Which interventions are useful for managing muscle spasticity in individuals who sustained traumatic brain injury? – A Cochrane Review summary with commentary

2 What is the aim of the Cochrane Review?

The aim of this Cochrane Review was to assess the effects of different interventions used for the management of skeletal muscle spasticity in after TBI.

3 What was studied in the Cochrane Review?

The population addressed in this review were people who suffered from TBI regardless the age (children and adults were included). The interventions studied were pharmacological (botulinum toxin or baclofen) and non-pharmacological interventions (splinting, casting). The interventions were compared among each other or with placebo. The primary review outcomes included spasticity as measured using the Tardieu or Modified Tardieu Scale, the Ashworth Scale or Modified Ashworth Scale as well as adverse events.

As secondary outcomes different domains of the International Classification of Functioning, Disability and Health (ICF) (Laxe et al., 2013) were included such as Sensory functions and pain, Neuromusculoskeletal and movement-related functions, general task and demands, mobility, self-care, domestic life, major life areas and community, social and civic life.

4 Search methodology and up-to-dateness of the Cochrane Review

The search for relevant studies was done using the Cochrane Injuries Group Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (Ovid), Embase (Ovid), clinical trials registries and others as well as the reference lists of included studies, the information being current to June 2017.

5 What are the main results of the Cochrane Review?

The review included nine studies which involved 134 TBI participants. Four studies did not report between group differences yielding only five studies and 105 patients with TBI. The main results of the review include the following:

The effect of baclofen on spasticity was greater than placebo at six-hour post-treatment based on one study (to be interpreted with caution). The quality of the evidence on the effect was very low due to the risk of bias limitations. Therefore, there is uncertainty about the effect of baclofen compared to placebo in terms of benefits on spasticity or on neuromusculoskeletal and movement-related functions (as measured by spasm and deep tendon reflexes).

6 What is the evidence about spasticity treatment for TBI?

The authors (Synnot et al., 2017) concluded that there is significant uncertainty about the effectiveness or harms of these interventions in the management of post-TBI spasticity due to the very low quality and limited amount of evidence of the studies. One of the main reasons of this low quality was the poor report of the results of the studies that tested the effectiveness of baclofen and tizanidine. Additionally, two studies were funded by pharmaceutical or medical technology companies. In general, most of the studies concluded that the intervention tested had beneficial effects on spasticity. In the case of casting and splinting, some secondary effects such minor skin damage was seen.

7 What are the implications of the Cochrane evidence for practice in TBI neurorehabilitation?

Spasticity is one of the main complications in patients with TBI. Regaining functioning is the main objective in rehabilitation. Functioning according to the WHO International Classification of Functioning (ICF) is understood as the balance between body functions, activities and participation. Therefore, when treating spasticity it is presumed that pain, skin status, movement disorders will improve and activities and participation will be enhanced, decreasing disability due to spasticity. Unfortunately, most of the outcomes reported by the studies in this review were limiting the effect to the interventions to the decrease of spasticity (body function of the ICF) and there were no other outcomes reported in the domains of activity and participation (such as improving the ability of doing the daily life activities, improving gait ...). The results of this review agree with the findings of other reviews which also conclude that there is a lack of high quality evidence for many modalities of treatment of spasticity (Khan, Amatya, Bensmail, & Yelnik, 2017).

Apart from the fact that this review could not conclude a benefit, antispasticity interventions are extensively used since there is a variety of evidence of their use in other conditions with spasticity i.e stroke. It is assumed that if it is effective in stroke that they will also be effective in post-TBI spasticity but this review showed that the evidence for existing interventions of managing spasticity in TBI patients is limited. Therefore there is an urgent need to develop high quality adequately powered trials in patients with TBI that include comprehensive collection and reporting of adverse event data, as well as information about activities of daily living and return to work.