1

Introduction

The following AFSSAPS’s guidelines have been produced by a working group of experts in the field of spasticity treatment. An exhaustive analysis of the literature was performed. Each article was discussed by the expert committee and then selected and classified according to the standard criteria recommended by France’s Drug Authority (AFSSAPS). The result is the fruit of the critical review of these articles and, when literature data were insufficient, the expert committee’s discussions.

Whatever its aetiology, spasticity usually has a negative impact on motricity and the locomotor system; this justifies treatment of the symptom itself (i.e. independently of the aetiological context) as a function of the patient’s neurological disorders and any links between the latter.

Treating spasticity can only be envisaged after rigorous clinical analysis, in order to determine the condition’s intensity, true consequences and distribution. This presupposes a good degree of knowledge and investigational rigour.

Evaluating the real impact of spasticity is essential. The measurement of spasticity in a patient at rest does not reflect the condition’s impact during movement.

Spasticity is subject to variations due to a number of different factors; the main one is the patient’s body position and activity because the condition predominantly affects weight-bearing muscles and thus becomes more intense in the standing position.

Only the most detailed possible analysis of the impact of spasticity in all its functional aspects enables the practitioner to decide on the appropriateness of a given treatment and to set reasonable patient objectives in terms of function, comfort, hygiene and pain relief.

Evaluation of spasticity is performed on two levels:

• •
  

  the symptom itself: hypertonia is measured on the Ashworth scale (which is most frequently used) or the Tardieu scale (which is more appropriate); the spasms are measured on the Penn scale;

  
  
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  the impact of the symptom:

  
  
  
  
  • ∘
    

    joint amplitudes, as measured by goniometry,

    
    
  • ∘
    

    pain on a visual analogue scale,

    
    
  • ∘
    

    impairment noted during nursing on scales intended for caregivers or the patient him/herself (the Disability Assessment Scale, for example),

    
    
  • ∘
    

    impairment of active movement on clinical scales (the Box and Block test, the Motor Activity Log or the Frenchay Arm Test to evaluate prehension; speed and distance tests to evaluate gait, for example) and using very useful instrumental analysis (notably kinematic analyses).

  
  

Generic personal independence scales (such as the Barthel Index and the Functional Independence Measure) are too general to enable measurement of the effects of treatments.

A list of personal objectives must be drawn up for each patient; these must be evaluable separately, after having untangled the various components of the motor disorder and having evaluated as accurately as possible their respective contributions to the functional impairment. The therapeutic strategy is based on this objective-driven approach. Not all spastic patients necessarily require treatment.

The examination must answer the following three questions:

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  is spasticity problematic and, if so, in what respects? This is the key question;

  
  
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  is spasticity the main cause of the disability or only one of the components? In the latter case, which components are involved? The likelihood of a successful treatment outcome depends on the answer to these questions;

  
  
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  is the problematic spasticity limited to one muscle group or spread more widely? Again, choosing the right treatment depends on the answer.

This clinical analysis can be usefully supported by an instrumental analysis (notably kinematic analysis) and by the application of neuromuscular blocks which enable (on a case-by-case basis) the diagnosis of muscle retraction or a movement analysis.

Moreover, treatment must also address potential aggravating causes (bed sores, urinary infection or lithiasis, etc.), with which the spasticity is sometimes tightly intermeshed; the so-called “nociceptive triggering factors increases spasticity (even in anesthetized and paralysed zones) but treatment of the latter also sometimes help to treat the nociceptive stimulus (sores, pain, etc.).

These guidelines only cover drug treatments, although the latter should generally be considered as just one component of a therapeutic programme that combines (to a varying extent) physiotherapy (which remains the basic treatment for all spastic patients), ergotherapy, the use of an orthosis and technical aids, auto-rehabilitation, orthopaedic surgery and neurosurgery.

Specialists in physical and rehabilitation medicine are at the heart of this management strategy, in collaboration with the rehabilitation team, neurosurgeons, orthopaedic surgeons, neurologists and paediatricians.

These guidelines address each drug separately and then suggest a decision tree for each type of pathology in the form of algorithms and tables which summarize the dual approach that is required (site-driven and objective-driven). The drugs mentioned in the text are presented in an Appendix.

2

Botulinum toxin type A

Botulinum toxin type A is recommended because there is established scientific evidence of its efficacy in the local reduction of spasticity after intramuscular injection ( Grade A ). It can be used as a first-line treatment of spasticity when the objective is focal or multifocal ( professional consensus ).

In adults, most of the results come from studies on stroke patients and, in children, from studies on patients with cerebral palsy. However, the use of botulinum toxin can be envisaged regardless of the pathology in question ( professional consensus ), since the indication is more symptomatic than aetiological. This is what is anticipated in the product marketing approval (PMA) granted by the French health authorities in adults, although the same approach can be adopted in children.

Botulinum toxin type B may have the same effects but there are currently too few studies to draw reliable conclusions. It is available on the market (as Neurobloc ^® ) but does not have a PMA for this indication.

2.2

Dose

The units differ, there are no international units and there is no recognised equivalence. There is no information concerning the dilution which would enable recommendation of practices other than those covered in the PMA:

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  1 ml for Botox ^® , 100 Allergan U/ml;

  
  
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  2.5 ml for Dysport ^® , 500 Speywood U/1 to 2.5 ml.

Intramuscular injection is performed, while ensuring that injection into a vessel does not occur.

The recommended total maximum dose is as follows:

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  in adults: 500 Allergan U for Botox ^® and 1,500 Speywood U for Dysport ^® ;

  
  
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  in children: 20 Allergan U/kg for Botox ^® and 30 Speywood U/kg for Dysport ^® ( professional consensus );

  
  
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  the recommended maximum dose of Botox ^® per session is higher than the ceiling dose in the PMA. However, this overshoot appears to be justified when multifocal treatment is required ( professional consensus ).

The recommended doses per muscle differ slightly from those presented in the PMA. By way of an example, three different maximum doses are suggested for three different muscle groups, according to their size ( professional consensus ).

	Botox ® Allergan	Dysport ® Speywood
	Units	Units
Large muscles, such as the triceps surae	400	1,000
Medium-sized muscles, such as the flexor carpi radialis	100	300
Small muscles, such as the interosseous muscles	20	50

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