National Collaborating Centre for Women's and Children's Health

Intrathecal baclofen
reported improved muscle tone in the upper and lower limbs at 12 and/or 24 months after starting
CITB treatment. One of the studies showed that CITB also had a positive effect on generalised
dystonia in children and young people with cerebral palsy. Some of the studies also reported
improvement in ‘individually formulated problems’, GMFM score (overall or in relation to specific motor
skills) and ease of care. Two of the studies reported that at 12 months there was a reduction of pain
or discomfort compared with baseline. Almost 90% of parents in one study stated that they would
have been prepared to agree to the procedure again, indicating a high level of satisfaction.
The GDG noted that neither of two case–control studies showed an effect of CITB on the rate of
scoliosis progression following CITB pump implantation. The group further noted that in one small
prospective case series study of hip migration after CITB pump implantation there was only a 12
month follow-up period. In this study a 5% alteration in hip migration index was reported as being
statistically significant, and the GDG questioned whether this was clinically meaningful given the
method of measurement. The GDG’s view was, therefore, that caution should be used when
considering CITB in children and young people with scoliosis.
Together, the case series described a high incidence of complications associated with the infusion
pump for CITB, including surgical complications in 59%, mechanical complications in 39% and pump
failure in 2%. The GDG noted that since the introduction of CITB treatment there have been technical
advances and refinements in surgical techniques and in pump and catheter design, such that the risks
described in the published case series included in the guideline review are unlikely to reflect current
experience. The group also noted the high level of satisfaction reported by parents, even in the
historical studies.
While recognising the limitations of the available evidence, the GDG concluded that CITB treatment
had the potential to alleviate spasticity and to produce clinically important changes. Evidence from the
RCT included in the guideline review, supported by the reports from the prospective case series,
indicated that CITB treatment could reduce muscle tone and produce clinical benefits with respect to
various clinical problems and goals.
The GDG’s experience of using CITB was also that, in properly selected patients, it could produce
important benefits.
The GDG recognised, based on the evidence and their clinical consensus, that there were potential
risks associated with the CITB treatment and these included all the general risks associated with
surgery, such as the need for general anaesthetic. However, the group concluded that the benefit that
could be derived from treatment had the potential to render these risks acceptable.
The GDG also agreed that effectiveness of CITB treatment in any child or young person could not be
assured without an appropriate form of concomitant physical therapy.
The group therefore recommended that consideration be given to using CITB treatment if, despite the
use of appropriate non-invasive treatments, spasticity or dystonia were continuing to cause difficulties
with pain or muscle spasms, posture or function, and/or self-care (or ease of care by parents or
carers).
The GDG considered CITB treatment to be a major intervention that would not be justified in the
absence of clinically important difficulties. The group noted that the strongest evidence for
improvement in quality of life was in children and young people with the most complex physical needs
(GMFCS level V). This observation, in the opinion of the GDG, was not sufficient to preclude more
functional children (GMFCS level III, IV or V) from pump implantation where clinical judgement
indicates benefits are likely to outweigh possible harms, and where ITB testing has been undertaken
and a positive response to such testing has been obtained. Therefore, based on the available
evidence and the knowledge and experience of the GDG members, the group chose to highlight in
the recommendations that children and young people who are likely to benefit from CITB treatment
are those with bilateral spasticity, typically affecting both upper and lower limbs, and moderate or
severe motor functional problems (GMFCS level III, IV or V).
The GDG agreed, based on clinical opinion, that there were circumstances in which CITB treatment
would not be appropriate and that this should be highlighted in the recommendations. The group
noted that the reduction in spasticity that CITB treatment is likely to achieve would not be helpful if the
child or young person depended on this increased tone to compensate for muscle weakness and to
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