memoranda 2005

View Archived Items 2011 2010 2009 2008 2007 2006 2005

All news


5/23/2005 12:00:00 AM

BOTOX PROTOCOL AND ARTICLE (Memo sent to Medical Directors. This information will be discussed at the June 8 meeting.)

M e m o r a n d u m

TO:                  Members, Medical Directors Council


FROM:            Deb Williams, Director of Affiliate Services


DATE:             May 23, 2005

RE:                 Botox Protocol and Article

Enclosed is an article and protocol regarding Botox from Dr. Dan Silverman.  We will be discussing the protocol at the June 8, 2005 meeting.   Please note, both of these items were previously sent via email, so you may have already received them.

If you have any questions or comments, please forward them to me at (518) 436-0178.  Thank you.


cc:  Executive Directors

Guidelines of Botulinum Toxin Therapy for Spasticity Treatment


Spasticity is pathological state that is due a velocity-dependent increase to tonic stretch. It is a result of overactivity of the reflex arc and changes that occur within the central nervous system that stems from a loss of descending inhibitory input from either the spinal cord or brain.  It may result in increased tone in both agonist and antagonist muscle groups and therefore impair functionality in the effective appendages. It may also result in contractures, chronic pain, hygienic difficulties and skin breakdowns.

“Botulinum Toxin Type A Purified Neurotoxin Complex blocks the nerve impulses that trigger muscle hyperactivity. Although the exact mechanism of action is not yet known, the neurotoxin is thought to bind to certain receptors on cholinergic terminals on nerve endings. The neurotoxin is then absorbed into the nerve ending, where it interferes with the cholinergic vesicles that release acetylcholine. This interference leads to chemodenervation and reduced muscular contractions. In 2000, the FDA approved BOTOX® for the treatment of CD in adults to decrease the severity of abnormal head position and neck pain associated with CD.” [1] t Botulinum Toxin therapy has been expanded to many non-label uses that are presently well documented and covered by CMS and other health care insurers. [2]


  • Maximize current tolerable pharmacological treatment prior to consideration Botulinum Toxin injection
  • Institute rehabilitation program prior to Botulinum Toxin injection.
  • Note that Botulinum Toxin may result in sudden and dramatic change in clinical and functional status and body image
  • Successful treatment depends upon identification of realistic goals
  • Successful treatment of spasticity with botulinum toxin depends as much on careful patient selection as it does on proper drug administration.
  • Pre-injection muscle imbalance is present with identifiable and relatively stronger spastic agonist muscle(s).
  • Antagonist muscle(s) must be:
    • sufficiently powerful for functional control if "agonists" are weakened, or...
    • capable of hypertrophy and strengthening if allowed to perform through the appropriate range of motion, or..           
    • acceptable in flaccid state.
  • Re-assessment of efficacy at one month post initial injection
    • Discontinue or alter Botulinum Toxin therapy if ineffective
  • Prior to and during the course of treatment participation of physical or occupational therapy is crucial in achieving outcome goals; and  attention should be given to appropriateness of the existing assistive device, possible pressure and/or skin breakdown from splints/braces, and balance disturbance
    • Immediate attention should be given to appropriateness of the existing assistive device, possible pressure and/or skin breakdown from splints/braces, and balance disturbance

Focal clinical patterns that may benefit from Botulinum Toxin treatment include:

    • Upper Limb
  • Thumb-in-palm
    • Adducted/internally rotated shoulder
    • Flexed elbow
    • Pronated forearm
    • Flexed wrist
    • Clenched fist
    • Intrinsic plus hand
  • Lower Limb
    • Flexed hip
    • Flexed knee
    • Adducted thighs
    • Stiff (extended) knee
    • Equinovarus foot
    • Striatal toe (Hitchhiker's great toe)

Frequency and Dosing

It is presently recommended that be Botulinum Toxin repeated every three months.  However individual response may vary and longer intervals may be possible in selected individuals.

I order to achieve the desired dennervation effects:

·        A sufficient number of units of toxin must be injected in order to neutralize neuromuscular junction (NMJ) activity.

·        An appropriate drug volume is required in order to optimize the delivery of the toxin to the NMJs.

·        Localization of the injecting needle through the fascia of the target muscle is neccessary. Localization of the injection may be facilitated by active electromyography, ultrasonography, palpation of the muscle belly, and/or use of anatomic landmarks.[3]

Exclusion Criteria:

  • No fixed joint deformity present.
  • Weakening of the spastic limb will not further compromise the residual function - including the gait.
  • Generalized spasticity (may benefit from ITB if other measures have failed)


  • During pregnancy and lactation (safety unkown)
  • In patients with pre-existing disorders of neuromuscular function: myasthenia gravis, Eaton-Lambert syndrome, or motor neuron disease
  • In patients taking aminoglycosides class of antibiotics (these drugs may enhance the effect of the toxin)


Neutralizing antibodies to Botulinum Toxin have been reported in 3-10% of treated patients. [4] The rate of antibody formation was directly proportional to the cumulative dose of toxin received.[5] There is some suggestion that Botulinun antibody production may reduce the efficacy of treatment although this is not a  consistent finding.[6]

[1] Package Insert

[2] CMS website

[3] Koman LA, Paterson Smith B, Balkrishnan R. Spasticity associated with cerebral palsy in children: guidelines for the use of botulinum A toxin. Paediatr Drugs. 2003;5(1):11-23

[4] Rollnick, JD. et. Al. “Neutralizing Botulism Toxin Type A antibodies: Clinical Observations in Patients with Cervical Dystonia. Clinical Neurology and Neurophsyiology, Vol 2001. No. 3a

[5] Göschel H et al. Botulinum A toxin therapy: Neutralizing and nonneutralizing antibodies -- therapeutic consequences. Exp Neurol 1997; 147:96-102

[6] Zuber M, Sebald M, Bathien N, de Recondo J, Rondot P. Botulinum antibodies in dystonic patients treated with type A botulinum toxin: frequency and significance. Neurology. 1993 Sep;43(9):1715-8.

Facebook Twitter DZone It! Digg It! StumbleUpon Technorati NewsVine Reddit Blinklist Add diigo bookmark