialis

Flexor

digitorumprofundus

Palmarislongus

Flexor carpi ulnaris

Flexor digitorum profundus

Flexor carpi radialis

Median nerve

Radial artery

Radial nerve

Cephalic vein

Radius Ulna

Ulnar nerve and artery

Palmaris longus tendon

Flexor digitorum superficialis

Extensor carpi radialislongus and brevis

Extensor digitorum

Extensordigiti minimi

Extensor carpi ulnaris

Muscles possibly involved Flexed WristFlexor carpi radialis

Flexor carpi ulnarisFlexor digitorum profundusPalmaris longus

FLEXED WRIST 41


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Extended Wrist Dosing Ranges

Botox(BTX-A)units1*

Myobloc(BTX-B)units2*


Extensor carpi radialis(longus and brevis)

4020100

1,000300012

Extensor carpi ulnaris 4020100

1,0003,00012



*Values for flexor carpi ulnaris under flexed wrist.2

Injection TechniqueExtensor carpi radialislongus

Midbelly of the muscle located at one-thirdof the distance from the lateral epicondyleto the radial styloid process and over theradius.

Extensor carpi radialis

brevis

Midbelly of the muscle located at one-fourth of the distance from the lateral

epicondyle to the radial styloid process andover the radius.

Extensor carpi ulnaris Midbelly of the muscle located at half thedistance from the lateral epicondyle tothe wrist and over the ulna.

Guidelines1,3



400600 10,00015,000


75/207

Muscles possibly involved Extended WristExtensor carpi radialis

longusExtensor carpi radialis

brevisExtensor carpi ulnaris

EXTENDED WRIST 43




Median nerve

Radial artery

Radial nerve

Cephalic vein

Radius Ulna





Extensor digitorum

Extensordigiti minimi


Extensor carpiradialis longus

Extensor carpiradialis brevis

Extensorcarpi ulnaris


76/207


Clenched Fist Dosing Ranges

Botox(BTX-A)units1*

Myobloc(BTX-B)units2*


Flexor digitorum

superficialis (per fascicle)202050

1,0003,0001

Flexor digitorumprofundus (per fascicle)

202050

1,0003,0001




Injection Technique

Flexor digitorum

superficialisMidbelly of the muscle at the midpoint fromthe biceps tendon to the wrist and mainly overthe proximal and middle ulna and interosseusmembrane. The median and ulnar nerves liesbetween the FDS and FDP.

Flexor digitorum

profundus

Midbelly of the muscle at the midpoint from

the biceps tendon to the wrist and mainly overthe ulna and interosseus membrane. A medialapproach just above the ulna and below theflexor carpi ulnaris will minimize exposure tothe ulnar nerve.

Guidelines1,2


Total maximum

body dose/visit

400600 10,00015,000


77/207

Muscles possibly involved Clenched FistFlexor digitorum superficialis


Flexordigitorumprofundus

Flexordigitorumsuperficialis




Median nerve

Radial artery

Radial nerve

Cephalic vein

Radius Ulna





Extensor digitorumExtensordigiti minimi


CLENCHED FIST 45


78/207


Thumb-in-Palm Dosing Ranges

Botox(BTX-A)units1



Flexor pollicis longus 201050

1,0002,50012

Flexor pollicis brevis/

opponens

10530

5001,5001

Adductor pollicis 10530

5002,5001

First dorsal interosseus 2.5 250500* 1



Pediatric dosing see page 61.*Dose from the task-specific dystonia chart.2

*Dose from intrinsic plus hand.1

Injection Technique

Flexor pollicislongus

Midbelly at one-third of the distance fromthe wrist to the biceps tendon over the radius.

Flexor pollicis

brevis/opponens

Midbelly at the midpoint and medial borderof the first metacarpal bone.

Adductor pollicis Midbelly over the middle of the secondmetacarpal bone.

First dorsalinterosseus

Midbelly at the midpoint of radial borderof the second metacarpal bone.

Guidelines1,2



400600 10,00015,000


79/207

THUMB-IN-PALM 47

Flexorpollicis longus

Flexorpollicis brevis

First dorsalinterosseus

Adductorpollicis

Opponenspollicis

Abductordigiti minimi

Muscles possibly involved Thumb-in-PalmFlexor pollicis longus

Flexor pollicis brevisAdductor pollicisFirst dorsal interosseusOpponens pollicis


80/207


Adducted Thumb Dosing Ranges

Botox(BTX-A)units1



Adductor pollicis 10530*

5002,500*1



*Dose for thumb-in-palm.3

Injection Technique


Guidelines1,2



400600 10,00015,000


81/207

Muscles possibly involved Adducted ThumbAdductor pollicis

ADDUCTED THUMB 49

Adductorpollicis


82/207


Intrinsic Plus Hand Dosing Ranges

Botox(BTX-A)Units



Lumbricals/interossei

10 (515)/lumbrical1

1,500 4,500/hand

1

Dorsal interosseus 2.5/muscle7.525/m.

group2*

250500/hand* 14

Lumbricals 2.5/ muscle7.520/m.group2*

1


EMG needle 27 G, 37 mmPediatric dosing see page 61.*For task-specific dystonia.

Injection Technique

Dorsal interossei/Lumbricals

Midbelly of muscles at the midpoint ofthe metacarpals.

Guidelines1,2


Total maximum body

dose/visit

400600 10,00015,000


83/207

Muscles possibly involved Intrinsic Plus HandDorsal interossei

Lumbrical

Dorsal interossei

Lumbricals

INTRINSIC PLUS HAND 51


84/207


Extended Digits Dosing Ranges

Botox(BTX-A)units1



Extensor indicisproprius

201050*

1,0002,500* 1

Extensor digitorum

communis

202050

1,0003,000 12



*Dose from flexor pollicis longus in thumb-in-palm section.3 Dose from flexor digitorum superficialis in clenched fist section.3

Injection Technique

Extensor digitorum

communis

Midbelly of the muscle at the midpoint ofthe lateral epicondyle and the wrist over theradius.


Midbelly one finger breadth of the muscle onthe radial side of the ulna one finger breadthabove the ulnar styloid process.

Guidelines2,3


Total maximum body

dose/visit

400600 10,00015,000


85/207

EXTENDED DIGITS 53

Muscles possibly involved Extended DigitsExtensor indicis

propriusExtensor digitorum

communis




Median nerve

Radial artery

Radial nerve

Cephalic vein

Radius Ulna





Extensor digitorumExtensordigiti minimi


Extensordigitorum

Extensorindices


86/207


Writers Cramp 1/3 Dosing Ranges

Botox(BTX-A)units1



Flexor digitorumprofundus

15 (1540) 2501,500 13

Flexor carpi radialis 15 (1550) 5002,500 12

Flexor digitorum

superficialis

15 (1540) 2501,500 13

Flexor carpi ulnaris 15 (1550) 5002,500 12

Pronator teres 10 (1035) 5001,500 12

Pronator quadratus 10 (1035) 5001,500 1

Flexor pollicis longus 10 (525) 1,0002,500 1



Injection Technique

Flexor

digitorumprofundus

Midbelly of the muscle at the midpoint of the biceps

tendon and the ulnar styloid process.

Flexor carpiradialis

Midbelly of the muscle at four finger breadths belowthe elbow crease. Insert one finger breadth medial tothe distal part of the biceps tendon.

Flexor

digitorum

superficialis

Midbelly of the muscle at the midpoint from the bicepstendon to the wrist and mainly over the proximal and

middle ulna and interosseus membrane. The medianand ulnar nerves lie between the FDS and FDP.

Flexor carpiulnaris

Midbelly of the muscle at one-third the distance fromthe medial epicondyle to the wrist.

Pronatorteres

Midbelly of the muscle is three finger breadths distal tothe biceps tendon and one finger breadth medially.

Pronatorquadratus

Dorsal approach between the radius and ulnar atone-quarter the distance from the ulnar styloidprocess to the insertion of the biceps tendon.

Flexorpollicis

longus

Midbelly at one-third of the distance from the wristto the biceps tendon over the radius.


87/207

Guidelines1,2

Dystonia BTX-A BTX-B StartingDose


300 10,00015,000


88/207



Botox(BTX-A)units1



Extensor digitorum 15 (1030) 5001,500 12

Extensor carpi ulnaris 10 (1040) 5001,500 12

Extensor carpi radialis 10 (1040) 5001,500 12

Extensor pollicis longus 7.5 (1515) 5001,000* 1

Extensor pollicis brevis* 2.5 (2.525)* 250500 1

Extensor indicis proprius 2.5 (2.525) 5001,000 1



*Value used as for extensor indicis.Value used as for extensor indicis.2Value used for dorsal interosseus.2

Injection Technique

Extensor digitorumcommunis

Midbelly of the muscle at the midpoint of thelateral epicondyle and the wrist over the radius.

Extensor carpi

ulnaris

Midbelly of the muscle located at half thedistance from the lateral epicondyle to theulnar styloid process and over the ulna.

Extensor carpi

radialis

Midbelly of the muscle located at one-third ofthe distance from the lateral epicondyle to theradial styloid process and over the radius.

Extensor pollicis

longus

Midbelly of the muscle at one-third to one-half the distance from the wrist to the lateralepicondyle and over the interosseus membrane.

Extensor pollicis

brevis

Midbelly of the muscle three finger breadthsabove the ulnar styloid process and on theulnar side of the radius.


Midbelly of the muscle on the radial side ofthe ulna one finger breadth above the ulnarstyloid process.

Guidelines*

Dystonia BTX-A BTX-B Starting Dose


300 10,00015,000


89/207

References

1. MDVU. MD Virtual University. We Move. BTX-A Adult Dosing Guidelines.

Management of Spasticity with Botulinum Toxin Type A

(Botox). Edition 2.0. Revised August 2005.

2. MDVU. MD Virtual University. We Move. BTX-B Adult Dosing Guidelines



Muscles possibly involved Writers Cramp 2/3Flexor digitorum profundus Extensor digitorum

Flexor carpi radialis Extensor carpi ulnarisFlexor digitorum superficialis Extensor pollicis longusFlexor carpi ulnaris Extensor pollicis brevisPronator teres Extensor indicisPronator quadratus Adductor pollicis Opponens pollicisFlexor pollicis longus Abductor digiti minimi Dorsal interosseus

Extensordigitorum

Extensor

carpi ulnarisExtensorindices

Extensor

pollicislongusExtensorpollicisbrevis

Extensor carpiradialis longus

Extensor carpiradialis brevis

WRITERS CRAMP 2/3 57


90/207



Botox(BTX-A)units1



Adductor pollicis 5 (525) 5001,500 1

Abductor digiti minimi 5 (2.525) 125250 1

Opponens pollicis 5 (535) 125250 1

Dorsal interosseus 2.5/ muscle7.525/ musclegroup

250500 1

Dilution 100 U/4 cc Dilutions, seepage xxvii


Injection Technique


Abductor digitiminimi

Midbelly at the midpoint of the fifthmetacarpal bone on the palmar side.

Opponens pollicis Midbelly of the muscle over the midpoint of

the first metacarpal bone.

Dorsal interosseus Midbelly of muscles at the midpoint of themetacarpals.

Guidelines*

Dystonia BTX-A BTX-B Starting

DoseTotal maximum bodydose/visit

300 10,00015,000


91/207

Muscles possibly involved Writers Cramp 3/3Flexor digitorum profundus Extensor digitorum

Flexor carpi radialis Extensor carpi ulnarisFlexor digitorum superficialis Extensor pollicis longusFlexor carpi ulnaris Extensor pollicis brevisPronator teres Extensor indicisPronator quadratus Adductor pollicis Opponens pollicisFlexor pollicis longus Abductor digiti minimi Dorsal interosseus

Dorsal interossei

Adductorpollicis

Opponenspollicis

Abductordigiti minimi

WRITERS CRAMP 3/3 59


92/207


Safety Information Update

At the time of this writing the U.S. Food & Drug Administration (FDA)has issued an early communication about an ongoing safety review ofbotulinum toxins type A and B. The FDA has received reports of sys-temic adverse reactions including respiratory compromise and deathfollowing the use of botulinum toxins types A and B for both FDA-approved and unapproved uses. The reactions reported are suggestiveof botulism, which occurs when botulinum toxin spreads in the bodybeyond the site where it was injected. The most serious cases had

outcomes that included hospitalization and death, and occurred mostlyin children treated for cerebral palsy-associated limb spasticity. Useof botulinum toxins for trea

Botulinum Toxin Injection Guid

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